Mitoxantrone Hydrochloride Listed

Jan 23, 2015

Chemical Listed Effective January 23, 2015 as Known to the State of California to Cause Cancer: Mitoxantrone Hydrochloride

Effective January 23, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) is adding mitoxantrone hydrochloride (CAS No. 70476-82-3) to the list of chemicals known to the State to cause cancer for purposes of Proposition 65¹. Mitoxantrone hydrochloride has been listed under Proposition 65 as causing reproductive toxicity (developmental endpoint) since July 1, 1990. With this action, the chemical is now listed under Proposition 65 as causing reproductive toxicity (developmental endpoint) and cancer.

The listing of mitoxantrone hydrochloride is based on a formal requirement by a state or federal agency that the chemical be identified or labeled as causing cancer² as provided under the Act. Mitoxantrone hydrochloride 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 mitoxantrone hydrochloride is included in the Notice of Intent to List A Chemical by the “Formally Required to Be Labeled or Identified” Mechanism: Mitoxantrone Hydrochloride, published in the November 7, 2014 issue of the California Regulatory Notice Register (Register 2014, No. 45-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 on the OEHHA website at www.oehha.ca.gov.

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