Chemical Listed Effective March 8, 2019 as Known to the State of California to Cause Reproductive Toxicity: Bevacizumab

Effective March 8, 2019, the Office of Environmental Health Hazard Assessment (OEHHA) is adding Bevacizumab (CAS No. 216974-75-3) to the list of chemicals known to the state to cause reproductive toxicity (developmental and female endpoints), for purposes of Proposition 65[1].  

The listing of bevacizumab is based on a formal requirement by the US Food and Drug Administration (FDA) that the chemical be identified or labeled as causing reproductive toxicity[2] (developmental and female endpoints). The criteria for listing chemicals under the “formally required to be labeled or identified” mechanism are set out in Title 27, California Code of Regulations, section 25902.

The documentation supporting OEHHA’s determination that bevacizumab meets the criteria for listing is included in the Notice of Intent to List Bevacizumab posted on OEHHA’s website and published in the October 5, 2018 issue of the California Regulatory Notice Register (Register 2018, No. 40-Z). OEHHA received no public comments on the proposed listing.

A complete, updated chemical list is published in this issue of the California Regulatory Notice Register and is available on the OEHHA website at http://oehha.ca.gov/proposition-65/proposition-65-list.

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*

Bevacizumab

216974-75-3

Developmental toxicity

Female 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

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