HEMOSIL APTT-SP

HEMOSIL® APTT-SP Safety Data Sheet According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015) Doc. ID: SDS00020006300_EN CO: 529262 Date of issue: 2010-07-28 Revision date: 2021-03-19 Version: 05

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IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product identifier Product name : HEMOSIL® APTT-SP Product code : 0020006300 Relevant identified uses of the substance or mixture and uses advised against Use of the substance/mixture : For in vitro diagnostic use. Uses advised against No additional information available

Details of the supplier of the safety data sheet

Emergency telephone number Emergency number : +44 (0) 3700 492 795 +1 215 207 0061 (USA and Canada)

INFORMATION ON COMPOSITION/HAZARD OF THE PRODUCT

P/N Mixture name Mixture classification According to

Hazard Communication Standard, 29 CFR 1910.1200 (HCS)

Hazardous Product Regulation HPR (WHMIS 2015)

Mixture classification According to

1272/2008/EC Regulation

Kit configuration

0020006310 APTT REAGENT Not classified Not classified 5 x 9 ml

0019741900 CALCIUM CHLORIDE 0.025M Not classified Not classified 5 x 8 ml

Disclaimer This document is intended only as a guide to appropriate precautionary handling of this product by a trained person, or supervised by a person trained in chemical handling. The product shall not be used for purposes different from those indicated in section 1, unless having received suitable written instructions on how to handle the material. Use the product in accordance with the Good Laboratory Practice. This document cannot describe all potential dangers of use or interaction with other chemicals or materials. It is the user’s responsibility for the product’s safe use, the product’s suitability for the intended use and the product’s safe disposal. No representation or warranties, either expressed or implied, of merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to the information set forth herein or to the product to which the information refers. The contained information in this SDS are in accordance with Annex II of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR (WHMIS 2015) as recommended by Health Canada (HC).

Prepared by: Chemsafe Srl

Manufacturer Instrumentation Laboratory Co. 180 Hartwell Road Bedford MA 01730-2443 - USA T +1 800 678 0710 - F +1 781 863 9928 E-mail address of competent person responsible for the SDS : [email protected]

Distributor EU Instrumentation Laboratory Co.

Via Leonardo da Vinci 36

20877 Roncello (MB)

Distributor US/CANADA Instrumentation Laboratory Co.

18B Independence Dr.

Devens, MA 01434-5294 (USA)

APTT REAGENT Safety Data Sheet According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015) Doc. ID: SDS00020006300_EN CO: 529262 Date of issue: 2010-07-28 Revision date: 2021-03-19 Version: 05

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SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form : Mixture Product name : APTT REAGENT Product code : 0020006310 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.2.1. Relevant identified uses Use of the substance/mixture : For in vitro diagnostic use.

1.2.2. Uses advised against No additional information available 1.3. Details of the supplier of the safety data sheet

1.4. Emergency telephone number Emergency number : +44 (0) 3700 492 795 +1 215 207 0061 (USA and Canada)

SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified

Classification according to Regulation OSHA 29 CFR 1910.1200 and Hazardous Product Regulation HPR (WHMIS 2015) Not classified

Adverse physicochemical, human health and environmental effects Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment. Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet. 2.2. Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP]Extra labelling to displayExtra classification(s) to display No labelling applicable 2.3. Other hazards Other hazards not contributing to the classification : The mixture does not meet the criteria for PBT or vPvB.

SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable




20877 Roncello (MB)





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3.2. Mixtures Comments : Composition: liquid containing organic and inorganic components.

Name Product identifier Conc. % w/w*

Classification 29 CFR 1910.1200 (HCS) HPR (WHMIS 2015)

Classification according to Regulation (EC) No. 1272/2008 [CLP]

2-pyridinethiol-1-oxide sodium salt

(CAS-No.) 3811-73-2 (EC-No.) 223-296-5

<0.02 Acute Toxicity – Oral, cat. 4 Acute Toxicity – Dermal, cat. 4 Acute Toxicity – Inhalation, cat. 4 Skin Corrosion/Irritation, cat.2 Eye damage/Eye Irritation, cat.2A Aquatic Acute, cat. 1** Aquatic Chronic, cat. 1**

Acute Tox. 4 (Oral), H302 Acute Tox. 4 (Dermal), H312 Acute Tox. 4 (Inhalation), H332 Skin Irrit. 2, H315 Eye Irrit. 2, H319 Aquatic Acute 1, H400 (M=100) Aquatic Chronic 1, H410 (M=10)

Comments : The mixture does not contain substances listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA. See Section 11 and 15

For exposure limits see Ch. 8, for hazard statements text see Ch. 16. * a range may be indicated, considering batch-to batch variation. **Environmental classification according to Reg. N. 1272/2008 (EC) and subsequent amendments.

SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation : If inhaled, move person to fresh air. If breathing is difficult, oxygen should be administered.

Get medical advice if adverse symptoms appear. First-aid measures after skin contact : Remove contaminated clothes and shoes. Wash immediately affected area with soap or mild

detergent and plenty of water until the removal of the mixture (15-20 minutes). Get medical advice if adverse symptoms appear.

First-aid measures after eye contact : Wash immediately with plenty of water or normal saline for at least 15 minutes. Keep eyelid open with the finger. Get medical advice if adverse symptoms appear.

First-aid measures after ingestion : If swallowed rinse mouth with plenty of water provided person is conscious. Do not induce vomiting. Get medical advice if adverse symptoms appear.

4.2. Most important symptoms and effects, both acute and delayed Symptoms/effects after inhalation : May cause irritation. Symptoms/effects after skin contact : May be irritant for skin. Symptoms/effects after eye contact : May cause eye irritation. Symptoms/effects after ingestion : May be harmful if swallowed. Chronic symptoms : Delayed symptoms and effects are not known. 4.3. Indication of any immediate medical attention and special treatment needed No additional information available

SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media : CO2. Water spray. Foam. Dry powder. 5.2. Special hazards arising from the substance or mixture Hazardous decomposition products in case of fire : Thermal decomposition or combustion may generate toxic and hazardous fumes of COx,

NOx, Na2O, SOx, HCl. 5.3. Advice for firefighters Protection during firefighting : Water jets can be used successfully to cool containers exposed to the fire and disperse

fumes. Other information : Self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves.

Equipment must be conformed with the national/international standards and used in highest condition of protection on the basis of the information reported in the previous sub-sections.

SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures 6.1.1. For non-emergency personnel Protective equipment : Respiratory protection: is not required. Where risk assessment shows air-purifying

respirators are appropriate, use masks with approved filter. Suitable protective clothing, rubber or polythene gloves, rubber shoes, safety glasses.

Emergency procedures : Evacuate area. Ventilate spillage area. No flames, no sparks. Eliminate all sources of ignition.


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6.1.2. For emergency responders Protective equipment : Do not attempt to take action without suitable protective equipment. For further information

refer to section 8: "Exposure controls/personal protection". 6.2. Environmental precautions Do not let the product enter drainage system, surface and ground-water or soil. Contact local authorities in case of environmental release. Do not empty into drains. 6.3. Methods and material for containment and cleaning up Methods for cleaning up : Soak up with inert absorbent material (for example sand, sawdust, a universal binder, silica

gel). Clean contaminated surfaces with an excess of water. Collect spillage. 6.4. Reference to other sections For further information refer to section 8: "Exposure controls/personal protection". For further information refer to section 13.

SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Handle in a well ventilated place, and away from sparks and flames - sources of ignition.

Keep the mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear suitable Personal Protection Equipment (see section 8).

Hygiene measures : Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Remove contaminated clothing and personal protective equipments (PPE) before entering eating areas.

7.2. Conditions for safe storage, including any incompatibilities Storage conditions : Keep containers tightly closed and labelled with the name of the product. Avoid

environmental release. Keep away from food and drinks. Incompatible materials : Heat sources. Direct sunlight. Storage temperature : 2 - 8 °C Storage area : Store in a well-ventilated place. 7.3. Specific end use(s) APTT Reagent is intended for in vitro diagnostic use. Use the product in accordance with the Good Laboratory Practice.

SECTION 8: Exposure controls/personal protection 8.1. Control parameters

2-pyridinethiol-1-oxide sodium salt (3811-73-2) Austria - Occupational Exposure Limits

MAK (mg/m³) 1 mg/m³

MAK Short time value (mg/m³) 4 mg/m³

Denmark - Occupational Exposure Limits

Local name Natriumpyrithion

Grænseværdie (langvarig) (mg/m³) 1 mg/m³

Anmærkninger (DK) H (betyder, at stoffet kan optages gennem huden)

Regulatory reference BEK nr 655 af 31/05/2018

Germany - Occupational Exposure Limits (TRGS 900)

TRGS 900 Local name Pyridin-2-thiol-1-oxid, Natriumsalz

Occupational exposure limit value (mg/m³) 0.5 mg/m³ (E)

Limitation of exposure peaks 2(II)

TRGS 900 Remark DFG;H;Y

TRGS 900 Regulatory reference TRGS900

Slovenia - Occupational Exposure Limits

Local name piridin-2-tiol-1-oksid, natrijeva sol

OEL TWA (mg/m³) 1 mg/m³

OEL STEL (mg/m³) 2 mg/m³

Remark (SI) K (Lastnost lažjega prehajanja snovi v organizem skozi kožo)

Regulatory reference Uradni list RS, št. 78/2018 z dne 4.12.2018


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2-pyridinethiol-1-oxide sodium salt (3811-73-2) Switzerland - Occupational Exposure Limits

MAK (mg/m³) 1 mg/m³ inhalable aerosol

KZGW (mg/m³) 2 mg/m³ inhalable aerosol

Monitoring methods

Monitoring methods The measurement of substances at the workplace must be carried out with standardized methods or, failing that, with appropriate methods.

8.2. Exposure controls Appropriate engineering controls: Appropriate risk management measures, that must be adopted at the workplace, have to be selected and applied, following the risks assessment carried out by the employer, in connection with his working activity. If the results of this evaluation show that the general and collective prevention measures are not sufficient to reduce the risk, and if you cannot prevent exposure to the mixture by other means, adequate personal protective equipment must be adopted, complying with the relevant technical national/international standards.

Personal protective equipment: Personal protective equipment (PPE) useful for reducing individual exposure.

Hand protection:

protective gloves

Eye protection:

Safety glasses

Skin and body protection:

Protective clothing, rubber gloves.

Respiratory protection:

Respiratory protection is not required. Where risk assessment shows air-purifying respirators are appropriate, use masks with approved filter. Use only devices approved by the Competent Authorities such as NIOSH (USA) and CEN (EU).

Environmental exposure controls: Avoid release to the environment.

SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Appearance : Liquid. Colour : Slightly turbid. Odour : odourless. Odour threshold : No data available pH : 7.55 Relative evaporation rate (butylacetate=1) : No data available Melting point : Not applicable Freezing point : No data available Boiling point : No data available Flash point : No data available Auto-ignition temperature : No data available Decomposition temperature : No data available Flammability (solid, gas) : Not applicable Vapour pressure : No data available Relative vapour density at 20 °C : No data available Relative density : No data available Density : 0.9987 g/ml Solubility : Water: miscible Log Pow : No data available Viscosity, kinematic : No data available


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Viscosity, dynamic : No data available Explosive properties : Aqueous solution, not expected to be explosive. Oxidising properties : Aqueous solution, not expected to have oxidizing properties. Explosive limits : No data available 9.2. Other information No additional information available

SECTION 10: Stability and reactivity 10.1. Reactivity This mixture is considered not reactive under the normal conditions of the usage. 10.2. Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 – 8 °C. 10.3. Possibility of hazardous reactions Under normal conditions of storage and use, hazardous reactions will not occur. 10.4. Conditions to avoid Keep away from heat and light. 10.5. Incompatible materials Oxidizing agent. reducing agents. 10.6. Hazardous decomposition products Thermal decomposition or combustion may include toxic and hazardous fumes of COx, NOx, SOx, HCl.

SECTION 11: Toxicological information 11.1. Information on toxicological effects Potential adverse human health effects and symptoms

: Dermal: Prolonged or repeated skin contact may cause irritation. Ingestion: Ingestion may cause irritation to the gastrointestinal mucous membranes. Inhalation: Inhalation of the product may cause irritation to respiratory ways. Contact with eyes: May cause irritation.

Toxicokinetics, metabolism and distribution : Sodium pyrithione (2-pyridinethiol-1-oxide sodium salt) is readily absorbed from the gastrointestinal tract and through the skin. In rats was rapidly absorbed, metabolized, and excreted at all dosing levels. There was no evidence of bioaccumulation of Sodium omadine or its metabolites in the tissues. The urine is the major route of excretion of Sodium omadine (73-85% of the dose); the feces are only a minor route of excretion (5-12% of the dose). Sodium omadine and its metabolites were not excreted in expired air. The major metabolite in rat urine was 2-pyridinethiol-1-oxide-S-glucuronide.

Experience with humans : The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided bellow.

Acute toxicity (oral) : Not classified Acute toxicity (dermal) : Not classified Acute toxicity (inhalation) : Not classified

2-pyridinethiol-1-oxide sodium salt (3811-73-2) LD50 oral rat 1500 mg/kg Sodium omadine 40%

LD50 oral 750 mg/kg rat

LD50 dermal rat 1800 µg/kg Sodium omadine 40%

LD50 dermal 700 mg/kg rat

LC50 inhalation rat (mg/l) 1.08 mg/l/4h Sodium omadine 40% LC50(rat)=1.1 mg/l/4h

Skin corrosion/irritation : Not classified pH: 7.55

Additional information : Sodium pyrithione: A single dose applied occlusively for 4 hours to the skin of rabbits as a 40% aqueous solution caused mild edema and erythema which had regressed after 72 hours

Serious eye damage/irritation : Not classified pH: 7.55

Additional information : Sodium pyrithione: Instillation of a 40 % solution (0.1 ml) into the eyes of rabbits caused mild, transient clouding of the cornea in 2/6 animals 24 hours after application. In all animals mild reddening of the conjunctiva developed and in 2/6 animals had not regressed after 72 hours. Conjunctival reddening was also observed after application of the substance in powder form (10 mg).


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Respiratory or skin sensitisation : Not classified Additional information : Sodium pyrithione was not found to be a dermal sensitizer in the tests conducted. Germ cell mutagenicity : Not classified Additional information : Sodium pyrithione: Genotoxic effects of the substance could not be demonstrated in the

Salmonella mutagenicity test, in the HPRT (hypoxanthine guanine phosphoribosyl transferase) test or in the test for DNA repair in rat hepatocytes. However, because the substance is cytotoxic, only low concentrations could be tested. Negative results were also obtained in vivo in the micronucleus test.

Carcinogenicity : Not classified Additional information : Sodium pyrithione is not carcinogenic either after dermal application to mice or after oral

administration to rats.

Reproductive toxicity : Not classified

2-pyridinethiol-1-oxide sodium salt (3811-73-2) Sodium pyrithione Reproductive toxicity is not observed, either after dermal application to rats or rabbits or

after oral administration to rats. Embryotoxicity develops in rats but not in rabbits after maternally toxic doses of sodium pyrithione.

STOT-single exposure : Not classified

2-pyridinethiol-1-oxide sodium salt (3811-73-2) Additional information There are no reports of toxic effects of single exposures of persons to sodium pyrithione

STOT-repeated exposure : Not classified

2-pyridinethiol-1-oxide sodium salt (3811-73-2) Sodium pyrithione No signs of toxic effects were observed in nine male workers who had been employed for

between 2 and 13 years in the production of sodium pyrithione. In the 90 day dermal toxicity study, rats were given daily doses of Sodium omadine at levels of 0, 5, 15 or 50 mg/kg/day. There was no evidence of dose-related dermal irritation. The NOEL was 15 mg/kg/day in males and 5 mg/kg/day in females. Sodium omadine (41.41% and 40.5% purity) in 40% aqueous solution was administered in water by gavage to groups of 5 male and 5 female Cynomolgus monkeys for 1 year at dose levels of 0, 5, 25, or 150 mg/kg/day. No evidence of toxicity was seen at the 5 mg/kg/day dose other than emesis in some monkeys. The NOAEL was 5 mg/kg/day

Aspiration hazard : Not classified Other information : Sodium pyrithione: Although no signs of neurotoxic effects were seen in monkeys even after

intubation of relatively high doses for a period of 1 year, the possibility remains that such effects could develop in man after high level exposures.

SECTION 12: Ecological information 12.1. Toxicity Hazardous to the aquatic environment, short-term (acute)

: Not classified

Hazardous to the aquatic environment, long-term (chronic)

: Not classified

Additional information : The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided bellow.

2-pyridinethiol-1-oxide sodium salt (3811-73-2) LC50 fish 1 6.6 - 8 μg/l Lepomis macrochirus

EC50 Daphnia 1 0.022 mg/l

EC50 72h algae (1) 0.46 mg/l

NOEC chronic algae 0.08 mg/l 72 h


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Additional information Toxicity data on soil micro- and macroorganisms - EC50 = 120 mg/L/3 h Toxicity data on birds, bees and plants - Mallard duck 8 day dietary LC50 = 10033 ppm Bobwhite quail 8 day dietary LC50 = 3075 ppm Mallard duck acute oral LD50 = 92 mg/kg Bobwhite quail acute oral LD50 = 200 mg/kg

12.2. Persistence and degradability 2-pyridinethiol-1-oxide sodium salt (3811-73-2) Persistence and degradability Sodium pyrithione (40.8% sol.) is readily biodegradable.

12.3. Bioaccumulative potential No additional information available 12.4. Mobility in soil No additional information available 12.5. Results of PBT and vPvB assessment No additional information available 12.6. Other adverse effects No additional information available

SECTION 13: Disposal considerations 13.1. Waste treatment methods Regional legislation (waste) : Disposal must be done according to official regulations. Waste treatment methods : Used waste product, surplus product or spillage products shall be disposed of in accordance

with national, state and local laws.

SECTION 14: Transport information In accordance with ADR / RID / IMDG / IATA / ADN

ADR IMDG IATA RID

14.1. UN number Not applicable Not applicable Not applicable Not applicable

14.2. UN proper shipping name Not applicable Not applicable Not applicable Not applicable

14.3. Transport hazard class(es) Not applicable Not applicable Not applicable Not applicable

14.4. Packing group Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards Not applicable Not applicable Not applicable Not applicable

No supplementary information available 14.6. Special precautions for user Overland transport Not applicable

Transport by sea Not applicable

Air transport Not applicable

Rail transport Not applicable 14.7. Transport in bulk according to Annex II of Marpol and the IBC Code Not applicable


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SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture 15.1.1. EU-Regulations

Contains no REACH substances with Annex XVII restrictions Contains no substance on the REACH candidate list Contains no REACH Annex XIV substances Contains no substance subject to REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals. Contains no substance subject to Regulation (EU) No 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants Other information, restriction and prohibition regulations

: Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (Official Journal L 183, 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements. Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal protective equipment. Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131, 05/05/1998 P. 0011 – 0023. Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.


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15.1.2. US and Canada regulations

US Federal Regulations:

State Components listed Note

Massachusetts No component listed

New York No component listed

New Jersey No component listed

Pennsylvania No component listed

California Prop. 65

Ingredient name Cancer Reproductive NSRL or MADL (µg/day)

No component listed

Clean Water Act (CWA) 307 No component listed

Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs) No component listed

Clean Air Act Section 602 Class I Substances No component listed

Clean Air Act Section 602 Class II Substances No component listed

DEA List I Chemicals (Precursor Chemicals) No component listed

DEA List II Chemicals (Essential Chemicals) No component listed

EPA List of Lists

Regulatory Name CAS No./SARA/ 313 Category

Code I

SARA/ EPCRA 302

EHS TPQ II

SARA/ EPCRA 304

EHS RQ III

CERCLA RQ IV

SARA/EPCRA 313 TRI V

RCRA Code VI

CAA 112(r) RMP TQ VII

No component listed ISARA/313 Category Code: Emergency Planning and Community Right‐to Know Act Section 313 Category Code II ISARA/EPCRA 302 EHS TPQ: Extremely Hazardous Substance Threshold Planning Quantity (Emergency Planning and Community Right‐to Know Act Section 302 Category Code) III ISARA/EPCRA 304 EHS RQ: Extremely Hazardous Substance Reportable Quantity (Emergency Planning and Community Right‐to Know Act Section 304 Category Code) IVCERCLA RQ: Reportable Quantity (Comprehensive Environmental Response, Compensation, and Liability Act) V ISARA/EPCRA 313 TRI: Toxics Release Inventory (Emergency Planning and Community Right‐to Know Act Section 313 Category Code) VIRCRA Code: Resource Conservation and Recovery Act Code VIICAA 112(r) RMP TQ: Risk Management Plan Threshold Quantity (Clean Air Act Section 112(r))

United States Inventory (TSCA 8b): All components are listed or exempted.

Canada Domestic Substances List (DSL): All components are listed or exempted.

15.2. Chemical safety assessment No chemical safety assessment has been carried out

SECTION 16: Other information

Revisions Edition n. 01, dated 2010-07-28.

Revision n. 01, dated 2012-04-24.




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Revision n. 04, dated 2015-09-25. Main changes are in sections 2 to16, adapting the SDS format and contents to Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012), Hazardous Product Regulation HPR (WHMIS 2015), and Regulation (EU) 2015/830 of 28 May 2015.

Revision n. 05, dated 2021-03-19. Small content changes (sections 1 to 16)

Abbreviations and acronyms:

ACGIH American Conference of Governmental Industrial Hygienists

AIHA American Industrial Hygiene Association

ADR European Agreement concerning the International Carriage of Dangerous Goods by Road

BCF Bioconcentration factor

BEI Biological Esposure Indices

CAS Chemical Abstract Service (division of the American Chemical Society)

CLP Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008

DNEL Derived-No Effect Level

EC50 Median effective concentration

EINECS European Inventory of Existing Commercial Substances

EPA US Environmental Protection Agency

IARC International Agency for Research on Cancer

IATA International Air Transport Association

IMDG International Maritime Dangerous Goods

LC50 Median lethal concentration

LD50 Median lethal dose

LOAEL Lowest Observed Adverse Effect Level

MADL Maximum Allowable Daily (or Dose) Level

NOAEL No-Observed Adverse Effect Level

NOEC No-Observed Effect Concentration

NSRL National Science Research Laboratory

NTP National Toxicology Program

OEL Occupational Exposure Limit

OSHA Occupational Safety and Health Administration

PPE Personal protective Equipment

PBT Persistent Bioaccumulative Toxic

PNEC Predicted No-Effect Concentration

RID Regulations concerning the International Carriage of Dangerous Goods by Rail

TLV/TWA Threshold Limit Value/Threshold Weighted Average

vPvB Very Persistent and Very Bioaccumulative

WEEL Workplace Environmental Exposure Level (air concentration of agents in a healthy worker's breathing zone)

Training advice : Follow National requirements to ensure protection of human health and the environment.

Full text of H- and EUH-statements:

Acute Tox. 4 (Dermal) Acute toxicity (dermal), Category 4

Acute Tox. 4 (Inhalation) Acute toxicity (inhal.), Category 4

Acute Tox. 4 (Oral) Acute toxicity (oral), Category 4


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Aquatic Acute 1 Hazardous to the aquatic environment — Acute Hazard, Category 1

Aquatic Chronic 1 Hazardous to the aquatic environment — Chronic Hazard, Category 1

Eye Irrit. 2 Serious eye damage/eye irritation, Category 2

Skin Irrit. 2 Skin corrosion/irritation, Category 2

H302 Harmful if swallowed.

H312 Harmful in contact with skin.

H315 Causes skin irritation.

H319 Causes serious eye irritation.

H332 Harmful if inhaled.

H400 Very toxic to aquatic life.

H410 Very toxic to aquatic life with long lasting effects.

Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to HPR (WHMIS 2015) :

Classification: Classification procedure

Not classified -

Bibliographic references

GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Office of Prevention, Pesticides And Toxic Substances, Registration Eligibility Decision(RED) Sodium Omadine, EPA 738-R-95-031, January 1996 Sodium omadine® 40% aq. Sol. Industrial fungicide/bactericide, SDS of the supplier up the supply chain Sodium pyrithione, Registration Dossier, ECHA, http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ea00f77-8e69-65ae-e044-00144f67d031/DISS-9ea00f77-8e69-65ae-e044-00144f67d031_DISS-9ea00f77-8e69-65ae-e044-00144f67d031.html The MAK Collection for Occupational Health and Safety, Volume 10, Sodium pyrithione, The MAK Collection for Occupational Health and SafetyPublished Online: 31 JAN 2012 http://e-aair.org - Allergy, Asthma and Immunology Research (AAIR) 2009, October, Occupational asthma caused by inhalation of bovine serum albumin powder, Case report

SDS EU (REACH Annex II) The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No 1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR (WHMIS 2015) as recommended by Health Canada (HC).

CALCIUM CHLORIDE 0.025M Safety Data Sheet According to Regulation (EC) No 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015) Doc. ID: SDS00020006300_EN CO: 529262 Date of issue: 2010-07-28 Revision date: 2021-03-19 Version: 05

9/25/2015 (Version: 0.4)

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SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form : Mixture Product name : CALCIUM CHLORIDE 0.025M Product code : 0019741900 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.2.1. Relevant identified uses Use of the substance/mixture : For in vitro diagnostic use.

1.2.2. Uses advised against No additional information available 1.3. Details of the supplier of the safety data sheet

1.4. Emergency telephone number Emergency number : +44 (0) 3700 492 795 +1 215 207 0061 (USA and Canada)

SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Regulation (EC) No. 1272/2008 [CLP] Not classified

Classification according to Regulation OSHA 29 CFR 1910.1200 and Hazardous Product Regulation HPR (WHMIS 2015) Not classified

Adverse physicochemical, human health and environmental effects Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment. Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this sheet. 2.2. Label elements Labelling according to Regulation (EC) No. 1272/2008 [CLP]Extra labelling to displayExtra classification(s) to display No labelling applicable 2.3. Other hazards Other hazards not contributing to the classification : The mixture does not meet the criteria for PBT or vPvB.

SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Comments : Composition: Liquid containing inorganic components.




20877 Roncello (MB)





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Name Product identifier Conc. % w/w*

Classification 29 CFR 1910.1200 (HCS) HPR (WHMIS 2015)

Classification according to Regulation (EC) No. 1272/2008 [CLP]

Calcium chloride dihydrate

(CAS-No.) 10035-04-8 (10043-52-4 as anhydrous) (EC-No.) 233-140-8 (EC Index-No.) 017-013-00-2

<0.4 Eye damage/irritation, cat. 2 Eye Irrit. 2, H319

Sodium Azide (CAS-No.) 26628-22-8 (EC-No.) 247-852-1 (EC Index-No.) 011-004-00-7

<0.03 Acute Toxicity – Oral, cat. 2 Acute Toxicity – Dermal, cat. 2 Acute Toxicity – Inhalation, cat. 2 Specific Target Organ toxicity – Repeated exposure, cat. 2 Aquatic Acute cat. 1** Aquatic Chronic cat. 1**

Acute Tox. 2 (Oral), H300 Acute Tox. 2 (Dermal), H310 Acute Tox. 2 (Inhalation), H330 STOT RE 2, H373 Aquatic Acute 1, H400 (M=1) Aquatic Chronic 1, H410 (M=1)

Comments : The mixture contains one substance listed in the Hazardous Substance Lists and/or evaluated for carcinogenicity by IARC, NTP, OSHA: Sodium azide. See Section 11 and 15.

For exposure limits see Ch. 8, for hazard statements text see Ch. 16. * a range may be indicated, considering batch-to batch variation. **Environmental classification according to Reg. N. 1272/2008 (EC) and subsequent amendments.

SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation : If inhaled, move person to fresh air. If breathing is difficult, oxygen should be administered.

Get medical advice if adverse symptoms appear. First-aid measures after skin contact : Remove contaminated clothes and shoes. Wash immediately affected area with soap or mild

detergent and plenty of water until the removal of the mixture (15-20 minutes). Get medical advice if adverse symptoms appear.

First-aid measures after eye contact : Wash immediately with plenty of water or normal saline for at least 15 minutes. Keep eyelid open with the finger. Get medical advice if adverse symptoms appear.

First-aid measures after ingestion : If swallowed rinse mouth with plenty of water provided person is conscious. Do not induce vomiting. Get medical advice if adverse symptoms appear.

4.2. Most important symptoms and effects, both acute and delayed Symptoms/effects after inhalation : May cause irritation. Symptoms/effects after skin contact : May be irritant for skin. Symptoms/effects after eye contact : May cause eye irritation. Symptoms/effects after ingestion : May be harmful if swallowed. Chronic symptoms : Delayed symptoms and effects are not known. 4.3. Indication of any immediate medical attention and special treatment needed No additional information available

SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media : CO2. Water spray. Dry powder. Foam. 5.2. Special hazards arising from the substance or mixture Hazardous decomposition products in case of fire : Thermal decomposition or combustion may generate toxic and hazardous fumes of HCl,

NOx, Na2O. 5.3. Advice for firefighters Protection during firefighting : Water jets can be used successfully to cool containers exposed to the fire and disperse

fumes. Other information : Self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves.

Equipment must be conformed with the national/international standards and used in highest condition of protection on the basis of the information reported in the previous sub-sections.


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SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures 6.1.1. For non-emergency personnel Protective equipment : Respiratory protection: is not required. Where risk assessment shows air-purifying

respirators are appropriate, use masks with approved filter. Suitable protective clothing, rubber or polythene gloves, rubber shoes, safety glasses.

Emergency procedures : Evacuate area. Ventilate spillage area. No flames, no sparks. Eliminate all sources of ignition.

6.1.2. For emergency responders Protective equipment : Do not attempt to take action without suitable protective equipment. For further information

refer to section 8: "Exposure controls/personal protection". 6.2. Environmental precautions Do not let the product enter drainage system, surface and ground-water or soil. Contact local authorities in case of environmental release. Do not empty into drains. 6.3. Methods and material for containment and cleaning up Methods for cleaning up : Soak up with inert absorbent material (for example sand, sawdust, a universal binder, silica

gel). Clean contaminated surfaces with an excess of water. Collect spillage. 6.4. Reference to other sections For further information refer to section 8: "Exposure controls/personal protection". For further information refer to section 13.

SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Handle in a well ventilated place, and away from sparks and flames - sources of ignition.

Keep the mixture away from drains, surface or ground waters. Avoid contact with incompatible materials. Wear suitable Personal Protection Equipment (see section 8).

Hygiene measures : Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Remove contaminated clothing and personal protective equipments (PPE) before entering eating areas.

7.2. Conditions for safe storage, including any incompatibilities Storage conditions : Keep containers tightly closed and labelled with the name of the product. Avoid

environmental release. Keep away from food and drinks. Incompatible materials : Direct sunlight. Heat sources. Storage temperature : 2 - 8 °C Storage area : Store in a well-ventilated place. 7.3. Specific end use(s) Calcium Chloride 0.025M is intended for in vitro diagnostic use.. Use the product in accordance with the Good Laboratory Practice.

SECTION 8: Exposure controls/personal protection 8.1. Control parameters

Sodium Azide (26628-22-8) EU - Occupational Exposure Limits

Local name Sodium azide

IOELV TWA (mg/m³) 0.1 mg/m³

IOELV STEL (mg/m³) 0.3 mg/m³

Notes Skin

Regulatory reference COMMISSION DIRECTIVE 2000/39/EC

Austria - Occupational Exposure Limits

MAK (mg/m³) 0.1 mg/m³

MAK Short time value (mg/m³) 0.3 mg/m³

Belgium - Occupational Exposure Limits

Limit value (mg/m³) 0.1 mg/m³

Short time value (mg/m³) 0.3 mg/m³

Czech Republic - Occupational Exposure Limits

Local name Azid sodný


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Sodium Azide (26628-22-8) Expoziční limity (PEL) (mg/m³) 0.1 mg/m³

Expoziční limity (PEL) (ppm) 0.038 ppm

Expoziční limity (NPK-P) (mg/m³) 0.3 mg/m³

Expoziční limity (NPK-P) (ppm) 0.113 ppm

Remark (CZ) D (při expozici se významně uplatňuje pronikání látky kůží), I (dráždí sliznice (oči, dýchací cesty) resp. Kůži)

Regulatory reference Nařízení vlády č. 361/2007 Sb. (zapracovány změny č. 246/2018 Sb.)

Denmark - Occupational Exposure Limits

Local name Natriumazid

Grænseværdie (langvarig) (mg/m³) 0.1 mg/m³

Anmærkninger (DK) E (betyder, at stoffet har en EF-grænseværdi); H (betyder, at stoffet kan optages gennem huden)

Regulatory reference BEK nr 655 af 31/05/2018

Finland - Occupational Exposure Limits

Local name Natriumatsidi

HTP-arvo (8h) (mg/m³) 0.1 mg/m³

HTP-arvo (15 min) 0.3 mg/m³

Huomautus (FI) iho

Regulatory reference HTP-ARVOT 2018 (Sosiaali- ja terveysministeriö)

France - Occupational Exposure Limits

Local name Azide de sodium

VME (mg/m³) 0.1 mg/m³

VLE (mg/m³) 0.3 mg/m³

Note (FR) Valeurs règlementaires contraignantes; risque de pénétration percutanée

Regulatory reference Article R4412-149 du Code du travail (réf.: INRS ED 984, 2016)

Germany - Occupational Exposure Limits (TRGS 900)

TRGS 900 Local name Natriumazid

Occupational exposure limit value (mg/m³) 0.2 mg/m³

Limitation of exposure peaks 2(I)

TRGS 900 Remark DFG;EU

TRGS 900 Regulatory reference TRGS900

Greece - Occupational Exposure Limits

Local name Νατραζίδιο

OEL TWA (mg/m³) 0.3 mg/m³

OEL TWA (ppm) 0.1 ppm

OEL STEL (mg/m³) 0.3 mg/m³

Regulatory reference Π.Δ. 90/1999

Hungary - Occupational Exposure Limits

Local name NÁTRIUM-AZID

AK-érték 0.1 mg/m³

CK-érték 0.3 mg/m³

Megjegyzések (HU) EU1 (2000/39/EK irányelvben közölt érték)

Regulatory reference 25/2000. (IX. 30.) EüM–SZCSM együttes rendelet a munkahelyek kémiai biztonságáról


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Sodium Azide (26628-22-8) Ireland - Occupational Exposure Limits

OEL (8 hours ref) (mg/m³) 0.1 mg/m³

OEL (15 min ref) (mg/m3) 0.3 mg/m³

Italy - Occupational Exposure Limits

Local name Azoturo di sodio



Notes pelle

Regulatory reference Allegato XXXVIII del D.Lgs. 9 aprile 2008, n. 81 e s.m.i.

Lithuania - Occupational Exposure Limits

Local name Natrio azidas

IPRV (mg/m³) 0.1 mg/m³

TPRV (mg/m³) 0.3 mg/m³

Remark (LT) O (medžiaga į organizmą gali prasiskverbti pro nepažeistą odą); Ū (ūmus poveikis)

Regulatory reference LIETUVOS HIGIENOS NORMA HN 23:2011 (Nr. V-695/A1-272, 2018-06-12)

Netherlands - Occupational Exposure Limits

Local name Natriumazide

Grenswaarde TGG 8H (mg/m³) 0.1 mg/m³

Grenswaarde TGG 15MIN (mg/m³) 0.3 mg/m³

Remark (MAC) H (Huidopname) Stoffen die relatief gemakkelijk door de huid kunnen worden opgenomen, hetgeen een substantiële bijdrage kan betekenen aan de totale inwendige blootstelling, hebben in de lijst een H-aanduiding. Bij deze stoffen moeten naast maatregelen tegen inademing ook adequate maatregelen ter voorkoming van huidcontact worden genomen.

Regulatory reference Arbeidsomstandighedenregeling 2018

Poland - Occupational Exposure Limits

Local name Azydek sodu

NDS (mg/m³) 0.1 mg/m³

NDSCh (mg/m³) 0.3 mg/m³

Remark (PL) Skóra (Oznakowanie substancji notacją „skóra” oznacza, że wchłanianie substancji przez skórę może być tak samo istotne jak przy narażeniu drogą oddechową)

Regulatory reference Dz. U. 2018 poz. 1286

Portugal - Occupational Exposure Limits

Local name Azida de sódio

OEL - Ceilings (mg/m³) 0.11 mg/m³ como vapor de Ácido hidroazóico

OEL - Ceilings (ppm) 0.29 ppm como Azida de sódio

Regulatory reference Norma Portuguesa NP 1796:2014

Slovakia - Occupational Exposure Limits

Local name Azid sodný

NPHV (priemerná) (mg/m³) 0.1 mg/m³


Upozornenie (SK) K - znamená, že faktor môže byť ľahko absorbovaný kožou

Regulatory reference Nariadenie vlády č. 33/2018 Z.z.

Slovenia - Occupational Exposure Limits


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Sodium Azide (26628-22-8) Local name natrijev azid



Remark (SI) K (Lastnost lažjega prehajanja snovi v organizem skozi kožo), EU

Regulatory reference Uradni list RS, št. 78/2018 z dne 4.12.2018

Spain - Occupational Exposure Limits

Local name Azida de sodio (Aziduro de sodio; Trinitruro de sodio)

VLA-ED (mg/m³) 0.1 mg/m³

VLA-EC (mg/m³) 0.3 mg/m³

Notes Vía dérmica (Indica que, en las exposiciones a esta sustancia, la aportación por la vía cutánea puede resultar significativa para el contenido corporal total si no se adoptan medidas para prevenir la absorción. En estas situaciones, es aconsejable la utilización del control biológico para poder cuantificar la cantidad global absorbida del contaminante), VLI (Agente químico para el que la U.E. estableció en su día un valor límite indicativo).

Regulatory reference Límites de Exposición Profesional para Agentes Químicos en España 2019. INSHT

Sweden - Occupational Exposure Limits

Limit value – short term 0,29 mg/m³ - ceiling limit value

United Kingdom - Occupational Exposure Limits

WEL TWA (mg/m³) 0.1 mg/m³

WEL STEL (mg/m³) 0.3 mg/m³

Switzerland - Occupational Exposure Limits

MAK (mg/m³) 0.2 mg/m³ inhalable aerosol

KZGW (mg/m³) 0.4 mg/m³ inhalable aerosol

USA - ACGIH - Occupational Exposure Limits

ACGIH STEL (mg/m³) 0.29 mg/m³

ACGIH chemical category Not Classifiable as a Human Carcinogen

USA - NIOSH

Short time value (ppm) 0.1 ppm – ceiling limit value (as HN3)

Short time value (mg/m3) 0,3 mg/m³ – ceiling limit value (as NaN3)

Canada – Québec

Short time value (mg/m³) 0,3 mg/m³; 0.11 ppm – ceiling value

Canada - Ontario

Short time value (ppm) 0.29 ppm – ceiling limit value

Short time value (ppm) 0.11 ppm – ceiling limit value as HN3

Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous))

Canada - Ontario

Occupational exposure limit (OEL) for calcium chloride of 5 mg/m3 has been established by the Ministry of Labor

Monitoring methods

Monitoring methods The measurement of substances at the workplace must be carried out with standardized methods or, failing that, with appropriate methods.


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Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) DNEL/DMEL (Workers)

Acute - local effects, inhalation 10 µg/m³

Long-term - local effects, inhalation 5 µg/m³

DNEL/DMEL (General population)

Acute - local effects, inhalation 5 µg/m³

Long-term - local effects, inhalation 2.5 µg/m³ 8.2. Exposure controls Appropriate engineering controls: Appropriate risk management measures, that must be adopted at the workplace, have to be selected and applied, following the risks assessment carried out by the employer, in connection with his working activity. If the results of this evaluation show that the general and collective prevention measures are not sufficient to reduce the risk, and if you cannot prevent exposure to the mixture by other means, adequate personal protective equipment must be adopted, complying with the relevant technical national/international standards.

Personal protective equipment: Personal protective equipment (PPE) useful for reducing individual exposure.

Hand protection:

protective gloves

Eye protection:

Safety glasses

Skin and body protection:

Protective clothing, rubber gloves.

Respiratory protection:

Respiratory protection is not required. Where risk assessment shows air-purifying respirators are appropriate, use masks with approved filter. Use only devices approved by the Competent Authorities such as NIOSH (USA) and CEN (EU).

Environmental exposure controls: Avoid release to the environment.

SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Appearance : Liquid. Colour : clear. Odour : odourless. Odour threshold : No data available pH : No data available Relative evaporation rate (butylacetate=1) : No data available Melting point : No data available Freezing point : No data available Boiling point : No data available Flash point : No data available Auto-ignition temperature : No data available Decomposition temperature : No data available Flammability (solid, gas) : No data available Vapour pressure : No data available Relative vapour density at 20 °C : No data available Relative density : No data available Density : 1 g/ml


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Solubility : Water: miscible Log Pow : No data available Viscosity, kinematic : No data available Viscosity, dynamic : No data available Explosive properties : Aqueous solution, not expected to be explosive. Oxidising properties : Aqueous solution, not expected to have oxidizing properties. Explosive limits : No data available 9.2. Other information Miscibility : miscible

SECTION 10: Stability and reactivity 10.1. Reactivity This mixture is considered not reactive under the normal conditions of the usage. 10.2. Chemical stability The product is stable until the expiration date shown on the box and on the labels when stored at 2 – 8 °C. 10.3. Possibility of hazardous reactions Under normal conditions of storage and use, hazardous reactions will not occur. 10.4. Conditions to avoid Keep away from heat and light. 10.5. Incompatible materials Strong oxidising agents, acids, alkalis, heavy metals and their salts. Sodium azide has been reported to form lead or copper azide in laboratory plumbing which may explode on percussions. Sodium azide reacts vigorously with heated water. 10.6. Hazardous decomposition products Thermal decomposition or combustion may generate toxic and hazardous fumes of HCl, NOx, Na2O.

SECTION 11: Toxicological information 11.1. Information on toxicological effects Potential adverse human health effects and symptoms

: Dermal: May cause skin irritation. Ingestion: May cause breathlessness, tachycardia, nausea, vomiting, headache, restlessness and diarrhea. Inhalation: May cause irritation to the mucous membranes and upper respiratory tract. Contact with eyes: May cause eye irritation.

Toxicokinetics, metabolism and distribution : Sodium azide is rapidly absorbed from the respiratory and gastrointestinal tract, and from injection sites. It is also rapidly absorbed by the lungs, and through the skin. The degree of skin penetration via undamaged skin is not clear. The azide anion appeared within 5 min in the plasma of rats following oral administration of 40 mg/kg sodium azide. After 24 h, no more azide could be detected in either plasma or tissue. Sodium azide penetrates the blood-brain barrier and is mainly metabolized in the liver. Its main metabolite in the liver is nitric oxide. Azide anions may be metabolized to nitric oxide (NO) also in the CNS. In aqueous solution, it rapidly transforms into hydrazoic acid, which may be responsible for the irritating effects attributed to sodium azide. Following oral administration of 40 mg/kg sodium azide, no sodium azide was detectable in the feces or in exhaled air and only 7.9 μg were excreted in the 24 h urine. Calcium chloride. It is easily dissociated into calcium and chloride ions in water. The absorption, the distribution and the excretion of the ions in animals are regulated separately. Both ions are essential constituents of the body of all animals.

Experience with humans : The health effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided bellow.

Acute toxicity (oral) : Not classified Acute toxicity (dermal) : Not classified Acute toxicity (inhalation) : Not classified

Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) LD50 oral rat 3.798 - 4.179 mg/kg The acute oral toxicity is attributed to the severe irritating property of

the original substance or its high-concentration solutions to the GI tract.

LD50 oral 500 - 1000 mg/kg rabbit

LD50 dermal rabbit > 5000

LC50 inhalation rat (mg/l) > 40 mg/m³ 4h


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Sodium Azide (26628-22-8) LD50 oral rat 27 mg/kg

LD50 dermal rabbit 18 - 60 mg/kg

LC50 inhalation rat (mg/l) 0.052 - 0.52 mg/m³

Additional information The most commonly reported health effect from azide exposure is hypotension, almost independent of route of exposure. Fatal doses occur with exposures of > or =700 mg (10 mg/kg). Nonlethal doses ranged from 0.3 to 150 mg (0.004 to 2 mg/kg). Onset of hypotension within minutes or in less than an hour is indicative of a pharmacological response and a benign course. Hypotension with late onset (>1 hour) constitutes an ominous sign for death.

Skin corrosion/irritation : Not classified Additional information : Sodium azide: Dermal (semi-occlusive and occlusive) exposure to 0.5 g/patch solid sodium

azide for 1 hour did not produce signs of local irritation in rabbits, whereas exposure for 4 hours was corrosive. In an in vitro Skin Irritation Reconstructed Human Epidermis (RhE) Test Method (9 September 2009), sodium azide was non irritant to skin. Calcium chloride: Not irritating for the skin.

Serious eye damage/irritation : Not classified Additional information : Sodium azide: In a Bovine Corneal Opacity and Permeability Test Method for Identifying

Ocular Corrosives and Severe Irritants (September, 2009) was not considered to be an eye irritant. Calcium chloride: Irritating for the eyes.

Respiratory or skin sensitisation : Not classified Additional information : Sodium azide: In a Mouse local lymphnode assay (LLNA) (OECD Guideline 429), sodium

azide was not a skin sensitizer. Calcium chloride: Due to lack of data the classification is not possible.

Germ cell mutagenicity : Not classified Additional information : Sodium azide is highly mutagenic in many plant and bacterial species but marginally

mutagenic in mammalian cells. Sodium azide was mutagenic in Salmonella typhimurium strains TA100 and TA1535 with or without exogenous metabolic activation (S9); it was not mutagenic in strain TA1537 or TA98. Mutagenicity as observed in bacteria is not relevant for mammals, because of the specific metabolism of sodium azide in bacteria. The existing data support the conclusion that azide may be further modified in mammalian cells to an intermediate that is not genotoxic. Negative in a Chromosomal aberration test. In a Cytogenetic tests with Chinese hamster ovary cells, Sodium azide induced sister chromatid exchanges, but not chromosomal aberrations. No studies in mammals are available to adequately assess germ cell effects. Calcium chloride. Genetic toxicity of calcium chloride was negative in the bacterial mutation tests and the mammalian chromosome aberration test.

Carcinogenicity : Not classified Additional information : Sodium azide: Two long-term oral studies in rats provided no convincing evidence of

carcinogenicity, although in both cases the suitability of the test doses has been questioned. At concentrations of 5 and 10 mg/kg sodium azide there was no evidence of carcinogenicity in rats during a 2-year study.

Reproductive toxicity : Not classified

Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) Additional information Calcium chloride. No reproductive toxicity study has been reported. A developmental toxicity

study equivalent to an OECD Guideline Study reveals no toxic effects on dams or fetuses at doses up to 189 mg/kg bw/day (mice), 176 mg/kg bw/day (rats) and 169 mg/kg bw/day (rabbits).

STOT-single exposure : Not classified

Sodium Azide (26628-22-8) Additional information Sodium azide is not an irritant but is rapidly hydrolyzed to hydrazoic acid in the acidic

environment of mucous membranes and the tracheobronchial tree. Hydrazoic acid vapor in concentrations of 0.5 ml/m3 (0.9 mg/m3) or more caused irritation of the nasal mucosa. Irritation of the conjunctiva has also been described.

STOT-repeated exposure : Not classified


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Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) Additional information Calcium chloride. A study for repeated dose oral toxicity in rats shows no adverse effect of

calcium chloride on rats fed 20 mg CaCl2/g diet (comparable to 1000 mg/kg bw/day or more) for 12 months.

Sodium Azide (26628-22-8) Sodium azide It was tested in a 2-year carcinogenicity study conducted by the NTP (1991). In this

study, adverse effects were found after oral administration by gavage of sodium azide in male and female rats. Based on the brain necrosis, mortality which was attributed to brain necrosis, other pathological findings, body weight, food consumption and clinical and behavioral signs, a NOAEL of 5 mg/kg bw was determined.

Aspiration hazard : Not classified Other information : The occupational neuropsychotoxicology of sodium azide was investigated annually, for three

years in 41 sodium azide exposed workers in a chemical production plant, compared to 42 unexposed ones working in the same plant. Exposed workers presented significantly more acute symptoms of exposure than unexposed workers. Symptoms reported included headache, vertigo, nausea, fatigue, cardiac palpitations, irritated or red eyes. The only recurring chronic symptom was trembling of the hands. No psychological or neuropsychological tests differentiated the exposed from the unexposed group.

SECTION 12: Ecological information 12.1. Toxicity Hazardous to the aquatic environment, short-term (acute)

: Not classified

Hazardous to the aquatic environment, long-term (chronic)

: Not classified

Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) LC50 fish 1 4630 mg/l Pimephales promelas

EC50 Daphnia 1 1062 mg/l

EC50 72h algae (1) 2900 mg/l Selenastrum capricornutum

NOEC chronic crustacea The chronic toxicity study with Daphnia magna shows that a 16% impairment of reproduction (EC16) is caused at the concentration of 320 mg/l.

Sodium Azide (26628-22-8) LC50 fish 1 0.7 - 5.5 mg/l

EC50 other aquatic organisms 1 0.4 - 6.4 mg/l 96h

EC50 96h algae (1) 0.35 mg/l Pseudokirchneriella 12.2. Persistence and degradability CALCIUM CHLORIDE 0.025M Persistence and degradability The methods for determining the biological degradability are not applicable to inorganic

substances.

Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) Persistence and degradability Once emitted into the environment, calcium chloride which hasa high water solubility, will

dissociate into the calcium and the chloride anion. The calcium ion may bind to soil particulate or may form stable inorganic salts with sulphate and carbonate ions.

Sodium Azide (26628-22-8) Persistence and degradability Sodium azide is an inorganic substance and therefore biotic breakdown processes are not

considered important when considering the environmental fate of the substance.


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12.3. Bioaccumulative potential Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) Bioaccumulative potential Considering its dissociation properties, Calcium chloride per se is not expected to

accumulate in living organisms. 12.4. Mobility in soil Calcium chloride dihydrate (10035-04-8 (10043-52-4 as anhydrous)) Mobility in soil The chloride ion is mobile in soil and eventually drains into surface water because it is

readily dissolved in water.

Sodium Azide (26628-22-8) Mobility in soil The dissipation of azides in soil is not by microbial action but is strictly a chemical process

accelerated by increasing acidity and elevated temperatures. 12.5. Results of PBT and vPvB assessment No additional information available 12.6. Other adverse effects No additional information available

SECTION 13: Disposal considerations 13.1. Waste treatment methods Regional legislation (waste) : Disposal must be done according to official regulations. Waste treatment methods : Used waste product, surplus product or spillage products shall be disposed of in

accordance with national, state and local laws.

SECTION 14: Transport information In accordance with ADR / RID / IMDG / IATA / ADN

ADR IMDG IATA RID

14.1. UN number Not applicable Not applicable Not applicable Not applicable

14.2. UN proper shipping name Not applicable Not applicable Not applicable Not applicable

14.3. Transport hazard class(es) Not applicable Not applicable Not applicable Not applicable

14.4. Packing group Not applicable Not applicable Not applicable Not applicable

14.5. Environmental hazards Not applicable Not applicable Not applicable Not applicable

No supplementary information available 14.6. Special precautions for user Overland transport Not applicable

Transport by sea Not applicable

Air transport Not applicable

Rail transport Not applicable 14.7. Transport in bulk according to Annex II of Marpol and the IBC Code Not applicable


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SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture 15.1.1. EU-Regulations

Contains no REACH substances with Annex XVII restrictions Contains no substance on the REACH candidate list Contains no REACH Annex XIV substances Contains no substance subject to REGULATION (EU) No 649/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 concerning the export and import of hazardous chemicals. Contains no substance subject to Regulation (EU) No 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants Other information, restriction and prohibition regulations

: Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (Official Journal L 183, 29/06/1989 P. 0001 – 0008) and following amendment and National reinforcements. Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal protective equipment. Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Official Journal L 131, 05/05/1998 P. 0011 – 0023. Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.


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15.1.2. US and Canada regulations

US Federal Regulations:

State Components listed Note

Massachusetts Sodium azide Extraordinarily hazardous

New York Sodium azide A – acutely hazardous substances

New Jersey Sodium azide -

Pennsylvania Sodium azide E - Substance is on the Environmental Hazard List

California Prop. 65

Ingredient name Cancer Reproductive NSRL or MADL (µg/day)

No component listed

Clean Water Act (CWA) 307 No component listed

Clean Air Act Section 112(b) Hazardous Air Pollutants (HAPs) No component listed

Clean Air Act Section 602 Class I Substances No component listed

Clean Air Act Section 602 Class II Substances No component listed

DEA List I Chemicals (Precursor Chemicals) No component listed

DEA List II Chemicals (Essential Chemicals) No component listed

EPA List of Lists

Regulatory Name CAS No./SARA/ 313 Category

Code I

SARA/ EPCRA 302 EHS TPQ II

SARA/ EPCRA 304

EHS RQ III

CERCLA RQ IV

SARA/EPCRA 313 TRI V

RCRA Code VI

CAA 112(r) RMP TQ VII

Sodium azide 26628-22-8 500 1,000 1,000 313 P105 - ISARA/313 Category Code: Emergency Planning and Community Right‐to Know Act Section 313 Category Code II ISARA/EPCRA 302 EHS TPQ: Extremely Hazardous Substance Threshold Planning Quantity (Emergency Planning and Community Right‐to Know Act Section 302 Category Code) III ISARA/EPCRA 304 EHS RQ: Extremely Hazardous Substance Reportable Quantity (Emergency Planning and Community Right‐to Know Act Section 304 Category Code) IVCERCLA RQ: Reportable Quantity (Comprehensive Environmental Response, Compensation, and Liability Act) V ISARA/EPCRA 313 TRI: Toxics Release Inventory (Emergency Planning and Community Right‐to Know Act Section 313 Category Code) VIRCRA Code: Resource Conservation and Recovery Act Code VIICAA 112(r) RMP TQ: Risk Management Plan Threshold Quantity (Clean Air Act Section 112(r))

United States Inventory (TSCA 8b): the product contains substances exempted from the United States Environmental Protection Agency Toxic Substances Control Act (TSCA) Inventory when supplied for research and development purposes or used under the supervision of a technically qualified individual as defined by 40CFR720.3. All other components are listed or exempted.

Canada Domestic Substances List (DSL): All components are listed or exempted.

15.2. Chemical safety assessment No additional information available

SECTION 16: Other information

Revisions Edition n. 01, dated 2010-07-28.





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Revision n. 04, dated 2015-09-25. Main changes are in sections 2 to16, adapting the SDS format and contents to Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012), Hazardous Product Regulation HPR (WHMIS 2015), and Regulation (EU) 2015/830 of 28 May 2015.

Revision n. 05, dated 2021-03-19. Small content changes (sections 1 to 16)

Abbreviations and acronyms:

ACGIH American Conference of Governmental Industrial Hygienists

AIHA American Industrial Hygiene Association

ADR European Agreement concerning the International Carriage of Dangerous Goods by Road

BCF Bioconcentration factor

BEI Biological Esposure Indices

CAS Chemical Abstract Service (division of the American Chemical Society)

CLP Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008

DNEL Derived-No Effect Level

EC50 Median effective concentration

EINECS European Inventory of Existing Commercial Substances

EPA US Environmental Protection Agency

IARC International Agency for Research on Cancer

IATA International Air Transport Association

IMDG International Maritime Dangerous Goods

LC50 Median lethal concentration

LD50 Median lethal dose

LOAEL Lowest Observed Adverse Effect Level

MADL Maximum Allowable Daily (or Dose) Level

NOAEL No-Observed Adverse Effect Level

NOEC No-Observed Effect Concentration

NSRL National Science Research Laboratory

NTP National Toxicology Program

OEL Occupational Exposure Limit

OSHA Occupational Safety and Health Administration

PPE Personal protective Equipment

PBT Persistent Bioaccumulative Toxic

PNEC Predicted No-Effect Concentration

RID Regulations concerning the International Carriage of Dangerous Goods by Rail

TLV/TWA Threshold Limit Value/Threshold Weighted Average

vPvB Very Persistent and Very Bioaccumulative

WEEL Workplace Environmental Exposure Level (air concentration of agents in a healthy worker's breathing zone)

Training advice : Follow National requirements to ensure protection of human health and the environment.

Full text of H- and EUH-statements:

Acute Tox. 2 (Dermal) Acute toxicity (dermal), Category 2

Acute Tox. 2 (Inhalation) Acute toxicity (inhal.), Category 2

Acute Tox. 2 (Oral) Acute toxicity (oral), Category 2


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Aquatic Acute 1 Hazardous to the aquatic environment — Acute Hazard, Category 1

Aquatic Chronic 1 Hazardous to the aquatic environment — Chronic Hazard, Category 1

Eye Irrit. 2 Serious eye damage/eye irritation, Category 2

STOT RE 2 Specific target organ toxicity — Repeated exposure, Category 2

H300 Fatal if swallowed.

H310 Fatal in contact with skin.

H319 Causes serious eye irritation.

H330 Fatal if inhaled.

H373 May cause damage to organs through prolonged or repeated exposure.

H400 Very toxic to aquatic life.

H410 Very toxic to aquatic life with long lasting effects.

Classification and procedure used to derive the classification for mixtures according to Regulation (EC) 1272/2008, according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to HPR (WHMIS 2015) :

Classification: Classification procedure

Not classified -

Bibliographic references

GESTIS International Limit Values, available on http://limitvalue.ifa.dguv.de/WebForm_ueliste.aspx ACGIH, TLVs and BEIs based on the Documentation of the Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices, 2019 HSDB Hazardous Substances Databank, Sodium azide Recommendation from the Scientific Committee on Occupational Exposure Limits for sodium azide, SCOEL/SUM/51,September 2009 http://www.ncbi.nlm.nih.gov/pubmed/12851150, Human health effects of sodium azide exposure: a literature review and analysis. Int J Toxicol. 2003 May-Jun;22(3):175-86. http://www.ncbi.nlm.nih.gov/pubmed/2671718, Sodium azide mutagenesis in mammals: inability of mammalian cells to convert azide to a mutagenic intermediate. Arenaz P1, Hallberg L, Mancillas F, Gutierrez G, Garcia S. Sodium azide, registration Dossier on ECHA, last modified 02-Jul-2018, https://echa.europa.eu/it/registration-dossier/-/registered-dossier/14174/1 National Toxicology Program database Search Application, Toxicology and Carcinogenesis Studies of Sodium azide (CAS: 26628-22-8) in F344 Rats (Gavage Studies) http://www.bibra-information.co.uk/downloads/toxicity-profile-for-sodium-azide-1992/, Toxicity Profile for Sodium azide (1992) Calcium Chloride, SIDS Initial Assessment Report For SIAM 15 Boston, USA 22-25th October 2002 Calcium chloride anh, Registration dossier, available at: http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb43f6f-23a1-5205-e044-00144f67d031/AGGR-dc2ba8fd-c7fc-402e-906e-b6cd0864ad5e_DISS-9eb43f6f-23a1-5205-e044-00144f67d031.html#AGGR-dc2ba8fd-c7fc-402e-906e-b6cd0864ad5e

SDS EU (REACH Annex II) The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No 1907/2006 (REACH) and its subsequent amendments, in accordance with Hazard Communication Standard (HCS), 29 CFR 1910.1200 (HazCom 2012) as recommended by US OSHA, and in accordance with Hazardous Product Regulation HPR (WHMIS 2015) as recommended by Health Canada (HC).

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