Chemical Listed Effective May 24, 2013 as Known to the State of California to Cause Cancer: Clomiphene Citrate

Effective May 24, 2013, the Office of Environmental Health Hazard Assessment (OEHHA) is adding clomiphene citrate (CAS No. 50-41-9) to the list of chemicals known to the State to cause cancer for purposes of Proposition 651.

The listing of clomiphene citrate is based on a formal requirement by a state or federal agency that the chemical be identified or labeled as causing cancer or reproductive toxicity pursuant to an administrative listing mechanism2 provided under the Act. Clomiphene citrate has been identified or labeled to communicate a risk of cancer in accordance with formal requirements by the U.S. Food and Drug Administration. Regulations governing the listing of chemicals under the “formally required to be labeled or identified” mechanism are published in Title 27, California Code of Regulations, section 25902. 

The documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for clomiphene citrate is included in the Notice of Intent to List A Chemical by the “Formally Required to Be Labeled or Identified” Mechanism: Clomiphene Citrate, published in the April 5, 2013 issue of the California Regulatory Notice Register (Register 2013, No. 14-Z). Please note that the CAS number for clomiphene citrate, CAS No. 911-45-5, cited in the Notice of Intent to List A Chemical by the “Formally Required to Be Labeled or Identified” Mechanism:  Clomiphene Citrate, is incorrect. The correct CAS number is 50-41-9.

A complete, updated chemical list is published in this issue of the California Regulatory Notice Register.

In summary, the following chemical is listed under Proposition 65 as known to the State to cause cancer:

Chemical

CAS No.

Toxicological Endpoints

Listing Mechanism3

Clomiphene citrate

50-41-9

cancer

FR

Footnotes and References

1 The Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code section 25249.5 et seq.

2 See Health and Safety Code section 25249.8(b) and Title 27, Cal. Code of Regs., section 25902.

3 Listing mechanism:
FR – “formally required to be labeled or identified” mechanism (Health and Safety Code section 25249.8(b) and Title 27 Cal. Code of Regs., section 25902).