General Information
Version
01
Revision date
2015-10-27
Product name
Factor Xa 71 nkat
1.2.1 Relevant identified uses
Relevant use For in vitro diagnostic use
Manufacturer Name
Instrumentation Laboratory Co
Emergency telephone
+44 (0) 3700 492 795, +1 215 207 0061
Icons in SDS
Company Information
company name
Instrumentation Laboratory Co
e-mail address of the competent person responsible for the Safety Data Sheet
infosds@mail.ilww.it
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H334
Hazard statements
Code
Statements
H334
May cause allergy or asthma symptoms or breathing difficulties if inhaled
Section 2
SECTION 2: Hazards identification
Hazard categories
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
Danger Danger
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) 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 INHALED: Remove person to fresh air and keep comfortable for breathing. (P304 + P340) 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.
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 Regulations (EC) No 1272/2008, Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and Hazardous Product Regulation HPR (WHMIS 2015): Hazard class Hazard category Hazard statement RESPIRATORY OR SKIN SENSITISATION cat. 1 May cause allergy or asthma symptoms or breathing 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. 2.2 Label elements: According to Regulation (EC) No 1272/2008 Hazard pictogram(s): Signal word(s): Danger Hazard statement(s): 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) Precautionary statement(s): 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 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. according to Hazard Communication Standard, 29 CFR 1910.1200 (HCS), and according to Hazardous Product Regulation HPR (WHMIS 2015): Hazard pictogram(s): Signal word(s): Danger Hazard statement(s): 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 statement(s): 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. 2.3 Other hazards (which do not results in the 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. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Composition: solid containing organic and inorganic components, bovine material. 3.1 Hazardous components EINECS/ Conc. % Classification Name