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Abiraterone Acetate Listed Effective April 8, 2016 as Known to the State of California to Cause Reproductive Toxicity

Effective April 8, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) is adding abiraterone acetate (CAS No. 154229-18-2) to the list of chemicals known to the state to cause reproductive toxicity (developmental, female, and male endpoints) for purposes of Proposition 65[1].  

The listing of abiraterone acetate is based on a formal requirement by a state or federal agency that the chemical be identified or labeled as causing reproductive toxicity[2] as provided under Proposition 65.  Abiraterone acetate has been identified or labeled to communicate a risk of reproductive harm (developmental, female, and male endpoints) in accordance with formal requirements by the US 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 abiraterone acetate meets the criteria for administrative listing is included in the Notice of Intent to List Abiraterone Acetate, published in the January 29, 2016 issue of the California Regulatory Notice Register (Register 2016, No. 5-Z).  No public comments were received.

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

In summary, the following chemical is listed under Proposition 65 as known to the state to cause reproductive toxicity:

Chemical

CAS No.

Toxicological

Endpoints

Listing Mechanism*

Abiraterone acetate

154229-18-2

Developmental toxicity

Female reproductive toxicity

Male reproductive toxicity

FR

* 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

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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