Hydroxyprogesterone Caproate Injection USP - Single dose vial (Hospira, Inc.)

Hazard statements (CLP)

H303, H351, H360FD, H400, H411

Code

Statements

H303

May be harmful if swallowed

SECTION 2: Hazards identification

OSHA Classification of the substance or mixture Acute toxicity - Oral Category 5 - (H303) Carcinogenicity Category 2 - (H351) 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 2 - (H411) Endocrine disruption for the environment Category 1 - (EUH430)

2.3 Other hazards

Not applicable (HNOC)

Signal word

Danger

Hazard statements

H303 - May be harmful if swallowed H351 - Suspected of causing cancer H360FD - May damage fertility. May damage the unborn child H400 - Very toxic to aquatic life H411 - 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 P263 - Avoid contact during pregnancy/while nursing P273 - Avoid release to the environment P280 - Wear protective gloves P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell 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

Other hazards

An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8). 17-ALPHA-HYDROXYPROGESTERONE CAPROATE Pfizer OEL TWA-8 Hr: PBT & vPvB 50 µg/m3 The product does not contain any substance(s) classified as PBT or vPvB. Endocrine Disruptor Information 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) 17-ALPHA-HYDROXYPROGESTERONE CAPROATE 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 active substance or its intermediates 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.

2.1 Classification of the substance or mixture

Acute toxicity - Oral Category 5 - (H303) Carcinogenicity Category 2 - (H351) 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 2 - (H411) 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