COATESTTM HEPARIN

Hazard statements (CLP)

H301, H311, H331, H334, H373, H412

Code

Statements

H301

Toxic if swallowed

SECTION 2: Hazards identification

Classification procedure Not classified ‐ The contained information in this SDS are in accordance with Annex II of the COMMISSION REGULATION (EU) No

Hazard categories

Hazard statement Not classified For exposure limits see section 8 Potential adverse physicochemical, human health and environmental effects see also Ch. 9-12) Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment Hazard statement May cause allergy or asthma symptoms or breathing RESPIRATORY OR SKIN SENSITISATION cat. 1 difficulties if inhaled. (H334) For exposure limits see Ch. 8 Potential adverse physicochemical, human health and environmental effects see also Ch. 9-12) The product may cause allergy or asthma symptoms or breathing difficulties if inhaled Under normal conditions of use, the mixture does not cause adverse effects to the environment

Signal word

None Hazard statement(s) None Precautionary statement(s): None 2.4% of the mixture consists of component of unknown acute toxicity (dermal, inhalation) for Other labeling details the human health and unknown hazard to the aquatic environment Use the product in accordance with the Good Laboratory Practice Safety precautions Wear suitable protective clothing, gloves and eye/face protection Do not let the product enter drainage system, surface and ground-water or soil. Do not empty into drains Other hazards (which do not results in the classification) The mixture does not meet the criteria for PBT or vPvB SSEECCTTIIO ON N 33.. CCO OM MPPO OSSIITTIIO ON N//IIN NFFO ORRM MAATTIIO ON N O ON N IIN NGGRREED DIIEEN NTTSS Composition: solid containing organic components Hazardous components Classification Name EINECS/ CAS n° Conc. % Danger Danger

Aspiration hazard

Not available Other information Reasons for the lack of classification Where the mixture resulted in a non-classification, this may be due to the availability of data which does not impose a classification for that specific end-point, or due to lack of data, or due to availability of inconclusive data or data which are not sufficient to get a classification as for the criteria adopted in Regulations mentioned in this data sheet SSEECCTTIIO ON N 1122.. EECCO OLLO OGGIICCAALL IIN NFFO ORRM MAATTIIO ON N The environmental effects of the product have not been thoroughly investigated. Data on toxicological effects of the hazardous ingredients are provided bellow Toxicity species, media, units, test duration and test conditions Related to Acute toxicity with fish LC50 Brachydanio rerio = 87.6 mg/l/96 hours p-nitroaniline Chronic toxicity with fish Not available Acute toxicity with crustaceans: EC50 crustaceans = 24 mg/l/48hours p-nitroaniline Chronic toxicity with Not available crustaceans Acute toxicity with algae EC50 = 68 mg/l/24 h p-nitroaniline Chronic toxicity with algae Not available Toxicity data on soil micro- and Not available macroorganisms Toxicity data on birds, bees and Not available plants Persistency and p-nitroaniline is not biodegradable and is expected to have moderate persistence potential.(7) degradability Bioaccumulation potential p-nitroaniline is are expected to have low bioaccumulation potential Mobility in soil p-Nitroaniline: If released to soil, is expected to have high mobility, based upon Koc values of 54-87.(10) Results of PBT and vPvB Not available assessment Other toxic effects Not available SSEECCTTIIO ON N 1133.. DDIISSPPO OSSAALL CCO ON NSSIID DEERRAATTIIO ON N National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected Waste treatment methods Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws SSEECCTTIIO ON N 1144.. TTRRAAN NSSPPO ORRTT IIN NFFO ORRM MAATTIIO ON N Not classified in accordance with ADR/RID, IMDG, IATA and DOT regulations SSEECCTTIIO ON N 1155.. RREEGGUULLAATTO ORRYY IIN NFFO ORRM MAATTIIO ON N Safety, health and environmental regulations/legislation specific for the substance or mixture EU 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

Environmental hazards

“Reactive” is used interchangeably with the NFPA term “instability.”

Hazard statements

May cause allergy or asthma symptoms or breathing difficulties if inhaled. (H334) Avoid breathing dust/fume. (P261) [In case of inadequate ventilation] wear respiratory protection. (P284) IF INHALED: Remove person to fresh air and keep comfortable for breathing. (P304 + P340) May cause allergy or asthma symptoms or breathing difficulties if inhaled. Avoid breathing dust/fume. [In case of inadequate ventilation] wear respiratory protection. IF INHALED: If breathing is difficult, remove person to fresh air and keep comfortable for

Precautionary statements

If experiencing respiratory symptoms: Call a POISON CENTER/doctor. (P342 + P311) Dispose of contents/container in accordance with local/regional/national/international regulation. (P501) breathing. If experiencing respiratory symptoms: Call a POISON CENTER/doctor. Dispose of contents/container in accordance with local/regional/national/international regulation. Up to 11.3% of the mixture consists of components of unknown acute toxicity (oral, dermal, Other labeling details: inhalation) for the human health. Up to 7.4% of the mixture consists of components of unknown hazard to the aquatic environment.

Contains

Factor Xa Up to 11.3% of the mixture consists of components of unknown acute toxicity (oral, dermal, Other labeling details: inhalation) for the human health. Up to 7.4% of the mixture consists of components of unknown hazard to the aquatic environment.

Other hazards which do not result in classification

The mixture does not meet the criteria for PBT or vPvB. Warning: The product contains bovine material. All donor animals were sourced from BSE-free herds. The cattle received ante- and post mortem health inspection by a veterinarian, and they were apparently free from infectious and contagious material. However, the material should be treated as potentially infectious. Bovine serum albumin (BSA) might cause allergic skin reaction and/or allergy or asthma symptoms or breathing difficulties if inhaled. SSEECCTTIIO ON N 33.. CCO OM MPPO OSSIITTIIO ON N//IIN NFFO ORRM MAATTIIO ON N O ON N IIN NGGRREEDDIIEEN NTTSS Composition: powder containing organic and inorganic components, bovine source material. 3.1 Hazardous components EINECS/ Conc. %

2.1 Classification of the substance or mixture

according to Hazardous Product Regulation HPR (WHMIS 2015): Hazard class Hazard category Hazard statement Not classified For exposure limits see section 8. Potential adverse physicochemical, human health and environmental effects (see also Ch. 9-12) Under normal conditions of use, the mixture does not cause adverse effects to humans and to the environment. 2.2 Label elements, 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): Hazard pictogram(s): None