HET COLLEGE VOOR DE TOELATING VAN ......van deel A van het registratierapport. 1.4 Aflever- en...
Transcript of HET COLLEGE VOOR DE TOELATING VAN ......van deel A van het registratierapport. 1.4 Aflever- en...
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 1 of 66
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1. BESLUIT
Op 30 april 2015 is van
FMC Operational Netherlands B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
een aanvraag tot nationale toelating van een gewasbeschermingsmiddel (NL=CMS) ontvangen als
bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het
gewasbeschermingsmiddel
Benevia
op basis van de werkzame stof cyantraniliprole. Nederland is in deze een betrokken lidstaat, als
bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is het Verenigd Koninkrijk.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel
van dit besluit.
1.1 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.2 Gebruik
Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en
zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende
aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden
vermeld:
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Registration Report – Central zone Page 2 of 66
� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I.
� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel
A van het registratierapport, Appendix I.
� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de
voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2
van deel A van het registratierapport.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Niet van toepassing. Het betreft een nieuwe toelating.
2. WETTELIJKE GRONDSLAG
Besluit artikel 28 en artikel 36, derde lid, van de Verordening (EG)
1107/2009
Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009
Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal
2.0
3. BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn
bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het
middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die
vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd
gebruik.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het
werkzaam is.
Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het
Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit
beleidsregel bekendmaken delen A en B van het Registration Report.
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Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de
Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes
weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College
voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.
Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift
opengesteld.
Ede, 26 april 2018
Het College voor de toelating van
gewasbeschermingsmiddelen en biociden,
voor deze:
de voorzitter,
Ir. J.F. de Leeuw
Benevia Part A
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BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer: 20150820 NLTG
Type aanvraag: aanvraag tot nationale toelating
gewasbeschermingsmiddel (NL=CMS)
Middelnaam: Benevia
Verzenddatum aanvraag: 16 april 2015
Formele registratiedatum: * 4 juni 2015
Datum in behandeling name: 11 september 2017
Datum compliance check: n.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
Aangezien Benevia een voor Nederland nieuwe werkzame stof bevat (cyantraniliprole, zie
hieronder), is de zienswijzeprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling
toelating gewasbeschermingsmiddelen en biociden Ctgb 2007 toegepast. Er zijn geen zienswijzen
ontvangen binnen de daarvoor gestelde termijn.
2.2 Stofinformatie
Werkzame stof Gehalte
cyantraniliprole 100 g/L
• De stof is per 14 september 2016 goedgekeurd volgens Verordening (EU) 1107/2009
(Uitvoeringsverordening (EU) 2016/1414 d.d. 24 augustus 2016). De goedkeuring van deze
werkzame stof expireert op 14 september 2026.
2.3 Toelatingsinformatie
Toelatingsnummer: 15569 N
Expiratiedatum: 14 september 2027
Afgeleide parallel of origineel: Origineel
Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel
Gebruikers: Professioneel
2.4 Verpakkingsinformatie
Aard van het preparaat:
Olie dispersie
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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Benevia
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
-
Pictogram GHS07
GHS09
Signaalwoord Waarschuwing
Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.
H410 Zeer giftig voor in het water levende organismen, met langdurige
gevolgen.
Voorzorgsmaatregelen P261 Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden.
P272 Verontreinigde werkkleding mag de werkruimte niet verlaten.
P280 Beschermende handschoenen/beschermende
kleding/oogbescherming/gelaatsbescherming dragen.
P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen.
P333 + P313 Bij huidirritatie of uitslag: een arts raadplegen.
P321 Specifieke behandeling vereist (zie ... op dit etiket).
P362 + P364 Verontreinigde kleding uittrekken en wassen alvorens
deze opnieuw te gebruiken.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water
verontreinigt.
Aanvullende
etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de
menselijke gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht Nee
Voelbare gevaarsaanduiding verplicht Nee
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REGISTRATION REPORT
PART A
RISK MANAGEMENT
PRODUCT CODE: BENEVIA
OIL DISPERSION FORMULATION
ACTIVE SUBSTANCE: CYANTRANILIPROLE 100 g/L
CENTRAL ZONE
ZONAL RAPPORTEUR MEMBER STATE: UNITED KINGDOM
NATIONAL ADDENDUM – FIELD – THE NETHERLANDS
APPLICANT: FMC OPERATIONAL NETHERLANDS B.V.
DATE: FEBRUARY 2018
EVALUATOR: CTGB, NL
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TABLE OF CONTENTS
Table of Contents ........................................................................................................................................... 7
Table of Tables ......................................................................................... Fout! Bladwijzer niet gedefinieerd.
PART A – Risk Management ....................................................................................................................... 9
1 Details of the application ............................................................................................................. 9
1.1 Application background ......................................................................................................... 9
1.2 Active substance approval ...................................................................................................... 9
1.3 Regulatory approach ............................................................................................................... 9
1.4 Data protection claims ............................................................................................................ 9
1.5 Letters of access ................................................................................................................... 10
2 Details of the authorisation ....................................................................................................... 10
2.1 Product identity .................................................................................................................... 10
2.2 Classification and labelling .................................................................................................. 10
2.2.1 Classification and labelling according to CLP .............................................................. 10
2.2.2 R and S phrases under Directive 2003/82/EC (Annex IV and V)Fout! Bladwijzer niet gedefinieerd.
2.2.3 Other phrases .......................................................... Fout! Bladwijzer niet gedefinieerd.
2.3 Product Uses ......................................................................................................................... 12
3 Risk Management ...................................................................................................................... 14
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles .............................................................................................................................. 14
3.1.1 Physical and chemical properties (Part B, Section 1, Points IIIA 2.0 and
IIIA 4.0) ......................................................................................................................... 14
3.1.2 Methods of analysis (Part B, Section 2, Point IIIA 5.0) ................................................ 14 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point IIIA 5.2) ............ 14 3.1.2.2 Analytical method for residues (Part B, Section 2, Points IIIA 5.3 to
IIIA 5.8) ................................................................................................................. 17
3.1.3 Mammalian Toxicology (Part B, Section 3, Point IIIA 7.0) .......................................... 17 3.1.3.1 Acute Toxicity (Part B, Section 3, Point IIIA 7.1) ................................................. 17 3.1.3.2 Operator Exposure (Part B, Section 3, Point IIIA 7.3) ........................................... 17 3.1.3.3 Bystander and Resident Exposure (Part B, Section 3, Point IIIA 7.4) ................... 17 3.1.3.4 Worker Exposure (Part B, Section 3, Point IIIA 7.5) ............................................. 17
3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point IIIA 8.0) .......................... 18 3.1.4.1 Residues (Part B, Section 4, Points IIIA 8.3 and 8.7) ............................................ 18 3.1.4.2 Consumer exposure (Part B, Section 4, Point IIIA 8.10) ....................................... 19
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point IIIA 9.0) .......................... 19 3.1.5.1 Predicted environmental concentration in soil (PECsoil) (Part B, Section 5,
Points IIIA 9.4 and IIIA 9.5) .................................................................................. 19 3.1.5.2 Predicted environmental concentration in ground water (PECgw) (Part B,
Section 5, Point IIIA 9.6) ....................................................................................... 19 3.1.5.3 Predicted environmental concentration in surface water (PECsw) (Part B,
Section 5, Points IIIA 9.7 and IIIA 9.8) ................................................................. 21 3.1.5.4 Predicted Environmental Concentration in Air (PECair) (Part B, Section 5,
Point IIIA 9.9) ........................................................................................................ 22
3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10.0) ....................................................... 23
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3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and
IIIA 10.3) ............................................................................................................... 23 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2) ............................ 23 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA
10.4 and IIIA 10.5) ................................................................................................. 24 3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6,
Point IIIA 10.6) ...................................................................................................... 25 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6) ............ 25 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point
IIIA 10.7) ............................................................................................................... 25 3.1.6.7 Assessment of Potential for Effects on Other Non-Target Organisms (Flora
and Fauna) (Part B, Section 6, Point IIIA 10.8) ..................................................... 26
3.1.7 Efficacy (Part B, Section 7, Point IIIA 6.0)................................................................... 27
3.2 Conclusions .......................................................................................................................... 32
3.3 Substances of concern for national monitoring .................................................................... 32
3.4 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation ............................................... 32
Appendix 1 Copy of the WG ................................................................ Fout! Bladwijzer niet gedefinieerd.
Appendix 2 Data Protection Claims in the Netherlands ....................................................................... 39
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PART A – RISK MANAGEMENT
This document is a national assessment containing information specific to the Netherlands.
This document describes the acceptable use conditions required for the first authorization of Benevia containing
the new active substance cyantraniliprole in the Netherlands. The active substance cyantraniliprole was
approved under Reg. (EC) No. 1107/2009 on 14/09/2016, expiring on 14/09/2026 (Reg. (EU) 2016/1414).
Benevia (cyantraniliprole 100 g/L OD) was a representative formulation reviewed during the review for active
substance approval.
Information on the detailed composition of Benevia can be found in the confidential dossier of this submission
(Registration Report - Part C).
The risk assessment conclusions on cyantraniliprole are based on the information, data and assessments
provided in Benevia Registration Report, Part B, Sections 1-8 and Part C, and where appropriate the national
addenda prepared to address country-specific risk assessment requirements for the Netherlands. The
information, data, and assessments provided in Benevia Registration Report, Part B, Sections 1-8 include
assessment of further data that has not been considered in the EU review. Otherwise, assessments for the safe
use of Benevia have been made using the EFSA Conclusion on the peer review of the pesticide risk assessment
of the active substance cyantraniliprole as published in the EFSA Journal 2014, 12 (9):3814.
1 DETAILS OF THE APPLICATION
1.1 Application background
The Registration Report is being submitted to support the first approval of Benevia containing the new active
substance cyantraniliprole. The active substance cyantraniliprole was approved under Reg. (EC) No. 1107/2009
on 14/09/2016, expiring on 14/09/2026 (Reg. (EU) 2016/1414).
The United Kingdom acted as Rapporteur for the Central Zone. All other countries in the Central Zone,
including the Netherlands, were concerned Member States.
1.2 Active substance approval
The active substance cyantraniliprole was approved under Reg. (EC) No. 1107/2009 on 14/09/2016, expiring on
14/09/2026 (Reg. (EU) 2016/1414).
Benevia was a representative formulation reviewed during the review for active substance approval. The United
Kingdom acted as the Rapporteur Member State and France as the Co-RMS.
1.3 Regulatory approach
This Benevia application was based on the agreed endpoints in the RR. The assessments are prepared per the
Uniform Principles, using RR agreed end-points.
1.4 Data protection claims
FMC Operational Netherlands B.V. claims protection of data on the active substance and the plant protection
product supporting the application for the authorisation of Benevia per the provisions set in Articles 33.4, 59 and
(where applicable) 80.2.
Studies for which data protection is claimed are identified in the list of data submitted in support of the
evaluation in Appendix 1 of each Part B Section of the Core assessment and in Appendix 2 of this country
specific Part A document.
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Appendix 2 of this document contains data protection claims for the Netherlands.
1.5 Letters of access
The data on cyantraniliprole and Benevia are owned by FMC, no LoA is required.
2 DETAILS OF THE AUTHORISATION
2.1 Product identity
Product Name Benevia (Cyantraniliprole 100 g/L OD)
Authorisation Number (for re-registration) n/a
Function Insecticide
Applicant FMC Operational Netherlands B.V.
Composition 100 g/L of cyantraniliprole
Formulation type Oil Dispersion - OD
Packaging 50-5000 mL COEX-HDPE/EVOH (High Density Polyethylene
co-extruded with ethylene vinyl alcohol copolymer) bottles
2.2 Classification and labelling
2.2.1 Classification and labelling according to CLP
The following is proposed in accordance with Regulation (EU) 1272/2008:
The identity of all substances in the mixture that contribute to the classification of the mixture *:
-
Pictogram: GHS07 Signal word: Warning
GHS09
H-statements: H317 May cause an allergic skin reaction.
H410 Very toxic to aquatic life with long lasting effects.
P-statements: P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P272 Contaminated work clothing should not be allowed out
of the workplace.
P280 Wear protective gloves/protective clothing/eye
protection/face protection.
P302+P352 IF ON SKIN: Wash with plenty of water/...
P333+P313 If skin irritation or rash occurs: Get medical
advice/attention.
P321 Specific treatment (see … on this label).
P362+P364 Take off contaminated clothing and wash it before
reuse.
P391 Collect spillage.
P501 Dispose of contents/container to ....
Supplemental Hazard
information:
EUH401 To avoid risks to human health and the environment,
comply with the instructions for use.
SP1 Do not contaminate water with the product or its
container.
Child-resistant fastening obligatory? not applicable
Tactile warning of danger obligatory? not applicable
Explanation:
Pictogram: -
H-statements: -
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P-statements: -
Other: -
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
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2.3 Authorised uses
1 2 3 4 5 6 7 8 10 11 12 13 14
Use-No.
Member state(s)
Crop and/ or situation
F G or I
Pests or Group of pests controlled
Application Application rate per treatment
PHI (days)
Remarks:
a) max. no. of applications per crop and season
b) Maximum product rate per season
c) additional remarks
Method / Kind
Timing / Growth stage of crop & season
Number / (min. Interval between applications)
kg, L product / ha
g, kg as/ha
Water L/ha min / max
1 NL Potato F Coleoptera: Leptinotarsa decemlineata
hydraulic ground directed boom
BBCH 12-70
(May-Aug)
2 (7 days) 0.125 L/ha
12.5 g/ha
300-600 14 a) 2
b) 0.25 L/ha
c) None
3 NL
Cauliflower Broccoli Head Cabbage Brussels sprout
F Lepidoptera Pieris spp. Mamestra brassica Evergestis forficalis Clepsis spectrana Plutella xylostella
hydraulic ground directed boom
BBCH 12-49
(Mar-Nov)
2 (7 days)
0.5 L/ha 50 g/ha 300-800
7 a) 2
b) 1 L/ha
c) None
4 Whitefly Aleyrodes proletella
0.75 L/ha
75 g/ha a) 2
b) 1.5 L/ha
c) For improved performance on whitefly use with the addition of a suitable oil adjuvant
5 NL Carrots, parsnips, celeriac, hamburg root parsley (turnip-rooted parsley), skirret
F Diptera Chamaepsila rosae
hydraulic ground directed boom
BBCH 11-89
(Mar-Nov)
2 (10 days) 0.75 L/ha
75 g/ha 300-1000 14 a) 2
b) 1.5 L/ha
c) None
6 NL Bulb vegetables (Onion, Shallots, Garlic) and Stem vegetables (Leek,
F Thrips Thrips tabaci Frankliniella occidentalis
hydraulic ground directed boom
BBCH 12-80
(April-Oct)
2 (7 days) 0.75 L/ha
75 g/ha 200-800 14 a) 2
b) 1.5 L/ha
c) For improved performance on sucking pests use with
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spring onion) the addition of a suitable oil adjuvant.
Minor uses according to article 51
7 NL Swede, red beet, celeriac, black salsify
F Lepidoptera Mamestra brassica Pieris spp.
hydraulic ground directed boom
BBCH 11-89
(Mar-Nov)
2 (10 days) 0.5 L/ha 50 g/ha 300-1000 14 a) 2
b) 1.0 L/ha
c) None
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3 RISK MANAGEMENT
3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles
3.1.1 Physical and chemical properties (Part B, Section 1, Points IIIA 2.0 and IIIA 4.0)
Benevia was one of the representative products in the DAR (then named Cyantraniliprole 100 g/L OD).
Consequently, the majority of the data summarised has been reproduced from the DAR, where they were
evaluated during the EU review.
Safety: Benevia is non-flammable, non-explosive, and not an oxidizer. The auto-ignition temperature was
determined to be 254°C, and therefore considered to be not self-igniting. The pH of a 1% concentration of the
preparation in water was between 4.9-5.1 pH units. The kinematic viscosity at 40°C is not provided, however
the content H304 classified components is <10%. The surface tension indicates that the formulation is surface
active and the relative density is 0.978 at 20°C.
Performance: Benevia has an off white colour with a mild oily characteristic odour.. The physical and chemical
properties of the preparation were measured using CIPAC Methods, when available. All physical and chemical
properties specifications, as defined by “The 3Manual on the Development and Use of FAO/WHO
Specifications for Plant Protection Products,” were met both prior to and after completion of high, ambient and
low temperature storage. The preparation was stored at a temperature of 54°C for a period of 2 weeks and at 0°C
for a period of one week and 3 years at ambient temperature in PET and coex-HDPE/EVOH, as required by the
relevant test methods. Based on the results of the accelerated storage test, a low temperature storage test, and a
three-year shelf-life storage stability at ambient temperature test it can reasonably be assumed that Benevia will
be stable under expected storage conditions in the Netherlands for 2 years in coex-HDPE/EVOH packaging.
The technical properties are acceptabl for an OD-formulation.
Implications for labelling: None
Compliance with FAO specifications: The product complies with FAO specifications.
Tank mixtures: Cyantraniliprole was tested with various potential tank mix partners in two-way combinations.
Method(s) and results are presented in the Benevia Registration Report, Part B, Section 7, DuPont-35950 CEU.
Tank mixes could therefore be mentioned on the product label for Benevia, however no specific tank mix
recommendations are included in the product label.
Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of
opening, type of closure, strength, leak proofness, resistance to normal transport and handling, resistance to and
compatibility with the contents of the packaging, have been submitted, evaluated, and is considered to be
acceptable.
Nature and characteristics of the protective clothing and equipment: Boots, gloves and coveralls are
required during preparation of the spray liquid.
3.1.2 Methods of analysis (Part B, Section 2, Point IIIA 5.0)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point IIIA 5.2)
Benevia was a representative formulation in the EU review of cyantraniliprole. Analytical methods for
determination of cyantraniliprole in Benevia were evaluated as part of the EU review of Benevia. All data are
considered adequately validated according to SANCO/3030/99 rev. 4.
The impurities IN-Q6S09, IN-RYA13, methanesulfonic acid, acetonitrile, heptane and 3-picoline were
considered relevant in the technical material (EFSA Conclusion (EFSA Journal 2014, 12 (9):3814)). Analytical
methods for these relevant impurities except methanesulfonic acid are considered adequately validated
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according to SANCO/3030/99 rev. 4. For impurity methanesulfonic acid attempts were made to develop a
method for methanesulfonic acid employing a common technique: ion chromatography with detection by
conductivity. However, numerous interferences from formulation ingredients were detected, which precluded
the accurate quantitation of methanesulfonic acid. An alternative approach employing ion chromatography with
detection by mass spectrometry has been developed and has been provided. This study has not been evaluated
by the zRMS and is therefore summarized below (KIIIA1 5.2.4/04).
There are no existing CIPAC methods for cyantraniliprole in OD-formulations.
Report: KIIIA1 5.2.4/04, Robson, D. 2017
Title: DESCRIPTION AND VALIDATION OF THE ANALYTICAL METHODS FOR
DETERMINATION OF METHANESULFONIC ACID IN CYANTRANILIPROLE (DPX-
HGW86) END-USE PRODUCTS
This study was conducted to provide analytical data for the validation of the analytical method
for determination of methanesulfonic acid in cyantraniliprole (DPX-HGW86) end-use
products. This includes data for specificity, linearity, limits of detection/quantitation, accuracy,
precision, and confirmation of identity.
Document No: DuPont-46998
Guidelines: Guidance document SANCO/3030/99 rev.
GLP Yes (certified laboratory)
Principle of the method Methanesulfonic acis is ultrasonically extracted from a weighed sample of 100 OD
cyantraniliprole (DPX-HGW86) and analyzed by ion chromatography (IC) using
mass spectrometry detection (m/z/ 95.1) with an IonPac AS 19 column. External
standard technique is used for method calibration. The applicable concentration
range for methanesulfonic acid is 0.0001-0.009 mg/mL (0.001-0.09% for a 2
mg/mL (100 OD) sample solution concentration).
Precision data
methanesulfonic acid Injection
number
Concentration
(mg/mL)
Average
peak
area
Weight
(%)
Average
weight
(%)
RSD
(Modified
Horwitz)
(%)
1 1.99 1979.3 0.00733
0.00700 5.07
(5.66)
2 1.86 1837.9 0.00708
3 2.09 1990.1 0.00703
4 2.37 2172.2 0.00695
5 2.47 2115.9 0.00646
6 2.13 1911.8 0.00652
7 2.51 2386.0 0.00742
8 2.35 2225.7 0.00724
Accuracy data methane
sulfonic acid Spike (batch
DPX-
HGW86)
Sample
prep
(mg/mL)
Spiked in
technical
(mg/mL)
Native in
sample
(mg/mL)
Average
(n=2)
(mg/mL)
Recovery
(%)
(between
75-120%)
Low 1 (750) 2.45 0.0016023 0.000804 0.0024225 101.04
Low 2 (750) 2.79 0.0016023 0.000915 0.0024455 95.51
High 1 (750) 2.86 0.0128180 0.000938 0.0136195 98.94
High 2 (750) 2.425 0.0128180 0.000795 0.0134977 99.10
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Low 1 (797) 10.125 0.0016023 0.001418 0.0028883 91.80
Low 2 (797) 9.635 0.0016023 0.001349 0.0028218 91.93
High 1 (797) 9.805 0.0128180 0.001379 0.0136821 96.03
High 2 (797) 9.920 0.0128180 0.001389 0.0136031 95.29
Low 1 (802) 2.63 0.0002272 0.000299 0.0004936 85.50
Low 2 (802) 2.31 0.0002272 0.000263 0.0004873 98.75
High 1 (802) 2.44 0.0045445 0.000278 0.0040930 83.96
High 2 (802) 2.305 0.0045445 0.000262 0.0040160 82.60
Low 1 (812) 1.895 0.0002272 0.000133 0.0003996 117.50
Low 2 (812) 2.2 0.0002272 0.000154 0.0003950 106.05
High 1 (812) 1.95 0.0045445 0.000137 0.0041630 88.60
High 2 (812) 2.48 0.0045445 0.000174 0.0044023 93.05
Linearity 8 levels in duplicate between 0.000114 and 0.009089 mg/mL in standards in
solvent (corresponding to 0.0006 – 0.05%).
Y95.1=1.0e+007X+524.03 (r=0.9988)
Specificity The specificity was established by demonstrating the purity of the IC peaks of
interest versus potential interferences. Solutions of each component were prepared
using standard materials, and injected in duplicate. Chromatograms were examined
to determine if there was complete separation between known impurity and
formulation peaks and the Methanesulfonic Acid peak being measured by the
method. No interferences were found in the end use product material. The
methanesulfonic acid exists in the formulation ingredients thus it is also present in
the formulation blank.
Confirmation:
Confirmation of impurity identities is accomplished utilizing two techniques: First,
the chromatographic peak retention time, generated from Manufacturer-
characterized analytical standard, is compared to the peak retention time for
methanesulfonic acid in DPX-HGW86 end-use products. Second, IC/MS spectral
data are generated for the impurity analytical standard chromatographic peaks. The
spectra are compared with the associated chromatographic peaks for a sample
solution. For non-detectable impurity components in the sample solution, a fortified
sample solution is analyzed.
A solution of methanesulfonic acid and DPX-HGW86 formulated material were
prepared as specified in the Analytical Method section of this report. IC/MS
spectral data for methanesulfonic acid in DPX-HGW86 were generated utilizing a
Dionex 2000 ICS with a Dionex MSQ and Chromeleon software. Typical
chromatograms are provided in the report.
Limit of Quantification
and Limit of detection Component
Actual
amount
(mg/mL)
Amount
found
(mg/mL)
Recovery
(%)
RSD (n=7)
(Modified
Horwitz)
(%)
Methanesulfonic
acid (100 OD
formulation
concentration is
2 mg/mL)
0.000114
(equivalent
to 0.0006%
w/w in 100
OD
formulation)
0.000126 110.82
5.61
(10.26)
0.000133 116.87
0.000124 117.67
0.000147 129.26
0.000138 121.07
0.000134 117.42
0.000125 109.45
A solution of methanesulfonic acid was prepared at the concentration equivalent to
the targeted limit of quantitation. A minimum of six injections are made. The mean
recovery, standard deviation and relative standard deviation (RSD) are calculated.
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The RSD is compared to the Horwitz limit for acceptability. The limit of detection
is calculated from the limit of quantitation. The LOQ is established at 0.0006 %
w/w and the LOD is calculated at 0.002% w/w.
Matrix-effect Not provided.
Extract and standard
stability
The standard and sample solutions are stable for 48 hours.
Conclusion RMS The analytical method is fully validated in terms of specificity, linearity, accuracy
and repeatability for the determination of the relevant impurity methanesulfonic
acid in the formulation Benevia with an LOQ of 0.0006%.
3.1.2.2 Analytical method for residues (Part B, Section 2, Points IIIA 5.3 to IIIA 5.8)
All analytical monitorings/enforcement methods for plant and animal matrices and the environmental matrices
soil, water and air have been developed and are active substance data and were provided in the EU review of
cyantraniliprole and were considered adequate.
The analytical method for the determination of cyantraniliprole residues in surface water is compliant with
Dutch national requirements (LOQ ≤ 0.1 µg/L for cyantraniliprole).
3.1.3 Mammalian Toxicology (Part B, Section 3, Point IIIA 7.0)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point IIIA 7.1)
Benevia was a representative formulation in the EU review of cyantraniliprole. The acute toxicity studies for
Benevia were evaluated during the review and were considered adequate.
Benevia has low acute toxicity and is not irritating to eyes or skin. Benevia may cause allergic skin reactions.
Benevia is classified as a skin sensitiser (GHS07) with the hazard statement H317.
3.1.3.2 Operator Exposure (Part B, Section 3, Point IIIA 7.3)
Benevia was a representative formulation in the EU review of cyantraniliprole. The intended use pattern is
within the use pattern considered for EU review. Operator risk assessments of Benevia for all uses show no
operator risk without PPE and default values using the German and UK POEM models.
3.1.3.3 Bystander and Resident Exposure (Part B, Section 3, Point IIIA 7.4)
In the original evaluation, the risk assessment for bystanders and residents was performed with the UK model.
For the Netherlands, a calculation with the DE model is also required. Based on the risk assessment using both
the UK model and the DE model, it is concluded that there is no undue risk to any bystander or resident after
accidental short-term exposure to Benevia.
3.1.3.4 Worker Exposure (Part B, Section 3, Point IIIA 7.5)
Worker exposure to cyantraniliprole resulting from contact from foliage treated with Benevia during hand
harvesting activities has been calculated using the EUROPOEM II re-entry model. The systemic exposure to
individuals undertaking hand harvesting activities is estimated to be equivalent to 3% of the systemic AOEL for
cyantraniliprole. This value is within acceptable limits and no further assessment is required.
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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point IIIA 8.0)
3.1.4.1 Residues (Part B, Section 4, Points IIIA 8.3 and 8.7)
Benevia is an OD formulation containing 100 g/L cyantraniliprole for use as an insecticide on a wide variety of
arable and vegetable field crops. Plant and animal metabolism data for cyantraniliprole was submitted and
evaluated in the EU DAR.
The intended use of the product within this application is on potato, cauliflower, broccoli, head cabbage,
Brussels sprout, carrots, parsnips, celeriac, hamburg root parsley (turnip-rooted parsley), skirret and swede, red
beet, celeriac, black salsify.
The proposed use of cyantraniliprole on potato is within the uses considered in the cyantraniliprole DAR. For
the other uses, new residues trials data has been submitted and evaluated in Part B section 4 (zRMS UK). The
trials are sufficient to support the proposed GAPs in each case. Results of the residue trials showed that the
current EU MRLs for the crops under consideration will not be exceeded if the product is used according to the
intended GAPs with the exception of leek where an MRL of 0.8 mg/kg is calculated on the basis of the data
(0.011, 0.012, 0.061, 0.09, 0.11, 0.24, 0.32, 0.38 mg/kg). The current MRL for cyantraniliprole in leek is 0.01*
mg/kg. The use on leek cannot be supported unless the MRL is raised.
Rotational crops data has been considered previously in the EU DAR. The rotational crop trials considered in
the cyantraniliprole DAR indicated that residues of cyantraniliprole above the LOQ are not expected in
rotational crops at a single seasonal application rate (1 x 450 ai/ha to soil before planting of wheat, beetroot and
lettuce). However, the DT90 in soil were estimated to be in the range of 4 to 9 years for several metabolites.
Accordingly, since accumulation of several very persistent metabolites is expected following multiple years of
consecutive applications, EFSA is of the opinion that the submitted trials conducted with a single seasonal
application rate are not fully appropriate to address the transfer of cyantraniliprole residues in rotational crops.
Additional data was required to address the possible transfer of persistent soil metabolites in rotational crops.
following multiple years of consecutive applications (EFSA Journal 2014; 12(9):3814).
In the DAR for cyantraniliprole, accumulated PECsoil values were calculated for four critical GAPs and the
confined and field rotational crop studies. The accumulated PECsoil values indicate that metabolites would be
present in the soil at the time of planting at levels >0.01 mg/kg. However, based on the results of the rotational
crop metabolism study, it appears that these metabolites are not taken up by the plant, as very low levels of
metabolites (<0.005 mg/kg) were observed even at the first plant back interval. Levels of metabolites in food
commodities decreased further at the longer plant back intervals. A similar trend was observed in feed
commodities (wheat straw, hay and forage) (<0.08 mg/kg in crops planted after 365 days). In agreement with
the analysis of zRMS UK, accumulated PECsoil levels which correspond to the proposed GAP, are lower than
the PECsoil for the metabolites expected after the confined rotational crop study. Accumulated PECsoil levels
which correspond to the proposed GAP (and take into account seven annual treatments at that GAP leading to a
plateau level), are at most two thirds of the PECsoil for the metabolites expected after the confined rotational
crop study. Therefore it is considered that residues in food and feed commodities will be lower in commodities
treated at the GAP. On the basis of this outcome in order to mitigate the risk of metabolites with undetermined
toxicological relevance being present in food commodities, the zRMS proposed restricting application in
accordance with the GAP to a maximum of once per year and to state that no other cyantraniliprole containing
products must be applied in the same year. Therefore the following restriction is included on the WG: “Om
residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te
voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift.
Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals
op hetzelfde perceel worden toegepast.”
Sufficient processing data was available in the EU DAR to support the proposed uses except for the pickling of
cabbage. New data was submitted to support this processing procedure. As there is different residue definition
for processed plant commodities and the RAC is in place, the residue levels in the processed commodities were
considered in the risk assessment. The worst case STMR (accounting for the highest conversion factor and
processing factor and assuming that all of the commodity is consumed) lead to an estimate which did not exceed
the ADI, and hence further consideration of consumption patterns was not required.
Consideration of livestock intakes from produce treated at the proposed GAP indicates that no further
consideration of likely residues in animal commodities is required.
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3.1.4.2 Consumer exposure (Part B, Section 4, Point IIIA 8.10)
Chronic intakes for all consumer groups are below the ADI of 0.01 mg/kg for cyantraniliprole therefore no
health effects are expected. With the current EFSA model the chronic risk assessment ranges from 11.0 to
70.1% of ADI. The diet with the highest TMDI is “WHO Cluster Diet B”. For this diet, the highest contributor
is tomatoes with 13.0% of ADI. The second diet with the highest TMDI is “NL Child” with 69.5% of ADI
where spinach is the major contributor with 17.9% of ADI. An assessment of acute dietary intake (NESTI) has
not been made as cyantraniliprole is not acutely toxic and an ARfD has not been allocated.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point IIIA 9.0)
Predicted environmental concentrations in soil are revised according to the EFSA Conclusion.
3.1.5.1 Predicted environmental concentration in soil (PECsoil) (Part B, Section 5, Points IIIA 9.4
and IIIA 9.5)
Predicted environmental concentrations in soil (PECsoil) for cyantraniliprole, its soil metabolites IN-JCZ38,
IN-JSE76, IN-K5A79, IN-PLT97, IN-J9Z38, IN-K5A77, IN-K5A78, and IN-M2G98 and photo-degradation
products IN-QKV54 and IN-RNU71 were assessed following the long-term application of Benevia formulation
in the field, assuming that the product is used at the maximum single use rate of 200 g a.s./ha (i.e., 2 × 100
g a.s./ha), with 0% foliar interception. The application rate of 2 × 100 g a.s./ha is protective of use of Benevia
formulation on all the crops. The Benevia formulation is intended for use in potatoes, strawberry, cauliflower,
broccoli, head cabbage, Brussels sprouts, carrot, wild parsnip, celeriac, turnip-rooted parsley, head and
flowering brassica, bulb vegetables (onions, shallots, garlic), stem vegetables (leek, spring onion) and root and
tuber vegetables.
Input parameters recommended in the EFSA conclusion (EFSA, 2014) were used in PECsoil calculation for both
cyantraniliprole and metabolites. The maximum plateau and time-weighted average (TWA) concentrations of
PECsoil were calculated using the method based on the recommendations of FOCUS (1996) and on the Guidance
Document on Persistence of Soil (EU Commission, 2000) and recommended in the revised Cyantraniliprole
Draft Assessment Report Volume 3, B8, June 2014.
The PECsoil of cyantraniliprole after multiple years of application was calculated by summing up contributions
of previous years of application at time t. The maximum PECsoil over a period of 20 years was selected as a
plateau concentration. The actual and time weighted average PECsoil after the peak concentration was calculated
and reported in support of ecotoxicological assessment. The same method was also used to calculate the actual
and time weighted average PECsoil for metabolites. However, the application rate of metabolites is calculated by
multiplying the parent application rate by the maximum percentage of metabolite observed in soil degradation
study, the molecular weight ratio of metabolite to parent, and then the ratio of plateau PECsoil to initial PECsoil of
cyantraniliprole (revised Cyantraniliprole Draft Assessment Report Volume 3, B8, June 2014).
The overall maximum PECsoil of cyantraniliprole after application with Benevia formulation is predicted to be
0.299 mg a.s./kg soil. The maximum PECsoil values for IN-JCZ38, IN-JSE76, IN-J9Z38, IN-K5A77, IN-K5A78,
IN-K5A79, IN-M2G98, IN-PLT97, IN-QKV54, and IN-RNU71 from either calculation method are 0.143,
0.273, 0.619, 0.062, 0.377, 0.033, 0.009, 0.253, 0.134, and 0.091 mg/kg soil, respectively.
The results indicate that neither cyantraniliprole nor its metabolites will accumulate in soils after the long-term
application on target crops.
The results for PECsoil for the active substance and its metabolites were used for the ecotoxicological risk
assessment.
3.1.5.2 Predicted environmental concentration in ground water (PECgw) (Part B, Section 5,
Point IIIA 9.6)
The leaching behaviour of cyantraniliprole and its metabolites IN-JCZ38, IN-J9Z38, IN-JSE76, IN-K5A77,
IN-K5A78, IN-K5A79, IN-PLT97, IN-M2G98, IN-RNU71, IN-NXX70, and IN-QKV54 was assessed multiple
application dates to cover the uses at a wide range of BBCH stages such as BBCH 12-89. Therefore, the
simulations for cyantraniliprole and its soil metabolites were conducted with the Tier 1 endpoints from the
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EFSA conclusion (EFSA, 2014a). In addition, simulations were also conducted with the degradation endpoints
of metabolites as derived from pathway kinetic analyses for ten field dissipation studies. For photo-degradation
products, the simulations under different application dates were conducted using the Tier 2 modeling endpoints
only, which was agreed by Ctgb (2017).
The leaching behaviour assessment was carried out in compliance with the Dutch decision tree for the
evaluation of pesticide leaching (Cornelese and Pol, 2010; van der Linden et al., 2004). Thus, the ground water
simulations were conducted following a tiered approach using the leaching model GeoPEARL 3.3.3, in
compliance with the Dutch decision tree for the evaluation of pesticide leaching. A plant uptake factor of 0.5 for
cyantraniliprole and 0.0 for metabolites was used in the simulation. A Q10 of 2.58 was used. The foliar
interception rate from the FOCUS guidance (FOCUS, 2011) was applied based on the BBCH stages of crops but
they are either the same as or even more conservative than those recommended in the EFSA guidance (2014b).
Since lettuce, cauliflower, broccoli, head cabbage, and Brussels sprout crops are not available in the GeoPEARL
crop groups, cabbage is used as a representative surrogate crop in the modeling. Similarly, onion is used as
surrogate representative crop for bulb vegetables, shallots, garlic, and leeks, and the sugar beet is used as
surrogate representative crop for carrots, root and tuber vegetables.
Tier 1 and Tier 2 PECgw of cyantraniliprole and its soil metabolites:
At Tier 1, the modeling endpoints recommended in the revised Draft Assessment Report for cyantraniliprole
(UK CRD, 2014) and accepted in the EFSA conclusion (EFSA, 2014a) were used. The degradation of
cyantraniliprole in soils under laboratory conditions displays a significant pH dependency (r2 = 0.99), with a
regression equation of DT50 = -21.174 pH + 185.83. Therefore, “calculated” half-life option was selected in
GeoPEARL to use the regression equation. The longest DegT50 of 87.0 days measured at pH 4.6 and shortest
DegT50 of 13.3 days for cyantraniliprole measured at pH 7.9 was used as maximum and minimum limit in the
model. In addition, the arithmetic mean KFOC of 26 L/kg for IN-K5A79 in soils of pH > 6.5 was also used due
to pH dependency of adsorption.
At Tier 2, for the parent compound, as recommended in the revised DAR (UK CRD, 2014), the laboratory
degradation DT50 and FOCUS field DT50 (calculated from field dissipation studies following the FOCUS
guidance (2006)) were pooled together and examined for its pH dependency. As pH dependency is significant,
the geomean DT50 of 52.2 days for the combined lab and field DT50 at pH < 7.0 was used to assess leaching
risk of cyantraniliprole. The PECgw of metabolites with the Tier 2 field endpoints under multiple application
dates are not calculated.
Tier 2 PECgw of photo-degradation products
The photodegradation products of cyantraniliprole were also simulated using a tiered approach, as requested by
RMS - UK CRD (UK CRD, 2014) in the original report – DuPont-37848 NL., Tier 1 and Tier 2 modeling
endpoints of photo-degradation endpoints are accepted for modeling. Thus, only the Tier 2 simulation was
conducted at the early, middle, and late application dates.
The Tier 2 simulation was conducted with the formation fractions (0.05 for both transformation routes) based
on the upper limit of total photodegradation products observed in the field dissipation studies.
Tier 1 and Tier 2 simulation using EFSA approved endpoint at early, middle, and late application dates
At Tier 1, the 90th percentile PECgw of cyantraniliprole was below 0.01 μg/L for cabbage, onion, and potatoes
at all the application dates. For strawberries at early, middle, and late application dates and for carrots at early
application date, the 90th percentile PECgw of cyantraniliprole is above 0.01 μg/L but below 0.1 μg/L (Table 1).
The 90th percentile PECgw of metabolites IN-JCZ38, IN-J9Z38, and IN-K5A77 was predicted to be <0.001
μg/L for all crops at all application dates.
The 90th percentile PECgw of metabolites IN-K5A78 and IN-PLT97 is < 0.1 μg/L for potatoes at all application
dates, but > 0.1 μg/L and < 0.75 μg/L for all other crops at all application dates or at least one application date
(carrots).
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The 90th percentile PECgw of the metabolites IN-JSE76 and IN-K5A79, and IN-M2G98 are > 0.75 μg/L for
some crops at certain application dates but <10 μg/L for all crops at all application dates.
At Tier 2, the 90th percentile PECgw of cyantraniliprole as predicted with DegT50 of 52.2 days for
cyantraniliprole was below 0.01 μg/L for carrots, strawberries, and potato, while, it slightly exceeded 0.01 μg/L
for onion at the early, middle, and late application dates and cabbage at the early application date.
Since the degradation of cyantraniliprole is pH dependent, it is recommended that the Tier 1 PECgw to be used
in leaching risk assessment.
Tier 2 simulation for photo degradation products
The Tier 2 90th percentile PECgw of photodegradation products of cyantraniliprole and its metabolites were
predicted to be less than 0.01 μg/L for all crops at all application dates, except for the metabolite IN-RNU71.
For IN-RNU71, the 90th percentile PECgw of metabolite IN-RNU71 are < 0.01 μg/L for potatoes at all
application dates, and > 0.01 μg/L but < 0.1 μg/L for all other crops.
Metabolites IN-JSE76 and IN-PLT97 have been proven to not be toxicologically relevant. For metabolite IN-
K5A79 a non-relevance package has been submitted accepted. Metabolite K5A79 is therefore judged to be not
toxicologically relevant.
Refined modelling for metabolite IN-M2G98
A refined PECgw modelling for metabolite IN-M2G98 was provided. The results clearly indicated that IN-
M2G98 is not likely to pose leaching risk to ground water in the Netherlands, given the restriction for use in
drinking water protection areas stated below.
In conclusion, the results with multiple application dates in this study indicate that the OD formulation of
cyantraniliprole does not pose ground water leaching risk if the product is applied in the Netherlands according
to the label instructions. However, for all uses with the exception of potatoes it should be indicated on the label
of the product that application in groundwater protection areas is prohibited (as stated in the Netherlands CTGB
Evaluation Manual) due to the metabolite IN-RNU71.
This results in the following restriction sentence placed on the WG: “Om het grondwater te beschermen mag dit
product in de teelt van sluitkoolachtigen, bloemkoolachtigen, wortelgewassen, knolselderij, ui-achtigen, prei,
koolraap, rode biet, knolselderij en schorseneer niet worden gebruikt in grondwater beschermingsgebieden.”
3.1.5.3 Predicted environmental concentration in surface water (PECsw) (Part B, Section 5,
Points IIIA 9.7 and IIIA 9.8)
Predicted environmental concentrations in surface water (PECsw) and sediment (PECsed) were calculated for
cyantraniliprole and its major water and sediment metabolites in order to support Benevia authorization in the
Netherlands. All major aquatic metabolites (IN-J9Z38, IN-K5A77) and the photo-degradation metabolites (IN
QKV54, IN-RNU71 and IN-NXX70) of cyantraniliprole were included in the assessment using the endpoints
recommended in the revised Cyantraniliprole DAR Volume 3, B8, June 2014 and in the EFSA conclusion on
cyantraniliprole (EFSA, 2014Fout! Bladwijzer niet gedefinieerd.).
The PECsw PECsed calculations for the Dutch standard edge-of-field ditch were carried out using the assessment
tool TOXSWA v.1.2 (Beltman and Adriaanse, 19991) following guidance from the Ctgb Evaluation Manual
(Ctgb, 2014Fout! Bladwijzer niet gedefinieerd.). The assessment of surface water destined for drinking water production
was performed according to the NL guidance (Ctgb, 2014Fout! Bladwijzer niet gedefinieerd.). The PECTier1 at the
abstraction points and polder Bommelerwaard were calculated by the DROPLET model v. 1.1 (Van Leerdam et
1 Beltman, W. H. J. and Adriaanse, P. I. (1999): User's manual TOXSWA 1.2; simulation of pesticide fate in small surface waters. Technical
Document 54. DLO Winand Staring Centre Wageningen, The Netherlands.
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al., 20102). The calculations were performed for the Ctgb standard spring and autumn scenarios considering
standard drift rates of 1 % for vegetables (bulb, leafy, and root) and potatoes.
The overall maximum predicted environmental concentrations of cyantraniliprole in surface water calculated for
the use in vegetables (bulb and leafy) considering drift rates of 1% were calculated to be 0.682 µg/L for the
spring applications in the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.0176 mg/kg.
The overall maximum predicted environmental concentrations of cyantraniliprole in surface water calculated for
the use in vegetables (root) considering drift rates of 1% were calculated to be 0.675 µg/L for the spring
applications in the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.0175 mg/kg.
The overall maximum predicted environmental concentrations of cyantraniliprole in surface water calculated for
the use in potatoes considering drift rates of 1% were calculated to be 0.113 µg/L for the spring applications in
the edge-of-field ditch. Highest PECsed for cyantraniliprole was 0.003 mg/kg.
The overall maximum predicted environmental concentrations of the metabolites IN-J9Z38, IN-K5A77,
IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in vegetables (bulb and leafy)
considering drift rates of 1% were calculated to 0.492, 0.074, 0.095, 0.276, and 0.343 µg/L, respectively. The
maximum concentrations in sediment were 0.116, 0.018, 0.002, 0.062, and 0.078 mg/kg.
The overall maximum predicted environmental concentrations of for the metabolites IN-J9Z38, IN-K5A77,
IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in vegetables (root) considering
drift rates of 1% were calculated to be 0.478, 0.072, 0.094, 0.267, and 0.331 µg/L, respectively. The maximum
concentrations in sediment were 0.114, 0.018, 0.002, 0.061, and 0.077 mg/kg.
The overall maximum predicted environmental concentrations of the metabolites IN-J9Z38, IN-K5A77,
IN-RNU71, IN-NXX70, and IN QKV54 in surface water calculated for the use in potatoes considering drift
rates of 1% were calculated to be 0.081, 0.012, 0.016, 0.046, and 0.055 µg/L, respectively. The maximum
concentrations in sediment were 0.020, 0.003, <0.001, 0.011, and 0.014 mg/kg.
Results for the Dutch drinking water abstraction points (PECTier1) calculated using a default market share
parameter of 0.4 at all nine drinking water abstraction points and the Bommelerwaard polder were calculated to
be <0.001 µg/L, thus well below the drinking water standard (0.1 µg/L).
It can be concluded that the use of cyantraniliprole is not likely to pose an unacceptable risk to drinking water
from surface water in the Netherlands if the active substance is used in compliance with label recommendations.
The calculated PECsw, PECsw twa, and PECsed values are considered suitable to be used in the subsequent
ecotoxicological risk assessment.
3.1.5.4 Predicted Environmental Concentration in Air (PECair) (Part B, Section 5, Point
IIIA 9.9)
Volatilisation of cyantraniliprole is negligible as indicated by a vapour pressure of 5.133 × 10-15 Pa at 20°C. It
can be estimated that <0.0001% (5.55 × 10-14 percent) of applied cyantraniliprole would be lost from a treated
field into the air within 24 hours. This rate of loss is likely to result in negligible concentrations in air (PECair)
due to the combination of a low rate of loss as well as the dilution effects of moving air.
2 Van Leerdam, R.C., Adriaanse, P.I., ter Horst, M.M.S. and te Roller, J.A. (2010): DROPLET to calculate concentrations at drinking water
abstraction points – User manual for evaluation of agricultural use of plant protection products for drinking water production from
surface waters in the Netherlands. Alterra-report 2020, Wageningen.
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3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10.0)
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and IIIA 10.3)
Birds
Benevia was a representative formulation in the EU review of cyantraniliprole. The avian risk assessment was
conducted according to the ‘Guidance of EFSA. Risk Assessment for Birds and Mammals’, European Food
Safety Authority (EFSA), Parma, Italy. EFSA Journal 2009: 7(12):1438.
The acute, short-term, and long-term risks of Benevia to birds were assessed from toxicity exposure ratios
between toxicity endpoints, estimated from studies with cyantraniliprole, and maximum residues occurring on
food items and drinking water following applications according to the proposed use pattern.
The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and
short-term risk and 5 for long-term risk (including drinking water and secondary poisoning), thus indicating no
unacceptable risk to birds from the proposed uses.
Terrestrial vertebrates (other than birds)
Benevia was a representative formulation in the EU review of cyantraniliprole. The mammal risk assessment
was conducted according to the ‘Guidance of EFSA. Risk Assessment for Birds and Mammals’, European Food
Safety Authority (EFSA), Parma, Italy (EFSA Journal 2009: 7(12):1438). The TERa and TERlt values for
Benevia are higher than the Annex VI trigger values, indicating that Benevia poses no unacceptable risk to
mammals following application of Benevia at the proposed use rates.
The long-term hazard quotient (HQ) for exposure via drinking water is below the trigger value of 50 for less
sorptive substances (Koc <500 L/kg) indicating a low risk to mammals via the uptake of drinking water in
puddles and that no specific calculations of exposure and TERlt are necessary.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2)
Following acute toxicity exposure ratios (TERa) and chronic toxicity exposure ratios (TERlt) on fish for
cyantraniliprole using the Dutch Model, the TERa and TERlt values for cyantraniliprole based on the worst-case
PECsw exceed the Regulation (EC) 546/2011 trigger of 100 for acute exposure. Therefore Benevia, when used
according to Good Agricultural Practices, will pose a low risk to fish in the Netherlands.
Following acute toxicity exposure ratios (TERa) and chronic toxicity exposure ratios (TERlt) on Daphnia
magna for cyantraniliprole and its metabolites based on worst-case PECsw, the TERa and TERlt value for
cyantraniliprole is lower than the Regulation (EC) 546/2011 trigger of 100, indicating a potential acute risk and
low long-term risk to aquatic invertebrates. The acute TER values for the metabolites of cyantraniliprole are
greater than the Regulation (EC) 546/2011 trigger of 100, indicating a low acute risk to aquatic invertebrates.
To evaluate inter-species variability in detail, the effect endpoints on the active substance cyantraniliprole were
re-evaluated to construct a species sensitivity distribution from which an HC5 was obtained. The agreed
assessment factor (AF) remains 3. An additional safety factor of 2.2 was applied to account for the difference in
toxicity between formulation and active substance.
Toxicity exposure ratios were calculated using the refined HC5 and worst-case PECsw value. The acute TER
based on the HC5 for aquatic invertebrates exceeds the trigger of concern, indicating low acute to aquatic
invertebrates risk following application of Benevia according to the proposed use pattern.
Because the TERa values for Daphnia magna indicated that cyantraniliprole poses low acute risk to aquatic
invertebrates, an acute risk assessment to aquatic insects is not needed since Daphnia magna was identified as
the most sensitive aquatic invertebrate, including aquatic insects, when exposed to cyantraniliprole in acute
toxicity tests.
Acceptable chronic risk to aquatic invertebrates could not be demonstrated. Drift reduction of 75% is required to
achieve acceptable chronic risk to aquatic invertebrates. Additional restriction sentence for aquatic organisms
however is not required because drift mitigation measures for non-target arthropods are more strict and are
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sufficient to ensure acceptable risk to aquatic organisms. Restriction sentence for non-target arthropods was
adapted also to account for aquatic organisms.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA 10.4 and
IIIA 10.5)
Bees
The attractiveness of the crop plant to honeybees may be considered as an entry point for this risk assessment.
The intended use in potato is BBCH 12-70, in cauliflower, broccoli, head cabbage, brussels sprout is BBCH 12-
49, in carrots, parsnips, celeriac, turnip-rooted parsley is BBCH 11-89, and in swede, red beet, celeriac, black
salsify is BBCH 11-89. Of all these, according to CTGB guidance potatoes is to be considered a bee-attractive
crop. As the flowering period is at BBCH 60-69 and this falls within the BBCH ranges applied for, bees could
be directly exposed to the product if treatment of these crops occurs during flowering.
The risk assessment for bees is based on the Hazard Quotient (HQ), see 10.4.1., the ratio between the highest
single application rate and toxicity endpoint (LD50 value). Where there is a possibility of honeybees being
exposed, no authorization shall be granted if the hazard quotients for oral or contact exposure of honeybees are
greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions
there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development
after use of the plant protection product according to the proposed conditions of use.
For use in potatoes the hazard quotients are below the trigger of 50 (see Fout! Verwijzingsbron niet
gevonden.). ‘Benevia’ in potato crops (2 x 12.5 g a.s./ha with a 7-day minimum spray interval) poses a low risk
to bees. Therefore, product authorisation is agreed for this use without need for bee related risk mitigation
measures.
For use in leafy, bulb, root and fruiting vegetables the in-field QHC and QHO are above the trigger of 50,
indicating a possible risk for honey bees when used in bee-attractive crops (which these crops are not) or when
bees are foraging in the field for another reason (flowering weeds or honeydew). Based on the default national
drift value an off-field risk to honeybees could be excluded for all leafy, bulb, root, fruiting vegetables. Further
work including semi-field and tunnel studies was conducted to assess the potential in-field risk to bees under
actual conditions of use. These studies were considered previously in the revised DAR, Vol.3 B.9. Part B (2014)
and the results are briefly summarised in the EFSA (2014) peer review conclusion. The results of these tests are
that it is unlikely that Benevia sprayed twice at up to 75 g cyantraniliprole/ha with one spray made during
flowering and after daily honeybee foraging activity poses a risk to honeybees. Flowering weeds growing in
fields might also attract bees and be sprayed.
Acceptable in-field risk to bees could not be achieved for all uses except potatoes. Acceptable off-field risk was
demonstrated for all uses. To achieve acceptable risk to bees, a warning sentence has to be placed on the label.
NL instructions for use the following has to be included:
“Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei
staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen
toepassen tussen zonsondergang en zonsopkomst. “
Other non-target arthropods
In the Annex I first tier risk assessment for non-target arthropods, a low in-field and off-field risk was indicated
by the derived Hazard Quotient values for the standard indicator species T. pyri. However, HQ values for the
other standard (first tier) indicator species A. rhopalosiphi were above the trigger value of 2 for all the
representative field uses – indicating a potential risk. To address this potential risk, a higher tier risk assessment
was conducted in the Annex I evaluation based on the result of extended lab and semi-field studies. However,
this higher tier assessment ‘suggested there is still a high in-field and off-field risk for field uses.
To achieve acceptable risk to non-target arthropods, the following restriction sentence has to be placed on the
WG:
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte
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teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan
wanneer gebruik wordt gemaakt van één van de volgende maatregelen:
- Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en
Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter
(gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de
sloot).
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik
wordt gemaakt van één van de volgende maatregelen:
- Overkapte beddenspuit.
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 cemtimeter (gemeten
vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 75% driftreducerende spuitdoppen in combinatie met een kantdop en
luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point
IIIA 10.6)
Benevia was a representative formulation in the EU review of cyantraniliprole. The intended use pattern for
national authorisation is within the use pattern considered for EU review. Therefore, appropriate assessments
for earthworms and other soil non-target macro-organisms to exposure from Benevia were evaluated as part
of the EU review of cyantraniliprole, where all study references and conclusions can be found.
Earthworms
Based on studies with the active substance and relevant soil metabolites (IN-JCZ38, IN-JSE76, IN-K5A79,
IN-PLT97, IN-J9Z38, IN-K5A77, IN-K5A78, IN-RNU71, and IN-QKV54) TER’s were greater than the
Annex VI criterion.
Effect on other soil non-target macro-organisms
Taking into account that the zRMS has concluded that levels of soil exposure to the active substance and its
metabolites from Benevia’s proposed crop uses are within that already assessed for the representative Annex
I uses (ref. Section B.3.1.5.1 of the Part A ‘Risk management’ Registration report), and that a low and
acceptable risk to earthworms and other soil macro-organisms was concluded in the Annex I evaluation from
these uses, the risk to these soil organisms from the proposed crop uses of ‘Benevia’ will also be acceptable.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6)
No significant effects were found on decomposition compared to the controls over the 6-month exposure period
for the active substance or any of the tested metabolites (IN-J9Z38, IN-JCZ38, IN-JSE76, IN-K5A77,
IN-K5A78, IN-K5A79 and IN-PLT97). Therefore, it can be concluded that Benevia poses a low risk to
organisms responsible for organic matter breakdown.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point IIIA 10.7)
Taking into account that zRMS has concluded that levels of soil exposure to the active substance and its
metabolites from Benevia’s proposed crop uses are within that already assessed for the representative Annex I
uses (ref. Section B.3.1.5.1 of the Part A ‘Risk management’ Registration report), and that a low and acceptable
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risk to soil micro-organisms was concluded in the Annex I evaluation from these uses, the risk to soil micro-
organisms from the proposed crop uses of ‘Benevia’ will also be acceptable.
3.1.6.7 Assessment of Potential for Effects on Other Non-Target Organisms (Flora and Fauna)
(Part B, Section 6, Point IIIA 10.8)
Non-target plants
The Annex I evaluation concluded (Section 5, EFSA Conclusion report, 2014) a ‘low risk’ to terrestrial non-
target plants from the proposed field and glasshouse uses of cyantraniliprole – which included use of an
identical formulation to ‘Benevia’ applied via hydraulic boom sprayers in vegetable field crops at rates more
than that proposed for ‘Benevia’.
Therefore, the proposed uses are within the ‘risk envelope’ of the Annex I representative uses and based on this
evaluation a low risk to terrestrial non-target plants may be concluded. No further evaluation is required.
Other non-target species (Flora and Fauna)
Cyantraniliprole is an insecticide and would, therefore, be most active on insect species. There is no indication
from screening studies that would indicate impact on non-target species that are not already apparent from
regulatory testing with cyantraniliprole.
Implications for labelling resulting from ecotoxicological assessment:
In order to protect groundwater this product is not be applied in vegetables or strawberries in groundwater
protection areas.
The following restriction sentence should be added to the WG to protect aquatic organisms, bees and non-target
arthropods:
“Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei
staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen
toepassen tussen zonsondergang en zonsopkomst. “
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte
teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan
wanneer gebruik wordt gemaakt van één van de volgende maatregelen:
- Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en
Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter
(gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de
sloot).
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik
wordt gemaakt van één van de volgende maatregelen:
- Overkapte beddenspuit.
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten
vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 75% driftreducerende spuitdoppen in combinatie met een kantdop en
luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
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3.1.7 Efficacy (Part B, Section 7, Point IIIA 6.0)
Preliminary test
Preliminary data were provided for cyantraniliprole on a range of organisms. The activity of cyantraniliprole
was evaluated in screening tests against eight insect species. The product was also screened as a nematicide,
fungicide and herbicide. Some fungicidal effect was observed in the premiminary test, however no instrinstic
activity can be concluded. Thus, no further consideration is therefore required in regard to preliminary data.
Adjuvant is recommended to be used:
The applicant proposed the following wording ‘Use of Adjuvants – The use of suitable, crop safe, oil adjuvants,
can offer enhanced pest control when added to DPX-HGW86 100 g/L OD. For example addition of the rape
seed oil adjuvant, Codacide enhances control of thrips, aphids and whiteflies when applied at a rate up to 2.5
L/ha in field crops’. Codacide is authorised in the Netherlands in 2015, the authroziation number is 13843 N.
The GAP table contains the following wording:
• For ‘Thrips tabaci, Frankiniella occidentalis, Delia antiqua, Anthonomus rubi, Drosophila suzukii:
‘For improved performance use with the addition of a suitable oil adjuvant’.
• For Aleyrodes proletella: ‘Use with the addition of a suitable oil adjuvant’.
zRMS consideres that only for Drosophila suzukii and white fly the addition of an oil-based adjuvant is helpful,
supported current data.
In the Dutch label the following remark is given for Drosophila suzukii and Aleyrodes proletella:
Het middel in combinatie met een uitvloeier op basis van plantaardige olie toepassen.
Minimum Effective Dose
Minimum effective dose (MED) trials were presented on eight pests: Thrips tabaci, Chamaepsila rosae,
Mamestra brassicae, Plutella xylostella, Pieris brassicae, Delia radicum, Aleurodes proletella, and Anthonomus
rubi (and also Leptinotarsa decemlineata, which is being evaluated for CMS, but separately from the UK label).
The applicant has summarised the species on which data are presented as follows, and has argued that these are
the major key species:
Potato
Leptinotarsa decemlineata
Recommended dose: 125ml/ha (12.5g as/ha)
Data from 6 or trials in the Maritime zone (1 Austria, 3 Czech Republic, 2 Germany) are presented.
A slight dose response was seen. Whilst it may be argued the difference between 125 and 100 ml (12.5 and 10 g
a.s)/ha was small, larger differences started to emerge at doses lower than these. Given the economic
importance of Colorado beetle, achieving high levels of control is important, and the dose is considered
justified.
Strawberry
Anthonomus rubi
Recommended dose: 750ml/ha (75g as/ha)
In 2 trials in Poland (North East zone), rates lower than the label dose were applied for control of Anthonomus
rubi.
Drosophila suzukii
recommended dose: 750 ml/ha rate
No trials have been carried out in the Maritime EPPO Zone. The zRMS pointed out that data of Drosophila
suzukii was not provided by the applicant under Minimum Effective Dose section, however there were data
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available of 3 trials in the Mediterranean zone (Spain and Italy) showed no dose response between 60 and 75g
as/ha. NL concluded that the data is not sufficient for authorisation.
Brassicas
Delia radicum
Recommended dose: 750ml/ha (75g as/ha)
There was no apparent dose response in the single Maritime trial on cauliflower against Delia radicum in the
Netherlands, assessed at 28 days after treatment two.
Results in the 7 trials in the North East zone (Poland) some dose response thought it was not consistent. The
zRMS advised that the proposed minimum effective dose 75 g as/ha is justified. However without any trials in
the Maritime zone it is not possible to justifiy the minimum effective dose in the Netherlands.
Aleurodes proletella
Recommended dose: 750ml/ha (75g as/ha)
Add a suitable oil type adjuvant, e.g. Codacide at a rate of 2.5 L/ha.
12 trials were carried out on Brussels sprout in comparison to the label recommended rate. Of these, all the
trials were in the Maritime zone (Netherlands, Germany, UK). Dose response was observed with and without
the addition of the oil adjuvant (Codacide).
The trials where Codacide was used, as recommended in the GAP as always necessary for this pest. 75g as/ha
(plus Codacide) as the minimum effective dose is justified.
Lepidoptera
Recommended dose: 500ml/ha (50g as/ha)
In the RR evaluated by the zRMS, the lower dose of 40-50g as/ha is proposed for Lepidoptera, expressed as a
range to allow grower choice. In the Netherlands only 50g as/ha is claimed.
Mamestra brassicae
Data were presented from one trial in Germany (Maritime), where ‘Benevia 10OD’ was applied at a range of
dose rates (30-50g as/ha) once on cauliflower. Dose response was clear although pest pressure in this trial was
low with only 0.13 larvae per plant. The number of trials is very limited, but according to the Dutch
extrapolation document, it is possible to extrapolate from P. xygostella to P. rapae, C. spectrana, M. brassicae
and E. forficalis. MED for M. brassicae is acceptable.
Plutella xylostella
Data were presented from one trial in the Maritime zone (UK) and 3 trials in the North East zone (Poland),
where ‘Benevia 10OD’ was applied at different doses against Plutella xylostella.
In the one UK trial on head cabbage, no dose response between 30, 40 and 50g as/ha was seen and pest pressure
was very low. In the 3 Polish trials on head cabbage, a marked dose response was observed in all three trials.
In 4 additional trials on cauliflower in the Netherlands, where pest damage (severity) was increased control with
dose was seen in some trials, but results were very variable.
The number of trial in Maritime zone is sufficient, although the result is not constant, considering the all the
trials in Lepidorptera MED for P. xylostella is acceptable.
Pieris brassicae
Data were presented from 6 trials in the Maritime zone (Germany, France, UK) on head cabbage, Brussels
sprout, curly kale and cauliflower, a slight increase in mean control overall with the recommended dose of 40g
as/ha, compared with the lower dose of 30g as/ha, and no clear dose response between 40 g as/ha and 50 g as/ha.
There were an additional 2 trials in Poland (North East zone) where a range of doses was applied, which
supports 40g as/ha as the minimum effective dose on Pieris brassicae, especially in the North East zone.
Minimum effective dose is justified for this use.
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Carrot
Chamaepsila rosae
Recommended dose: 750ml/ha (75g as/ha)
13 trials were carried out in the Maritime zone (UK, Germany, France and Netherlands). However only in 6
trials of Maritime zone applied the recommended number of treatments (1 or 2). All the other trials applied
more than the recommended number of treatments (3-5). Assessments of pest numbers for the fully supporting
trials were generally made at 61-128 days after the second treatment.
These trials demonstrated that there is a dose response on carrot fly, the proposed minimum effective dose 75g
as/ha is justified.
Bulb and stem (Allium) vegetables
Thrips tabaci
Recommended dose: 750ml/ha (75g as/ha)
18 trials were carried out on leek and onion. 14 trials were in the Maritime zone (UK, Germany and
Netherlands). Assessments of pest numbers were generally made at 6-10 days after the second treatment,
however for 2 of the trials in the UK this was at 2 days after treatment. Overall some dose response from the
50g as/ha dose to the 75g as/ha dose was observed.
There were 9 trials (in the UK, Netherlands, Germany and Poland) where Codacide was added,
which demonstrate an overall dose response between the 50 and 75gas/ha rates for Thrips tabaci more clearly
than treatments without Codacide.
No evidence has been provided for other target pests on Alliums: Delia antiqua.
Delia antiqua is considered like to be a similar major pest as thrips, the lack of MED data for Delia antiqua
does not support the claim. As bulb vegetables as a group is not a minor use, no extrapolation can be applied to
authorize this use.
Efficacy
Potato
Colorado beetle (Leptinotarsa dece mlineata) LPTNDE
6 trials were carried out on Leptinotarsa decemlineata in the Maritime zone (3 in Czech Republic, 2 in
Germany, 1 in Austria, and 1 in the Netherlands). Control of various life stages was assessed in the trials.
Benevia 10OD showed good efficacy, similar to or better than the standards used in all cases. The claimed use is
supported by the data and can be authorised.
The zRMS noted that “The proposed water volume in the GAP is 150-600 L/ha. However, the lower end of the
range is considered to be low and is not supported by the trials data. The lowest water volume applied in any of
the trials was 300 L/ha. Therefore the recommended range must be amended to 300-600 L/ha.” NL agrees with
the zRMS and the GAP have been amended to 300-600 l/ha. In the Dutch label the following sentences are
added:
In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.
In de teelt van aardbei, wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in
300-1000 liter water per ha.
In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha.
Strawberry
Spotted wing drosophila (Drosophila suzukii)
No trials have been carried out in the Maritime EPPO Zone, the South East or North East EPPO zones. There
are therefore no trials that are directly supporting this recommendation in the Central Zone. Data from 3 trials
carried out in the field in the Mediterranean zone were submitted.
At the proposed dose of 75g as/ha, mean control of insect numbers by ‘Benevia 10OD’ was 89.63% (without the
addition of Codacide, and 95.37% with Codacide. No reference product is visible in the RR. The zRMS
recommended that CMS may consider this is sufficient to support an authorisation on strawberry, as spotted
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 30 of 66
wing drosophila is an increasing pest of concern, difficult to control, and causes significant economic damage in
a range of fruit crops.
The Netherlands agree with the zRMS that the spotted wing drosophila is an increasing pest of concern, and
difficult to control. However three trials from the Mediteranean zone are not sufficient to support a claim in NL.
Army worm (Spodoptera exigua) and Blossom weevil (Anthonomus rubi)
With these pest-crop conbinations no trials or a limited number of trials are carried out. According the zRMS
extrapolation is not possible and therefore these uses cannot be authorised.
Brassicas (Cauliflower, Broccoli, Cabbage, Brussels sprouts)
Cabbage root fly (Delia radicum)
4 trials were carried out on Brussels sprouts and 1 trial on cauliflower in the Nethelrands. Benevia 10OD
showed comparable or better efficacy than reference products. Noted that the number of trials is limited, the
zRMS considers there is sufficient evidence, considering there are trials on a number of Dipteran pests and
taken together. However, the efficacy in present data was not high enough to justify a claim in NL from 12
central zone trials, and 4 trials in the Maritime zone with an average control of 51% in the Maritime zone. In
addition MED data is not sufficient.
Whitefly (Aleyrodes proletella)
Data from 16 trials in the Maritime zone (9 Netherlands, 1 Germany, 6 United Kingdom). Benevia 10OD
without adjuvant showed variable results and not always comparable/higher than the reference. With the
addition of Codacide the performance Benevia 10OD is cleary enhanced.
The zRMS concluded that “The levels of control achieved when Codacide was added are acceptable for a claim
for whitefly in the Maritime EPPO area of the Central zone”. NL follows this conclusion and an authorization
can be granted.
Lepidoptera
Cabbage moth (Mamestra brassicae)
3 trials were carried out using 50 g/ha dose, in Germany and Netherlands on cauliflower, and in the Netherlands
on red cabbage. Additionally 1 trial with 40 g/ha is carried out in Germany. The summarized data showed that
50 g/ha gives high levels of control of the pest, which is higher than that of reference products. According to the
Dutch extrapolation document, it is possible to extrapolate from P. xygostella to P. rapae, C. spectrana, M.
brassicae and E. forficalis. The trials submitted are sufficient in P. xygostella and therefore this claim can be
extended to the aforementioned species.
Diamondback moth (Plutella xylostella)
Two trials were carried out in the Maritime zone against diamondback moth (1 in the Netherlands on
cauliflower, and 1 in the UK on head cabbage) where insect numbers were assessed. 5 additional trials in the
Maritime zone in the Netherlands, all on cauliflower, where pest damage severity was used as the assessment
criteria. The summarized data showed that 50 g/ha gives high levels of control of the pest, which is higher than
that of reference products. 40 g/ha also gives comparable or higher efficacy than the reference products. This
use can be authorized.
Cabbage white (Pieris brassicae)
Six trials were carried out in the Maritime zone (2 in Germany on head cabbage and cauliflower, 1 in France on
head cabbage, 3 in UK on head cabbage, Brussels sprout and curly kale). At dose of 50 g/ha, used in only 4 of
the 6 trials, mean 99.5% control of cabbage white larvae was recorded (range 97.8-100%). Which is higher than
that of reference products. 40 g/ha also gives comparable or higher efficacy than the reference products. This
use can be authorized.
Silver-Y moth (Autographa gamma)
No trials have been carried out in the Maritime, or Central zone, only the Mediterranean zone 3 trials were
submitted. This claim is insufficient justified, few trials were conducted, and evidence for extrapolation is not
clearly outlined. This species are not justified for extrapolation in NL.
Garden pebble moth (Evergestis forficalis)
No trials data were submitted. However, the applicant would have this claim based on extrapolation from
Plutella xylostella (hardest to control caterpillar) and one other species (e.g. Mamestra brassicae or Pieris
brassicae) to Evergestis forficalis. This is possible based on the EPPO Standard PP 1/257 “Efficacy and crop
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 31 of 66
safety extrapolations for minor uses” then authorisation can be recommended Benivia 10OD 50 g a.s./ha
controlling Evergestis forficalis on brassica crops on the basis of extrapolation from other Lepidopteran
caterpillar species.
Cabbage leafroller (Clepsis spectrana)
No trials data were submitted. However, the applicant would have this claim based on extrapolation from
Plutella xylostella (hardest to control caterpillar) and one other species (e.g. Mamestra brassicae or Pieris
brassicae) . This is possible based on the EPPO Standard PP 1/257 “Efficacy and crop safety extrapolations for
minor uses” then authorisation can be recommended Benivia 10OD 50 g a.s./ha controlling Clepsis spectrana on
brassica crops on the basis of extrapolation from other Lepidopteran caterpillar species.
Army worm (Spodoptera exigua) and sawfly (Athalia rosae)
With these pest-crop conbinations no trials are carried out. According the zRMS extrapolation is not possible
and therefore these uses cannot be authorised.
Carrot
Carrot fly (Chamaepsila rosae)
17 trials were carried out in Maritime zone (5 in UK, 7 in Netherlands, 3 in Germany, 2 in France). Only 7 trials
had the recommended number of 2 treatments or less (5 UK, 1 Netherlands, 1 Germany). In these trials Benevia
10OD 75 g/ha performed consistently better than the reference products. Extrapolation is possible from carrot
fly on carrot to ‘all umbelliferous crops’. NL considers the claimed use can be authorized; on carrots, parsnips,
celeriac, hamburg root parsley and skirret.
Bulb and stem vegetables (Onion, shallots, Garlic, Leek, spring onion)
Onion thrips (Thrips tabaci)
18 trials were assessed for control of Thrips tabaci on leek and onion, among which, 14 were done in the
Maritime zone (8 in Netherlands on leek, 3 UK on leek, 2 UK on onion, 1 in Germany on onion). The overall
mean value damostrated moderate (and variable) control on insect number and crop damage, which is slightly
higher or comparable efficacy than reference products. Addition of adjuvant codacide did not increase the
efficacy. The Dutch authorization protocol does not allow for a claim for 'moderate control' on the label as
given on the ZRMS label. The mean control from all life stages of this pest was roughly 50-60%. Based on
expert judgement and knowlegde of the reference products which show the same efficacy and variability, a
claim for use against T. tabaci in onions in the Netherlands is acceptable.
Onion fly (Delia antiqua)
6 trials were carried out in the Maritime zone (Netherlands) on garden onions/scallions and pearl onions. the
aggregated data showed a good level of control with a mean of 89.4% reduction in pest damage. However,
zRMS poined out that “trials were all assessed at different timings and had different numbers of treatments, and
this aggregated figure has little value. Treatment timings were between April and July. Assessments were
mainly made 52-162 days after the last application.” Only in 2 trials the results were collected after the
proposed number of 2 treatments. These showed 96.6% reduction in pest damage at 1DAT, 100% at 21 DAT
(bulb), and 94.4% at 162 DAT. The trial number is considered limited and insufficient for authorization. As
bulb vegetables as a group is not a minor use, no extrapolation can be applied to authorize this use.
Onion leaf miner (Phytomyza gymnostoma)
Two trials were carried out in the Maritime zone on leek. The trial number is considered limited and insufficient
for authorisation. As bulb vegetables as a group is not a minor use, no extrapolation can be applied to authorise
this use.
Effects on yield and quality
Yield and quality was assessed in some of the efficacy trials on leek and oinion, and cabbage. No negative
effects on yield quality/potential after application of cyantraniliprole 100 g/l OD (with or without the adjuvant
Codacide oil) were observed in any trial. In some of the trials Cyantraniliprole at proposed dose rate applied
alone or in mixture with Codacide oil tended to increase the proportion of the crop that was marketable relative
to the untreated, or improve the crop colour.
Effects on the processing procedure
Taint tests on cyanatraniliprole were still carried out on claimed crops including tomato (ketchup, canned),
potato (quick frozen), strawberry (jam, fresh), carrot (canned), cabbage (pickled), olives (in oil). The results
Benevia Part A
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15569 N
Registration Report – Central zone Page 32 of 66
showed that there was no taint on a range of vegetable and other crops in any of the tests when cyantraniliprole
was applied at up to 120g as/ha in as a commercial formulation containing 100 g a.s./l (with or without
Codacide oil as recommended on the label). Some of the tests identified a sensory difference, however this was
not described in more detail in the BAD or dRR, and is not regarded as taint.
Phytotoxicity to host crop
The applicant has provided phytotoxicity data from 117 trials on 12 different crops. In 101 efficacy trials
phytotoxicity symptoms were assessed. Additionally 16 phytotoxicity trials were carried out. No phytotoxic
symptoms were observed for the product in mixture with Codacide at any assessment.
No phytotoxicity trials were carried out on salad onion, shallot, garlic or parsnip. However, extrapolation is
possible from leek, onion and carrot.
Adverse effects on parts of plant used for propagating purposes
Based on the extensive crop safety data set showing no phytotoxic effects, safety to propagating material is
considered to be satisfactorily addressed.
Impact on succeeding crops
No risk to succeeding crops is expected , no specific restrictions required.
Impact on other plants including adjacent crops
Sufficient information is provided. No warnings regarding adjacent crops are required.
Possible development of resistance or cross-resistance
Cyantraniliprole is a ryanodine receptor modulator, belonining to the group of anthranilic diamide. The IRAC
code is 28. The applicant provided an extensive analysis on resistance development. A few cases of resistance to
diaminde insecticides have been reported in Asia-Pacific, Latin America, and North America. The applicant
stated that so for no resistance cases has been reported in Europe. The mechanism of resistance was explained
(metabolic, penetration and behavioural). Field monitoring and lab experiments showed no cross resistance.
Overall, the resistance risk can be concluded as high for many of the recommended pests. In the Dutch label the
following warning is included:
Resistentiemanagement:
Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor
modulators. De Irac code is 28.
Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de
adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
3.2 Conclusions
The assessment conducted for Benevia was in accordance with the Uniform Principles and demonstrates an
acceptable risk to human health and the environment. An authorisation can therefore be granted except for the
use in strawberry, the uses against Lepidoptera (Spodotera exigua and Autographa gamma), Hymenoptera
(Athalia rosae) and Diptera (Delia radicum) in cauliflower, broccoli, head cabbage and Brussels sprout and the
uses against Diptera (Delia antiqua) and Leafminer (Phytomyza gymnostoma) in bulb vegetables and stem
vegetables due to unsufficient efficacy data. Furthermore, the use on leek cannot be authorised unless the
current MRL is raised.
3.3 Substances of concern for national monitoring
Cyantraniliprole is not a substance of concern for national monitoring.
3.4 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
None.
Benevia Part A
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Registration Report – Central zone Page 33 of 66
3.5 Legal instructions
As of January 1st 2018 an amendment of the Activity Decree has come into force, some of the restriction
sentences that have been included on the Legal Instructions will become unnecessary or change. Therefore the
following sentences will be included on the Legal instructions:
Om residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te
voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift.
Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals
op hetzelfde perceel worden toegepast.
In de teelt van knolselderij maximaal 1,5 L/ha middel per teeltcyclus toepassen.
In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.
In de teelt van wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in 300-
1000 liter water per ha.
In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha.
Om het grondwater te beschermen mag dit product in de teelt van sluitkoolachtigen, bloemkoolachtigen,
wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer niet worden gebruikt in
grondwaterbeschermingsgebieden.
Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei
staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen
toepassen tussen zonsondergang en zonsopkomst.
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte
teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan
wanneer gebruik wordt gemaakt van één van de volgende maatregelen:
- Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone
van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de
perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en
Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter
(gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de
sloot).
Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te
beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik
wordt gemaakt van één van de volgende maatregelen:
- Overkapte beddenspuit.
- lage spuitboomhoogte (maximaal 30 centimeter boven de top van het gewas) met driftarme
Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten
vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
- conventionele spuit met minimaal 75% driftreducerende spuitdoppen in combinatie met een kantdop en
luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het
midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot).
Resistentiemanagement:
Benevia Part A
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15569 N
Registration Report – Central zone Page 34 of 66
Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor
modulators. De Irac code is 28.
Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de
adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 35 of 66
APPENDIX 1
COPY OF THE PROPOSED PRODUCT LABEL
Wettelijk Gebruiksvoorschrift Het middel is uitsluitend toegelaten als insectenbestrijdingsmiddel voor het professionele gebruik door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0 Ctgb juni 2011) onder de hierna vermelde toepassingsvoorwaarden Toepassingsvoorwaarden:
Toepassingsgebied
Werkzaamheid getoetst op
Maximale dosering* middel per toepassing
Maximaal aantal toepassingen per teeltcyclus
Minimum interval tussen toepassingen in dagen
Veiligheidstermijn in dagen
Aardappelen kevers1 0,125 L/ha 2 7 14
Sluitkoolachtigen (onbedekte teelt)
rupsen 2,3,4,5,6 0,5 L/ha 2
7
7
wittevlieg7 **
0,75 L/ha
Bloemkoolachtigen (onbedekte teelt)
rupsen 2,3,4,5,6 0,5 L/ha 2
7
7
wittevlieg7 ** 0,75 L/ha
Wortelgewassen (onbedekte teelt)
vliegen en muggen8 0,75 L/ha 2 10 14
Knolselderij (onbedekte teelt)
vliegen en muggen8 0,75 L/ha 2 10 14
Ui-achtigen (onbedekte teelt)
Trips9 0,75 L/ha 2 7 14
* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. ** Het middel in combinatie met een uitvloeier op basis van plantaardige olie toepassen. 1 Coloradokever (Leptinotarsa decemlineata) 2 kooluil (Mamestra brassica) 3 Pieris soorten (Pieris spp.) 4 late koolmot (Evergestis forficalis) 5 koolbladroller (Clepsis spectrana)
Benevia Part A
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6 koolmot (Plutella xylostella) 7 koolwittevlieg (Aleyrodes proletella) 8 wortelvlieg (Chamaepsila rosae) 9 tabakstrips (Thrips tabaci). Het gebruik in de teelt van koolraap, rode biet, knolselderij en schorseneer is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker.
Toepassingsgebied Werkzaamheid aannemelijk tegen
Maximale dosering* middel per toepassing
Maximaal aantal toepassingen per teeltcyclus
Minimum interval tussen toepassingen in dagen
Veiligheidstermijn in dagen
Koolraap (onbedekte teelt)
rupsen2,3 0,5 L/ha 2 10 14
Rode biet (onbedekte teelt)
rupsen2,3 0,5 L/ha 2 10 14
Knolselderij (onbedekte teelt)
rupsen2,3 0,5 L/ha 2 10 14
Schorseneer (onbedekte teelt)
rupsen2,3 0,5 L/ha 2 10 14
* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. 2 kooluil (Mamestra brassica) 3 Pieris soorten (Pieris spp.) Overige Toepassingsvoorwaarden Om residuen in voedings- of voedergewassen ten gevolge van ophoping van persistente bodemmetabolieten te voorkomen, is het gebruik van dit product beperkt tot 2 toepassingen per jaar volgens het gebruiksvoorschrift. Dit product, of andere producten die cyantraniliprole bevatten, mogen gedurende hetzelfde jaar niet nogmaals op hetzelfde perceel worden toegepast. In de teelt van knolselderij maximaal 1,5 L/ha middel per teeltcyclus toepassen. In de teelt van aardappel het middel toepassen in 300-600 liter water per ha.
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 37 of 66
In de teelt van wortelgewassen, knolselderij, koolraap, rode biet en schorseneer het middel toepassen in 300-1000 liter water per ha. In de teelt van bloemkoolachtigen en sluitkoolachtigen het middel toepassen in 300-800 liter water per ha. Om het grondwater te beschermen mag dit product in de teelt van sluitkoolachtigen, bloemkoolachtigen, wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer niet worden gebruikt in grondwaterbeschermingsgebieden. Gevaarlijk voor bijen. Om de bijen en andere bestuivende insecten te beschermen mag u dit middel op in bloei staande gewassen of op niet-bloeiende gewassen wanneer deze actief bezocht worden door bijen alleen toepassen tussen zonsondergang en zonsopkomst. Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te beschermen is toepassing van het middel in de teelt van sluitkoolachtigen en bloemkoolachtigen (onbedekte teelt), wortelgewassen, knolselderij, ui-achtigen, koolraap, rode biet en schorseneer uitsluitend toegestaan wanneer gebruik wordt gemaakt van één van de volgende maatregelen: - Sleepdoek met minimaal 50% driftreducerende spuitdoppen met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas) met driftarme Venturidoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). - conventionele spuit met minimaal 50% driftreducerende spuitdoppen in combinatie met een kantdop en Hardi TwinForce luchtondersteuning, met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). Om niet tot de doelsoorten behorende geleedpotigen / insecten en in het water levende organismen te beschermen is toepassing van het middel in de teelt van aardappelen uitsluitend toegestaan wanneer gebruik wordt gemaakt van één van de volgende maatregelen: - Overkapte beddenspuit - lage spuitboomhoogte (maximaal 30 cm boven de top van het gewas) met driftarme Venturidoppen en een kantdop met inachtneming van een teeltvrije zone van tenminste 150 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot) - Sleepdoek met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot) - conventionele spuit met minimaal 75% driftreducerende spuitdoppen in combinatie met een kantdop en luchtondersteuning met inachtneming van een teeltvrije zone van tenminste 200 centimeter (gemeten vanaf het midden van de laatste rij of de laatste plant in de rij tot aan de perceelsgrens/insteek van de sloot). Resistentiemanagement:
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 38 of 66
Dit middel bevat de werkzame stof cyantraniliprole. Cyantraniliprole behoort tot de ryanodine receptor modulators. De Irac code is 28. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
Benevia Part A
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Registration Report – Central zone Page 39 of 66
APPENDIX 2
DATA PROTECTION CLAIMS IN THE NETHERLANDS
ANNEX III STUDIES
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA, 2.7.5/01 2011 DPX-HGW86 100 g/liter OD oil
dispersion (oil-bases suspension concentrate) formulation (in PET
container): Laboratory study of
shelf-life stability (3 years) Advinus Therapeutics Limited DuPont-25620
Final
GLP: Yes Published: No
Y Y FMC
KIIIA, 2.7.5/02 2012 DPX-HGW86 100 g/L OD oil
dispersion (oil-based suspension
concentrate) formulation (in PV/EVOH container): Laboratory study of
shelf-life stability Advinus Therapeutics
Limited DuPont-21308 Final GLP: Yes Published: No
Y Y FMC
KIIIA, 5.2.1/01
2013 Validation of the analytical method for
the determination of cyantraniliprole
(DPX-HGW86) in DPX-HGW86 end-use products
DuPont Stine-Haskell Research Center
DuPont-37394 and DuPont-37394 confidential attachment GLP: Yes
Published: No
Y Y FMC
KIIIA, 5.2.1/02 2013 Determination of cyantraniliprole (DPX-
HGW86) in DPX-HGW86 end-use product DuPont Stine-Haskell Research
Center DuPont-35229, Revision No. 1
GLP: No Published: No
N Y FMC
KIIIA, 5.2.4/01 2014 Description and validation of the
analytical method for determination of
IN-Q6S09 in cyantraniliprole (DPX-HGW86) end-use products
DuPont Stine-Haskell Research Center
DuPont-39012, Revision No. 1 GLP: Yes Published: No
Y Y FMC
KIIIA, 5.2.4/02 2014 Description of validation of the
analytical method for determination of
IN-RYA13 in cyantraniliprole (DPX-HGW86) end-use products
DuPont Stine-Haskell Research Center
DuPont-39515, Revision No. 1 GLP: Yes Published: No
Y Y FMC
KIIIA, 5.2.4/03 2014 Description of validation of the
analytical method for determination of
acetonitrile, n-hepane, and 3-picoline in cyantraniliprole (DPX-HGW86) end-use
products MPI Research, Inc. DuPont-41064 GLP: Yes Published: No
Y Y FMC
KIIIA, 5.2.4/04 2017 Description and validation of the
analytical methods for determination of
methanesulfonic acid in cyantraniliprole (DPX-HGW86) end-use products
DuPont-46998
GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 40 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA,
8.3.2/01
2012 Magnitude and decline of
cyantraniliprole and metabolite residues in green onion and dry bulb onion (bulb
vegetables) following foliar application
of DPX-HGW86 100 g/L OD - Europe - 2010 initiation Charles River
Laboratories (UK) DuPont-29225 GLP:
Yes Published: No
Y Y FMC
KIIIA, 8.3.2/02 2012 Magnitude and decline of DPX-HGW86 and metabolite residues in leeks (stem
vegetables) following foliar application
of DPX-HGW86 100 g/L OD - Europe - 2010 initiation
Charles River Laboratories (UK) DuPont-29955 GLP: Yes Published: No
Y Y FMC
KIIIA, 8.3.3/01
2013 Magnitude and decline of
cyantraniliprole (DPX-HGW86) and
metabolite residues in strawberries (berries and small fruit) following foliar
application of DPX-HGW86 100 g/L
OD - Europe - 2011 Initiation Charles River Laboratories (UK) DuPont-29223
GLP: Yes Published: No
Y Y FMC
KIIIA, 8.3.4/01 2013 Magnitude and decline of
cyantraniliprole (DPX-HGW86) and metabolite residues in carrots (root and
tuber vegetables) following foliar
application of DPX-HGW86 100 g/L OD - Europe - 2011 initiation Charles
River Laboratories (UK) DuPont-32187
GLP: Yes Published: No
Y Y FMC
KIIIA, 8.3.6/01
KIIIA, 8.5.4.1/01
2014 Combined processing and magnitude
and decline of cyantraniliprole (DPX-
HGW86) and metabolite residues in cauliflower/broccoli, Brussels sprouts,
and cabbage (flowering and head
brassica vegetables) following foliar application of DPX-HGW86 100 g/L
OD and soil application of DPX
HGW86 200 g/L SC - Europe - 2012 initiation Charles River Laboratories
(UK)
DuPont-34095 GLP: Yes Published: No
Y Y FMC
KIIIA, 9.1/01 2017 Rate of degradation of [14C]IN-M2G98 in five soils
Wildlife International Ltd (USA)
DuPont-47642 GLP: Yes
Published: No
Y Y FMC
KIIIA, 9.2.1/01 2012 Derivation of modelling DT50 of
cyantraniliprole (DPX-HGW86) and its metabolites from terrestrial field
dissipation study following FOCUS kinetics guidance DuPont Stine-Haskell
Research Center DuPont-33684 EU
GLP: No Published: No
N Y FMC
KIIIA, 9.2.1/02 2014 Derivation of modelling DT50 of cyantraniliprole (DPX-HGW86) and its
metabolites from terrestrial field
dissipation studies following FOCUS kinetics guidance Supplement No. 1:
Refined kinetic fits for IN-JSE76 and
IN-K5A78 DuPont Stine-Haskell Research Center
DuPont-33684 EU, Supplement No. 1
GLP: No Published: No
N Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 41 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA, 9.2.1/03 2014 Evaluation of cyantraniliprole (DPX-
HGW86) field dissipation studies in North America and Europe following
the EFSA (2014) guidance Waterborne
Environmental, Inc. (WEI) DuPont-41056, Revision No. 1 GLP: No
Published: No
N N FMC
KIIIA, 9.2.1/04 2016 The field soil dissipation of DPX-
HGW86 following a single application to bare ground - UK 2015
Charles River Laboratories (UK)
DuPont-43619 IM GLP: Yes
Published: No
Y Y FMC
KIIIA, 9.2.1/05 2017 Degradation of cyantraniliprole (DPX-HGW86) in the field dissipation study
conducted in the United Kingdom - a
kinetic calculation report Waterborne Environmental, Inc. (WEI)
DuPont-47676 EU
GLP: No Published: No
N N FMC
KIIIA, 9.3/01 2017 [14C]IN-M2G98: Batch equilibrium
(adsorption/desorption) in five soils
EAG Laboratories DuPont-47641
GLP: Yes
Published: No
Y Y FMC
KIIIA, 9.4/01
KIIIA, 9.5/01
2014 Predicted environmental concentrations
of cyantraniliprole (DPX-HGW86) and
its metabolites in soils GVK Biosciences Private Limited, DuPont Stine-Haskell
Research Center DuPont-41063 EU
GLP: No Published: No
N N FMC
KIIIA, 9.6/01 2014 Evidences for plant uptake of cyantraniliprole (DPX-HGW86) by
crops from soils under greenhouse and
field conditions DuPont Stine-Haskell Research Center DuPont-39549 EU
GLP: No Published: No
N N FMC
KIIIA, 9.6/02 2014 Leaching behaviour of the OD
formulation of cyantraniliprole (DPX HGW86) and its metabolites - a
modeling study conducted with the
endpoints recommended by UK CRD and derived from field dissipation
studies
GVK Biosciences Private Limited DuPont Stine-Haskell Research Center
DuPont-38334 EU GLP: No Published:
No
N N FMC
KIIIA, 9.6/03 2014 Leaching behaviour of the OD
formulation of cyantraniliprole (DPX
HGW86) and its metabolites - a modeling study conducted with the
endpoints recommended by UK CRD
and derived from field dissipation studies
GVK Biosciences Private Limited
DuPont Stine-Haskell Research Center DuPont-38334 EU, Supplement No. 1
GLP: No Published: No
N N FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 42 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA, 9.6/04
2013 Soil pH range of arable land by member
state in Europe Dr. Knoell Consult GmbH, DuPont
Stine-Haskell Research Center DuPont-
36136 EU GLP: No Published: No
N N FMC
KIIIA, 9.7/01 KIIIA, 9.8/01
2014 Predicted environmental concentrations of cyantraniliprole (DPX-HGW86) and
its soil and water metabolites in surface
water and sediment following applications of the OD formulation - a
modeling study conducted with the
endpoints recommended in the EFSA Conclusion Dr. Knoell Consult GmbH,
DuPont Stine-Haskell Research Center DuPont-38329 EU GLP: No Published:
No
N N FMC
KIIIA, 9.6/05 2014 Leaching behaviour of the OD
formulation of cyantraniliprole (DPX-HGW86) and its metabolites - a
modeling study conducted for the
Netherlands with GeoPEARL 3.3.3 GVK Biosciences Private Limited
DuPont Stine-Haskell Research Center
DuPont-37848 NL GLP: No Published: No
N N FMC
KIIIA, 9.6/06 2017a Leaching behaviour of the OD
formulation of cyantraniliprole (DPX-
HGW86) and its metabolites - a modeling study conducted for the
Netherlands with GeoPEARL 3.3.3
Supplement no.1: additional modeling with multiple application dates
Excelra Knowledge Solutions Private
Limited DuPont Stine-Haskell Research Center
DuPont-37848 NL, Supplement No. 1
GLP: No Published: No
N N FMC
KIIIA, 9.6/07 2017b Leaching behaviour of the OD
formulation of cyantraniliprole (DPX-
HGW86) and its metabolites - a modeling study conducted for the
Netherlands with GeoPEARL 3.3.3
Supplement no.2: refined modeling for IN-M2G98
Excelra Knowledge Solutions Private
Limited DuPont Stine-Haskell Research Center
DuPont-37848 NL, Supplement No. 2
GLP: No Published: No
N N FMC
KIIIA, 9.6/08 2017 Cyantraniliprole 625 g/l FS Registration Report part B section 8: Assessment of
the relevance of metabolites in
groundwater - detailed summary of the risk assessment
DuPont
DuPont-36028 EU, Revision No. 1 GLP: No Published: No
N N FMC
KIIIA, 9.6/09 2017 IN-K5A79: Bacterial Reverse Mutation
Test DuPont Haskell Global Centers for
Health & Environmental Sciences
DuPont-44973 Revision 1 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 43 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA, 9.6/10 2015 IN-K5A79: In Vitro Mammalian
Chromosome Aberration Test in Human Peripheral Blood Lymphocytes
DuPont Haskell Global Centers for
Health & Environmental Sciences DuPont-44974
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/11 2015 IN-K5A79: In Vitro Mammalian Cell
Forward Gene Mutation (CHO/HPRT) Assay with
Duplicate Cultures
BioReliance Corporation DuPont-44975
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/12 2017 IN-K5A78: Bacterial Reverse Mutation Test
DuPont Haskell Global Centers for
Health & Environmental Sciences DuPont-45113
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/13 2015 IN-K5A78: In Vitro Mammalian
Chromosome Aberration Test in Human Peripheral Blood Lymphocytes
DuPont Haskell Global Centers for
Health & Environmental Sciences DuPont-45114
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/14 2015 IN-K5A78: In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT)
Assay with
Duplicate Cultures BioReliance Corporation
DuPont-45115
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/15 2017 IN-K5A79: Acute Oral Toxicity Study in Rats - Up-and- Down Procedure
DuPont Haskell Global Centers
for Health & Environmental Sciences DuPont-45251, Revision 1
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/16 2016 IN-K5A79: Repeated-Dose Oral
Toxicity 28-Day Feeding Study in Rats
DuPont Haskell Global Centers
for Health & Environmental Sciences DuPont-45276 VO1 & VO2
GLP: Yes Published: No
Y Y FMC
KIIIA, 9.6/17 2017 Leaching behaviour of cyantraniliprole (DPX-HGW86) and its metabolite IN-
M2G98 in Europe: Refined modeling
study conducted for SC, OD, SE and FS
formulations
Excelra Knowledge Solution Private Limited
DuPont-47675 EU
GLP: No Published: No
N N FMC
KIIIA,9.6/18 2017 Degradation of cyantraniliprole (DPX-HGW86) in the field dissipation study
conducted in the United Kingdom – a
kinetic calculation report Waterborne Environmental, Inc. (WEI)
DuPont-47676 EU
GLP: No Published: No
N N FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 44 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
KIIIA, 9.7/02
KIIIA, 9.8/02
2014 Predicted environmental concentrations
of the OD formulation of cyantraniliprole (DPX-HGW86) and its
metabolites in surface water and
sediment following applications to various crops in the Netherlands: A
modelling study using TOXSWA 1.2
and DROPLET 1.1 Dr. Knoell Consult GmbH, DuPont DuPont-36651 NL GLP:
No Published: No
N N FMC
KIIIA, 10.2.2.2/01 2014 Cyantraniliprole (DPX-HGW86)
technical: A 48-hour static-renewal acute toxicity test with Hyalella Azteca
Wildlife International Ltd. (USA) DuPont-37852 GLP: Yes Published: No
Y Y FMC
KIIIA, 10.4/01 2011 Cyantraniliprole: Honeybee risk
assessment DuPont de Nemours
(Deutschland) GmbH DuPont-31516 EU, Revision No. 1 GLP: No Published:
No
N N FMC
KIIIA, 10.4.6/01 2011 Data supporting insignificant exposure
of cyantraniliprole and its metabolites to honey bees from uptake of soil residues
DuPont Stine-Haskell Research Center
Laboratories DuPont-30776 EU GLP: No Published: No
N N FMC
KIIIA, 6.0/01
KIIIA, 6.0/02
2014 Cyantraniliprole 100 g/L OD, 100 g/L
oil in water dispersion (OD): Biological assessment dossier (Central zone) E. I.
du Pont de Nemours and Company
DuPont-37256 CEU GLP: No Published: No
N N FMC
KIIIA, 6.1/01 2014 DPX-HGW86 100 g/L OD: Trial reports
efficacy, selectivity and yield (Central
zone) DuPont de Nemours (France) S.A.S. DuPont-43004 CEU GEP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 45 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
IIIA,1.4.1/01 2011 Product identity and compostion of end-
use product DPX-HGW86 100 g/L OD DuPont Stine-Haskell Research Center
DuPont-24546, Revision No.2 and
DuPont-24546 Revision No. 2 confidential attachment GLP: No
Published: No
Y Y FMC
IIIA, 2.1/01 2009 Cyantraniliprole (DPX-HGW86) 100 g/Liter OD oil-based suspension
concentrate formulation: Summary
report of laboratory study of physical and chemical characteristics Advinus
Therapeutics Private Limited, Chilworth
Technology Ltd. DuPont-21817 GLP: No Published: No
Y Y FMC
IIIA, 2.1/02 2008 DPX-HGW86 100 g/Liter OD oil
dispersion (oil-based suspension
concentrate) formulation: Laboratory study of physical and chemical
properites Advinus Therapeutics Private
Limited DuPont-21307 GLP: Yes Published: No
Y Y FMC
IIIA, 2.2.1/02 2009 Cyantraniliprole 100 g/Liter OD Oil
dispersion (oil-based suspension concentrate) formulation
(DPX-HGW86): Laboratory study of
flash point, explosive properties and auto-ignition temperature of liquids
Chilworth Technology Limited DuPont-
21816 GLP: Yes Published: No
Y Y FMC
IIIA, 2.13/01 2010 Cyantraniliprole (DPX-HGW86) 100
g/liter OD oil-based suspension
concentrate formulation: Laboratory study of storage stability and corrosion
characteristics International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-21553 GLP: Yes Published:
No
Y Y FMC
IIIA, 4.2.2/01 2010 Cyantraniliprole 100 g/Liter OD:
Laboratory study of spray tank cleanout International Institute of Biotechnology
and Toxicology (IIBAT) DuPont-29886
GLP: No Published: No
Y Y FMC
IIIA, 7.1.1/01 2008 DPX-HGW86 100 g/L OD: Acute oral
toxicity - up and down procedure in rats
DuPont-26449 GLP: Yes Published: No
Y Y FMC
IIIA, 7.1.2/01 2008 DPX-HGW86 100 g/L OD: Acute
dermal toxicity study in rats DuPont-
26450 GLP: Yes Published: No
Y Y FMC
IIIA, 7.1.3/01 2009 Cyantraniliprole (DPX-HGW86)
100 g/L OD: Inhalation median lethal
concentration (LC50) study in rats DuPont-27807 Revision No. 1 GLP:
Yes Published: No
Y Y FMC
IIIA, 7.1.4/01 2006 DPX-HGW86 100 g/L OD: Acute dermal irritation study in rabbits
DuPont-19079 GLP: Yes Published:
No
Y Y FMC
IIIA, 7.1.5/01 2006 DPX-HGW86 100 g/L OD: Acute eye irritation study in rabbits DuPont-19080
GLP: Yes Published: No
Y Y FMC
IIIA, 7.1.6/01 2006 DPX-HGW86 100 g/L OD: Local lymph node assay (LLNA) in mice
DuPont-19081 GLP: Yes Published:
No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 46 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
IIIA, 7.1.6/02 2009 DPX-HGW86 100 g/L OD: Dermal
sensitization test - Buehler method DuPont-22769, Revision No. 1 GLP:
Yes Published: No
Y Y FMC
IIIA, 7.6.1/01 2008 Cyantraniliprole (DPX-HGW86) 100 g/L OD: In vivo dermal absorption
of cyantraniliprole in rat DuPont-24503
GLP: Yes Published: No
Y Y FMC
IIIA, 7.6.2/01 2008 Cyantraniliprole (DPX-HGW86) 100 g/L OD: In vitro kinetics of
cyantraniliprole in rat and human skin
DuPont-24504 GLP: Yes Published: No
Y Y FMC
IIIA, 9.4/01 2010 The degradation of cyantraniliprole
(DPX-HGW86) and metabolites in aerobic soil - summary of kinetic
calculations Waterborne
Environemental, Inc. (WEI) DuPont-29554, Revision No. 2 GLP:
Not given Published: No
Y Y FMC
IIIA, 9.4/02 2010 Predicted environmental concentrations
of cyantraniliprole (DPX-HGW86) and its metabolites in soil Simulogic
Environmental Consulting Pvt. Ltd.
DuPont-29548 EU GLP: No Published: No
Y N FMC
IIIA, 9.6/01 2011 Tier 1 groundwater and surface water
and Tier 2 surface water exposure assessment of cyantraniliprole
(DPX-HGW86) and its metabolites in
the United States Waterborne Environmental, Inc. DuPont-29549
GLP: No Published: No
Y N FMC
IIIA, 9.6/02 2010 Leaching behaviour of the OD formulation of cyantraniliprole
(DPX-HGW86) and its metabolites - a
modeling study conducted with FOCUS PELMO 3.3.2 and FOCUS PEARL
3.3.3 Simulogic Environmental
Consulting Pvt. Ltd. DuPont-29249 EU GLP: No Published: No
Y N FMC
IIIA, 9.6/03 2010 The degradation of cyantraniliprole
(DPX-HGW86) in aquatic systems, via
photolysis and in anaerobic soil - summary of kinetic calculations DuPont
Stine-Haskell Research Center DuPont-
29552 GLP: No Published: No
Y Y FMC
IIIA, 9.7/01 2011 Predicted concentrations of
cyantraniliprole - OD formulation
(DPX-HGW86), and its metabolites in surface waters in Europe - a modeling
study conducted with FOCUS surface
water scenarios Simulogic Environmental Consulting Pvt. Ltd.
DuPont-29252, Revision No. 1 GLP:
No Published: No
Y N FMC
IIIA, 10.1.6/01 2009 Cyantraniliprole 100 g/L OD: An acute
oral toxicity study with the northern
bobwhite (Colinus virginianus) Wildlife International, Ltd. DuPont-24484
GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 47 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Data protection granted Y/N
Owner
IIIA, 10.2.2.1/01 2009 Cyantraniliprole (DPX-HGW86)
100 g/L OD: A 96-hour static acute toxicity test with the bluegill
(Lepomis macrochirus) Wildlife
International, Ltd. DuPont-26581 GLP: Yes Published: No
Y Y FMC
IIIA, 10.2.2.2/01 2006 DPX-HGW86 100 g/L OD: Static,
acute, 48-hour toxicity test to Daphnia magna DuPont Haskell
Laboratories DuPont-19853 GLP: Yes
Published: No
Y Y FMC
IIIA, 10.2.2.2/02 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus codacide, oil: Static,
acute, 48-hour toxicity test with the
cladoceran, Daphnia magna DuPont Haskell Laboratories; Critical Path
Services, LLC (CPS) DuPont-29051
GLP: Yes Published: No
Y Y FMC
IIIA, 10.2.2.3/01 2009 Cyantraniliprole (DPX-HGW86)
100 g/L OD: A 72-hour toxicity test
with the freshwater alga, Pseudokirchneriella subcapitata
Wildlife International, Ltd.
DuPont-26715 GLP: Yes Published: No
Y Y FMC
IIIA, 10.5/01 2011 Cyantraniliprole: Non-target arthropod
risk assessment for the EU DuPont de Nemours (Deutschland) GmbH DuPont-
31525 EU GLP: Not applicable -
position paper Published: No
Y Y FMC
IIIA, 10.6.2/01 2008 DPX-HGW86 100 g/L OD: Acute toxicity to the earthworm, Eisenia fetida
in artificial soil International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-24879 GLP: Yes Published:
No
Y Y FMC
IIIA, 10.6.3/01 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus codacide oili: Effects
on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat Institut fur
Biologische Analytik und Consulting
IBACON GmbH DuPont-29052 GLP: Yes Published:
No
Y Y FMC
IIIA, 10.7.1/01 2008 Cyantraniliprole (DPX-HGW86)
100 g/L OD: Assessment of the effects on soil microflora Institut fur
Biologische Analytik und Consulting
IBACON GmbH DuPont-24875 Revision No. 1 GLP:
Yes Published: No
Y Y FMC
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 48 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.0
Mode of action of cyantraniliprole
and implications on the selection of
efficacy data presented. Internal
position paper.
DuPont N N Y Y Y 201
6
DuPont-
46963
6.0 Cyantraniliprole active substance
Labels and leaflets DuPont N N Y Y Y
201
3
DP-
27752
6.0
Laboratory evaluation of time to
stop feeding for DPX-E2Y45
35WG, DPX-HGW86 10OD,
indoxacarb 30WG and competitive
products on 2nd instar Mamestra
brassicae larvae, on cabbage leaves
DuPont
ERDC,
FR
N N Y Y Y 200
9 I-09-001
6.0
Laboratory evaluation of time to
stop feeding and time to kill of
DPX-E2Y45 35WG, DPX-HGW86
10OD, DPX-MP062 30WG,
methomyl 20L vs. competitive
products on 2nd and 4th instar
Helicoverpa armigera larvae on
cotton leaves.
DuPont
ERDC,
FR
N N Y Y Y 201
1 I-11-008
6.0
Laboratory evaluation of time to
kill of DPX-E2Y45 20SC and
DPX-HGW86 10OD vs. competitor
products on Leptinotarsa
decemlineata on potato leaves
DuPont N N Y Y Y 201
1 I-11-020
6.0
Laboratory evaluation of time for
feeding cessation of various
feeding stages of Leptinotarsa
decemlineata exposed to potato
leaves treated with DPX-E2Y45
20SC, DPX-HGW86 10OD or
competitive products
DuPont N N Y Y Y 201
1 I-11-021
6.0
Laboratory evaluation of the
residual activity of DPX-E2Y45
35WG, DPX-HGW86 10OD and
indoxacarb 30WG on Helicoverpa
armigera on tomato, in comparison
with competitors (methoxyfenozide
and metaflumizone).
DuPont N N Y Y Y 200
9 I-09-003
6.0
Evaluation of potency and residual
performance of DPX-E2Y45
35WG and DPX-HGW86 10OD
used straight or with 0.25%v/v of
Codacide® on Helicoverpa
armigera eggs.
DuPont N N Y Y Y 201
1 I-11-006
6.0
Laboratory evaluation of Lannate®
20L (methomyl), DPX-E2Y45
35WG, DPX-HGW86 10OD and
Talstar® Flo (bifenthrin) applied
by direct spray on Helicoverpa
DuPont N N Y Y Y 201
0 I-10-004
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 49 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
armigera adults.
6.0
Larvae instars sensitivity of
Helicoverpa armigera to DPX-
HGW86 10OD in laboratory
conditions.
DuPont N N Y Y Y 201
2 I-12-001
6.0
Laboratory evaluation of the
potency of DuPont Insecticides
Portfolio on Tuta absoluta, activity
on different stages of the insect.
DuPont N N Y Y Y 201
2 I-11-501
6.0
Potency of DPX-E2Y45 20Sc and
DPX-HGW86 10OD against
Leptinotarsa decemlineata adults
on potato plants in laboratory
conditions.
DuPont N N Y Y Y 201
3 I-13-001
6.0 Cyazypyr™ translaminar activity
on Myzus persicae on pepper DuPont N N Y Y Y
200
8 I-08-001
6.0 Evaluation of Cyazypyr™ and
Rynaxypyr™ potency on
Leptinotarsa decemlineata larval
instars.
DuPont N N Y Y Y 201
1 I-11-002
6.2.5 Cyantraniliprole OECD Dossier
IIA Section 4 Residue chemistry. DuPont Y N Y Y Y
201
1
DuPont-
27749
6.2.6 Cyantraniliprole Annex IIIA:
Section 5: Fate in the environment. DuPont N N Y Y Y
201
1
DuPont-
27750
6.1.1 Cyazypyr™ Biological Activity in
Discovery Screens
DuPont,
US N N Y Y Y
201
0
DuPont-
37990
6.1.1.1 Cyazapyr™ translaminar activity
on Myzus persicae on pepper
DuPont
ERDC,
FR
N N Y Y Y 200
8 I-08-001
6.1.1.1
Laboratory characterization of
Cyazapyr™ applied by foliar
application against Bemisia tabaci
on sweet pepper
DuPont
ERDC,
FR
N N Y Y Y 201
0 I-10-013
6.1.2,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD on Colorado
Potato Beetle in Potatoes
ATC
Gerhaus Y N Y Y Y
200
9
AST-09-
330
6.1.2,
6.2.1
Insekticide: The efficacy and crop
safety of DPX-HGW86 10OD on
Colorado Potato Beetle in Potatoes
Krasne
Udoli Y N Y Y Y
201
0
CZE-10-
610
6.1.2,
6.2.1
Insekticide: The efficacy and crop
safety of DPX-HGW86 10OD on
Colorado Potato Beetle in Potatoes
Zkusebni
Stanice
Trutnov.
s.r.o.
Y N Y Y Y 201
0
CZF-10-
610
6.1.2,
6.2.1
Insekticide: The efficacy and crop
safety of DPX-HGW86 10OD on
Colorado Potato Beetle in Potatoes
Zs
Kujavy Y N Y Y Y
201
0
CZM-10-
610
6.1.2,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD and 10SE on
Colorado Potato Beetle in Potatoes
DuPont
DE Y N Y Y Y
200
8
DUH-08-
641
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 50 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.1.2,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD and 10SE on
Colorado Potato Beetle in Potatoes
DuPont
DE Y N Y Y Y
200
8
DUL-08-
831
6.1.2,
6.2.1
Efficacy evaluation of insecticides
against the Colorado potato beetle HLB Y N Y Y Y
200
8
BNB-08-
836
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety of DPX-
E2Y45 20SC and DPX-HGW86
10OD on Colorado Potato Beetle in
Potatoes
Agrostat
Sp. Y N Y Y Y
200
8
PLF-08-
303
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD and DPX-
E2Y 45 20 SC on Colorado Potato
Beetle in Potatoes
Agrostat
Sp. Y N Y Y Y
200
9
PLF-09-
610
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD and DPX-
E2Y 45 20 SC on Colorado Potato
Beetle in Potatoes
Agrostat
Sp. Y N Y Y Y
200
9
PLF-09-
611
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD on Colorado
Potato Beetle in Potatoes
Agrostat
Sp. Y N Y Y Y
201
0
PLF-10-
610
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-HGW86
10OD on Colorado Potato Beetle in
Potatoes
Agrostat
Sp. Y N Y Y Y
201
1
PLF-11-
610
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion after foliar
application of HGW86 10OD to
control Delia antiqua
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
0
BNE-10-
876
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion after foliar
application of HGW86 10OD to
control Delia antiqua
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
876
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion after foliar
application of HGW86 10OD to
control Delia antiqua
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
877
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion or leek after foliar
application of HGW86 10OD to
control Delia antiqua
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
876
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion after foliar
application of HGW86 10OD to
control Delia antiqua
Applied
Plant
Research
Y N Y Y Y 201
0
BNI-10-
877
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion after foliar
application of HGW86 10OD to
control Delia antiqua
Applied
Plant
Research
Y N Y Y Y 201
0
BNI-10-
878
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion or leek after foliar
Proeftuin
ZwaagdijY N Y Y Y
201
3
BNE-13-
877
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 51 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
application of HGW86 10OD to
control Delia antiqua
k
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD on Thrips
tobaci on onions.
Agrartest Y N Y Y Y 201
1
DUI-11-
849
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety of DPX-
HGW86 10OD on Thrips tabaci on
onions or leeks in the UK, OAT
Oxford
Agricultur
al Trials
Y N Y Y Y 201
0
GBA-10-
663
6.1.2,
6.1.3,
6.2.1
The Efficacy and crop safety of
DPX-HGW86 10OD on Thrips
tabaci on onions. Retford. OAT
Oxford
Agricultur
al Trials
Y N Y Y Y 201
1
GBA-11-
665
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety of DPX-
HGW86 10OD on Thrips tabaci on
onions or leeks in the UK, OAT
Oxford
Agricultur
al Trials
Y N Y Y Y 201
0
GBC-10-
663
6.1.2,
6.1.3,
6.2.1
The Efficacy and crop safety of
DPX-HGW86 10OD on Thrips
tabaci on onions.
BIOTEK
Agr. HU Y N Y Y Y
201
1
HUM-11-
805
6.1.2,
6.1.3,
6.2.1
The Efficacy and crop safety of
DPX-HGW86 10OD on Thrips
tabaci on onions.
BIOTEK
Agr. HU Y N Y Y Y
201
1
HUM-11-
810
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety of onion
and leeks after foliar application of
HGW86 10OD to control Thrips
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
664
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
834
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
835
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety and plant
health of onion and leeks after
foliar application of HGW86 10OD
to control Thrips
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
831
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Exploras
Agro
Developm
ent
Y N Y Y Y 201
0
BNG-10-
826
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Exploras
Agro
Developm
ent
Y N Y Y Y 201
0
BNG-10-
827
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Exploras
Agro
Developm
ent
Y N Y Y Y 201
1
BNG-11-
831
6.1.2,
6.1.3,
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
Exploras
Agro Y N Y Y Y
201
1
BNG-11-
832
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 52 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.2.1 application for the control of Thrips
tabaci in leek.
Developm
ent
6.1.2,
6.1.3,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD as a foliar
application for the control of Thrips
tabaci in leek.
Exploras
Agro
Developm
ent
Y N Y Y Y 201
1
BNG-11-
833
6.1.2,
6.1.3,
6.2.1
The Efficacy and crop safety of
DPX-HGW86 10OD on Thrips
tabaci on Leeks.
Oxford
Agricultur
al Trials
Y N Y Y Y 201
1
GBA-11-
666
6.1.2,
6.1.3,
6.2.1
HGW LEEKS – Thrips tabaci.
Coningsby. (Eurofins) Eurofins Y N Y Y Y
201
2
GBA-12-
606
6.1.2,
6.1.3,
6.2.1
Efficacy and crop safety of onion
and leeks after foliar application of
HGW86 10OD to control Thrips
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
663
6.1.3
Evaluation of the performance of
DPX-E2Y45 20SC and DPX-
HGW86 10OD against L.
decemlineata on potato at different
temperatures, vs. other commercial
products
DuPont/E
RDC N N Y Y Y
201
0 I-10-014
6.1.2,
6.1.3,
6.2.1
Rate justification of HGW86
100OD against Psila rosae – Carrot
Fly in Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
871
6.1.2,
6.1.3,
6.2.1
Rate justification of HGW86
100SE against Psila rosae – Carrot
Fly in Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
872
6.1.2,
6.1.3,
6.1.4,
6.2.1
Rate justification and interval
comparison of HGW86 100OD
against Psila rosae – Carrot Fly in
Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
871
6.1.3,
6.1.4,
6.2.1
Efficacy of HGW86 100OD against
Psila rosae – Carrot Fly in Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
872
6.1.3.
6.1.4,
6.2.1
Efficacy of HGW86 100OD against
Psila rosae – Carrot Fly in Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
873
6.1.2,
6.1.3,
6.1.4,
6.2.1
Rate justification and interval
comparison of HGW86 100OD
against Psila rosae – Carrot Fly in
Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
871
6.1.3,
6.1.4,
6.2.1
Rate justification and interval
comparison of HGW86 100OD
against Psila rosae – Carrot Fly in
Carrot
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
874
6.1.2,
6.1.3,
6.1.4,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD and 10SE on
against carrot fly in carrot.
Landwirts
chaftskam
mer
Nordrhein
Y N Y Y Y 201
1
DUR-11-
320
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 53 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
-
Westfalen
Dienststel
le Bonn
6.1.2,
6.1.3,
6.2.1
Rate justification and interval
comparison of HGW86 100OD
against Psila rosae – Carrot Fly in
Carrot
Landwirts
chaftskam
mer
Niedersac
hsen
Pflanzens
chutzamt
Y N Y Y Y 201
2
DUR-12-
382
6.1.2,
6.1.3,
6.2.1
Rate justification and interval
comparison of HGW86 100OD
against Psila rosae – Carrot Fly in
Carrot
Landwirts
chaftskam
mer
Niedersac
hsen
Pflanzens
chutzamt
Y N Y Y Y 201
3
DUR-13-
385
6.1.3,
6.2.1
DPX-E2Y45 35WG, DPX-HGW86
100OD / Carrot / Field efficacy on
Psila rosae
Unilet Y N Y Y Y 200
9
FRG-09-
741
6.1.2,
6.1.3,
6.2.1
Insect: EPPO 14 Psila rosae –
Carrot Fly Crop: Carrot Sileban Y N Y Y Y
200
9
FRG-09-
765
6.1.2,
6.1.3,
6.1.4
Control of carrot fly on carrots with
cyazypyr and rynaxypyr HRI Y N Y Y Y
200
9
GBA-09-
635
6.1.2,
6.1.3,
6.1.4,
6.2.1
Carrot Fly Mortality – Effects of
Aging residues HRI Y N Y Y Y
201
1
GBA-11-
668
6.1.2,
6.1.3,
6.1.4,
6.2.1
Control of Carrot Fly on Carrots.
Wellesbourne. HRI HRI Y N Y Y Y
201
2
GBA-12-
608
6.1.2,
6.1.3,
6.1.4
Control of carrot fly on carrots with
cyazypyr and rynaxypyr HRI Y N Y Y Y
200
9
GBB-09-
635
6.1.2,
6.1.3,
6.1.4,
6.2.1
Carrot Fly Mortality – Effects of
Aging residues HRI Y N Y Y Y
201
1
GBB-11-
668
6.1.2,
6.1.3,
6.1.4,
6.2.1
The efficacy and crop safety of
DPX-HGW86 10OD in control
Psila rosae – Carrot Fly on carrot
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
635
6.1.2,
6.1.3,
6.1.4,
The efficacy and crop safety of
DPX-HGW86 10OD in control
Psila rosae – Carrot Fly on carrot
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
636
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 54 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.2.1
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45 and
DPX-HGW86 for the control of
Plutella xylostella in cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 200
9
BND-09-
831
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45 and
DPX-HGW86 for the control of
Plutella xylostella in cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 200
9
BND-09-
832
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45
(Coragen) and DPX-HGW86 for
the control of Plutella xylostella in
cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 201
0
BND-10-
831
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45
(Coragen) and DPX-HGW86 for
the control of Plutella xylostella in
cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 201
0
BND-10-
832
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45
(Coragen) and DPX-HGW86 for
the control of Plutella xylostella in
cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 201
0
BND-10-
833
6.1.2,
6.1.3,
6.2.1
The efficacy of DPX-E2Y45
(Coragen) and DPX-HGW86 for
the control of Plutella xylostella in
cauliflower
De
Bredelaar
B.V.
Y N Y Y Y 201
0
BND-10-
834
6.1.3,
6.2.1
Efficacy of foliar appl. HGW86
100 OD and Coragen 20 SC against
Delia brassica in Brussels sprouts
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
823
6.1.3,
6.1.4
Efficacy of foliar appl. HGW86
100 OD and Coragen 20 SC against
Delia brassica in Brussels sprouts
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
824
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC t control Delia radicum
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
1
BNE-11-
826
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
821
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
822
6.1.2,
6.1.3,
6.2.1
Efficacy of HGW86 10OD as foliar
application to control Whiteflies in
Brussels sprouts
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
823
6.1.2,
6.1.3,
6.2.1
Efficacy of HGW86 10OD as foliar
application to control Whiteflies in
Brussels sprouts
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
2
BNE-12-
824
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control flea beetles
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
818
6.1.2, Efficacy, crop safety/health of Proeftuin Y N Y Y Y 201 BNE-13-
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 55 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.1.3,
6.2.1
cabbage after foliar appl. HGW86
10OD to control flea beetles
Zwaagdij
k
3 819
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
821
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
822
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
823
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
824
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
825
6.1.2,
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC t control Delia radicum
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
826
6.1.2,
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC t control Delia radicum
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
827
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Delia radicum
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
828
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Delia radicum
Proeftuin
Zwaagdij
k
Y N Y Y Y 201
3
BNE-13-
829
6.1.2,
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Landwirts
chaftskam
mer
Niedersac
hsen
Pflanzens
chutzamt
Y N Y Y Y 201
2
DUR-12-
385
6.1.2,
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control lepidoptera
Landwirts
chaftskam
mer
Nordrhein
-
Westfalen
Dienststel
le Bonn
Y N Y Y Y 201
2
DUR-12-
386
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control Whiteflies
Landwirts
chaftskam
mer
Y N Y Y Y 201
3
DUR-13-
381
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 56 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
Niedersac
hsen
Pflanzens
chutzamt
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control whiteflies
Landwirts
chaftskam
mer
Nordrhein
-
Westfalen
Dienststel
le Bonn
Y N Y Y Y 201
3
DUR-13-
382
6.1.2.
6.1.3,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD to control lepidoptera
Biochem
Agrar
Gmbh
Y N Y Y Y 201
3
DUR-13-
383
6.1.2,
6.1.3,
6.2.1
DPX-HGW86 100OD / Cabbage /
Field efficacy on Lepidoptera
Eurofins
Agroscien
ce
Y N Y Y Y 201
3
FRL-13-
714
6.1.2,
6.1.3,
6.2.1
HGW86 10OD with and without
Codacide on Lepidoptera (Plutella
xylostella, P.brassicae, P.rapae,
M.brassicae) on cabbage
Oat Y N Y Y Y 201
0
GBA-10-
631
6.1.2,
6.1.3
DPX-HGW86 10OD plus Codacide
for whitefly (Aleyrodes proletella)
control on cabbage, cauliflower
Oat Y N Y Y Y 201
0
GBA-10-
632
6.1.2,
6.1.3,
6.1.4,
6.2.1
Evaluation of Cyazypyr for control
of cabbage root fly. HRI
Wellesbourne
HRI Y N Y Y Y 201
2
GBA-12-
603
6.1.2,
6.1.4,
6.2.1
HGW 1 Cabbage - Whitefly. Kirton
Holme. Eurofins Eurofins Y N Y Y Y
201
2
GBA-12-
605
6.1.2,
6.1.3,
6.1.4,
6.2.1
Title: HGW 100OD Brassica :
Whitefly. Whaplode. eurofins Eurofins Y N Y Y Y
201
3
GBA-13-
601
6.1.2,
6.1.3,
6.1.4,
6.2.1
HGW 100OD Brassica: Leps.
Whaplode. Eurofins Eurofins Y N Y Y Y
201
3
GBA-13-
602
6.1.4 HGW 200SC Brassica: Delia
radicum . Little Cherry. HRI HRI Y N Y Y Y
201
3
GBA-13-
603
6.1.2,
6.1.3
DPX-HGW86 10OD plus Codacide
for whitefly (Aleyrodes proletella)
control on cabbage, cauliflower
Oat Y N Y Y Y 201
0
GBB-10-
632
6.1.2,
6.1.3,
6.1.4,
6.2.1
Evaluation of Cyazypyr for control
of cabbage root fly. HRI
Wellesbourne
HRI Y N Y Y Y 201
2
GBB-12-
603
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 57 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.1.2,6.1
.3, 6.1.4,
6.2.1
HGW 2 Cauliflower - Whitefly.
Kirton Holme. Eurofins Eurofins Y N Y Y Y
201
2
GBB-12-
605
6.1.2,
6.1.3,
6.1.4,
6.2.1
Title: HGW 100OD Brassica:
Whitefly. Melbourne Eurofins Eurofins Y N Y Y Y
201
3
GBB-13-
601
6.1.2,
6.1.3,
6.2.1
HGW 100OD Brassica: Leps.
Kirton Holme. Eurofins Eurofins Y N Y Y Y
201
3
GBB-13-
602
6.1.2,
6.1.3,
6.2.1
HGW86 10OD with and without
Codacide on Lepidoptera (Plutella
xylostella, P.brassicae, P.rapae,
M.brassicae) on cabbage
Oat Y N Y Y Y 201
0
GBC-10-
631
6.1.2,
6.1.3,
6.1.4,
6.2.1
Title: HGW 100OD Brassica:
Whitefly. Fosdyke Eurofins Eurofins Y N Y Y Y
201
3
GBC-13-
601
6.1.2,
6.1.3,
6.1.4,
6.2.1
HGW86 10OD on Lepidoptera
(Plutella xylostella, P.brassicae,
P.rapae, M.brassicae) on cabbage
Biotek
Ag. Y N Y Y Y
201
0
PLE-10-
631
6.1.2,
6.1.3,
6.1.4,
6.2.1
HGW86 10OD on Lepidoptera
(Plutella xylostella, P.brassicae,
P.rapae, M.brassicae) on cabbage
Biotek
Ag. Y N Y Y Y
201
0
PLE-10-
632
6.1.2,
6.1.3,
6.2.1
HGW86 10OD plus Codacide -
Lepidop (P.brassicae, P.rapae,
M.brassicae) on cabbage,
cauliflower
Agrostat
Sp. Y N Y Y Y
201
0
PLF-10-
632
6.1.2,
6.1.3,
6.1.4,
6.2.1
Effectiveness of HGW86 100SC
and HGW86 100OD on Delia
radicum (Root Fly ) on cabbage
Agrostat
Sp. Y N Y Y Y
201
1
PLF-11-
633
6.1.2,
6.1.3,
6.1.4,
6.2.1
Effectiveness of HGW86 100SC
and HGW86 100OD on Delia
radicum (Root Fly ) on cabbage
Agrostat
Sp. Y N Y Y Y
201
1
PLF-11-
634
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC to control Delia radicum
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
630
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC to control Delia radicum
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
631
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
632
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 58 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
20SC to control Delia radicum
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC to control Delia radicum
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
633
6.1.3,
6.1.4,
6.2.1
Efficacy, crop safety/health of
cabbage after foliar appl. HGW86
10OD or drench appl. HGW86
20SC t control Delia radicum
Agrostat
Sp. Y N Y Y Y
201
3
PLF-13-
603
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
668
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
669
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
670
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
671
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
672
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
2
PLF-12-
673
6.1.2,
6.1.3,
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
10OD/20SC on Anthonomus rubi
on strawberry /raspberry
Agrostat
Sp. Y N Y Y Y
201
3
PLF-13-
623
6.1.2,
6.1.3,
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
10OD/20SC on Anthonomus rubi
on strawberry /raspberry
Agrostat
Sp. Y N Y Y Y
201
3
PLF-13-
624
6.1.3,
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
3
PLF-13-
625
6.1.3,
6.1.4,
6.2.1
Registration trial to determine
efficacy and crop safety of HGW86
20SC/10OD on Anthonomus rubi
on strawberry
Agrostat
Sp. Y N Y Y Y
201
3
PLF-13-
626
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 59 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
6.1.4.1
Sensory evaluation of tomatoes
treated with DPX-HGW86 10 OD
(a.i. Cyantraniliprole) and DPX-
HGW86 10 OD + Codacide oil.
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
2
S-REP-
125374-1
6.1.4.1
Sensory evaluation of canned
tomatoes treated with DPX-
HGW86-329 (a.i.
Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 200
9
S-REP-
109991-1
6.1.4.1
Sensory evaluation of tomatoes
treated with DPX-HGW86-434 (a.i.
Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
0
S-REP-
114299-1
6.1.4.1
Sensory evaluation of green beans
treated with DPX-HGW86-329 (a.i.
Cyazapyr(Cyantraniliprole)).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 200
9
S-REP-
109991-3
6.1.4.1
Sensory evaluation of Green Beans
treated with DPX-HGW86 10 OD
(a.i. Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
2
S-REP-
125208-1
6.1.4.1
Sensory evaluation of potatoes
treated with DPX-HGW86-329 (a.i.
Cyazapyr).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 200
9
S-REP-
109991-2
6.1.4.1
Sensory Evaluation of Strawberries
treated with DPX-HGW86 100 OD
(a.i. Cyantraniliprole) with and
without Codacide Oil.
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
4
S-REP-
130044-7
(Strawber
ry_OD)
6.1.4.1
Sensory Evaluation of Carrots
Treated with DPX-HGW86 100
OD (a.i. Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
4
S-REP-
130044-4
(Carrots_
OD)
6.1.4.1
Sensory Evaluation of Cabbage
Treated with DPX-HGW86 100
OD (a.i. Cyantraniliprole) +
Codacide oil.
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
4
S-REP-
130044-3
(Cabbage
_OD)
6.1.4.1
Sensory Evaluation of Carrots
Treated with DPX-HGW86 (a.i.
Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
2
S-REP-
127173-9
6.1.4.1
Sensory Evaluation of Strawberries
Treated with DPX-HGW86 (a.i.
Cyantraniliprole).
CCFRA
Technolo
gy
Limited
Y N Y Y Y 201
2
S-REP-
127173-6
6.2.8
Insecticidal activity of a
developmental compound against
whiteflies.
Rothamst
ed
Research
N N Y Y Y 201
0 I-10-700
6.5.1 HGW86 SE (100g/L) and OD
(100g/L). Their sprayability and
DuPont
ERDC, Y N Y Y Y
200
8
AT-JPH-
08-011
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 60 of 66
Point Title
Test
Organisa
tion
GLP
/GE
P
Stud
y
(Y/N
)
Publ
ishe
d
(Y/N
)
Data
prote
ction
claim
ed
(Y/N)
Dat
a
prot
ecti
on
gra
nted
(Y/
N)
Stu
dies
relie
d on
(Y/
N)
Yea
r
DuPont
Report #
robustness to long tank sprayer
time residence
FR
6.5.1
Sprayability evaluation of HGW 86
SE and OD with Codacide in
different water volumes
DuPont
ERDC,
FR
Y N Y Y Y 201
0
AT-JPH-
10-006
6.5.1 Sprayability of HGW 10 OD and
SE in premix with Codacide.
DuPont
ERDC,
FR
Y N Y Y Y 201
0
AT-JPH-
10-016
6.5.3
Evaluation of Rynaxypyr 20SC and
Cyazyrpyr 10OD rain fastness vs.
commercial competitors on patato,
targeting Leptinotarsa decemlineata
neonate larvae.
DuPont/E
RDC N N Y Y Y
200
9 I-09-002
6.2.4
Cyantraniliprole: Non target
arthropod risk assessment for the
EU. Section B6.
DuPont Y N Y Y Y 201
3
DuPont-
35949
6.2.6
Cyantraniliprole (DPX-HGW86)
100 g/L OD: A Greenhouse Study
to Investigate the Effects on
Seedling Emergence and Growth of
Ten Terrestrial Plants Following
Soil Exposure
Wildlife
Internatio
nal Ltd.
MA,
USA.
Y N Y Y Y 200
9
DuPont-
21476
6.2.6
Cyantraniliprole (DPX-HGW86)
100 g/L OD + Codacide Oil: A
Greenhouse Study to Investigate
the Effects on Seedling Emergence
and Growth of Ten Terrestrial
Plants Following Soil Exposure
Wildlife
Internatio
nal Ltd.
MA,
USA.
Y N Y Y Y 201
0
DuPont-
29049
6.2.7
Cyantraniliprole (DPX-HGW86)
100 g/L OD: A Greenhouse Study
to Investigate the Effects on
Vegetative Vigor of Ten Terrestrial
Plants Following Foliar Exposure
Wildlife
Internatio
nal Ltd.
MA,
USA.
Y N Y Y Y 200
9
DuPont-
21475
6.2.7
DuPont-17052 – DPX-HGW86:
Laboratory study of vapor pressure
GLP: Yes, Published: No
DuPont
Stine-
Haskell
Research
Center
Y N Y Y Y 200
7
DuPont-
17052
6.2.7
Cyantraniliprole (DPX-HGW86)
100 glL OD + Codacide Oil: A
Greenhouse Study to Investigate
the Effects on Vegetative Vigor of
Ten Terrestrial Plants Following
Foliar Exposure
Wildlife
Internatio
nal Ltd.
MA,
USA.
Y Y Y Y Y 201
0
DuPont-
29050
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 61 of 66
Annex II studies
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 1.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.8.1/01 2011 Technical grade cyantraniliprole: Product identity and
composition, material use to produce products, production
process and formation of impurities DuPont Stine-Haskell
Research Center DuPont-28593, Revision No. 1 and DuPont-
28593, Revision No. 1, Confidential attachment GLP: No
Published: No
Y Y FMC
IIA, 1.8.1/02 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.8.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.9/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.9.2/01 2011 Cyantraniliprole (DPX-HGW86) certified limits
DuPont Stine-Haskell Research Center DuPont-31311,
Revision No. 1 and DuPont-31311, Revision No. 1,
Confidential attachment GLP: No Published: No
Y Y FMC
IIA, 1.10.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.11.1/01 2011 Batch analysis of IN-Q6S09 in cyantraniliprole (DPX-
HGW86) technical DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-32301 and DuPont-32301,
Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 1.11.1/02 2011 Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-27220, Supplement No. 1, Revision No. 1 and
DuPont-27220, Supplement No. 1, Revision No. 1,
Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 1.11.1/03 2011 Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center, DuPont Corporate
Center for Analytical Sciences, Galbraith Laboratories, Inc.
DuPont-27220, Revision No. 1 and DuPont-27220, Revision
No. 1, Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 1.11.1/04 2012a Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34347 and
DuPont-34347 Confidential attachment GLP: Yes Published:
No
Y Y FMC
IIA, 1.11.1/05 2012b Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34348 and
DuPont-34348 Condfidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.1/06 2012c Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34349 and
DuPont-34349 Condfidential attachment GLP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 62 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 1.11.1/07 2012d Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34347, Supplement No. 1 and DuPont-34347,
Supplement No. 1 Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.1/08 2012e Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34348, Supplement No. 1 and DuPont-34348,
Supplement No. 1 Condfidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.1/09 2012f Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34349, Supplement No. 1 and DuPont-34349,
Supplement No. 1 Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.2/01 2011a Characterization of cyantraniliprole toxicological sample
DPX-HGW86-141 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28165, Revision No. 1 and
DuPont-28165, Revision No. 1, Confidential attachment
GLP: Yes Published: Yes
Y Y FMC
IIA, 1.11.2/02 2011b Characterization of cyantraniliprole toxicological sample
DPX-HGW86-230 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28166, Revision No. 1 and
DuPont-28166, Revision No. 1, Confidential attachment
GLP: Yes Published: Yes
Y Y FMC
IIA, 1.11.2/03 2011c Characterization of cyantraniliprole toxicological sample
DPX-HGW86-412 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28167, Revision No. 1 and
DuPont-28167, Revision No. 1, Confidential attachment
GLP: Yes Published: Yes
Y Y FMC
IIA, 1.11.2/04 2011d Characterization of cyantraniliprole toxicological sample
DPX-HGW86-425 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28168, Revision No. 1 and
DuPont-28168, Revision No. 1, Confidential attachment
GLP: Yes Published: Yes
Y Y FMC
IIA, 1.11.2/05 2011e Characterization of cyantraniliprole toxicological sample
DPX-HGW86-648 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-31190, Revision No. 1 and
DuPont-31190, Revision No. 1, Confidential attachment
GLP: Yes Published: Yes
Y Y FMC
IIA,
2.5.2.1/01
2013 Confirmation of identity for determination of impurities in
technical grade cyantraniliprole (DPX-HGW86) DuPont
Stine-Haskell Research Center DuPont-38269, and DuPont-
38269, Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA,
2.5.2.3/01
2013 Confirmation of identity for determination of impurities in
technical grade cyantraniliprole (DPX-HGW86) DuPont
Stine-Haskell Research Center DuPont-38269, and DuPont-
38269, Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA,
2.5.2.4/01
2013 Confirmation of identity for determination of impurities in
technical grade cyantraniliprole (DPX-HGW86) DuPont
Stine-Haskell Research Center DuPont-38269, and DuPont-
38269, Confidential attachment GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 63 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 4.2.1/03 2009 Validation of the analytical method for determination of
DPX-HGW86 in technical grade DPX-HGW86 and DPX-
HGW86 end-use products Advinus Therapeutics Private
Limited DuPont-26440, Revision No. 1, and DuPont-26440,
Revision No. 1, Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 4.2.3/01 2011 Description and validation of the analytical methods for
determination of impurities in technical grade
cyantraniliprole (DPX-HGW86) DuPont Stine-Haskell
Research Center; DuPont Experimental Station; Galbraith
Laboratories, Inc. DuPont-28125, Revision No.1 and
DuPont-28125, Revision No. 1, Confidential attachment
GLP: Yes Published: No
Y Y FMC
IIA, 1.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.8.1/01 2011 Technical grade cyantraniliprole: Product identity and
composition, material use to produce products, production
process and formation of impurities DuPont Stine-Haskell
Research Center DuPont-28593 and DuPont-28593
Confidential attachment GLP: No Published No.
N N FMC
IIA, 1.8.1/02 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.8.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.9/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.9.2/01 2011 Cyantraniliprole (DPX-HGW86) certified limits DuPont
Stine-Haskell Research Center DuPont-31311, Revision No.
1 and DuPont-31311, Revision No. 1 Confidential attachment
GLP: No Published No.
N N FMC
IIA, 1.10.2/01 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 1.11.1/01 2011 Batch analysis of IN-Q6S09 in cyantraniliprole (DPX-
HGW86) technical DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-32301 and DuPont-32301
Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 1.11.1/02 2011 Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-27220, Supplement No. 1, Revision No. 1 and
DuPont-27220, Supplement No. 1, Revision No. 1,
Confidential attachment GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 64 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 1.11.1/03 2011 Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center, DuPont Corporate
Center for Analytical Sciences, Galbraith Laboratories, Inc.
DuPont-27220, Revision No.1 and DuPont-27220, Revision
No.1 Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 1.11.1/04 2012a Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34347 and
DuPont-34347 Confidential attachment GLP: Yes Published:
No
Y Y FMC
IIA, 1.11.1/05 2012b Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34348 and
DuPont-34348 Confidential attachment GLP: Yes Published:
No
Y Y FMC
IIA, 1.11.1/06 2012c Batch analysis of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34349 and
DuPont-34349 Confidential attachment GLP: Yes Published:
No
Y Y FMC
IIA, 1.11.1/07 2012d Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34347, Supplement No. 1 and DuPont-34347,
Supplement No. 1 Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.1/08 2012e Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34348, Supplement No. 1 and DuPont-34348,
Supplement No. 1 Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.1/09 2012f Batch chromatograms from the analysis of cyantraniliprole
(DPX-HGW86) technical DuPont Stine-Haskell Research
Center DuPont-34349, Supplement No. 1 and DuPont-34349,
Supplement No. 1 Confidential attachment GLP: Yes
Published: No
Y Y FMC
IIA, 1.11.2/01 2011a Characterization of cyantraniliprole toxicological sample
DPX-HGW86-141 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28165, Revision No. 1 and
DuPont-28165, Revision No. 1 Confidential attachment GLP:
Yes Published: No
Y Y FMC
IIA, 1.
11.2/02
2011b Characterization of cyantraniliprole toxicological sample
DPX-HGW86-230 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28166, Revision No. 1 and
DuPont-28166, Revision No. 1 Confidential attachment GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 65 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 1.
11.2/03
2011c Characterization of cyantraniliprole toxicological sample
DPX-HGW86-412 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28167, Revision No. 1 and
DuPont-28167, Revision No. 1 Confidential attachment GLP:
Yes Published: No
Y Y FMC
IIA, 1.11.2/04 2011d Characterization of cyantraniliprole toxicological sample
DPX-HGW86-425 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-28168, Revision No. 1 and
DuPont-28168, Revision No. 1 Confidential attachment GLP:
Yes Published: No
Y Y FMC
IIA, 1.11.2/05 2011e Characterization of cyantraniliprole toxicological sample
DPX-HGW86-648 DuPont Stine-Haskell Research Center,
DuPont Corporate Center for Analytical Sciences, Galbraith
Laboratories, Inc. DuPont-31190, Revision No. 1 and
DuPont-31190, Revision No. 1 Confidential attachment GLP:
Yes Published: No
Y Y FMC
IIA, 1.12/01 2012 Smiles string notation for DPX-HGW86 and its metabolites
DuPont Stine-Haskell Research Center DuPont-35732 GLP:
No Published: No
N N FMC
IIA, 2.1.1/01 2006 DPX-HGW86: Laboratory study of melting, boiling and
decomposition points Covance Laboratories Ltd DuPont-
19679 GLP: Yes Published: No
Y Y FMC
IIA, 2.1.1/02 2009 DPX-HGW86: Laboratory study of physical and chemical
properties of appearance (physical state, colour, odor),
relative density,bulk density melting point and boiling point
IIBAT DuPont-27440 GLP: Yes Published: No
Y Y FMC
IIA, 2.1.2/01 2009 DPX-HGW86: Laboratory study of physical and chemical
properties of appearance (physical state, colour, odor),
relative density,bulk density melting point and boiling point
IIBAT DuPont-27440 GLP: Yes Published: No
Y Y FMC
IIA, 2.1.3/01 2006 DPX-HGW86: Laboratory study of melting, boiling and
decomposition points Covance Laboratories Ltd DuPont-
19679 GLP: Yes Published: No
Y Y FMC
IIA, 2.2/01 2007 DPX-HGW86: Laboratory study of appearance and relative
density/bulk density Charles River Laboratories DuPont-
18863 GLP: Yes Published: No
Y Y FMC
IIA, 2.2/02 2009 DPX-HGW86: Laboratory study of physical and chemical
properties of appearance (physical state, colour, odor),
relative density,bulk density melting point and boiling point
International Institute of Biotechnology and Toxicology
(IIBAT) DuPont-27440 GLP: Yes Published: No
Y Y FMC
IIA, 2.3.1/01 2007 DPX-HGW86: Laboratory study of vapor pressure DuPont
Stine-Haskell Research Center DuPont-17052 GLP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 66 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 2.3.2/01 2007 DPX-HGW85\6: Volatility, calculation of Henry's law
constant DuPont Stine-Haskell Research Center DuPont-
18861 GLP: No Published: No
N N FMC
IIA, 2.4.1/01 2007 DPX-HGW86: Laboratory study of appearance and relative
density/bulk density Charles River Laboratories DuPont-
18863 GLP: Yes Published: No
Y Y FMC
IIA, 2.4.1/02 2009 DPX-HGW86: Laboratory study of physical and chemical
properties of appearance (physical state, colour, odor),
relative density,bulk density melting point and boiling point
IIBAT DuPont-27440 GLP: Yes Published
Y Y FMC
IIA, 2.4.2/01 2007 DPX-HGW86: Laboratory study of appearance and relative
density/bulk density Charles River Laboratories DuPont-
18863 GLP: Yes Published: No
Y Y FMC
IIA, 2.4.2/02 2009 DPX-HGW86: Laboratory study of physical and chemical
properties of appearance (physical state, colour, odor),
relative density,bulk density melting point and boiling point
IIBAT DuPont-27440 GLP: Yes Published: No
Y Y FMC
IIA,
2.5.1.1/01
2007 DPX-HGW86: Laboratory study of UV/visible absorption
and molar absorptivity Charles River Laboratories DuPont-
18862 GLP: Yes Published: No
Y Y FMC
IIA,
2.5.1.2/01
2008 DPX-HGW86: Spectra (mass spectrum, infrared spectrum,
and NMR) ABC Laboratories, Inc. DuPont-17053 GLP: Yes
Published: No
Y Y FMC
IIA,
2.5.1.3/01
2008 DPX-HGW86: Spectra (mass spectrum, infrared spectrum,
and NMR) ABC Laboratories, Inc. DuPont-17053 GLP: Yes
Published: No
Y Y FMC
IIA,
2.5.1.4/01
2008 DPX-HGW86: Spectra (mass spectrum, infrared spectrum,
and NMR) ABC Laboratories, Inc. DuPont-17053 GLP: Yes
Published: No
Y Y FMC
IIA,
2.5.1.5/01
2007 DPX-HGW86: Laboratory study of UV/visible absorption
and molar absorptivity Charles River Laboratories DuPont-
18862 GLP: Yes Published: No
Y Y FMC
IIA, 2.5.2/01 2013 Confirmation of identity for determination of impurities in
technical grade cyantraniliprole (DPX-HGW86) DuPont
Stine-Haskell Research Center DuPont-38269, and DuPont-
38269, Confidential attachment GLP: Yes Published: No
Y Y FMC
IIA, 2.6/01 2007 DPX-HGW86: Laboratory study of water solubility Charles
River Laboratories DuPont-17050 GLP: Yes Published: No
Y Y FMC
IIA, 2.7/01 2009 DPX-HGW86: Laboratory study of solubility in organic
solvents International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-27447 GLP: Yes Published: No
Y Y FMC
IIA, 2.8.1/01 2006 DPX-HGW86: Laboratory study of partition coefficient
DuPont Stine-Haskell Research Center DuPont-17054 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 67 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 2.8.2/01 2006 DPX-HGW86: Laboratory study of partition coefficient
DuPont Stine-Haskell Research Center DuPont-17054 GLP:
Yes Published: No
Y Y FMC
IIA, 2.9.1/01 2005 Hydrolytic stability of [14C]-DPX-HGW86 in buffered
aqueous solutions at pH 4, 7, and 9 Inveresk DuPont-17058
GLP: Yes Published: N
Y Y FMC
IIA, 2.9.2/01 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and
natural water Charles River Laboratories DuPont-17060
GLP: Yes Published: No
Y Y FMC
IIA, 2.9.3/01 2010 Quantum efficiency calculation for IN-RNU71, IN-QKV54
& IN-NXX70 (photolysis metabolites of DPX-HGW86) in
water DuPont Stine-Haskell Research Center DuPont-20286
GLP: No Published: No
N N FMC
IIA, 2.9.3/02 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and
natural water Charles River Laboratories DuPont-17060
GLP: Yes Published: No
Y Y FMC
IIA, 2.9.4/01 2008 Calculated theoretical lifetime for DPX-HGW86 in the top
layer of aqueous systems DuPont Stine-Haskell Research
Center DuPont-21506 GLP: No Published: No
N N FMC
IIA, 2.9.5/01 2007 DPX-HGW86: Laboratory study of dissociation constant
Charles River Laboratories DuPont-19176 GLP: Yes
Published: No
Y Y FMC
IIA, 2.10/01 2008 Photochemical oxidative degradation of DPX-HGW86
DuPont Stine-Haskell Research Center DuPont-21505 GLP:
No Published: No
N N FMC
IIA, 2.11.1/01 2006 DPX-HGW86 technical insecticide: Laboratory study of
explosive properties, flammability of solids, and the relative
self-ignition (autoflammability) temperature DuPont Stine-
Haskell Research Center DuPont-19178 GLP: Yes Published:
No
Y Y FMC
IIA, 2.11.2/01 2006 DPX-HGW86 technical insecticide: Laboratory study of
explosive properties, flammability of solids, and the relative
self-ignition (autoflammability) temperature DuPont Stine-
Haskell Research Center DuPont-19178 GLP: Yes Published:
No
Y Y FMC
IIA, 2.13/01 2006 DPX-HGW86 technical insecticide: Laboratory study of
explosive properties, flammability of solids, and the relative
self-ignition (autoflammability) temperature DuPont Stine-
Haskell Research Center DuPont-19178 GLP: Yes Published:
No
Y Y FMC
IIA, 2.14/01 2009 DPX-HGW86: Laboratory study of surface tension
International Institute of Biotechnology and Toxicology
(IIBAT) DuPont-27439 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 68 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 2.15/01 2008 DPX-HGW86: Laboratory study of oxidising properites
Advinus Therapeutics Private Limited DuPont-26092 GLP:
Yes Published: No
Y Y FMC
IIA, 2.16/01 2007 DPX-HGW86: Laboratory study of pH Charles River
Laboratories DuPont-19177 GLP: Yes Published: No
Y Y FMC
IIA, 2.16/02 2012 Cyantraniliprole (DPX-HGW86): Determination of pH ABC
Laboratories, Inc. (Missouri) DuPont-35171 GLP: Yes
Published No
Y Y FMC
IIA, 2.17.1/01 2010 DPX-HGW86: Laboratory study of storage stability and
corrosion characteristics International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-28001 GLP:
Yes Published: No
Y Y FMC
IIA, 2.17.2/01 2009 DPX-HGW86: Stability to normal and elevated temperature,
metals and metal ions International Institute of Biotechnology
and Toxicology (IIBAT) DuPont-27973 GLP: Yes Published:
No
Y Y FMC
IIA, 2.18/01 2007 Laboratory determination of the n-octanol/water partition
coefficients of DPX-HGW86 metabolites: Estimation by
HPLC DuPont Stine-Haskell Research Center DuPont-20591
GLP: Yes Published: No
Y Y FMC
IIA, 2.18/02 2010a IN-RNU71, IN-QKV54 and IN-NXX70 (photolysis products
of DPX-HGW86): Laboratory determination of the n-
octanol/water partition International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-30366 GLP:
Yes Published: No
Y Y FMC
IIA, 2.18/03 2010b IN-RNU71, IN-QKV54, and IN-NXX70 (photolysis products
of DPX-HGW86): UV/visible absorption spectrum and molar
absorptivity International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-30531 GLP: Yes Published: No
Y Y FMC
IIA, 9.0/01 2012 Classification of cyantraniliprole (DPX-HGW86) technical
DuPont Stine-Haskell Research Center DuPont-34049 GLP:
No Published: No
N N FMC
IIA, 4.2.1/01 2011 Determination of cyantraniliprole (DPX-HGW86) in
technical grade cyantraniliprole and DPX-HGW86 end-use
products DuPont Stine-Haskell Research Center DuPont-
31822 GLP: No Published: No
N N FMC
IIA, 4.2.1/02 2011 Validation of the analytical method for the determination of
cyantraniliprole (DPX-HGW86) in technical grade
cyantraniliprole and DPX-HGW86 end-use products DuPont
Stine-Haskell Research Center DuPont-31805 GLP: Yes
Published:
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 69 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 4.2.1/03 2009 Validation of the analytical method for determination of
DPX-HGW86 in technical grade DPX-HGW86 and DPX-
HGW86 end-use products (confidential attachment) Advinus
Therapeutics Private Limited DuPont-26440, Revision No. 1,
and DuPont-26440, Revision No. 1 Confidential attachment
GLP: Yes Published: No
Y Y FMC
IIA, 4.2.3/01 2011 Description and validation of the analytical methods for
determination of impurities in technical grade
cyantraniliprole (DPX-HGW86) DuPont Stine-Haskell
Research Center; DuPont Experimental Station; Galbraith
Laboratories, Inc. DuPont-28125, Revision No. 1 and
DuPont-28125, Revision No. 1 Confidential attachment GLP:
Yes Published: No
N N FMC
IIA, 4.3/01 2009 Method assessment and validation for the determination of
residues of DPX-HGW86 in plants using multi-residue
method DFG S19 (LC-MS/MS module) PTRL Europe
DuPont-21328 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/02 2010 Method assessment and validation for the determination of
residues of DPX-HGW86 and metabolites in animal tissues
using multi-residue method DFG S19 (LC/MS/MS module)
PTRL Europe DuPont-25544 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/03 2010 Analytical method for the determination of DPX-HGW86
and metabolites in bovine tissues, dairy, and eggs using
LC/MS/MS DuPont Stine-Haskell Research Center DuPont-
18844 GLP: No Published: No
N N FMC
IIA, 4.3/04 2008 Method validation for the analysis of DPX-HGW86 and its
metabolites (IN-N7B69, IN-JCZ38, IN-K7H19, IN-MYX98,
IN-MLA84 and IN-J9Z38) in various crops with LC-MS/MS
detection Charles River Laboratories DuPont-18846 GLP:
Yes Published: No
Y Y FMC
IIA, 4.3/05 2010 Extraction efficiency of [14C]DPX-HGW86 from muscle,
liver and milk from goats and eggs from hens Charles River
Laboratories DuPont-27356 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/06 2009 Extraction efficiency of [14C]DPX-HGW86 from crops
Charles River Laboratories DuPont-24754 GLP: Yes
Published: No
Y Y FMC
IIA, 4.3/07 2009 Analytical method for the determination of DPX-HGW86
and metabolites in processed fractions using LC/MS/MS
ABC Laboratories, Inc. DuPont-15736, Supplement No. 1
GLP: No Published: No
N N FMC
IIA, 4.3/08 2011 Analytical method for the determination of DPX-HGW86
and metabolites in crops using LC/MS/MS DuPont Stine-
Haskell Research Center DuPont-15736, Revision No. 1
GLP: No Published: No
N N FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 70 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 4.3/09 2009 Multiresidue method testing for DPX-HGW86 and six
metabolites according to the FDA pesticide analytical manual
volume I (PAM, Vol. I as revised in October 1999),
Appendix II Pyxant Labs, Inc. DuPont-21329 GLP: Yes
Published: No
Y Y FMC
IIA, 4.3/10 2010 Independent laboratory validation of DuPont-18844 method
for the determination of residues of DPX-HGW86 and
metabolites in milk and bovine tissues using LC/MS/MS
PTRL Europe DuPont-26458 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/11 2010 Independent laboratory validation of "Analytical method for
the determination of DPX-HGW86 and metabolites in crops
and processed fractions using LC/MS/MS" Pyxant Labs, Inc.
DuPont-26000, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/12 2010 Validation of an analytical method for the determination of
DPX-HGW86, IN-HGW87, IN-N7B69, IN-K7H19, IN-
JCZ38, IN-MYX98, IN-J9Z38 and IN-MLA84 in bovine
tissues, milk and eggs Charles River Laboratories DuPont-
25543 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/13 2010a Independent laboratory validation for the determination of
residues of DPX-HGW86 in plants using multi-residue
method DFG S 19 (LC-MS/MS module) Eurofins Dr. Specht
GLP GmbH DuPont-21326 GLP: Yes Published: No
Y Y FMC
IIA, 4.3/14 2010b Independent laboratory validation for the determination of
residues of DPX-HGW86 in animal tissues using multi-
residue method DFG S 19 (LC-MS/MS module) Eurofins Dr.
Specht GLP GmbH DuPont-17942 GLP: Yes Published: No
Y Y FMC
IIA, 4.4/01 2006 Analytical method for the determination of DPX-HGW86
and metabolites in soil using LC/MS/MS DuPont Stine-
Haskell Research Center DuPont-15440 GLP: No Published:
No
N N FMC
IIA, 4.4/02 2010 Extraction efficiency of DPX-HGW86 from soil DuPont
Stine-Haskell Research Center DuPont-17804 GLP: Yes
Published: No
Y Y FMC
IIA, 4.4/03 2010 Independent laboratory validation of DuPont-15440 method
for the determination of residues of DPX-HGW86 and
metabolites in soil using LC/MS/MS PTRL Europe DuPont-
18847 GLP: Yes Published: No
Y Y FMC
IIA, 4.4/04 2010 Independent laboratory validation of "Analytical method for
the determination of DPX-HGW86 and photoproducts in soil
using LC/MS/MS" ABC Laboratories, Inc. DuPont-30770
GLP: Yes Published: No
Y Y FMC
IIA, 4.4/05 2010 Analytical method for the determination of DPX-HGW86
and photoproducts in soil using LC/MS/MS ABC
Laboratories, Inc. DuPont-29747 GLP: No Published: No
N N FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 71 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA 4.4/06 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 4.5/01 2010 Analytical method for the determination of DPX-HGW86
and metabolites in water (pond, stream, well, and tap) using
LC/MS/MS ABC Laboratories, Inc. DuPont-18850 GLP: No
Published: No
N N FMC
IIA, 4.5/02 2010 Independent laboratory validation of an analytical method for
the determination of DPX-HGW86 and metabolites in water
(surface, ground and tap) using LC-MS/MS Eurofins Dr.
Specht GLP GmbH DuPont-27357 GLP: Yes Published: No
Y Y FMC
IIA 4.5/03 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 4.6/01 2010 Sediment method validation (non-GLP) for HGW86 and
metabolites ABC Laboratories, Inc. DuPont-18848 GLP: No
Published: No
Y Y FMC
IIA 4.6/02 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 4.7/01 2009 Analytical method for the determination of DPX-HGW86 in
air using LC/MS/MS PTRL Europe DuPont-21330 GLP: Yes
Published: No
Y Y FMC
IIA 4.7/02 2012 Response to PMRA's request for additional chemistry data
for DuPont's cyantraniliprole technical material DuPont-
35884 and DuPont-35884 Confidential attachment GLP: No
Published: No
N N FMC
IIA, 4.9/01 2010 Validation of an analytical method for the determination of
DPX-HGW86 and metabolites in bee products Charles River
Laboratories DuPont-21331 GLP: Yes Published: No
Y Y FMC
IIA, 4.9/02 2010 Dissipation of dislodgeable foliar residues of DPX-HGW86
following foliar application of DPX-HGW86 SE (100 g ai/L)
to apple trees ABC Laboratories, Inc. DuPont-27935 GLP:
Yes Published: No
Y Y FMC
IIA, 5.1.1/01 2010 14C-DPX-HGW86: Absorption, distribution, metabolism and
excretion in male and female rats DuPont Haskell
Laboratories DuPont-16995, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.1.3/01 2010 14C-DPX-HGW86: Disposition in male and female rats
during and after multiple dose administration DuPont Haskell
Laboratories DuPont-17399, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.1/01 2008a DPX-HGW86 technical: Acute oral toxicity study in mice -
up-and-down procedure DuPont Haskell Laboratories
DuPont-18970 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 72 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.2.1/02 2008b DPX-HGW86 Technical: Acute oral toxicity study in rats -
up-and-down procedure DuPont Haskell Laboratories
DuPont-18965 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/03 2009a Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity study in rats - up-and-down procedure DuPont
Haskell Laboratories DuPont-27896 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/04 2009b Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity study in rats - up-and-down procedure DuPont
Haskell Laboratories DuPont-27558 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/05 2010 Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity = Up-and-down procedure in rats Eurofins PSL
DuPont-30993 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.2/01 2008 DPX-HGW86 technical: Acute dermal toxicity study in rats
DuPont Haskell Laboratories DuPont-18966 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.3/01 2009 Acute inhalation toxicity study of DPX-HGW86 technical in
albino rats WIL Research Laboratories, LLC DuPont-18971
GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/01 2008 DPX-HGW86 technical: Acute dermal irritation study in
rabbits DuPont Haskell Laboratories DuPont-18967 GLP:
Yes Published: No
Y Y FMC
IIA, 5.2.4/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute dermal
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27556 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute dermal
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27897 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary skin
irritation in rabbits Eurofins PSL DuPont-30995 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.5/01 2008 DPX-HGW86 technical: Acute eye irritation study in rabbits
DuPont Haskell Laboratories DuPont-18968 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.5/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute eye
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27557 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.5/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute eye
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27898 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.5/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary eye
irritation in rabbits Eurofins PSL DuPont-30994 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.6/01 2011 Cyantraniliprole (DPX-HGW86) technical: Local lymph
node assay (LLNA) in mice DuPont Haskell Laboratories
DuPont-27560, Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/02 2011 Cyantraniliprole (DPX-HGW86) technical: Dermal
sensitisation - Buehler method Eurofins PSL DuPont-30418,
Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/03 2007 DPX-HGW86: Local lymph node assay (LLNA) in mice
DuPont Haskell Laboratories DuPont-18969 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.6/04 2009 Cyantraniliprole (DPX-HGW86) technical: Local lymph
node assay (LLNA) in mice DuPont Haskell Laboratories
DuPont-27899 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/05 2011 A skin sensitisation study of DPX-HGW86 technical in
guinea pigs (maximization test) Kannami Laboratory, Bozo
Research Center Inc. DuPont-30996, Revision No. 1 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 73 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.2.6/06 2010 Cyantraniliprole (DPX-HGW86) technical: Dermal
sensitisation - Magnusson-Kligman maximization method
Eurofins, Product Safety Laboratories DuPont-29062 GLP:
Yes Published: No
Y Y FMC
IIA, 5.3.1/01 2009a DPX-HGW86 technical: Repeated dose oral toxicity 28-day
feeding study in rats DuPont Haskell Laboratories DuPont-
15206 GLP: No Published: No
N N FMC
IIA, 5.3.1/02 2009b DPX-HGW86 technical: Repeated dose oral toxicity 28-day
feeding study in mice DuPont Haskell Laboratories DuPont-
15205 GLP: No Published: No
N N FMC
IIA, 5.3.1/03 2007 DPX-HGW86: 28-day oral palatability study in dogs MPI
Research DuPont-15456 GLP: No Published: No
N N FMC
IIA, 5.3.1/04 2010 Cyantraniliprole (DPX-HGW86) technical: Repeated-dose
oral toxicity 2-week gavage study in rats with metabolism
and genetic toxicology DuPont Haskell Laboratories,
Experimental Pathology Laboratories, Inc. DuPont-13430,
Revision No. 1 GLP: No Published: No
N N FMC
IIA, 5.3.2/01 2007 DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in rats DuPont Haskell Laboratories DuPont-16993
GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/02 2011a DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in mice DuPont Haskell Laboratories DuPont-16992,
Supplement No. 1, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/03 2011b DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in rats DuPont Haskell Laboratories DuPont-16993,
Supplement No. 1, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/04 2007 DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in mice DuPont Haskell Laboratories, Experimental
Pathology Laboratories, Inc. DuPont-16992 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.3/01 2009 DPX-HGW86 Technical: 90-day dietary toxicity study in
dogs MPI Research DuPont-16994, Supplement No. 1,
Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.3/02 2007 DPX-HGW86 technical: 90-day dietary toxicity study in
dogs MPI Research DuPont-16994, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.4/01 2010 DPX-HGW86 technical: Chronic toxicity 1-year feeding
study in dogs MPI Research, Inc. DuPont-19180 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.4/02 2010 DPX-HGW86 technical: Chronic toxicity 1-year feeding
study in dogs DuPont Haskell Laboratories; MPI Research,
Inc. DuPont-19180, Supplement No. 1 GLP: Yes Published:
No
Y Y FMC
IIA, 5.3.5/01 2012 Cyantraniliprole: Additional information in support of
DuPont-32967, four-week inhalation toxicity study in rats
DuPont Stine-Haskell Research Center DuPont-35858 GLP:
Yes Published: No
Y Y FMC
IIA, 5.3.5/02 2012 Cyantraniliprole (DPX-HGW86) technical: Four-week
inhalation toxicity study in rats
DuPont Haskell Laboratories DuPont-32967, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 5.3.7/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28 day repeat
dermal application study in rats Eurofins, Product Safety
Laboratories DuPont-21316, Revision No.1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.4.1/01 2010 Cyantraniliprole (DPX-HGW86) technical: Bacterial reverse
mutation assay BioReliance DuPont-30991 GLP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 74 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.4.1/02 2009a Cyantraniliprole (DPX-HGW86): Bacterial reverse mutation
assay BioReliance DuPont-27160 GLP: Yes Published: No
Y Y FMC
IIA, 5.4.1/03 2009b Cyantraniliprole (DPX-HGW86) technical: Bacterial reverse
mutation assay BioReliance DuPont-27900 GLP: No
Published: No
N N FMC
IIA, 5.4.2/01 2009a Cyantraniliprole (DPX-HGW86) technical: In vitro
mammalian chromosome aberration test BioReliance
DuPont-27901, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.4.2/02 2009b Cyantraniliprole (DPX-HGW86) technical: In vitro
mammalian chromosome aberration test BioReliance
DuPont-27559, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.4.2/03 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro
mammalian chromosome aberration test BioReliance
DuPont-30990 GLP: No Published: No
N N FMC
IIA, 5.4.3/01 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro
mammalian cell gene mutation test (CHO/HGPRT) assay
BioReliance DuPont-30992 GLP: Yes Published: No
Y Y FMC
IIA, 5.4.3/02 2011 Cyantraniliprole (DPX-HGW86) technical: CHO/HPRT
forward mutation assay with duplicate cultures Covance
Laboratories, Inc. DuPont-31372 GLP: Yes Published: No
Y Y FMC
IIA, 5.4.4/01 2011 Cyantraniliprole (DPX-HGW86) technical: Mouse bone
marrow micronucleus test DuPont Haskell Laboratories
DuPont-31373 GLP: Yes Published: No
Y Y FMC
IIA, 5.5.1/01 2011 Cyantraniliprole technical (DPX-HGW86 commercial batch -
412): Combined chronic toxicity/oncogenicity study 2-year
feeding study in rats MPI Research, Inc. DuPont-26842 GLP:
Yes Published: No
Y Y FMC
IIA, 5.5.1/02 2013 Cyantraniliprole: Response to toxicology questions
(December 12, 2011) DuPont Stine-Haskell DuPont-34740,
Revision No. 1 GLP: No Published: No
Y Y FMC
IIA, 5.5.2/01 2011 Cyantraniliprole technical (DPX-HGW86 commercial batch -
412): Combined chronic toxicity/oncogenicity study 2-year
feeding study in rats MPI Research, Inc. DuPont-26842 GLP:
Yes Published: No
Y Y FMC
IIA, 5.5.3/01 2011 Cyantraniliprole (DPX-HGW86) technical: Oncogenicity
study 18-month feeding study in mice MPI Research, Inc.
DuPont-26843 GLP: Yes Published: No
Y Y FMC
IIA, 5.6.1/01 2011 DPX-HGW86 technical: Oral (diet) two-generation (one litter
per generation) reproduction toxicity study in rats Charles
River Laboratories, DuPont-19187 GLP: Yes Published: No
Y Y FMC
IIA, 5.6.10/01 2009 DPX-HGW86 technical: Developmental toxicity in rats
DuPont Haskell Laboratories DuPont-19188 GLP: Yes
Published: No
Y Y FMC
IIA, 5.6.11/01 2009 DPX-HGW86 technical: Developmental toxicity study in
rabbits DuPont Haskell Laboratories DuPont-19189 GLP:
Yes Published: No
Y Y FMC
IIA, 5.7.1/01 2006 DPX-HGW86 technical: Acute oral neurotoxicity study in
rats DuPont Haskell Laboratories DuPont-16996 GLP: Yes
Published: No
Y Y FMC
IIA, 5.7.4/01 2009 DPX-HGW86 technical: Subchronic oral neurotoxicity study
in rats DuPont Haskell Laboratories DuPont-19186 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8.01 2010 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Laboratories DuPont-28842 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8.02 2010a IN-PLT97: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-30571 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 75 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.8/03 2010b IN-N5M09: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-30713 GLP:
Yes Published: No
Y Y FMC
IIA, 5.8/04 2009 IN-JSE76: In vitro mammalian cell gene mutation test
(CHO/HGPRT Assay) BioReliance DuPont-24714 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/05 2010 IN-PLT97: In vitro mammalian cell gene mutation test
(CHO/HGPRT Assay) BioReliance DuPont-30365 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/06 2006 IN-F6L99: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-20595 GLP:
Yes Published: No
Y Y FMC
IIA, 5.8/07 2010 IN-JSE76: In vitro mammalian chromosome aberration test
BioReliance DuPont-24715, Revision No. 2 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/08 2011 IN-PLT97: In vitro mammalian chromosome aberration test
BioReliance DuPont-30551, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/09 2011 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Laboratories DuPont-28842,
Supplement No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/10 2006 IN-F6L99: Bacterial reverse mutation test DuPont Haskell
Laboratories DuPont-20597 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/11 2009 IN-JSE76: Acute oral toxicity - up-and-down procedure in
rats Eurofins, Product Safety Laboratories DuPont-26932,
Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/12 2010 IN-PLT97: Bacterial reverse mutation assay BioReliance
DuPont-30552 Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/13 2009a IN-JSE76: Bacterial reverse mutation assay BioReliance
DuPont-24716 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/14 2009b IN-N5M09: Bacterial reverse mutation assay BioReliance
DuPont-28800 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/15 2013 Cyantraniliprole: Toxicological assessment of the metabolite,
IN-M2G98 DuPont-37346, Revision No. 1 DuPont Stine-
Haskell Research Center GLP: No Published: No
N N FMC
IIA, 5.8/16 2006 IN-DBC80: Acute oral toxicity study in rats - up-and-down
procedure DuPont Haskell Laboratory for Health and
Environmental Sciences DuPont-17907 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/17 2006 IN-DBC80: Bacterial reverse mutation test DuPont Haskell
Laboratory for Health and Environmental Sciences DuPont-
17897 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/18 2007 IN-DBC80: In vitro mammalian chromosome aberration test
in human peripheral blood lymphocytes DuPont Haskell
Laboratory for Health and Environmental Sciences DuPont-
17900 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/19 2006 IN-DBC80: Local lymph node assay (LLNA) in mice DuPont
Haskell Laboratory for Health and Environmental Sciences
DuPont-17908 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/20 2006 IN-DBC80: Inhalation median lethal concentration (LC50)
study in rats DuPont Haskell Laboratory for Health and
Environmental Sciences DuPont-19828 GLP: Yes Published:
No
Y Y FMC
IIA, 5.10/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28-day
immunotoxicity feeding study in rats DuPont Haskell
Laboratories DuPont-21467 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 76 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.10/02 2011 Cyantraniliprole (DPX-HGW86) technical: 28-day
immunotoxicity feeding study in mice DuPont Haskell
Laboratories DuPont-21468, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.10/03 2010a Cyantraniliprole (DPX-HGW86) technical: Adrenal and
thyroid mechanistic: 90-day feeding study in rats DuPont
Haskell Laboratories; Experimental Pathology Laboratories,
Inc.; Laboratory for Advanced Electron and Light Optical
Methods (LAELOM) DuPont-24319 GLP: Yes Published:
No
Y Y FMC
IIA, 5.10/04 2010b Cyantraniliprole (DPX-HGW86) technical: Adrenal
mechanistic study 90-day feeding study in mice DuPont
Haskell Laboratories; Experimental Pathology Laboratories,
Inc.; Laboratory for Advanced Electron and Light Optical
Methods (LAELOM) DuPont-29405 GLP: Yes Published:
No
Y Y FMC
IIA, 5.10/05 2010 Cyantraniliprole (DPX-HGW86) technical: In vitro thyroid
peroxidase inhibition Dupont Haskell Laboratories DuPont-
27123 GLP: Yes Published: No
N N FMC
IIA, 5.8/21 2013 IN-M2G98: In vitro mammalian cell gene mutation test
(CHO/HGPRT assay) BioReliance, Alliance Pharma, Inc.
DuPont-37574 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/22 2013 IN-M2G98: In vitro mammalian chromosome aberration test
in human peripheral blood lymphocytes DuPont Haskell
Global Centers for Health & Environmental Sciences,
Alliance Pharma, Inc. DuPont-37573 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/23 2013 IN-M2G98: Bacterial reverse mutation test BioReliance
DuPont-37572 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/24 2012 IN-PLT97: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Global Centers for Health &
Environmental Sciences DuPont-33376 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/25 2012 IN-PLT97: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Global Centers for Health &
Environmental Sciences DuPont-33376, Supplement No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 5.11/01 2014 Cyantraniliprole toxicological assessment of ground water
metabolites in the context of EU Council Directive
91/414/EEC (SANCO/221/2000 – REV. 10, March 2003)
DuPont Stine-Haskell Laboratories DuPont-35730 GLP: No
Published: No
N N FMC
IIA, 5.1.1/01 2010 14C-DPX-HGW86: Absorption, distribution, metabolism and
excretion in male and female rats DuPont Haskell
Laboratories DuPont-16995, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.1.3/01 2010 14C-DPX-HGW86: Disposition in male and female rats
during and after multiple dose administration DuPont Haskell
Laboratories DuPont-17399, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.1/01 2008a DPX-HGW86 technical: Acute oral toxicity study in mice -
up-and-down procedure DuPont Haskell Laboratories
DuPont-18970 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/02 2008b DPX-HGW86 technical: Acute oral toxicity study in rats -
up-and-down procedure DuPont Haskell Laboratories
DuPont-18965 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 77 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.2.1/03 2009a Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity study in rats - up-and-down procedure DuPont
Haskell Laboratories DuPont-27896 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/04 2009b Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity study in rats - up-and-down procedure DuPont
Haskell Laboratories DuPont-27558 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.1/05 2010 Cyantraniliprole (DPX-HGW86) technical: Acute oral
toxicity = Up-and-down procedure in rats Eurofins PSL
DuPont-30993 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.2/01 2008 DPX-HGW86 technical: Acute dermal toxicity study in rats
DuPont Haskell Laboratories DuPont-18966 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.3/01 2009 Acute inhalation toxicity study of DPX-HGW86 technical in
albino rats WIL Research Laboratories, LLC DuPont-18971
GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/01 2008 DPX-HGW86 technical: Acute dermal irritation study in
rabbits DuPont Haskell Laboratories DuPont-18967 GLP:
Yes Published: No
Y Y FMC
IIA, 5.2.4/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute dermal
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27556 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute dermal
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27897 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.4/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary skin
irritation in rabbits Eurofins PSL DuPont-30995 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.5/01 2008 DPX-HGW86 technical: Acute eye irritation study in rabbits
DuPont Haskell Laboratories DuPont-18968 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.5/02 2009a Cyantraniliprole (DPX-HGW86) technical: Acute eye
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27557 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.5/03 2009b Cyantraniliprole (DPX-HGW86) technical: Acute eye
irritation study in rabbits DuPont Haskell Laboratories
DuPont-27898 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.5/04 2010 Cyantraniliprole (DPX-HGW86) technical: Primary eye
irritation in rabbits Eurofins PSL DuPont-30994 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.6/01 2011 Cyantraniliprole (DPX-HGW86) technical: Local lymph
node assay (LLNA) in mice DuPont Haskell Laboratories
DuPont-27560, Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/02 2011 Cyantraniliprole (DPX-HGW86) technical: Dermal
sensitisation - Buehler method Eurofins PSL DuPont-30418,
Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/03 2007 DPX-HGW86: Local lymph node assay (LLNA) in mice
DuPont Haskell Laboratories DuPont-18969 GLP: Yes
Published: No
Y Y FMC
IIA, 5.2.6/04 2009 Cyantraniliprole (DPX-HGW86) technical: Local lymph
node assay (LLNA) in mice DuPont Haskell Laboratories
DuPont-27899 GLP: Yes Published: No
Y Y FMC
IIA, 5.2.6/05 2011 A skin sensitisation study of DPX-HGW86 technical in
guinea pigs (maximization test) Kannami Laboratory, Bozo
Research Center Inc. DuPont-30996, Revision No. 1 GLP:
Yes Published: No
Y Y FMC
IIA, 5.2.6/06 2010 Cyantraniliprole (DPX-HGW86) technical: Dermal
sensitisation - Magnusson-Kligman maximization method
Eurofins, Product Safety Laboratories DuPont-29062 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 78 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.3.1/01 2009a DPX-HGW86 technical: Repeated dose oral toxicity 28-day
feeding study in rats DuPont Haskell Laboratories DuPont-
15206 GLP: No Published: No
N N FMC
IIA, 5.3.1/02 2009b DPX-HGW86 technical: Repeated dose oral toxicity 28-day
feeding study in mice DuPont Haskell Laboratories DuPont-
15205 GLP: No Published: No
N N FMC
IIA, 5.3.1/03 2007 DPX-HGW86: 28-day oral palatability study in dogs MPI
Research DuPont-15456 GLP: No Published: No
N N FMC
IIA, 5.3.1/04 2010 Cyantraniliprole (DPX-HGW86) technical: Repeated-dose
oral toxicity 2-week gavage study in rats with metabolism
and genetic toxicology DuPont Haskell Laboratories,
Experimental Pathology Laboratories, Inc. DuPont-13430,
Revision No. 1 GLP: No Published: No
N N FMC
IIA, 5.3.2/01 2007 DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in rats DuPont Haskell Laboratories DuPont-16993
GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/02 2011a DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in mice DuPont Haskell Laboratories DuPont-16992,
Supplement No. 1, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/03 2011b DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in rats DuPont Haskell Laboratories DuPont-16993,
Supplement No. 1, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.2/04 2007 DPX-HGW86 technical: Subchronic toxicity 90-day feeding
study in mice DuPont Haskell Laboratories, Experimental
Pathology Laboratories, Inc. DuPont-16992 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.3/01 2009 DPX-HGW86 Technical: 90-day dietary toxicity study in
dogs MPI Research DuPont-16994, Supplement No. 1,
Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.3.3/02 2007 DPX-HGW86 technical: 90-day dietary toxicity study in
dogs MPI Research DuPont-16994, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.4/01 2010 DPX-HGW86 technical: Chronic toxicity 1-year feeding
study in dogs MPI Research, Inc. DuPont-19180 GLP: Yes
Published: No
Y Y FMC
IIA, 5.3.4/02 2010 DPX-HGW86 technical: Chronic toxicity 1-year feeding
study in dogs DuPont Haskell Laboratories; MPI Research,
Inc. DuPont-19180, Supplement No. 1 GLP: Yes Published:
No
Y Y FMC
IIA, 5.3.5/01 2012 Cyantraniliprole: Additional information in support of
DuPont-32967, four-week inhalation toxicity study in rats
DuPont Stine-Haskell Research Center DuPont-35858 GLP:
Yes Published: No
Y Y FMC
IIA, 5.3.5/02 2012 Cyantraniliprole (DPX-HGW86) technical: Four-week
inhalation toxicity study in rats
DuPont Haskell Laboratories DuPont-32967, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 5.3.7/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28 day repeat
dermal application study in rats Eurofins, Product Safety
Laboratories DuPont-21316, Revision No.1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.5.1/01 2011 Cyantraniliprole technical (DPX-HGW86 commercial batch -
412): Combined chronic toxicity/oncogenicity study 2-year
feeding study in rats MPI Research, Inc. DuPont-26842 GLP:
Yes Published: No
Y Y FMC
IIA, 5.5.2/01 2011 Cyantraniliprole technical (DPX-HGW86 commercial batch -
412): Combined chronic toxicity/oncogenicity study 2-year
feeding study in rats MPI Research, Inc. DuPont-26842 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 79 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.5.3/01 2011 Cyantraniliprole (DPX-HGW86) technical: Oncogenicity
study 18-month feeding study in mice MPI Research, Inc.
DuPont-26843 GLP: Yes Published: No
Y Y FMC
IIA, 5.6.1/01 2011 DPX-HGW86 technical: Oral (diet) two-generation (one litter
per generation) reproduction toxicity study in rats Charles
River Laboratories, DuPont-19187 GLP: Yes Published: No
Y Y FMC
IIA, 5.6.10/01 2009 DPX-HGW86 technical: Developmental toxicity in rats
DuPont Haskell Laboratories DuPont-19188 GLP: Yes
Published: No
Y Y FMC
IIA, 5.6.11/01 2009 DPX-HGW86 technical: Developmental toxicity study in
rabbits DuPont Haskell Laboratories DuPont-19189 GLP:
Yes Published: No
Y Y FMC
IIA, 5.7.1/01 2006 DPX-HGW86 technical: Acute oral neurotoxicity study in
rats DuPont Haskell Laboratories DuPont-16996 GLP: Yes
Published: No
Y Y FMC
IIA, 5.7.4/01 2009 DPX-HGW86 technical: Subchronic oral neurotoxicity study
in rats DuPont Haskell Laboratories DuPont-19186 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8.01 2010 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Laboratories DuPont-28842 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8.02 2010a IN-PLT97: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-30571 GLP:
Yes Published: No
Y Y FMC
IIA, 5.8/03 2010b IN-N5M09: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-30713 GLP:
Yes Published: No
Y Y FMC
IIA, 5.8/04 2009 IN-JSE76: In vitro mammalian cell gene mutation test
(CHO/HGPRT Assay) BioReliance DuPont-24714 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/05 2010 IN-PLT97: In vitro mammalian cell gene mutation test
(CHO/HGPRT Assay) BioReliance DuPont-30365 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/06 2006 IN-F6L99: Acute oral toxicity study in mice - up-and-down
procedure DuPont Haskell Laboratories DuPont-20595 GLP:
Yes Published: No
Y Y FMC
IIA, 5.8/07 2010 IN-JSE76: In vitro mammalian chromosome aberration test
BioReliance DuPont-24715, Revision No. 2 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/08 2011 IN-PLT97: In vitro mammalian chromosome aberration test
BioReliance DuPont-30551, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.8/09 2011 IN-JSE76: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Laboratories DuPont-28842,
Supplement No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/10 2006 IN-F6L99: Bacterial reverse mutation test DuPont Haskell
Laboratories DuPont-20597 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/11 2009 IN-JSE76: Acute oral toxicity - up-and-down procedure in
rats Eurofins, Product Safety Laboratories DuPont-26932,
Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/12 2010 IN-PLT97: Bacterial reverse mutation assay BioReliance
DuPont-30552 Revision No.1 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/13 2009a IN-JSE76: Bacterial reverse mutation assay BioReliance
DuPont-24716 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/14 2009b IN-N5M09: Bacterial reverse mutation assay BioReliance
DuPont-28800 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/15 2013 Cyantraniliprole: Toxicological assessment of the metabolite,
IN-M2G98 DuPont-37346, Revision No. 1 DuPont Stine-
Haskell Research Center GLP: No Published: No
N N FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 80 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 5.8/16 2006 IN-DBC80: Acute oral toxicity study in rats - up-and-down
procedure DuPont Haskell Laboratory for Health and
Environmental Sciences DuPont-17907 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/19 2006 IN-DBC80: Local lymph node assay (LLNA) in mice DuPont
Haskell Laboratory for Health and Environmental Sciences
DuPont-17908 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/20 2006 IN-DBC80: Inhalation median lethal concentration (LC50)
study in rats DuPont Haskell Laboratory for Health and
Environmental Sciences DuPont-19828 GLP: Yes Published:
No
Y Y FMC
IIA, 5.10/01 2009 Cyantraniliprole (DPX-HGW86) technical: 28-day
immunotoxicity feeding study in rats DuPont Haskell
Laboratories DuPont-21467 GLP: Yes Published: No
Y Y FMC
IIA, 5.10/02 2011 Cyantraniliprole (DPX-HGW86) technical: 28-day
immunotoxicity feeding study in mice DuPont Haskell
Laboratories DuPont-21468, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 5.10/03 2010a Cyantraniliprole (DPX-HGW86) technical: Adrenal and
thyroid mechanistic: 90-day feeding study in rats DuPont
Haskell Laboratories; Experimental Pathology Laboratories,
Inc.; Laboratory for Advanced Electron and Light Optical
Methods (LAELOM) DuPont-24319 GLP: Yes Published:
No
Y Y FMC
IIA, 5.10/04 2010b Cyantraniliprole (DPX-HGW86) technical: Adrenal
mechanistic study 90-day feeding study in mice DuPont
Haskell Laboratories; Experimental Pathology Laboratories,
Inc.; Laboratory for Advanced Electron and Light Optical
Methods (LAELOM) DuPont-29405 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/22 2013 IN-M2G98: In vitro mammalian chromosome aberration test
in human peripheral blood lymphocytes DuPont Haskell
Global Centers for Health & Environmental Sciences,
Alliance Pharma, Inc. DuPont-37573 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/23 2013 IN-M2G98: Bacterial reverse mutation test BioReliance
DuPont-37572 GLP: Yes Published: No
Y Y FMC
IIA, 5.8/24 2012 IN-PLT97: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Global Centers for Health &
Environmental Sciences DuPont-33376 GLP: Yes Published:
No
Y Y FMC
IIA, 5.8/25 2012 IN-PLT97: Repeated-dose oral toxicity 28-day feeding study
in rats DuPont Haskell Global Centers for Health &
Environmental Sciences DuPont-33376, Supplement No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 6.1.1/01 2010 Stability of DPX-HGW86 and metabolite/degredation
product residues in representative crops stored frozen ABC
Laboratories, Inc. DuPont-16990, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 6.2.1/01 2010 The metabolism of [14C]DPX-HGW86 in rice Charles River
Laboratories DuPont-18780 GLP: Yes Published: No
Y Y FMC
IIA, 6.2.1/02 2008 The metabolism of [14C]DPX-HGW86 in cotton Charles
River Laboratories DuPont-16984, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 6.2.1/03 2008a The metabolism of [14C]DPX-HGW86 in tomatoes Charles
River Laboratories DuPont-16985 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 81 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.2.1/04 2008b The metabolism of [14C]DPX-HGW86 in lettuce Charles
River Laboratories DuPont-16986 GLP: Yes Published: No
Y Y FMC
IIA, 6.2.2/01 2008 The metabolism of [14C] DPX-HGW86 in the laying hen
Charles River Laboratories DuPont-16988 GLP: Yes
Published: No
Y Y FMC
IIA, 6.2.3/01 2008 Metabolism of [14C] DPX-HGW86 in the lactating goat
Charles River Laboratories DuPont-16987 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3/01 2011a Cyantraniliprole residue analytical method concurrent
recoveries for commodities of plant and animal origin
DuPont Stine-Haskell Research Center DuPont-27797 GLP:
No Published: No
N N FMC
IIA, 6.3/02 2011b Cyantraniliprole: Relative residues for different application
method treatment regimes DuPont Stine-Haskell Research
Center DuPont-30876 GLP: No Published: No
N N FMC
IIA, 6.3/03 2011c Cyantraniliprole formulated product residue bridging DuPont
Stine-Haskell Research Center DuPont-30877 GLP: No
Published: No
N N FMC
IIA, 6.3.1/01 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in field potatoes (potato group) following foliar
application of DPX-HGW86 100 g/L OD - Europe, 2008
Charles River Laboratories DuPont-21414 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.1/02 2010 Combined processing and magnitude of cyantraniliprole and
metabolite residues in tuberous and corm vegetables
(potatoes) following foliar applications (DPX-HGW86 100
g/L OD and DPX-HGW86 100 g/L SE), soil applications
(DPX-HGW86 200 g/L SC), and seed treatment (625 g/L FS)
– NAFTA, 2009 ABC Laboratories, Inc. DuPont-27583 GLP:
Yes Published: No
Y Y FMC
IIA, 6.3.2/01 2010 HGW86: Magnitude of the residue on dry bulb and green
onion ABC Laboratories, Inc. DuPont-27436 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.3/01 2010 Magnitude and decline of cyantraniliprole and metabolite
residues in protected lettuce, lamb's lettuce, and scarole (leaf
vegetables) following foliar application of DPX-HGW86 100
g/L OD and soil application of DPX-HGW86 200 g/L SC -
Europe, 2009 initiation Charles River Laboratories DuPont-
28200 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.3/02 2010 Combined processing and magnitude and decline of DPX-
HGW86 and metabolite residues in leafy vegetables
(head/leaf lettuce, celery, spinach) following foliar
applications of DPX-HGW86 100 g/L, DPX-HGW86 100
g/L SE, soil applications of DPX-HGW86 200 g/L SC – U.S.
The Carringers, Inc.; ABC Laboratories, Inc. DuPont-25644
GLP: Yes Published:
Y Y FMC
IIA, 6.3.3/03 2010 Magnitude and decline of cyantraniliprole and metabolite
residues in field-grown lettuce and sacrole following foliar
application of DPX-HGW86 100 g/L OD and soil application
of DPX-HGW86 200 g/L SC - France and southern Europe,
2009 initiation Charles River Laboratories DuPont-27713
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.3/04 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in protected lettuce (leaf vegetablies) following
foliar application of DPX-HGW86 100 g/L OD or drip
irrigation application of DPX-HGW86 200 g/L SC- Europe,
2008 Charles River Laboratories DuPont-21415, Revision
No. 1 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 82 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.3.4/01 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in brassica vegetables (broccoli/cauliflower,
cabbage, mustard greens) following foliar applications of
DPX-HGW86 100 g/L OD, DPX-HGW86 100 g/L SE, and
soil applications of DPX-HGW86 200 g/L SC – U.S. The
Carringers, Inc.; ABC Laboratories, Inc. DuPont-25641 GLP:
Yes Published: No
Y Y FMC
IIA, 6.3.5/01 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in protected green beens (fresh legume vegetables)
following foliar application of DPX-HGW86 100 g/L OD -
Europe, 2008 and 2009 Charles River Laboratories DuPont-
21413 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.5/02 2010 Magnitude and decline of cyantraniliprole and metabolite
residues in field-grown green beans (fresh legume
vegetables) following foliar application of DPX-HGW86 100
g/L OD - France and Southern Europe, 2009 initiation
Charles River Laboratories DuPont-27710 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.6/01 2010a Magnitude and decline of cyantraniliprole and metabolite
residues in protected cucumbers and courgettes (fruiting
vegetables, edible-peel cucurbits) following foliar appliaction
of DPX-HGW86 100 g/L OD and soil application of DPX-
HGW86 200 g/L SC - Europe, 2009 initiation Charles River
Laboratories DuPont-28201 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.6/02 2010b Magnitude and decline of cyantraniliprole and metabolite
residues in protected melons (fruiting vegetables, inedible-
peel cucurbits) following foliar application of DPX-HGW86
100 g/L OD and soil application of DPX-HGW86 200 g/L
SC - Europe, 2009 initiation Charles River Laboratories
DuPont-28186 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.6/03 2011 Magnitude and decline of cyantraniliprole and metabolite
residues in field grown melons, couurgettes and cumbers
(fruiting vegetables, inedible-peel cucurbits) following foliar
application of DPX-HGW86 100 g/L OD and soil application
of DPX-HGW86 200 g/L SC - France and sourthern Europe,
2009 initiation Charles River Laboratories DuPont-27711
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.6/04 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in cucurbits (cucumber, cantaloupe/muskmelon,
summer squash) following foliar applications of DPX-
HGW86 100 g/L OD and soil applications of DPX-HGW86
200 g/L SC - U.S. The Carringers, Inc.; ABC Laboratories,
Inc. DuPont-25642 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.6/05 2010 Determination of Cyazypyr residues in cucurbit fruit
AgriSolutions Austrailia Pty Ltd DuPont-31413 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.7/01 2010 Magnitude and decline of cyantraniliprole and metabolite
residues in protected tomatoes and cherry tomatoes (fruiting
vegetables, solanacea) following foliar application of DPX-
HGW86 100 g/L OD and soil application of DPX-HGW86
200 g/L SC - Europe, 2009 initiation Charles River
Laboratories DuPont-28187 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.7/02 2010 Magnitide and decline of DPX-HGW86 and metabolite
residues in fruiting vegetables (tomato, bell pepper, non-bell
pepper) following foliar application of DPX-HGW86 100 g/L
OD and soil applications of DPX-HGW86 200 g/L SC - U.S.
The Carringers, Inc.; ABC Laboratories, Inc. DuPont-25643
GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 83 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.3.7/03 2010 Magnitude and decline of DPX-HGW86 and metabolite
residues in protected peppers (fruiting vegetables, solanacea)
following foliar application of DPX-HGW86 100 g/L OD or
drip irrigation application of DPX-HGW86 200 g/L SC -
Europe 2008 Charles River Laboratories DuPont-23885 GLP:
Yes Published: No
Y Y FMC
IIA, 6.3.7/04 2011 Magnitude and decline of cyantraniliprole and metabolite
residues in field-grown tomatoes, peppers, and hot peppers
(fruiting vegetables, solanacea) following foliar application
of DPX-HGW86 100 g/L OD - Southern Europe, 2009
initiation Charles River Laboratories DuPont-27712 GLP:
Yes Published: No
Y Y FMC
IIA, 6.3.7/05 2010 Magnitude and decline of cyantraniliprole and metabolite
residues in protected peppers and hot peppers (fruiting
vegetables, solanacea) following foliar application of DPX-
HGW86 100 g/L OD and soil application of DPX-HGW86
200 g/L SC - Europe, 2009 initiation Charles River
Laboratories DuPont-28188 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.7/06 2010 Determination of CyazypyrTM residues in tomato and
capsicum fruit AgriSolutions Austrailia Pty Ltd DuPont-
31520 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.8/01 2010 Combined processing and magnitude of DPX-HGW86 and
metabolite residues in citrus fruit (orange, lemon, and
grapefruit) following foliar applications of DPX-HGW86 100
g/L SE and systemic delivery applications of DPX-HGW86
200 g/L SC - USA, 2009 ABC Laboratories, Inc. DuPont-
27554 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.8/02 2011 Magnitude and decline of cyantraniliprole and metabolite
residues in oranges and mandarins (citrus fruit) following
foliar application of DPX-HGW86 100 g/L SE - southern
Europe, 2009 initiation Charles River Laboratories DuPont-
27716 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/01 2010a SYN545377 - Residue study on apple in southern France and
Spain in 2009 Eurofins/ADME Bioanalyses S09-01572-Reg
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/02 2010b SYN545377 - Residue study on apple in northern France and
Germany in 2009 Eurofins/ADME Bioanalyses S09-01571-
Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/03 2011a Cyantraniliprole - Residue study on apples in northern
France, and Germany in 2010 Eurofins/ADME Bioanalyses
S10-01051 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/04 2011b Cyantraniliprole - Residue study on apples in southern
France,in 2010 Eurofins/ADME Bioanalyses S10-01052-Reg
GLP: Yes Published: N
Y Y FMC
IIA, 6.3.9/05 2011 Magnitude and decline of cyantraniliprole and metabolite
residues in apples and pears (pome fruit) following foliar
application of DPX-HGW86 100 g/L SE - Northern and
Southern Europe, 2009 initiation Charles River Laboratories
DuPont-27714 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/06 2010a SYN5455377 - Residue study on pears in northern France
and Germany in 2009 Eurofins/ADME Bioanalysis S09-
01573-Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/07 2010b SYN5455377 - Residue study on pears in southern France
and Spain in 2009 Eurofins/ADME Bioanalysis S09-01574-
Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/08 2011a Cyantraniliprole - Residue study on pears in northern France
and Germany in 2010 Eurofins/ADME Bioanalysis S10-
01053 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 84 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.3.9/09 2011b Cyantraniliprole - Residue study on pears in southern France
and Italy in 2010 Eurofins/ADME Bioanalysis S10-01054-
Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.9/10 2010 Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in pome fruit (apple
and pear) following foliar applications of DPX-HGW86 100
g/L SE - NAFTA, 2009 ABC Laboratories, Inc. DuPont-
27438 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/01 2011 Magnitude and decline of cyantraniliprole and metabolite
residues in peaches and apricots (stone fruit) following foliar
application of DPX-HGW86 100 g/L SE - Southern Europe,
2009 initiation Charles River Laboratories DuPont-27717
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/02 2011a Cyantraniliprole - Residue study on plums in southern
France, and Spain in 2010 Eurofins/ADME Bioanalyses S10-
01057 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/03 2011b Cyantraniliprole - Residue study on plums in northern
France, and Germany in 2010 Eurofins/ADME Bioanalyses
S10-01056-Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/04 2010 SYN545377 - Residue study on peaches in southern France,
Spain, and Italy in 2009 Eurofins/ADME Bioanalyses S09-
01576-Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/05 2011 Cyantraniliprole - Residue study on peaches in southern
France, Italy, and Spain, in 2010 Eurofins/ADME
Bioanalyses S10-01055-Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/06 2010a SYN545377 - Residue study on peaches in northern France,
and Germany in 2009 Eurofins/ADME Bioanalyses S09-
01577-Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/07 2010b SYN545377 - Residue study on plums in southern France,
and Spain in 2009 Eurofins/ADME Bioanalyses S09-01578-
Reg GLP: Yes Published: No
Y Y FMC
IIA, 6.3.10/08 2010 Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in stone fruit (peach,
plum, and cherry) following foliar applications of DPX-
HGW86 100 g/L SE - NAFTA, 2009 ABC Laboratories, Inc.
DuPont-27437 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.11/01 2010 Magnitude of cyantraniliprole and metabolite residues in
blueberries following foliar applications of DPX-HGW86
100 g/L SE - USA, 2009 ABC Laboratories, Inc. DuPont-
27971 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.11/02 2011 Cyantraniliprole: Magnitude of the residue on blueberry ABC
Laboratories, Inc. AAFC09-025R GLP: Yes Published: No
Y Y FMC
IIA, 6.3.11/03 2011 Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in wine and table
grapes (berries and small fruit) following foliar application of
DPX-HGW86 100 g/L SE - northern and southern Europe,
2009 initiation Charles River Laboratories DuPont-27718
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.12/01 2010 Magnitude of cyantraniliprole and metabolite residues in tree
nuts (almonds and pecans) following foliar applications
(DPX-HGW86 100 g/L OD and DPX-HGW86 100 g/L SE)
and soil applications (DPX-HGW86-200 g/L SC) - NAFTA,
2009 ABC Laboratories, Inc. DuPont-27446 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.13/01 2010a Determination of CyazypyrTM residues in canola seed, oil and
trash (fodder) AgriSolutions Austrailia Pty Ltd DuPont-
31412 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 85 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.3.13/02 2010b To determine CyazypyrTM residues in cotton following two
applications of DPX-HGW86 100 SE applied at a 7 day
interval AgriSolutions Austrailia Pty Ltd DuPont-31410
GLP: Yes Published: No
Y Y FMC
IIA, 6.3.13/03 2010a Combined processing and magnitude of cyantraniliprole and
metabolite residues in oil seeds (canola and sunflowers)
following foliar applications of DPX-HGW86 100 g/L OD
and seed treatment with 625 g/L FS - NAFTA, 2009 ABC
Laboratories, Inc. DuPont-27582 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.13/04 2010b Combined processing and magnitude of cyantraniliprole and
metabolite residues in cotton following foliar applications of
DPX-HGW86 100 g/L OD and soil applications of DPX-
HGW86 200 g/L SC - USA, 2009 ABC Laboratories, Inc.
DuPont-27565 GLP: Yes Published: No
Y Y FMC
IIA, 6.3.14/01 2011 Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in olives following
foliar application of DPX-HGW86 100 g/L SE - southern
Europe, 2009 initiation Charles River Laboratories DuPont-
27709 GLP: Yes Published: N
Y Y FMC
IIA, 6.3.15/01 2012 Residue test report of cyantraniliprole on the rice field Institut
of Quality and Standard fo rAgro-products, Zhejiang
Academy of Agricultural Sciences CL-2010-026 GLP: Yes
Published: No
Y Y FMC
IIA, 6.3.16/01 2011 Study of the residues of the insecticide DPX-HGW86 20%
SC and DPX-HGW86 10% OD (cyantraniliprole) in coffee
culture (Coffee arabica) 2010-2011 field season DuPont do
Brazil S/A, Paulina SP, Brazil and JM Bioanalises (BPL
0024), Botucato SP, Brazil BRI-10/11-008 GLP: Yes
Published: No
Y Y FMC
IIA, 6.4.1/01 2011 Magnitude of residues of cyantraniliprole (DPX-HGW86)
and metabolites in edible tissues and eggs of poultry
following dosing with cyantraniliprole Charles River
Laboratories DuPont-27181 GLP: Yes Published: No
Y Y FMC
IIA, 6.4.2/01 2011 DPX-HGW86: Magnitude of residues of cyantraniliprole
(DPX-HGW86) and metabolites in edible tissues and milk of
lactating diary cows following dosing with cyantraniliprole
Charles River Laboratories DuPont-27180, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 6.5.1/01 2005 High temperature hydrolysis of [14C]-DPX-HGW86 in
buffered aqueous solution at pH 4, 5, and 6 Charles River
Laboratories DuPont-16989 GLP: Yes Published: No
Y Y FMC
IIA, 6.5.4/01 2009 Magnitude of DPX-HGW86 and metabolite residues in
processed fractions of tomatoes following foliar applications
of DPX-HGW86 100 g/L OD - U.S., 2008 The Carringers,
Inc.; ABC Laboratories, Inc. DuPont-25645 GLP: Yes
Published: No
Y Y FMC
IIA, 6.5.4/02 2010 Combined processing and magnitude and decline of DPX-
HGW86 and metabolite residues in leafy vegetables
(head/leaf lettuce, celery, spinach) following foliar
applications of DPX-HGW86 100 g/L OD, DPX-HGW86
100 g/L SE, and soil applications of DPX-HGW86 200 g/L
SC - U.S. The Carringers, Inc.; ABC Laboratories, Inc.
DuPont-25644 GLP: Yes Published: No
Y Y FMC
IIA, 6.5.4/03 2010 Combined processing and magnitude of DPX-HGW86 and
metabolite residues in citrus fruit (orange, lemon, and
grapefruit) following foliar applications of DPX-HGW86 100
g/L SE and systemic delivery applications of DPX-HGW86
200 g/L SC - USA, 2009 ABC Laboratories, Inc. DuPont-
27554 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 86 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.5.4/04 2010a Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in stone fruit (peach,
plum, and cherry) following foliar applications of DPX-
HGW86 100 g/L SE - NAFTA, 2009 ABC Laboratories, Inc.
DuPont-27437 GLP: Yes Published: No
Y Y FMC
IIA, 6.5.4/05 2010b Combined processing and magnitude of cyantraniliprole and
metabolite residues in cotton following foliar applications of
DPX-HGW86 100 g/L OD and soil applications of DPX-
HGW86 200 g/L SC - USA, 2009 ABC Laboratories, Inc.
DuPont-27565 GLP: Yes Published: No
Y Y FMC
IIA, 6.5.4/06 2010c Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in pome fruit (apple
and pear) following foliar applications of DPX-HGW86 100
g/L SE - NAFTA, 2009 ABC Laboratories, Inc. DuPont-
27438 GLP: Yes Published: N
Y Y FMC
IIA, 6.5.4/07 2010d Combined processing and magnitude of cyantraniliprole and
metabolite residues in tuberous and corm vegetables
(potatoes) following foliar applications (DPX-HGW86 100
g/L OD and DPX-HGW86 100 g/L SE), soil applications
(DPX-HGW86 200 g/L SC), and seed treatment (625 g/L FS)
– NAFTA, 2009 ABC Laboratories, Inc. DuPont-27583 GLP:
Yes Published: No
Y Y FMC
IIA, 6.5.4/08 2011 Combined processing and magnitude and decline of
cyantraniliprole and metabolite residues in olives following
foliar application of DPX-HGW86 100 g/L SE - southern
Europe, 2009 initiation Charles River Laboratories DuPont-
27709 GLP: Yes Published: No
Y Y FMC
IIA, 6.6.2/01 2012 Confined rotational crop study using [14C] DPX-HGW86
Charles River Laboratories DuPont-15778, Revision No. 2
GLP: Yes Published: No
Y Y FMC
IIA, 6.6.2/02 2006 [14C]DPX-HGW86 pilot confined crop rotation study
(wheat, soybeans, and red beets) DuPont Stine-Haskell
Research Center DuPont-15513 GLP: No Published: No
N N FMC
IIA, 6.6.2/03 2012 DuPont/Syngenta responses to ANSES concerns regarding
the confined rotational crop study of cyantraniliprole as part
of the global joint review DuPont Stine-Haskell Research
Center DuPont-36046 EU GLP: No Published: No
N N FMC
IIA, 6.6.3/01 2010 Magnitude and decline of DPX-HGW86 and metabolite
and/or degradation product residues in field rotational crops
following foliar application of DPX-HGW86 100 g/L OD –
northern Europe, 2008 and 2009 Charles River Laboratories
DuPont-21447 GLP: Yes Published: No
Y Y FMC
IIA, 6.6.3/02 2010 Field crop rotation study with DPX-HGW86 insecticide -
southern Europe 2006–2009 Charles River Laboratories
DuPont-19678 GLP: Yes Published: No
Y Y FMC
IIA, 6.6.3/03 2009a Field crop rotation study with DPX-HGW86 10OD
insecticide - EPA region 11, USA, 2006 ABC Laboratories,
Inc. DuPont-19640 GLP: Yes Published: No
Y Y FMC
IIA, 6.6.3/04 2009b Field crop rotation study with DPX-HGW86 10OD
insecticide - EPA region 10, USA, 2006 ABC Laboratories,
Inc. DuPont-19639 GLP: Yes Published: N
Y Y FMC
IIA, 6.6.3/05 2010a Magnitude of DPX-HGW86 and metabolite and/or
degradation product residues in field rotational crops
following application of DPX-HGW86 100 g/L OD
insecticide - Ontario, Canada location 2008/2009 ABC
Laboratories, Inc. DuPont-21446 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 87 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 6.6.3/06 2011 Magnitude of cyantraniliprole and metabolite residues in field
rotational crops following bare ground applications of DPX-
HGW86 100 g/L SE - USA and Canada, 2010 ABC
Laboratories, Inc. DuPont-29456 GLP: Yes Published: No
Y Y FMC
IIA, 6.6.3/07 2010b Magnitude of cyantraniliprole and metabolite residues in field
rotational crops following bare ground applications of DPX-
100 g/L SE - USA, 2009 ABC Laboratories, Inc. DuPont-
27972 GLP: Yes Published: No
Y Y FMC
IIA, 6.7/01 2011a Cyantraniliprole relevant residues including parent equivalent
residue calculations for commodities of plant and animal
origin DuPont Stine-Haskell Research Center DuPont-27796
GLP: Not applicable position paper Published: No
N N FMC
IIA, 6.7/02 2011b Cyantraniliprole residue population assessments as inputs to
maximum residue level and residue dietary exposure
estimates DuPont Stine-Haskell Research Center DuPont-
30878 GLP: Not applicable position paper Published: No
N N FMC
IIA, 6.9/01 2011 Dietary risk assessments in support of Annex I inclusion and
maximum residue levels or import tolerances for
cyantraniliprole in Europe - food commodities Stine-Haskell
Research Center DuPont-29234 EU, Revision No. 1 GLP:
Not applicable position paper Published: No
N N FMC
IIA, 6.10/01 2010a Dissipation of dislodgeable foliar residues of DPX-HGW86
following foliar application of DPX-HGW86 SE (100 g ai/L)
to apple trees ABC Laboratories, Inc. DuPont-27935 GLP:
Yes Published: No
Y Y FMC
IIA, 6.10/02 2010b Dissipation of dislodgeable foliar residues of DPX-HGW86
following foliar application of DPX-HGW86 SE (100 g ai/L)
to lettuce ABC Laboratories, Inc. DuPont-27936 GLP: Yes
Published: No
Y Y FMC
IIA, 6.10/03 2012 Dupont/Syngenta responses to ANSES concerns regarding
the metabolism, residue and environmental fate of
cyantraniliprole as part of the global joint review DuPont
Stine-Haskell Research Center DuPont-34488 EU GLP: No
Published: No
N N FMC
IIA, 6.2.2/01 2008 The metabolism of [14C] DPX-HGW86 in the laying hen
Charles River Laboratories DuPont-16988 GLP: Yes
Published: No
Y Y FMC
IIA, 6.2.3/01 2008 Metabolism of [14C] DPX-HGW86 in the lactating goat
Charles River Laboratories DuPont-16987 GLP: Yes
Published: No
Y Y FMC
IIA, 6.4.1/01 2011 Magnitude of residues of cyantraniliprole (DPX-HGW86)
and metabolites in edible tissues and eggs of poultry
following dosing with cyantraniliprole Charles River
Laboratories DuPont-27181 GLP: Yes Published: No
Y Y FMC
IIA, 6.4.2/01 2011 DPX-HGW86: Magnitude of residues of cyantraniliprole
(DPX-HGW86) and metabolites in edible tissues and milk of
lactating diary cows following dosing with cyantraniliprole
Charles River Laboratories DuPont-27180, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 7.1.1/01 2006 Route of degradation and sorption of [14C]-DPX-HGW86 in
two aerobic soils DuPont Stine-Haskell Research Center
DuPont-15775 GLP: Yes Published: No
Y Y FMC
IIA, 7.1.2/01 2006 Anaerobic soil metabolism of [14C]-DPX-HGW86 Charles
River Laboratories DuPont-17057 GLP: Yes Published: No
Y Y FMC
IIA, 7.1.3/01 2005 Photodegradation of [14C]-DPX-HGW86 on soil Charles
River Laboratories DuPont-17056 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 88 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA 7.1.3/02 2010 Photodegradation of [14C]-DPX-HGW86 on moist soil
Charles River Laboratories DuPont-28730 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.1/01 2006 Rate of degradation and aged desorption of [14C]-DPX-
HGW86 in three aerobic soils Charles River Laboratories
DuPont-17055 GLP: Yes Published: No
Y Y FMC
IIA, 7.2.2/01 2006 Rate of degradation and aged desorption of [14C]-DPX-
HGW86 in three aerobic soils Charles River Laboratories
DuPont-17055 GLP: Yes Published: No
Y Y FMC
IIA, 7.2.3/01 2008 Rate of degradation [14C]-IN-PLT97 in five aerobic soils
DuPont Stine-Haskell Research Center DuPont-19077 GLP:
Yes Published: No
Y Y FMC
IIA, 7.2.3/02 2006 Rate of degradation of [14C]-IN-J9Z38 in five aerobic soils
Charles River Laboratories DuPont-17596 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/03 2010 Rate of degradation [14C]-IN-RNU71 in five aerobic soils
Charles River Laboratories DuPont-29809, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 7.2.3/04 2007a Rate of degradation of [14C]-IN-K5A78 in five aerobic soils
Charles River Laboratories DuPont-17599 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/05 2007b Rate of degradation of [14C]-IN-JSE76 in five aerobic soils
Charles River Laboratories DuPont-17598 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/06 2006 Rate of degradation of [14C]-IN-K5A77 in five aerobic soils
Charles River Laboratories DuPont-17602 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/07 2008 Rate of degradation of [14C]-IN-K5A79 in five aerobic soils
DuPont Stine-Haskell Research Center DuPont-18868 GLP:
Yes Published: No
Y Y FMC
IIA, 7.2.3/08 2007 Rate of degradation of [14C]-IN-JCZ38 in five aerobic soils
Charles River Laboratories DuPont-17597 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/09 2010 Rate of degradation [14C]-IN-QKV54 in five aerobic soils
Charles River Laboratories DuPont-29555 GLP: Yes
Published: No
Y Y FMC
IIA, 7.2.3/10 2012 The degradation and adsorption parameters proposed for use
in environmental exposure assessment of the metabolite IN-
M2G98 DuPont-35754, Revision No.1 GLP: No Published:
No
N Y FMC
IIA, 7.2.3/11 2012 Degradation of pyridine and benzamide rings in DPX-
HGW86 DuPont-35733 GLP: No Published: No
N Y FMC
IIA, 7.3.1/01 2010a Field soil dissipation of DPX-HGW86 following a single
application to bare ground - southern Europe (Italy) Charles
River Laboratories DuPont-17458 GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/02 2010b Field soil dissipation of DPX-HGW86 following a single
application to bare ground - northern Europe (Germany)
Charles River Laboratories DuPont-17063, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/03 2010a Field soil dissipation of DPX-HGW86 following a single
application to bare ground - southern Europe (Spain) Charles
River Laboratories DuPont-17061, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 7.3.1/04 2010b Field soil dissipation of DPX-HGW86 following a single
application to bare ground - northern Europe (France)
Charles River Laboratories DuPont-17062, Revision No.1
GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 89 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 7.3.1/05 2010 Freezer storage stability of DPX-HGW86 and its photolysis
degradation products DuPont Stine-Haskell Research Center
DuPont-30572 GLP: No Published: No
N Y FMC
IIA, 7.3.1/06 2010 Storage stability of DPX-HGW86 and metabolites (IN-
JCZ28, IN-K5A77, IN-K5A78, IN-K5A79, IN-J9Z38, IN-
JSE76, IN-PLT97) in frozen soil ABC Laboratories, Inc.
DuPont-21503 GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/07 2008 Terrestrial field dissipation of DPX-HGW86 insecticide on
bare soil and in the presence of a leafy vegetable crop in
California, USA ABC Laboratories, Inc. DuPont-17066 GLP:
Yes Published: No
Y Y FMC
IIA, 7.3.1/08 2009a Terrestrial field dissipation of DPX-HGW86 insecticide on
bare soil and in the presence of an alfalfa crop in Missouri,
USA ABC Laboratories, Inc. DuPont-17067 GLP: Yes
Published: No
Y Y FMC
IIA, 7.3.1/09 2009b Terrestrial field dissipation of DPX-HGW86 insecticide on
bare soil and in the presence of a potato crop in Washington,
USA ABC Laboratories, Inc. DuPont-17065, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/10 2010 Assessment of the global environmental conditions and soil
characteristics in relation to cyantraniliprole (DPX-HGW86)
field and laboratory studies Waterborne Environmental, Inc.
(WEI) DuPont-28155 GLP: No Published: No
N Y FMC
IIA, 7.3.1/11 2010 Field dissipation of cyantraniliprole (DPX-HGW86) in North
America and Europe - summary of normalized kinestic
calculations Waterborne Environmental, Inc. DuPont-31454
GLP: No Published: No
N Y FMC
IIA, 7.3.1/12 2010a Terrestrial field dissipation of DPX-HGW86 on bare soil in
Texas, USA ABC Laboratories, Inc. DuPont-17457, Revision
No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/13 2010b Terrestrial field dissipation of DPX-HGW86 on bare soil in
New York, USA ABC Laboratories, Inc. DuPont-17064
GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/14 2010c Terrestrial field dissipation of DPX-HGW86 on bare soil in
Manitoba, Canada ABC Laboratories, Inc. DuPont-17068
GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/15 2010a Analysis of photolysis products of DPX-HGW86 in field soil
dissipation samples - North America ABC Laboratories, Inc.
DuPont-29556, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 7.3.1/16 2010b Analysis of photolysis products of DPX-HGW86 in field soil
dissipation samples - EU studies ABC Laboratories, Inc.
DuPont-29557, Revision No. 2 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.1/01 2006 Rate of degradation and aged desorption of [14C]-DPX-
HGW86 in three aerobic soils Charles River Laboratories
DuPont-17055 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.1/02 2006 Route of degradation and sorption of [14C]-DPX-HGW86 in
two aerobic soils DuPont Stine-Haskell Research Center
DuPont-15775 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.1/03 2007 [14C]-DPX-HGW86: Batch equilibrium
adsorption/desorption) in five soils Charles River
Laboratories DuPont-18871 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.2/01 2008 Rate of degradation of [14C]-IN-PLT97 in five aerobic soils
DuPont Stine-Haskell Research Center DuPont-19077 GLP:
Yes Published: No
Y Y FMC
IIA, 7.4.2/02 2007 [14C]-IN-J9Z38 (a metabolite of DPX-HGW86): Batch
equilibrium (adsorption/desorption) in five soils Charles
River Laboratories DuPont-17603 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 90 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 7.4.2/03 2010 IN-K5A78 (a metabolite of DPX-HGW86): Batch
equilibrium (adsorption/desorption) in five soils Charles
River Laboratories DuPont-17606, Revsion No.1 GLP: Yes
Published: No
Y Y FMC
IIA, 7.4.2/04 2010 [14C]-IN-RNU71 a metabolite of [14C]-DPX-HGW86:
Batch equilibrium adsorption/desorption in five soils Charles
River Laboratories DuPont-29989 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.2/05 2007 IN-JSE76 (a metabolite of DPX-HGW86): Batch equilibrium
(adsorption/desorption) in five soils Charles River
Laboratories DuPont-17605 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.2/06 2010 Adsorption-desorption of [14C]-IN-K5A79 in five soils by
batch equilibrium DuPont Stine-Haskell Research Center
DuPont-18870, Revision No. 2 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.2/07 2006a [14C]-IN-K5A77 (a metabolite of [14C]-DPX-HGW86):
Batch equilibrium (adsorption/desorption) in five soils
Charles River Laboratories DuPont-17607 GLP: Yes
Published: No
Y Y FMC
IIA, 7.4.2/08 2006b [14C]-IN-JCZ38 (a metabolite of [14C]-DPX-HGW86):
Batch equilibrium (adsorption/desorption) in five soils
Charles River Laboratories DuPont-17604 GLP: Yes
Published: No
Y Y FMC
IIA, 7.4.2/09 2010 [14C]-IN-QKV54 a metabolite of [14C]-DPX-HGW86:
Batch equalibrium adsorption/desorption in five soils Charles
River Laboratories DuPont-29558 GLP: Yes Published: No
Y Y FMC
IIA, 7.4.2/10 2007 [14C]-IN-PLT97 (a metabolite of [14C]-DPX-HGW86):
Batch equilibrium (adsorption/desorption) in five soils
Charles River Laboratories DuPont-19078 GLP: Yes
Published: No
Y Y FMC
IIA, 7.4.2/11 2012 The degradation and adsorption parameters proposed for use
in environmental exposure assessment of the metabolite IN-
M2G98 DuPont-35754, Revision No.1 GLP: No Published:
No
N Y FMC
IIA, 7.5/01 2005 Hydrolytic stability of [14C]-DPX-HGW86 in buffered
aqueous solutions at pH 4, 7, and 9 Inveresk Research
International (IRI) Limited DuPont-17058 GLP: Yes
Published: No
Y Y FMC
IIA, 7.6/01 2007 Photodegradation of [14C]-DPX-HGW86 in pH 4 buffer and
natural water Charles River Laboratories DuPont-17060
GLP: Yes Published: No
Y Y FMC
IIA, 7.6/02 2010 Supplement to photodegredation of [14C]-DPX-HGW86 in
pH 4 buffer and natural water, identification of IN-RNU71
DuPont Stine-Haskell Research Center DuPont-31274 GLP:
No Published: No
N N FMC
IIA, 7.7/01 2008 DPX-HGW86: Laboratory study of ready biodegradability:
CO2 evolution test Advinus Therapeutics Private Limited
DuPont-21504 GLP: Yes Published: No
Y Y FMC
IIA, 7.8.1/01 2010 Fate of [14C]-DPX-HGW86 in flooded aerobic soil Charles
River Laboratories DuPont-24742, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 7.8.1/02 2006 [14C]-DPX-HGW86: Degradability and fate in the
sediment/water system Charles River Laboratories DuPont-
17059 GLP: Yes Published: No
Y Y FMC
IIA, 7.8.2/01 2010 Anaerobic aquatic metabolism of [14C]-DPX-HGW86 in a
water/sediment system Charles River Laboratories DuPont-
28191 GLP: Yes Published: No
Y Y FMC
IIA, 7.8.2/02 2010 Anaerobic aquatic metabolism of 14C-DPX-HGW86 in a
water-sediment system DuPont Stine-Haskell Research
Center DuPont-18869, Revision No. 1 GLP: Yes Published:
No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 91 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 7.8.3/01 2010 Outdoor water sediment study (aerobic aquatic metabolism)
of [14C]-DPX-HGW86 Charles River Laboratories DuPont-
24798, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 7.2/01 1987 Microbial metabolism of homocyclic and heterocyclic
aromatic compounds under Anaerobic conditions Microbiol.
Reviews Vol 51(1) 43-59 (1987) GLP: No Published: Yes
N N FMC
IIA, 7.2/02 1991 The transformation of heterocyclic aromatic compounds and
their derivatives under anaerobic conditions Pennsylvania
State, University Environmen. Contrl. Vol 21(3-4) 297-329
(1991) GLP: No Published: Yes
N N FMC
IIA, 7.2/03 1994 Microbial transformation of ethylpyridines Biodegradations
Vol 5(2) 121-128 (1994) GLP: No Published: Yes
N N FMC
IIA, 7.2/04 1980 A correlation study of biodegradability determinations with
various chemicals in various tests Department of Ecology
Ecotoxicol. Environ. Saf. Vol 5 45-55 (1981) GLP: No
Published: Yes
N N FMC
IIA, 7.2/05 1990 Anaerobic microbial transformation of nonoxygenated
aromatic and alicyclic compounds in soil, subsurface, and
freshwater sediments Soil Biochemistry Vol 6, 117-189
(1990) by Bollag and Stotzky GLP: No Published: Yes
N N FMC
IIA, 7.2/06 1972 Microbial metabolism of the pyridine ring University of New
Castle upon Tyne Biochem. J. 130 879-893 (1972) GLP: No
Published: Yes
N N FMC
IIA, 7.2/07 1979 Microbiological transformation of pyridine derivatives
(review) Chem. Heterocycl. Compd. Vol 14(10) 1049-1062
(1979) GLP: No Published: Yes
N N FMC
IIA, 7.2/08 1993 Transformation of 3- and 4-picoline under sulfate-reducing
conditions Pennsylvania State, University Applied and
Environ. Microbiol. Vol 59(3) 701-705 (1993) GLP: No
Published: Yes
N N FMC
IIA, 7.2/09 2010 A novel soil bacterial strain degrading pyridines
Enviromental Chemistry Letters 9(3) 439-445 (2011) GLP:
No Published: Yes
N N FMC
IIA, 7.2/10 1948 The utilization of pyridine by micro-organisms J. Gen.
Microb. Vol 3 143-147 (1949) GLP: No Published: Yes
N N FMC
IIA, 7.2/11 1965 Photochemical degradation of paraquat Microbiol. Reviews
Vol 51(1) 43-59 (1987) GLP: No Published: Yes
N N FMC
IIA, 7.2/12 1978 The scientific aspects of chemical substance control law in
Japan Ministry of Intl Trade and Industry 283-298 (1978)
GLP: No Published: Yes
N N FMC
IIA, 7.3/02a 2014 pH dependence of cyantraniliprole DuPont Stine-Haskell
Research Center DuPont-39294 EU GLP: No Published: No
N N FMC
IIA, 7.3/03a 2014 Further kinetic analyses for degradation of cyantraniliprole in
Tama and Lleida soils: Verification via full pathway kinetic
fit DuPont Stine-Haskell Research Center DuPont-39295 EU
GLP: No Published: No
N N FMC
IIA, 7.3/04a 2014 Evidences for plant uptake of cyantraniliprole (DPX-
HGW86) by crops from soils under greenhouse and field
conditions DuPont Stine-Haskell Research Center DuPont-
39549 EU GLP: No Published: No
Y Y FMC
IIA, 8.1.1/01 2008 DPX-HGW86 technical: An acute oral toxicity study with the
northern bobwhite Wildlife International, Ltd. DuPont-24248
GLP: Yes Published: No
Y Y FMC
IIA, 8.1.1/02 2009 Cyantraniliprole technical: An acute oral toxicity study with
the zebra finch (Poephila guttata) Wildlife International, Ltd.
DuPont-27316 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 92 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.1.2/01 2008 DPX-HGW86 technical: A dietary LC50 study with the
northern bobwhite Wildlife International, Ltd. DuPont-21470
GLP: Yes Published: No
Y Y FMC
IIA, 8.1.3/01 2008 DPX-HGW86 technical: A dietary LC50 study with the
mallard Wildlife International, Ltd. DuPont-21469 GLP: Yes
Published: No
Y Y FMC
IIA, 8.1.4/01 2008a DPX-HGW86 technical: A reproduction study with the
mallard Wildlife International, Ltd. DuPont-20917 GLP: Yes
Published: No
Y Y FMC
IIA, 8.1.4/02 2008b DPX-HGW86 technical: A reproduction study with the
northern bobwhite Wildlife International, Ltd. DuPont-20918
GLP: Yes Published: No
Y Y FMC
IIA, 8.2/01 2012 Responses to regulatory review of ecotoxicology section
DuPont Stine-Haskell Research Center DuPont-35731 GLP:
No Published No
N N FMC
IIA,
8.2.1.1/01
2006 DPX-HGW86 technical: Static, acute, 96-hour toxicity test
with rainbow trout, Oncorhynchus mykiss DuPont Haskell
Laboratories DuPont-19191 GLP: Yes Published: No
Y Y FMC
IIA,
8.2.1.2/01
2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour flow-
through acute toxicity test with the channel catfish (Ictalurus
punctatus) Wildlife International, Ltd. DuPont-19167 GLP:
Yes Published: No
Y Y FMC
IIA,
8.2.1.2/02
2009b Cyantraniliprole technical: A 96-hour flow-through acute
toxicity test with the sheepshead minnow (Cyprinodon
variegatus) Wildlife International, Ltd. DuPont-19165 GLP:
Yes Published: No
Y Y FMC
IIA,
8.2.1.2/03
2006 DPX-HGW86 technical: Static-renewal, acute, 96-hour
toxicity test to bluegill sunfish, Lepomis macrochirus DuPont
Haskell Laboratories DuPont-19164 GLP: Yes Published: No
Y Y FMC
IIA, 8.2.4/01 2009 Cyantraniliprole (DPX-HGW86) technical: An early life-
stage toxicity test with the sheepshead minnow (Cyprinodon
variegatus) Wildlife International, Ltd. DuPont-19193 GLP:
Yes Published: No
Y Y FMC
IIA, 8.2.4/02 2007 DPX-HGW86 technical: Early life-stage toxicity to rainbow
trout, Oncorhynchus mykiss DuPont Haskell Laboratories
DuPont-19192 GLP: Yes Published: No
Y Y FMC
IIA,
8.2.6.1/01
2010 14C-DPX-HGW86: Bioconcentration in bluegill sunfish,
Lepomis macrochirus ABC Laboratories, Inc. DuPont-21985
GLP: Yes Published: No
Y Y FMC
IIA, 8.3.1/01 2011 Cyantraniliprole: Rationale for selection of acute and chronic
aquatic invertebrate endpoints DuPont Stine-Haskell
Research Center DuPont-31209 GLP: No Published: No
N N FMC
IIA,
8.3.1.1/01
2008a Static, acute 48-hour toxicity of IN-JSE76 to the cladoceran,
Daphnia magna International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-24240 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/02
2008b Static-renewal, acute 48 hour toxicity test of IN-PLT97 to the
cladoceran, Daphnia magna International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-24246 GLP:
Yes Published: No
Y Y FMC
IIA,
8.3.1.1/03
2010 IN-QKV54: Static, acute, 48-hour toxicity test with the
cladoceran, Daphnia magna DuPont Haskell Laboratories
DuPont-29560 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/04
2010 IN-RNU71: 48-hour static, acute toxicity with cladoceran
Daphnia magna Springborn Smithers Laboratories DuPont-
30091 GLP: Yes Published: N
N N FMC
IIA,
8.3.1.1/05
2008a Static-renewal, acute 48 hour toxicity test of IN-JCZ38 to the
cladoceran, Daphnia magna International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-21322 GLP:
Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 93 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.3.1.1/06
2008b Static, acute 48 hour toxicity test of IN-K5A79 to the
cladoceran, Daphnia magna International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-24247 GLP:
Yes Published: No
Y Y FMC
IIA,
8.3.1.1/07
2008c Static-renewal, acute 48 hour limit test of IN-K5A78 to the
cladoceran, Daphnia magna International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-24237 GLP:
Yes Published: No
Y Y FMC
IIA,
8.3.1.1/08
2006 DPX-HGW86 technical: Static, acute, 48-hour toxicity test
with Daphnia magna DuPont Haskell Laboratories DuPont-
20148 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/09
2009 IN-NXX70: Static, acute, 48-hour toxicity test with the
cladoceran, Daphia magna DuPont Haskell Laboratories
DuPont-28367 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/10
2008a Static, acute 48-hour limit test of IN-J9Z38 to the cladoceran,
Daphnia magna Korea Institute of Toxicology, Korea
Research Institute of Chemical Technology DuPont-21321
GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/11
2008b Static, acute 48-Hour limit test of IN-K5A77 to the
cladoceran, Daphnia magna Korea Institute of Toxicology,
Korea Research Institute of Chemical Technology DuPont-
21392 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.1/12
2006 Acute toxicity test with IN-DBC80 in Daphnia magna
International Institute of Biotechnology and Toxicology
(IIBAT) DuPont-17937 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.2/01
2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
Soyedina carolinensis DuPont Haskell Laboratories DuPont-
18889 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.2/02
2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
the mayfly, Centroptilium triangulifer DuPont Haskell
Laboratories DuPont-18434 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.2/03
2007 DPX-HGW86 technical: Static, acute, 48-hour toxicity test
with Lepidostoma ontario DuPont Haskell Laboratories
DuPont-20941 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.1.3/01
2006 DPX-HGW86 technical: A 96-hour flow-through toxicity test
with the saltwater mysid (Americamysis bahia) Wildlife
International, Ltd. DuPont-17467 GLP: Yes Published: No
N N FMC
IIA,
8.3.1.3/02
2009 Cyantraniliprole (DPX-HGW86) technical: A 48-hour static-
renewal acute toxicity test with the crayfish (Procambarus
clarkii) Wildlife International, Ltd. DuPont-19194 GLP: Yes
Published: No
N N FMC
IIA,
8.3.1.3/03
2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
Hyalella azteca DuPont Haskell Laboratories DuPont-18436
GLP: Yes Published: No
N N FMC
IIA,
8.3.1.3/04
2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
Gammarus pseudolimnaeus DuPont Haskell Laboratories
DuPont-18433, Revision No. 1 GLP: Yes Published: No
N N FMC
IIA,
8.3.1.4/01
2006 DPX-HGW86: A 96-hour shell deposition test with the
eastern oyster (Crassostrea virginica) Wildlife International,
Ltd. DuPont-17466 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.2.1/01
2006 DPX-HGW86: A flow-through life-cycle toxicity test with
the saltwater mysid (Americamysis bahia) Wildlife
International, Ltd. DuPont-17468 GLP: Yes Published: No
Y Y FMC
IIA,
8.3.2.1/02
2004 Results of Ceriodaphnia chronic toxicity testing with DPX-
HGW86 EA Engineering, Science, and Technology, Inc.
DuPont-15590 GLP: No Published: No
N N FMC
IIA,
8.3.2.1/03
2006 DPX-HGW86 technical: 21-day chronic static-renewal
toxicity test to Daphnia magna DuPont Haskell Laboratories
DuPont-17002 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 94 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.3.2.1/04
2009a IN-J9Z38: 21-day chronic static-renewal toxicity test to
Daphnia magna Korea Institute of Toxicology, Korea
Research Institute of Chemical Technology DuPont-21479
GLP: Yes Published: No
Y Y FMC
IIA,
8.3.2.1/05
2009b IN-K5A77: 21-day chronic static-renewal toxicity test to
Daphnia magna Korea Institute of Toxicology, Korea
Research Institute of Chemical Technology DuPont-21480
GLP: Yes Published: No
Y Y FMC
IIA, 8.4/01 2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour
toxicity test with the freshwater alga (Anabaena flos-aquae)
Wildlife International, Ltd. DuPont-24876 GLP: Yes
Published: No
Y Y FMC
IIA, 8.4/02 2009b Cyantraniliprole (DPX-HGW86) technical: A 72-hour
toxicity test with the freshwater alga (Pseudokirchneriella
subcapitata) Wildlife International, Ltd. DuPont-19190 GLP:
Yes Published: No
Y Y FMC
IIA, 8.4/03 2009c Cyantraniliprole (DPX-HGW86) technical: A 96-hour
toxicity test with the marine diatom (Skeletonema costatum)
Wildlife International, Ltd. DuPont-24878 GLP: Yes
Published: No
Y Y FMC
IIA, 8.4/04 2009d Cyantraniliprole (DPX-HGW86) technical: A 96-hour
toxicity test with the freshwater, diatom, Navicula pelliculosa
Wildlife International, Ltd. DuPont-24877 GLP: Yes
Published: No
Y Y FMC
IIA, 8.5.1/01 2006a DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
the aquatic oligochaete, Lumbriculus variegatus DuPont
Haskell Laboratories DuPont-18435 GLP: Yes Published: No
Y Y FMC
IIA, 8.5.1/02 2006b DPX-HGW86 technical: Static, acute, 48-hour toxicity test to
Chironomus riparius DuPont Haskell Laboratories DuPont-
17465 GLP: Yes Published: No
Y Y FMC
IIA, 8.5.2/01 2007a 14C-DPX-HGW86: A prolonged sediment toxicity test with
Chironomus riparius using spiked water Wildlife
International, Ltd. DuPont-17464 GLP: Yes Published: No
Y Y FMC
IIA, 8.5.2/02 2007b 14C-DPX-HGW86: A prolonged sediment toxicity test with
Chironomus riparius using spiked sediment Wildlife
International, Ltd. DuPont-17463, Revision No.1 GLP: Yes
Published: No
Y Y FMC
IIA, 8.6/01 2009 Cyantraniliprole (DPX-HGW86) technical: A 7-day static-
renewal toxicity test with duckweed (Lemna gibba G3)
Wildlife International, Ltd. DuPont-21477 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.1/01 2008 DPX-HGW86 200 g/L SC: Acute oral and contact toxicity to
the honeybee, Apis mellifera L. International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-21860 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.1/02 2005 DPX-HGW86 technical: Acute oral and contact toxicity to
the honeybee, Apis mellifera L. GAB Biotechnologie GmbH
& GAB Analytik GmbH DuPont-17000 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.1/03 2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE: Acute oral and
contact toxicity to the honey bee, Apis mellifera L. eurofins-
GAB GmbH DuPont-25995 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.1/04 2009b DPX-HGW86 OD, DPX-HGW86 OD + codacide, DPX-
HGW86 SE. DPX-HGW86 SE + codacide and codacide:
Comparative acute oral and contact toxicity to the honeybee
Apis mellifera L. in the laboratory (non-GLP study) eurofins-
GAB GmbH DuPont-27977 GLP: No Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 95 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.7.1/05 2009c IN-J9Z38: Acute oral toxicity to the honey bee, Apis
mellifera L. eurofins-GAB GmbH DuPont-27449 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.1/06 2009d IN-HGW87: Acute oral toxicity to the honey bee, Apis
mellifera L. eurofins-GAB GmbH DuPont-27448 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.1/07 2009e IN-HGW87: Acute effects to the honey bee, Apis mellifera L.
at low dose levels eurofins-GAB GmbH DuPont-29021 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.1/08 2007 DPX-HGW86 100 g/L OD: Acute oral and contact toxicity to
the honey bee, Apis mellifera L. eurofins-GAB GmbH
DuPont-19229 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.1/09 2009 IN-K5A78: Acute oral toxicity to the honey bee, Apis
mellifera L International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-28264 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.2/01 2008 DPX-HGW86 200 g/L SC: Acute oral and contact toxicity to
the honeybee, Apis mellifera L. International Institute of
Biotechnology and Toxicology (IIBAT) DuPont-21860 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.2/02 2005 DPX-HGW86 technical: Acute oral and contact toxicity to
the honeybee, Apis mellifera L. GAB Biotechnologie GmbH
& GAB Analytik GmbH DuPont-17000 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.2/03 2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE: Acute oral and
contact toxicity to the honey bee, Apis mellifera L. eurofins-
GAB GmbH DuPont-25995 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.2/04 2007 DPX-HGW86 100 g/L OD: Acute oral and contact toxicity to
the honey bee, Apis mellifera L. eurofins-GAB GmbH
DuPont-19229 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/01 2010 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide
oil: A study to evaluate effects on the honey bee (Apis
mellifera L.; Hymenoptera, Apidae) under semi-field
conditions applied after daily bee-flight in Phacelia
tanacetifolia L. with additional asses BioChem agrar, Labor
für biologische und chemische Analytik GmbH DuPont-
27853 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/02 2010a DPX-HGW86 20SC and DPX-HGW86 10OD: A greenhouse
study to evaluate effects on the bumble bee (Bombus
terrestris L; Hymenoptera, Apidae) in tomato in Spain in
2009 Eurofins Agrosciences Services GmbH DuPont-27325
GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/03 2010b Cyantraniliprole 100 g/L SE plus Codacide oil: A semi-field
study to evaluate effects on the honey bee (Apis mellifera;
Hymenoptera, Apidae) in nectarines in Spain 2010 Eurofins
Agroscience Services GmbH DuPont-29812 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/04 2010c DPX-HGW86 100SE plus Codacide oil: A semi-field study
to evaluate effects on the honey bee (Apis mellifera;
Hymenoptera, Apidae) in apple in Spain 2009 Eurofins
Agroscience Services GmbH DuPont-27904 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/05 2011a Cyantraniliprole 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in nectarine flowers in
Italy 2010 Eurofins Agroscience Services GmbH DuPont-
30027 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 96 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.7.3/06 2011b DPX-HGW86 100OD plus Codacide oil: A field study to
evaluate residues in nectar and pollen in melon flowers at two
different locations in Spain 2009 Eurofins Agroscience
Services GmbH DuPont-27846, Revision No. 2 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/07 2011c Cyantraniliprole 200 g/L SC: A semi-field study to evaluate
effects on the honeybee (Apis mellifera; Hymenoptera,
Apidae) in melon in Spain 2010 Eurofins Agroscience
Services GmbH DuPont-29970 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/08 2011d Cyantraniliprole 100 OD plus Codacide oil: A field study to
evaluate residues in pollen in tomato flowers in Spain 2010
eurofins-GAB GmbH DuPont-30545 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.3/09 2011e Cyantraniliprole 100SE: A field study to evaluate residues in
pollen in olive flowers in Spain 2010 eurofins-GAB GmbH
DuPont-30030 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/10 2011f Cyantraniliprole 100 g/L OD: A field study to evaluate
residues in pollen and nectar in melon flowers in Italy 2010
eurofins-GAB GmbH DuPont-30553 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.3/11 2011g Cyantraniliprole 100SE: A field study to evaluate residues in
pollen in olive flowers in Italy 2010 eurofins-GAB GmbH
DuPont-30031 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/12 2011h Cyantraniliprole 100 g/L OD plus Codacide oil: A field study
to evaluate residues in pollen in tomato flowers in Italy 2010
eurofins-GAB GmbH DuPont-30544 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.3/13 2011i Cyantraniliprole 100 g/L OD: A field study to evaluate
residues in pollen and nectar in melon flowers in Spain 2010
eurofins-GAB GmbH DuPont-30543 GLP: Yes Published:
No
Y Y FMC
IIA, 8.7.3/14 2011j Cyantraniliprole 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in citrus flowers in
Italy 2010 eurofins-GAB GmbH DuPont-30029 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/15 2011k Cyantraniliprole 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in nectarine flowers in
Spain 2010 eurofins-GAB GmbH DuPont-30026, Revision
No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/16 2011L DPX-HGW86 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in apple flowers at two
different locations in Spain 2009 Eurofins Agroscience
Services GmbH DuPont-27847, Revision No. 2 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/17 2011m Cyantraniliprole 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in citrus flowers in
Spain 2010 eurofins-GAB GmbH DuPont-30028, Revision
No. 1 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/18 2011n DPX-HGW86 100OD plus Codacide oil: A field study to
evaluate residues in nectar and pollen in winter oilseed rape
flowers at two different locations in Spain 2009 eurofins-
GAB GmbH DuPont-27845, Revision No.2 GLP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 97 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.7.3/19 2011o DPX-HGW86 200SC: A semi-field study to determine
residues in nectar and pollen from foraging honey beeds
(Apis mellifera; Hymenoptera, Apidae), residues in fresh
honey, pollen and wax combs after exposure of the honey
bees to drip-irrigated melon in Spain 2009 Eurofins
Agroscience Services GmbH DuPont-27903, Revision No. 2
GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/20 2011q Cyantraniliprole 100SE plus Codacide oil: A laboratory study
to evaluate residues in nectar in citrus flowers collected in
study S09-00518 in Spain 2009 eurofins-GAB GmbH
DuPont-32611 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/21 2011r DPX-HGW86 100SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in citrus flowers at two
different locations in Spain 2009 Eurofins Agroscience
Services GmbH DuPont-27848, Revision No. 3 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/22 2007 The translocation of [14C]DPX-HGW86 into pollen and
stamens of sunflower, canola, tomatoes and zucchini Charles
River Laboratories DuPont-17705, Revision No. 1 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/23 2009 The translocation of [14C]DPX-HGW86 into pollen and
stamens of Phacelia tanacetifolia Charles River Laboratories
DuPont-26578 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/24 2006 DPX-HGW86 100 G/L OD: A semi-field study (non-GLP) to
evaluate effects on the honey bee (Apis mellifera carnica;
Hymenoptera, Apidae) in Phacelia in Germany 2006 Eurofins
Agroscience Services GmbH DuPont-19228 GLP: No
Published: No
N N FMC
IIA, 8.7.3/25 2009 DPX-HGW86 100 g/L OD: A semi-field study to evaluate
effects on the honey bee (Apis mellifera carnica;
Hymenoptera, Apidae) in Phacelia tanacetifolia in Germany
2008 Eurofins Agroscience Services GmbH DuPont-21984
GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/26 2010a DPX-HGW86 100 g/L OD plus Codacide oil: A semi-field
study to evaluate effects on the honey bee (Apis mellifera
carnica; Hymenoptera, Apidae) in Brassica napus in southern
Germany (Tubingen) 2009 Eurofins Agrosciences Services
GmbH DuPont-21318 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/27 2010b DPX-HGW86 100 g/L OD plus Codacide oil and DPX-
HGW86 100 g/L SE plus Codacide oil: A semi-field study to
evaluate effects on the honey bee (Apis mellifera carnica;
Hymenoptera, Apidae) in Brassica napus in southern
Germany (Niefern) 2009 Eurofins Agroscience Services
GmbH DuPont-21317 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/28 2011a DPX-HGW86 100 g/L SE plus Codacide oil: A field study to
evaluate residues in nectar and pollen in apple flowers at two
different locations in Germany 2009 Eurofins Agroscience
Services GmbH DuPont-28266 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/29 2011b Cyantraniliprole 100 g/L OD: A field study to evaluate
residues in pollen of potato flowers in Germany 2010
Eurofins Agroscience Services GmbH DuPont-30546 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.3/30 2011c DPX-HGW86 100 g/L OD: A semi-field study to determine
residues in nectar and pollen from foraging honey bees (Apis
mellifera carnica; Hymenoptera, Apidae), residues in fresh
nectar, pollen and wax from combs and residues in plants and
flowers after exposure of the honey bees to treated Phacelia
tanacetifolia in Germany in 2008 Eurofins Agroscience
Services GmbH DuPont-21481 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 98 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.7.3/31 2011d DPX-HGW86 100 g/L OD plus Codacide oil: A study to
evaluate effects on the honey bee (Apis mellifera carnica) in
the field in Brassica napus L. following application after and
during bee-flight in southern Germany (Tubingen) in 2009
Eurofins Agroscience Services GmbH DuPont-27324 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.3/32 2011e Cyantraniliprole 100 g/L OD: A field study to evaluate
residues in pollen of potato flowers in Italy 2010 Eurofins
Agroscience Services GmbH DuPont-30547 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/33 2011f 100 g/L SE: Bee pollen residue - Cyantraniliprole 100 g/L
OD: A field study to evaluate residues in pollen and nectar in
grapevine flowers in Italy 2010grapes/Italy Eurofins
Agroscience Services GmbH DuPont-30549 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/34 2011g Cyantraniliprole 100 g/L SE: A field study to evaluate
residues in pollen and nectar in grapevine flowers in
Germany 2010 Eurofins Agroscience Services GmbH
DuPont-30548 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/35 2011h DPX-HGW86 100 g/L OD plus Codacide oil: A study to
evaluate effects on the honey bee (Apis mellifera carnica) in
the field in Brassica napus L. following application after and
during bee-flight in northern Germany (Celle) in 2009
Eurofins Agroscience Services GmbH DuPont-27323 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.3/36 2011 Cyantraniliprole (DPX-HGW86) 100 g/L OD: A study to
evaluate effects on the honey bee (Apis mellifera carnica) in
the field in Brassica napus L. following application after and
during bee-flight in southern Germany (Tübingen) in 2010
and 2011 Eurofins Agroscience Services GmbH DuPont-
29572 Final GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/37 2011j DPX-HGW86 100 g/L OD plus Codacide oil: A study to
evaluate effects on the honey bee (Apis mellifera carnica) in
the field in Brassica napus L. following application after and
during bee-flight in northern Germany (Stade) in 2009
Eurofins Agroscience Services GmbH DuPont-27326 GLP:
Yes Published: No
Y Y FMC
IIA, 8.7.3/38 2011k Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide
oil: A study to evaluate effects on the honey bee (Apis
mellifera carnica) in the field in Brassica napus L. following
application after and during bee-flight in northern France
(Alsace) in 2010 and 2011 Eurofins Agroscience Services
GmbH DuPont-29571 Final GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/39 2010 DPX-HGW86 100 g/L OD and DPX-HGW86 100 g/L OD
plus Codacide oil: A semi-field study to evaluate effects on
the honey bee (Apis mellifera carnica; Hymenoptera, Apidae)
in Phacelia tanacetifolia in South Germany 2010 Eurofins
Agroscience Services GmbH DuPont-30550 GLP: Yes
Published: No
Y Y FMC
IIA, 8.7.3/40 2008a DPX-HGW86 100 g/L OD: A semi field study to evaluate
effects on the honey bee (Apis mellifer; Hymenoptera,
Apidae) on wheat treated with artificial honeydew in France
2008 Testapi DuPont-21705 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/41 2008b DPX-HGW86 100 G/L OD: A semi field study to evaluate
effects on the honey bee (Apis mellifer; Hymenoptera,
Apidae) on phacelia in France 2008 Testapi DuPont-21706
GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 99 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.7.3/42 2008 DPX-HGW86 100 g/L OD: Foliage residue toxicity to the
honeybee, Apis mellifera L. Wildlife International, Ltd.
DuPont-21474 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/43 2010 Magnitude of cyantraniliprole and metabolite residues in
canola nectar and pollen following seed treatment with 625
g/L FS – NAFTA, 2009 ABC Laboratories, Inc. DuPont-
28587 GLP: Yes Published: No
Y Y FMC
IIA, 8.7.3/44 2012 Cyantraniliprole (DPX-HGW86) 100 g/L OD plus Codacide
Oil: A study to evaluate effects on the honeybee (Apis
mellifera) in the field in melon in Spain in 2011 Eurofins
Agroscience Services GmbH DuPont-31672 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.1.1/01
2008a Cyantraniliprole (DPX-HGW86) 200 g/L SC: A laboratory
rate response test to evaluate the effects on the parasitoid
Aphidius rhopalosiphi (Hymenoptera, Braconidae) eurofins-
GAB GmbH DuPont-24250 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.1.1/02
2008b Cyantraniliprole (DPX-HGW86) 100 g/L OD: A laboratory
test to study the effects on the parasitoid Aphidius
rhopalosiphi (Hymenoptera, Braconidae) eurofins-GAB
GmbH DuPont-21472 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.1.1/03
2009 DPX-HGW86 100 g/L SE: A laboratory rate response test to
evaluate the effects on the parasitoid Aphidius rhopalosiphi
(Hymenoptera, Braconidae) eurofins-GAB GmbH DuPont-
25994 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.1.2/01
2008a Cyantraniliprole (DPX-HGW86) 100 g/L OD: A laboratory
test to evaluate the effects on the predatory mite
Typhlodromus pyri (Acari, Phytoseiidae) eurofins-GAB
GmbH DuPont-21471 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.1.2/02
2008b DPX-HGW86 200 g/L SC: A laboratory rate response test to
evaluate the effects on the predatory mite Typhlodromus pyri
(Acari, Phytoseiidae) eurofins-GAB GmbH DuPont-24249
GLP: Yes Published: No
Y Y FMC
IIA,
8.8.1.2/03
2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE: A laboratory
rate response test to evaluate the effects on the predatory mite
Typhlodromus pyri (Acari, Phytoseiidae) eurofins-GAB
GmbH DuPont-25993 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.1/01
2009 Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide
oil: An extended laboratory test with field-aged spray
deposits to study the effects on the aphid parasitoid, Aphidius
rhopalosiphi de Stefani Perez (Hymenoptera, Braconidae)
eurofins-GAB GmbH DuPont-27934 GLP: Yes Published:
No
Y Y FMC
IIA,
8.8.2.1/02
2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:
An extended laboratory test to evaluate the effects on the
parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-26915 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.1/03
2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended
laboratory rate response test to study the effects on the
parasitoid Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-25528 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.1/04
2009c Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
A semi-field test to evaluate the effects on the parasitoid,
Aphidius rhopalosiphi (Hymenoptera, Braconidae) Institut
für Biologische Analytik und Consulting IBACON GmbH
DuPont-28127 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 100 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.8.2.1/05
2009d Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:
An extended laboratory test to evaluate the effects on the
parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-28802 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.1/06
2009e Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
An extended laboratory test to evaluate the effects on the
parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
- aged residue test Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-27694 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.1/07
2010a Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
An extended laboratory test to evaluate the effects on the
parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-28801, Revision No. 1 GLP: Yes Published:
No
Y Y FMC
IIA,
8.8.2.1/08
2010b Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
A laboratory test to evalute the effects on the mummies of the
parasitoid, Aphidius rhopalosiphi (Hymenoptera, Braconidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-29294 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.1/09
2010c Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil
or without Codacide oil: A semi-field test to evaluate the
effects on the parasitoid, Aphidius rhopalosiphi
(Hymenoptera, Braconidae) Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-29957 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.1/10
2010d Cyantraniliprole (DPX-HGW86) 100 g/L SE + Codacide oil:
A semi-field test to evalute the effects on the parasitoid,
Aphidius rhopalosiphi (Hymenoptera, Braconidae) Institut
für Biologische Analytik und Consulting IBACON GmbH
DuPont-29958 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.2/01
2010a DPX-HGW86 100 g/L SE plus Codacide oil: A field study to
evaluate effects on predatory mites (Acari Phytoseiidae) in
apple orchards in Germany, 2009 eurofins-GAB GmbH
DuPont-27849 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.2/02
2010b DPX-HGW86 100 g/L SE plus Codacide oil: A field study to
evaluate effects on predatory mites (Acari: Phytoseiidae) in
grape vinyards in Italy, 2009 eurofins-GAB GmbH DuPont-
27850 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.3/01
2010 Cyantraniliprole (DPX-HGW86) 200 g/L SC: An extended
laboratory test to study the effects on the rove beetle,
Aleochara bilineata (Coleoptera, Staphylinidae) Dr. U.
Noack-Laboratorien DuPont-26172 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.3/02
2011 Cyantraniliprole (DPX-HGW86) 200 g/L SC: An extended
laboratory study to evaluate the effects on the staphylinid
beetle, Aleochara bilineata Gyll. - aged residue test -
IBACON DuPont-29908 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.4/01
2010 Cyantraniliprole (DPX-HGW86) 200 g/L SC: Extended
laboratory test (dose-response-test) on Pardosa spp.
(Araneae, Lycosidae) Dr. U. Noack-Laboratorien DuPont-
26173 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.4/02
2009a Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide
oil: An extended laboratory test with field-aged spray
deposits to study the effects on the green lacewing
Chrysoperla carnea steph. (Neuroptera, Chrysopidae)
eurofins-GAB GmbH DuPont-27851 GLP: Yes Published:
No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 101 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.8.2.4/03
2009b Cyantraniliprole (DPX-HGW86) 100 g/L SE plus Codacide
oil: An extended laboratory test with field-aged spray
deposits to study the effects on the ladybird beetle,
Coccinella septempunctata L. (Coleoptera, Coccinellidae)
eurofins-GAB GmbH DuPont-27852 GLP: Yes Published:
No
Y Y FMC
IIA,
8.8.2.4/04
2009a Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended
laboratory rate response test to study the effects on the lady
bird beetle, Coccinella septempunctata (Coleoptera,
Coccinellidae) Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-25526 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.4/05
2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: An extended
laboratory rate response test to study the effects on the green
lacewing, Chrysoperla carnea steph. (chrysopidae,
neuroptera) Institut für Biologische Analytik und Consulting
IBACON GmbH DuPont-25525 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.4/06
2009c Cyantraniliprole (DPX-HGW86) 100 g/L SE: An extended
laboratory test to evaluate the effects on the lacewing,
Chrysoperla carnea (Neuroptera: Chrysopidae) Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-26927 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.4/07
2009d Cyantraniliprole (DPX-HGW86) 100 g/L SE: An extended
laboratory test to evaluate the effects on the ladybird beetle,
Coccinella septempunctata (Coleoptera, Coccinellidae)
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-26928 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.4/08
2009e Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
An extended laboratory test to evaluate the effects on the
lacewing, Chrysoperla carnea (Neuroptera: Chrysopidae) -
aged residue test - Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-28013 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.4/09
2010f Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
An extended laboratory test to evaluate the effects on the
ladybird beetle, Coccinella septempunctata (Coleoptera,
Coccinellidae) - aged residue test - Institut für Biologische
Analytik und Consulting IBACON GmbH DuPont-28014,
Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/01
2010 Cyantraniliprole (DPX-HGW86) technical: Soil
microarthropod monitoring on plots of a litter bag study
Eurofins Agroscience Services GmbH DuPont-29708 GLP:
Yes Published: No
Y Y FMC
IIA,
8.8.2.5/02
2011 Field study to evaluate the effects of cyantraniliprole on
collembola in Germany in 2010 Eurofins Agroscience
Services GmbH DuPont-29454 Final GLP: Yes Published:
No
Y Y FMC
IIA,
8.8.2.5/03
2009a IN-J9Z38: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-28208 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/04
2009b IN-K5A79: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-28202 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 102 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.8.2.5/05
2009c Cyantraniliprole (DPX-HGW86) technical: Effects on
reproduction of the predatory mite Hypoaspis aculeifer in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-27445 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/06
2009d IN-PLT97: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-27978 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/07
2009e IN-J9Z38: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-28207 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/08
2009f IN-JCZ38: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-28198 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/09
2010a IN-JCZ38: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-28199 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/10
2010b IN-K5A78: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-28205 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/11
2010c IN-PLT97: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-27976 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/12
2010d IN-JSE76: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-28206 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/13
2010e IN-K5A78: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-28203 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/14
2010f IN-JSE76: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-28209 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/15
2010g IN-K5A79: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-28204 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/16
2010h Cyantraniliprole (DPX-HGW86) technical: Effects on the
Collembola Folsomia candida in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27444 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/17
2010i IN-K5A77: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-27979 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/18
2010j IN-K5A77: Effects on the collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-27975 GLP: Yes
Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 103 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA,
8.8.2.5/19
2010k IN-QKV54: Effects on the collembola Folsomia candida in
artificial soil with 5% peat IBACON DuPont-29990 GLP:
Yes Published: No
Y Y FMC
IIA,
8.8.2.5/20
2010L IN-RNU71: Effects on the Collembola Folsomia candida in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-30093 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/21
2010m IN-J9Z38: Effects on the breakdown of organic matter in
litter bags in the field Institute für Biologische Analytik und
Consulting IBACON GmbH DuPont-27647 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/22
2010n QKV54: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-31375 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/23
2010o RNU71: Effects on reproduction of the predatory mite
Hypoaspis aculeifer in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-31374 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/24
2010p IN-K5A78: Effects on the breakdown of organic matter in
litter bags in the field Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-27319 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/25
2010q IN-K5A79: Effects on the breakdown of organic matter in
litter bags in the field Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-27322 GLP: Yes
Published: No
Y Y FMC
IIA,
8.8.2.5/26
2010a Cyantraniliprole (DPX-HGW86) technical: Effects on the
decomposition of organic matter in the field Eurofins
Agroscience Services GmbH DuPont-28194, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/27
2010b IN-JSE76: Effects on the decomposition of organic matter in
the field Eurofins Agroscience Services GmbH DuPont-
28195, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/28
2010c IN-PLT97: Effects on the decomposition of organic matter in
the field Eurofins Agroscience Services GmbH DuPont-
28196, Revision No. 1 GLP: Yes Published: No
Y Y FMC
IIA,
8.8.2.5/29
2011 IN-K5A77: Effects on the breakdown of organic matter in
litter bags in the field Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-29959 GLP: Yes
Published: No
Y Y FMC
IIA, 8.9.1/01 2008a IN-K5A78: Acute toxicity to the earthworm, Eisenia fetida,
in artificial soil International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-24236 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/02 2008b IN-K5A79: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-24245 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/03 2007a IN-J9Z38: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil Institut für Biologische Analytik und Consulting
IBACON GmbH DuPont-21324 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/04 2007b IN-JCZ38: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil Institut für Biologische Analytik und Consulting
IBACON GmbH DuPont-21325 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/05 2007c IN-K5A77: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil Institut für Biologische Analytik und Consulting
IBACON GmbH DuPont-21393 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 104 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.9.1/06 2008 DPX-HGW86 technical: Acute toxicity to the earthworm,
Eisenia fetida in artificial soil with 5% peat Institut für
Biologische Analytik und Consulting IBACON GmbH
DuPont-24880 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/07 2008a IN-PLT97: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-24244 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.1/08 2008b IN-JSE76: Acute toxicity to the earthworm, Eisenia fetida in
artificial soil International Institute of Biotechnology and
Toxicology (IIBAT) DuPont-24239 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/01 2010 IN-RNU71: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
International Institute of Biotechnology and Toxicology
(IIBAT) DuPont-30092 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/02 2009a Cyantraniliprole (DPX-HGW86) technical: Effects on
reproduction and growth of the earthworm, Eisenia fetida, in
artificial soil with 5% peat Institut für Biologische Analytik
und Consulting IBACON GmbH DuPont-26883 GLP: Yes
Published: No
Y Y FMC
IIA, 8.9.2/03 2009b IN-K5A77: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27353 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/04 2009c IN-JSE76: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27352 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/05 2009d IN-JCZ38: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27351 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/06 2009e IN-K5A78: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27350 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/07 2009f IN-K5A79: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27349 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/08 2009g IN-J9Z38: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27347 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/09 2009h IN-PLT97: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-27348 GLP: Yes Published: No
Y Y FMC
IIA, 8.9.2/10 2010 IN-QKV54: Effects on reproduction and growth of the
earthworm, Eisenia fetida, in artificial soil with 5% peat
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-29960 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/01 2008a IN-K5A78: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-24238 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/02 2008b IN-K5A79: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-24242 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 105 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.10.1/03 2008c IN-PLT97: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-24241 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/04 2008d IN-JSE76: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-24243 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/05 2008e Cyantraniliprole (cyantraniliprole) technical assessment of
the effects on soil microflora Institut für Biologische
Analytik und Consulting IBACON GmbH DuPont-24874
GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/06 2010a IN-QKV54: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-29559 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/07 2010b IN-RNU71: Assessment of the effects on soil microflora
Institut für Biologische Analytik und Consulting IBACON
GmbH DuPont-30090 GLP: Yes Published: No
Y Y FMC
IIA, 8.10.1/08 2007a IN-J9Z38: Assessment of the effects on soil microflora
eurofins-GAB GmbH DuPont-21320 GLP: Yes Published:
No
Y Y FMC
IIA, 8.10.1/09 2007b IN-JCZ38: Assessment of the effects on soil microflora
eurofins-GAB GmbH DuPont-21319 GLP: Yes Published:
No
Y Y FMC
IIA, 8.10.1/10 2007c IN-K5A77: Assessment of the effects on soil microflora
eurofins-GAB GmbH DuPont-21391 GLP: Yes Published:
No
Y Y FMC
IIA, 8.12/01 2010a Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
A greenhouse study to investigate the effects on seedling
emergence and growth of ten terrestrial plants following soil
exposure Wildlife International, Ltd. DuPont-29049 GLP:
Yes Published: No
Y Y FMC
IIA, 8.12/02 2010b Cyantraniliprole (DPX-HGW86) 100 g/L OD + Codacide oil:
A greenhouse study to investigate the effects on vegetative
vigor of ten terresterial plants following foliar exposure
Wildlife International, Ltd. DuPont-29050 GLP: Yes
Published: No
Y Y FMC
IIA, 8.12/03 2009a Cyantraniliprole (DPX-HGW86) 100 g/L OD: A greenhouse
study to investigate the effects on vegetative vigor of ten
terrestrial plants following foliar exposure Wildlife
International, Ltd. DuPont-21475 GLP: Yes Published: No
Y Y FMC
IIA, 8.12/04 2009b Cyantraniliprole (DPX-HGW86) 100 g/L OD: A greenhouse
study to investigate the effects on seedling emergence and
growth of ten terrestrial plants following soil exposure
Wildlife International, Ltd. DuPont-21476 GLP: Yes
Published: No
Y Y FMC
IIA, 8.15/01 2010 DPX-HGW86 technical: Activated sludge, respiration
inhibition test Institut für Biologische Analytik und
Consulting IBACON GmbH DuPont-21473, Revision No. 1
GLP: Yes Published: No
Y Y FMC
IIA, 8.16.1/01 2012 Biological activity of cyantraniliprole and related metabolites
on selected insect species under laboratory conditions DuPont
Stine-Haskell Research Center DuPont-30351, Revision No.
1 GLP: No Published: No
N Y FMC
IIA, 8.7.1/10 2011 IN-DBC80: Acute oral toxicity to the honey bee, Apis
mellifera L. International Institute of Biotechnology and
Toxicology (IIBAT). DuPont-32968 GLP: Yes Published: No
Y Y FMC
Benevia Part A
National addendum – Field - The Netherlands
15569 N
Registration Report – Central zone Page 106 of 66
Annex point
Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Data pro-tection claimed Y/N
Data pro-tection granted Y/N
Owner
IIA, 8.1.1/01 2008 DPX-HGW86 technical: An acute oral toxicity study with the
northern bobwhite Wildlife International, Ltd. DuPont-24248
GLP: Yes Published: No
Y Y FMC
IIA, 8.1.1/02 2009 Cyantraniliprole technical: An acute oral toxicity study with
the zebra finch (Poephila guttata) Wildlife International, Ltd.
DuPont-27316 GLP: Yes Published: No
Y Y FMC
IIA, 8.1.2/01 2008 DPX-HGW86 technical: A dietary LC50 study with the
northern bobwhite Wildlife International, Ltd. DuPont-21470
GLP: Yes Published: No
Y Y FMC
IIA, 8.1.3/01 2008 DPX-HGW86 technical: A dietary LC50 study with the
mallard Wildlife International, Ltd. DuPont-21469 GLP: Yes
Published: No
Y Y FMC
IIA, 8.1.4/01 2008a DPX-HGW86 technical: A reproduction study with the
mallard Wildlife International, Ltd. DuPont-20917 GLP: Yes
Published: No
Y Y FMC
IIA, 8.1.4/02 2008b DPX-HGW86 technical: A reproduction study with the
northern bobwhite Wildlife International, Ltd. DuPont-20918
GLP: Yes Published: No
Y Y FMC
IIA,
8.2.1.1/01
2006 DPX-HGW86 technical: Static, acute, 96-hour toxicity test
with rainbow trout, Oncorhynchus mykiss DuPont Haskell
Laboratories DuPont-19191 GLP: Yes Published: No
Y Y FMC
IIA,
8.2.1.2/01
2009a Cyantraniliprole (DPX-HGW86) technical: A 96-hour flow-
through acute toxicity test with the channel catfish (Ictalurus
punctatus) Wildlife International, Ltd. DuPont-19167 GLP:
Yes Published: No
Y Y FMC
IIA,
8.2.1.2/02
2009b Cyantraniliprole technical: A 96-hour flow-through acute
toxicity test with the sheepshead minnow (Cyprinodon
variegatus) Wildlife International, Ltd. DuPont-19165 GLP:
Yes Published: No
Y Y FMC
IIA,
8.2.1.2/03
2006 DPX-HGW86 technical: Static-renewal, acute, 96-hour
toxicity test to bluegill sunfish, Lepomis macrochirus DuPont
Haskell Laboratories DuPont-19164 GLP: Yes Published: No
Y Y FMC
IIA, 8.2.4/01 2009 Cyantraniliprole (DPX-HGW86) technical: An early life-
stage toxicity test with the sheepshead minnow (Cyprinodon
variegatus) Wildlife International, Ltd. DuPont-19193 GLP:
Yes Published: No
Y Y FMC
IIA, 8.2.4/02 2007 DPX-HGW86 technical: Early life-stage toxicity to rainbow
trout, Oncorhynchus mykiss DuPont Haskell Laboratories
DuPont-19192 GLP: Yes Published: No
Y Y FMC
IIA,
8.2.6.1/01
2010 14C-DPX-HGW86: Bioconcentration in bluegill sunfish,
Lepomis macrochirus ABC Laboratories, Inc. DuPont-21985
GLP: Yes Published: No
Y Y FMC