Liquid Assayed Therapeutic Drug Control

Hazard statements (CLP)

H317, H334

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

Directive 1999/45/EC: Classification of the substance or mixture

2.2 Label elements

SECTION 2 - HAZARDS IDENTIFICATION …continued CLP/GHS hazard

Signal word

Danger CLP/GHS hazard H317 - May cause allergic skin reaction. H334 - May cause allergy or asthma US Hazard overview Danger May cause allergic respiratory reaction. May cause allergic skin reaction. This product contains human source material and should be treated/handled as a potential biohazard. Mixture not yet fully tested. Note This mixture is classified as hazardous according to Directive 1999/45/EC,

Hazard statements

symptoms or breathing difficulties if inhaled. CLP/GHS precautionary P261 - Avoid breathing mist or vapor. 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.

Precautionary statements

S2 - Keep out of reach of children. S23 - Do not breathe spray. S24 - Avoid contact with skin. S37 - Wear suitable protective gloves. 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, 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 bovine serum, 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. SECTION 2 - HAZARDS IDENTIFICATION …continued Other hazards …continued This product contains human source material and should be treated/handled as a potential biohazard. All such human source material has been derived from donors tested individually and shown by FDA approved methods to be free from antibodies to Human Immune Deficiency Virus and Hepatitis B and C. As no test method can offer complete assurance that these or other infectious agents are not present, this product should be handled using standard precautions.

2.1 Classification of the substance or mixture

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