Enfortumab vedotin for injection

Hazard statements (CLP)

H341, H360FD, H372

Code

Statements

H341

Suspected of causing genetic defects

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). Enfortumab vedotin Pfizer Occupational Exposure Band (OEB): PBT & vPvB B-OEB 5 (control exposure to <10 µg/day) 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

H341 - Suspected of causing genetic defects H360FD - May damage fertility. May damage the unborn child H372 - Causes damage to organs through prolonged or repeated exposure skin, liver, bone marrow, male reproductive system

Precautionary statements

P201 - Obtain special instructions before use P260 - Do not breathe dust/fume/gas/mist/vapors/spray P281 - Use personal protective equipment as required P308 + P313 - IF exposed or concerned: Get medical advice/attention P405 - Store locked up

Supplemental label elements

Compound, not fully tested, additional hazards may exist. Unknown acute toxicity 14.5 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 14.5 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 14.5 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). Unknown aquatic toxicity Contains 14.5 % 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. Germ cell mutagenicity Category 2 - (H341) Reproductive toxicity Category 1B - (H360FD) Specific target organ toxicity (repeated exposure) Category 1 - (H372) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable