CEDIA OFT Assays

Hazard statements (CLP)

H317, H334

Code

Statements

H317

May cause an allergic skin reaction

2.1 Classification of the substance or mixture

Regulation (EC) Respiratory sensitizer - Category 1. Skin sensitizer - Category 1. 1272/2008 [GHS] SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger

CLP CLASSIFICATION

H317 - May cause allergic skin reaction. H334 - May cause allergy or asthma symptoms or

Hazard statements

breathing difficulties if inhaled. EUH032 - Contact with acids liberates very toxic gas. CLP/GHS precautionary P261 - Avoid breathing dust/mist/vapors/spray. P272 - Contaminated work clothing should not be allowed out of the workplace. P280 - Wear protective gloves/ eye protection/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P302 + P352 - If on skin Wash with plenty of soap and water. P304 + P341 - IF INHALED If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P363 - Wash contaminated clothing before reuse. P501 - Dispose of contents/ container to location in accordance with local/regional/national/international regulations.

2.3 Other hazards

No data specific for the mixture were identified. The mixture contains bovine serum albumin which has been associated with occupational sensitization. Material produced in compliance with USDA and/or CPMP/BWP/1230/98 (Guidance on Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products). This is a CPMP/ BWP/1230/98 Category IV material: it does not contain nor is it derived from specified risk materials as defined in Commission decision 97/534/EC (or successive amendments). Because the mixture contains a protein, it may cause an allergic skin or respiratory reaction (e.g., potential to cause anaphylaxis). In a workplace setting, the likelihood of systemic effects following accidental ingestion is low, due to the rapid breakdown of proteins in the digestive tract. Note This mixture is classified as hazardous according to Regulation EC No 1272/2008 (EU CLP) and Hazard Communication Standard No. 1910.1200 (US OSHA). The pharmacological, toxicological and ecological properties of this mixture have not been fully characterized.