FACTOR REAGENT

Hazard statements (CLP)

H334

Code

Statements

H334

May cause allergy or asthma symptoms or breathing difficulties if inhaled

2.1 Classification of the substance or mixture

This product is hazardous according to Regulations (EC) No 1272/2008, OSHA 29 CFR 1910.1200 and Hazardous Product Regulation HPR (WHMIS 2015). Any additional information concerning the risks for health and/or the environment are given in sections 11 and 12 of this 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):

Hazard statements

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

Signal word

Danger

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)

Contains

Factor IXa, Factor X Other labeling details: Up to 60.7% of the mixture consists of component of unknown acute toxicity (oral, dermal, inhalation) for the human health and for 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.