CEDIA T4 Assay

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. Mixture not yet 1272/2008 [GHS] fully tested. Directive 67/548/EEC or Xn - R42 (Respiratory Sens.), R43 (Skin Sens.). Mixture not yet fully tested. 1999/45/EC

2.2 Label elements

SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger Danger US Hazard overview May cause allergic respiratory reaction. May cause allergic skin reaction. Mixture not yet fully tested. This product contains bovine serum albumin, which has been associated with occupational sensitization. Note This mixture is classified as hazardous according to Directive 1999/45/EC, Regulation (EC) No 1272/2008 (EU CLP) and applicable US regulations. The pharmacological, toxicological, and ecological properties of this mixture have not been fully characterized. The CLP/GHS classifications are based on Regulation (EC) 1272/2008 and on the revised OSHA hazard communication standard. The EU symbol/indicator of danger, R Phrases and Safety Advice are based on Directive 1999/45/EC.

CLP CLASSIFICATION

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

Hazard statements

symptoms or 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. EU symbol/indication of danger Xn - Harmful Risk (R) Phrase(s) R42/43 - May cause sensitization by inhalation and skin contact. R32 - Contact with acids liberates very toxic gas.

Precautionary statements

S2 - Keep out of reach of children. S23 - Do not breathe dust/mist/vapor/spray. S24 - Avoid contact with skin. S37 - Wear suitable protective gloves. S50 - Do not mix with acids. S63 - In case of accident by inhalation: remove casualty to fresh air and keep at rest.

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 SECTION 2 - HAZARDS IDENTIFICATION …continued Other hazards …continued likelihood of systemic effects following accidental ingestion is low, due to the rapid breakdown of proteins in the digestive tract.