Tucatinib Tablets

Hazard statements (CLP)

H361fd, H373, H411

Code

Statements

H361fd

Suspected of damaging fertility; Suspected of damaging the unborn child

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). Tucatinib Pfizer OEL TWA-8 Hr: SODIUM CHLORIDE 300 µg/m3 Contact Hazards Unknown Pfizer Occupational Exposure Band (OEB): POTASSIUM CHLORIDE OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) Pfizer Occupational Exposure Band (OEB): Sodium bicarbonate OEB 1 (control exposure to the range of 1000ug/m3 to 3000ug/m3) 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

Warning

Hazard statements

H373 - May cause damage to organs through prolonged or repeated exposure female reproductive system, male reproductive system H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child H411 - Toxic to aquatic life with long lasting effects

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P260 - Do not breathe dust P273 - Avoid release to the environment P280 - Wear protective gloves, protective clothing, eye protection and face protection P308 + P313 - IF exposed or concerned: Get medical advice/attention P391 - Collect spillage P405 - Store locked up P501 - Dispose of contents/container in accordance with local, regional, national, and international regulations as applicable Unknown acute toxicity 25 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 25 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 25 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist).

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Reproductive toxicity Category 2 - (H361fd) Specific target organ toxicity (repeated exposure) Category 2 - (H373) Hazardous to the aquatic environment - chronic Category 2 - (H411) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable