Training Session Product File Notes and Registration Reports, 23 October 2006 1 Product File Note...

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Training Session Product File Notes and Registration Reports, 23 October 2006

Product File NotePart Ecotoxicology

Ilse PittomvilsFederal Public Service of Public Health,

Food Chain Safety and EnvironmentBelgium

23 October 2006

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Training Session Product File Notes and Registration Reports

Federal Public Service ‘Public Health, Food Chain Safety and Environment’

Overview

Submitted studies LabellingExposureRisk assessmentExample

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Submitted studies

see presentation of M. Guelton two remarks:

Clearly indicate the units (e.g. 10 mg formulation/l or 10 mg active substance/l) because sometimes studies are carried out with the product but the endpoint is expressed in active substanceAlways mention the most critical endpoint, for algae this is most often the EbC50 and not the ErC50 value

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Labelling

Only labelling concerning ecotoxicology must be mentionned hereUse the most critical acute endpoints for labelling (e.g.algae: EbC50)Most critical acute endpoint < 1 mg product/ l R501 mg productl < Most critical acute endpoint < 10 mg/l R5110 mg productl < Most critical acute endpoint < 100 mg/l R52Most critical acute endpoint > 100 mg product/l no ecotox classification

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Labelling (2)

R53 is assigned by default for a product with R50, 51 or 52 unless a biodegradability study reveals that this phrase is not necessarySafety phrases

Professionals: S35-61 if R50 or 51S61 if R52

Non-professionals: S29-56 if R50, R51 or 52

If studies on non target arthropods: the product has no unacceptable effects on e.g. Typhlodromus pyri

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Exposure (of aquatic organisms) Excell sheet for cereals, maize = leafy crops, vegetables

= grassland, herbicide in orchards in case of aquatic risk evaluation

to be used for all ‘horizontal’ cultivated plants i.e. vegetables, grains, grasslandTo be used for herbicides

Excell sheet for grapevineTo be used for all ‘vertical’ cultivated crops i.e. grapes, small fruits, ornamentals, tomatoes, …

Excell sheet for orchardsTo be used for apple, pear, …

Excell sheets for hopsTo be used for hops

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Exposure (2)

PEC-calculations: By formula in the excell-sheet Input data: concentration of a.s. in the product, application rate, number of applications, interval, DT50 DT50 = 1000 unless data from water/sediment study are available known DT50 for products with more than one a.s. :

if one a.s. is clearly more toxic than the other one: take the DT50 of the most toxic a.s. if toxicity is related to both a.s., than take the worst case DT50

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Risk assessment

TER-calculationTER = EC50 / PECFish, daphnia: if TER > 100, then risk is acceptableAlgue: if TER > 10, then risk is acceptable

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Example: Risk evaluation by means of the excell sheets

Test Carried out with endpoint

results

a.s. formulation

Compar. Formul.

Acute algae

x EbC50 0,05 mg product/l

Acute daphnia

x EC50 2,5 mg product/l

Acute fish

x LC50 0,15 mg product/l

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Example (2)

Information about the exposure:Product X, 200 g/L a.s.Intended use: Apple: 2 x 1 L / ha leaf wall area 2 x 1,8 L / ha soil

applications before and after flowering Grapevine: 2 x 1 L / ha Potatoes: 2 x 1 L / ha

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Orchards (application by orchard airblast sprayer)

Formulation

Input data

Information on application

Active substance name a.s.

Formulation product X

Formulation conc (g/l) 200

Appl. rate (l/ha, kg/ha) 1,8

Nb of applications 2

Interval (days) 14

Drift reduction factor 1

Crop apple

Environmental data

DT50 soil DT50 water DT50 sediment Single appl. rate (g a.s./ha)

1000,0 1000,0 1000,0 360

Ecotoxicological data (expressed as formulation)

LD50 bird LC50 bird NOEL repro. bird

LD50 mammal NOEL repr mammal

LC50 fish EC50 daphnia EC50 algae Mesocosm assessment

0,15 2,5 0,05 -

NOEC chronic fish NOEC chronic daphniaNOEC chironomus EC50 lemna

- - - -

LD50 bee oral LD50 bee contact

- -

LC50 earthworm NOEC earthworm

- -

Predicted Environmental Concentrations (mg form./kg or mg form./l - just after last application)

soil (no intercept) mg/kg water (overspray) mg/lsed (overspray) mg/kg

4,777 1,194 13,779

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Toxicity exposure ratios for aquatic organisms drift reduction factor 1

Appl. rate (kg/ha, l/ha) Organism Distance TER (early) TER (late) Annex VI trigger

1,8 LC50 fish 0 0,1 0,1 100 R R

3 0,4 0,8 100 R R

5 0,6 1,5 100 R R

10 1,1 3,5 100 R R

15 2,3 6,9 100 R R

20 4,5 11,5 100 R R

30 12,1 23,3 100 R R

40 24,2 39,3 100 R R

50 41,9 57,1 100 R R

1,8 EC50 daphnia 0 2,1 2,1 100 R R

3 7,2 13,3 100 R R

5 10,5 24,9 100 R R

10 17,7 58,2 100 R R

15 37,7 115,7 100 R

20 75,6 192,1 100 R

30 201,3 387,7 100

40 402,6 654,2 100

50 697,8 951,6 100

1,8 EC50 algae 0 0,0 0,0 10 R R

3 0,1 0,3 10 R R

5 0,2 0,5 10 R R

10 0,4 1,2 10 R R

15 0,8 2,3 10 R R

20 1,5 3,8 10 R R

30 4,0 7,8 10 R R

40 8,1 13,1 10 R

50 14,0 19,0 10

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Orchards (application by orchard airblast sprayer)

Formulation

Input data





Appl. rate (l/ha, kg/ha) 1,8


Interval (days) 14

Drift reduction factor 0,1

Crop apple

Environmental data


1000,0 1000,0 1000,0 360





0,15 2,5 0,05 -


- - - -


- -


- -



4,777 1,194 13,779

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Toxicity exposure ratios for aquatic organisms drift reduction factor 0,1


1,8 LC50 fish 0 0,1 0,1 100 R R

3 4,3 8,0 100 R R

5 6,3 14,9 100 R R

10 10,6 34,9 100 R R

15 22,6 69,4 100 R R

20 45,3 115,2 100 R

30 120,8 232,6 100

40 241,6 392,5 100

50 418,7 570,9 100

1,8 EC50 daphnia 0 2,1 2,1 100 R R

3 71,7 133,1 100 R

5 105,3 248,9 100

10 177,3 581,5 100

15 377,2 1156,6 100

20 755,8 1920,6 100

30 2012,9 3876,7 100

40 4025,8 6542,0 100

50 6978,1 9515,6 100

1,8 EC50 algae 0 0,0 0,0 10 R R

3 1,4 2,7 10 R R

5 2,1 5,0 10 R R

10 3,5 11,6 10 R

15 7,5 23,1 10 R

20 15,1 38,4 10

30 40,3 77,5 10

40 80,5 130,8 10

50 139,6 190,3 10

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Grapevine, small fruit (currant,…)

Formulation

Input data



Formulation Product X


Appl. rate (l/ha, kg/ha) 1


Interval (days) 14

Drift reduction factor 0,5

Crop grapevine

Environmental data


1000,0 1000,0 1000,0 200





0,15 2,5 0,05 10






2,654 0,663 7,655

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Toxicity exposure ratios for aquatic organisms drift reduction factor 0,5


1 LC50 fish 0 0,2 0,2 100 R R

3 16,7 5,6 100 R R

5 38,3 12,5 100 R R

10 115,9 36,8 100 R

15 226,1 69,6 100 R

20 347,8 107,7 100

30 646,0 205,5 100

40 1130,5 323,0 100

50 1507,3 452,2 100

1 EC50 daphnia 0 3,8 3,8 100 R R

3 279,1 94,0 100 R

5 638,7 208,2 100

10 1932,4 612,7 100

15 3768,2 1159,4 100

20 5797,2 1794,4 100

30 10766,3 3425,6 100

40 18841,0 5383,1 100

50 25121,3 7536,4 100

1 EC50 algae 0 0,1 0,1 10 R R

3 5,6 1,9 10 R R

5 12,8 4,2 10 R

10 38,6 12,3 10

15 75,4 23,2 10

20 115,9 35,9 10

30 215,3 68,5 10

40 376,8 107,7 10

50 502,4 150,7 10

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Leafy crops (sugar beets, oilseed rape,…), vegetables

Formulation

Input data





Appl. rate (l/ha, kg/ha) 1


Interval (days) 14

Drift reduction factor 1

Crop potato

Environmental data


1000,0 1000,0 1000,0 200





0,15 2,5 0,05

NOEC chronic fish NOEC chronic daphnia NOEC chironomus EC50 lemna




soil (no intercept) mg/kg water (overspray) mg/l sed (overspray) mg/kg

2,654 0,663 7,655

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Toxicity exposure ratios for aquatic organisms drift reduction factor: 1

Appl. rate (kg/ha, l/ha) Organism Distance TER Annex VI trigger

1 LC50 fish 0 0,2 100 R

1 8,4 100 R

2 14,1 100 R

3 22,6 100 R

4 25,1 100 R

5 39,7 100 R

10 78,0 100 R

20 150,7 100

30 226,1 100

1 EC50 daphnia 0 3,8 100 R

1 139,6 100

2 235,5 100

3 376,8 100

4 418,7 100

5 661,1 100

10 1299,4 100

20 2512,1 100

30 3768,2 100

1 EC50 algae 0 0,1 10 R

1 2,8 10 R

2 4,7 10 R

3 7,5 10 R

4 8,4 10 R

5 13,2 10

10 26,0 10

20 50,2 10

30 75,4 10

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Example: Results of risk evaluation Crop category

Crops applied for

Dose (L product/ha)

Nr of applications

Drift mitigation measures

Horizontal crops

potato 1 2 20 meter with classic technique

Vertical crops

grapevine

1 2 20 meter with 50% drift reduction

Orchards apple 1.8 2 30 meter with 90% drift reduction

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Training Session Product File Notes and Registration Reports, 23 October 2006 1 Product File Note...

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