Chemical Listed Effective March 3, 2000 as Known to the State to Cause Reproductive Toxicity: Pravastatin sodium

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding one chemical, pravastatin sodium, to the list of chemicals known to the State to cause cancer or reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of this chemical is effective March 3, 2000.

Pravastatin sodium is listed as a chemical known to the State to cause developmental toxicity, 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 mechanism provided under the Act. Regulations governing the listing of chemicals under the "formally required to be labeled or identified" mechanism are published in Title 22, California Code of Regulations, Section 12902.

The reader is directed to the Notice of Intent to List Chemicals published in the October 29, 1999 issue of the California Regulatory Notice Register (Register 99, No. 44-Z) for the supporting documentation which OEHHA relied upon in making its determination that the criteria for administrative listing had been satisfied. A complete, updated chemical list is published elsewhere in this issue of the California Regulatory Notice Register.

The chemical being listed under Proposition 65 as known to cause reproductive toxicity is shown below:

Chemical CAS No. Toxicological Endpoints Listing Mechanism1
Pravastatin sodium 81131-70-6 Developmental toxicity FR1

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1Listing mechanism:
FR - "formally required to be labeled or identified" mechanism (22 CCR Section 12902)