Somatropin Powder for Solution for Injection

Hazard statements (CLP)

H302, H312, H315, H317, H318, H331, H361fd

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture

2.3 Other hazards

Not applicable (HNOC) An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). Somatropin Pfizer OEL TWA-8 Hr: Sodium phosphate, dibasic 10 µg/m3, Sensitizer Pfizer Occupational Exposure Band (OEB): PBT & vPvB OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information This product does not contain any known or suspected endocrine disruptors. Note This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

Signal word

Danger

Hazard statements

H302 - Harmful if swallowed H312 - Harmful in contact with skin H315 - Causes skin irritation H318 - Causes serious eye damage H317 - May cause an allergic skin reaction H331 - Toxic if inhaled H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child

Precautionary statements

P201 - Obtain special instructions before use P264 - Wash hands thoroughly after handling P270 - Do not eat, drink or smoke when using this product P271 - Use only outdoors or in a well-ventilated area P272 - Contaminated work clothing should not be allowed out of the workplace P280 - Wear protective gloves/protective clothing/eye protection/face protection P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing P311 - Call a POISON CENTER or doctor/physician P302 + P352 - IF ON SKIN: Wash with plenty of soap and water P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention P362 + P364 - Take off contaminated clothing and wash it before reuse P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P310 - Immediately call a POISON CENTER or doctor/physician P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable Unknown aquatic toxicity Contains 5 - 21 % of components with unknown hazards to the aquatic environment.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Acute toxicity - Oral Category 4 - (H302) Acute toxicity - Dermal Category 4 - (H312) Acute toxicity - Inhalation (Dusts/Mists) Category 3 - (H331) Skin corrosion/irritation Category 2 - (H315) Serious eye damage/eye irritation Category 1 - (H318) Skin sensitization Category 1 - (H317) Reproductive toxicity Category 2 - (H361fd) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable