Bazedoxifene - Conjugated Estrogen Tablets

Hazard statements (CLP)

H317, H350, H360FD, H400, H410

Code

Statements

H317

May cause an allergic skin reaction

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). Bazedoxifene Acetate Pfizer OEL TWA-8 Hr Conjugated estrogens Pfizer OEL TWA-8 Hr Ascorbic acid (Vitamin C) 1 µg/m3, Sensitizer 0.15 µg/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 Contains a known or suspected endocrine disruptor. Chemical name Endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100(3) or Commission Regulation (EU) 2018/605(4) Bazedoxifene Acetate Substance has endocrine disrupting properties Conjugated estrogens Substance has endocrine disrupting properties 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

H317 - May cause an allergic skin reaction H350 - May cause cancer H360FD - May damage fertility. May damage the unborn child H410 - Very toxic to aquatic life with long lasting effects EUH380 - May cause endocrine disruption in humans EUH430 - May cause endocrine disruption in the environment

Precautionary statements

P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P261 - Avoid breathing dust P263 - Avoid contact during pregnancy/while nursing P272 - Contaminated work clothing should not be allowed out of the workplace P273 - Avoid release to the environment P280 - Wear protective gloves and protective clothing 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 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

Supplemental label elements

Compound, not fully tested, additional hazards may exist.

2.1 Classification of the substance or mixture

GHS - Classification: Regulated according to Regulation (EC) 1272/2008 and/or other applicable regulations. Skin sensitization Category 1 - (H317) Carcinogenicity Category 1A - (H350) Reproductive toxicity Category 1A - (H360FD) Endocrine disruption for human health Category 1 - (EUH380) Hazardous to the aquatic environment - acute Category 1 - (H400) Hazardous to the aquatic environment - chronic Category 1 - (H410) Endocrine disruption for the environment Category 1 - (EUH430) OSHA Classification Hazards not otherwise classified (HNOC) Not applicable Hazards classified under paragraph (d)(1)(ii) of 1910.1200 Not applicable