QMS Tacrolimus 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/R43. 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/skin reaction. 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, 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. 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 vapor/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

The potential health hazards associated with exposure/handling of this mixture are unknown; no data specific for the mixture were identified. The following data describe the hazards of individual ingredients, where applicable. Product/mixture contains human serum albumin, a protein, and thus 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. Although protein particles are fairly large in size, it is not known if systemic effects can occur following accidental inhalation. Proteins, in general, can cause skin and/or respiratory sensitization. All 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 SECTION 2 - HAZARDS IDENTIFICATION …continued Other hazards …continued assurance that these or other infectious agents are not present, this product should be handled using standard biosafety precautions.