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Proposition 65

Notice of Intent to List Chemicals: Ethoprop, Indium phosphide, Lynestrenol, Norethynodrel, Propachlor, Amantadine hydrochloride, Diazoxide, Dichlorphenamide, Diltiazem hydrochloride, Filgrastim, Ribavirin, Rifampin, and Trientine hydrochloride
[12/29/00]

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) provides two mechanisms for administratively listing chemicals which are known to the State to cause cancer or reproductive toxicity [Health and Safety Code Section 25249.8(b)]. One mechanism by which a chemical is listed is if a body considered to be authoritative by the state's qualified experts has formally identified it as causing cancer or reproductive toxicity. For carcinogenicity, the United States Environmental Protection Agency (U.S. EPA), the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the United States Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH) have been identified as authoritative bodies for purposes of the Act. For reproductive toxicity, U.S. EPA, IARC (for transplacental carcinogenicity only), FDA, and NIOSH have been identified as authoritative bodies for purposes of the Act. The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations (22 CCR), Section 12306.

Under the second mechanism for the administrative listing, a chemical is listed when a state or federal agency has formally required that the chemical be labeled or identified as causing cancer or reproductive toxicity. The criteria for listing chemicals through this mechanism are set forth in 22 CCR, Section 12902.

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency intends to list the chemicals identified below as known to the State to cause cancer or reproductive toxicity, pursuant to the two administrative mechanisms provided in Health and Safety Code Section 25249.8(b).

In a public notice published on September 29, 2000, OEHHA announced 23 chemicals were under consideration for administrative listing based on a review of information indicating that the chemicals may meet the criteria set forth in 22 CCR, Section 12306 or Section 12902. OEHHA solicited comments and information relevant to the evaluation of these chemicals in the context of the regulatory criteria for administrative listing under Proposition 65. The public comment period began on September 29, 2000, and closed on November 28, 2000. [Except for famciclovir which was granted a comment period extension until December 8, 2000 and atorvastatin calcium, fluvastatin sodium, and nimodipine which were granted a comment period extension until December 28, 2000.] A public forum was held on October 26, 2000 to provide an opportunity for oral comments. Written comments have been received on DEF, catechol, naphthalene, strong inorganic acid mists containing sulfuric acid, albuterol, famciclovir, and felodipine and are under review by OEHHA staff. No comments were received on 13 of the chemicals during the public comment period. OEHHA has determined that these 13 chemicals meet the criteria for administrative listing: five chemicals meet the criteria for listing under the authoritative bodies mechanism (Table A), and eight chemicals meet the criteria for listing via the 'formally required to be labeled' mechanism (Table B). Documents providing the basis for the listing of these chemicals can be obtained from OEHHA's Proposition 65 Implementation Office at the address and telephone number indicated below, or from the OEHHA Home Page at www.oehha.ca.gov/.

Under the authoritative bodies mechanism, objections to the listing shall be made on the basis that there is no substantial evidence that the criteria of sufficiency of evidence of carcinogenicity or reproductive toxicity identified in 22 CCR, Section 12306 have been satisfied. Objections to listings via the second mechanism are made on the basis that the criteria and definitions in 22 CCR, Section 12902 have not been met. Any one wishing to object to the listing of chemicals in the tables below should submit written comments in triplicate, along with supporting documentation, by mail, fax or hand-delivery to:

Sam Delson
Office of Environmental Health Hazard Assessment
Street address: 1001 I Street
Sacramento, California 95814
Mailing address: P.O. Box 4010
Sacramento, California 95812-4010
Fax No.: (916) 327-1097
Telephone: (916) 445-6900

In order to be considered, comments must be postmarked (if sent by mail) or received at OEHHA (if hand-delivered or sent by fax) by 5:00 p.m. on Monday, January 29, 2001.

Table A1. Chemicals determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as causing cancer under the authoritative bodies mechanism:

Chemical

CAS No.

Reference

Ethoprop

13194-48-4

U.S. EPA (1997a)

Indium phosphide

22398-80-7

NTP (2000a; 2000b)

Lynestrenol

52-76-6

IARC (1999)

Norethynodrel

68-23-5

IARC (1999)

Propachlor

1918-16-7

U.S. EPA (1997b)

Table B. Chemicals which meet the criteria set forth in 22 CCR Section 12902 for listing as known to cause cancer and/or reproductive toxicity via the "formally required to be labeled or identified" mechanism:

Chemical

CAS No.

Toxicological Endpoints

Reference

Amantadine hydrochloride

665-66-7

Developmental toxicity

FDA (1993a)

Diazoxide

364-98-7

Developmental toxicity

FDA (1994a)

Dichlorphenamide

120-97-8

Developmental toxicity

FDA (1994b)

Diltiazem hydrochloride

42399-41-7

Developmental toxicity

FDA (1996)

Filgrastim

121181-53-1

Developmental toxicity

FDA (1992)

Ribavirin*

36791-04-5

Male reproductive toxicity

FDA (1993b)

Rifampin

13292-46-1

Developmental toxicity Female reproductive toxicity

FDA (1997)

Trientine hydrochloride

38260-01-4

Developmental toxicity

FDA (1988)

* Ribavirin was added to the list of chemicals known to cause reproductive toxicity on the basis of a developmental toxicity endpoint on April 1, 1990.

References:

Committee on Safety of Medicines (1972). Carcinogenicity Tests of Oral Contraceptives. London, Her Majesty's Stationery Office.

Food and Drug Administration (FDA, 1993a). Final printed labeling for the drug amantadine hydrochloride. FDA approved 1993.

Food and Drug Administration (FDA, 1994a). Final printed labeling for the drug diazoxide. FDA approved 1994.

Food and Drug Administration (FDA, 1994b). Final printed labeling for the drug dichlorphenamide. FDA approved 1994.

Food and Drug Administration (FDA, 1996). Final printed labeling for the drug diltiazem hydrochloride. FDA approved 1996.

Food and Drug Administration (FDA, 1992). Final printed labeling for the drug filgrastim. FDA approved 1992.

Food and Drug Administration (FDA, 1993b). Final printed labeling for the drug ribavirin. FDA approved 1993.

Food and Drug Administration (FDA, 1997). Final printed labeling for the drug rifampin. FDA approved 1997.

Food and Drug Administration (FDA, 1988). Final printed labeling for the drug trientine hydrochloride. FDA approved 1988.

International Agency for Research on Cancer (IARC, 1979). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 21: 407-415 and 461-477. Sex Hormones (II). IARC, Lyon France.

International Agency for Research on Cancer (IARC, 1999). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 72: 49-338. Hormonal Contraception and Post-Menopausal Hormonal Therapy. IARC, Lyon France.

Misdorp W (1991). Progestogens and mammary tumors in dogs and cats. Acta Endocrinol 125: 27-31.

National Toxicology Program (NTP, 2000a). Toxicology and Carcinogenesis Studies of Indium Phosphide (CAS No. 22398-80-7) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). Board Draft. NTP Technical Report Series No. 499. NTIS Publication No. 00-4433. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 2000b). Summary Minutes from Peer Review of Draft Technical Reports of Long-term Toxicology and Carcinogenesis Studies by the Technical Reports Review Subcommittee on May 18, 2000. NTP, Research Triangle Park, NC.

Rudali G (1975). Induction of tumors in mice with synthetic sex hormones. Gann Monogr 17: 243-252.

Schuppler J, Gunzel P (1979). Liver tumors and steroid hormones in rats and mice. Arch Toxicol Suppl 2: 181-195.

U.S. Environmental Protection Agency (U.S. EPA, 1997a). Cancer Assessment Document. Evaluation of the Carcinogenic Potential of Ethoprop. Cancer Assessment Review Committee. Health Effects Division. Office of Pesticide Programs. September 25, 1997.

U.S. Environmental Protection Agency (U.S. EPA, 1997b). Memorandum: Carcinogenicity Peer Review of Propachlor. Office of Prevention, Pesticides and Toxic Substances. October 16, 1997.

Download a copy of this notice as a PDF file.

Download a copy of the supporting document for Ethoprop, Indium phosphide, Lynestrenol, Norethynodrel and Propachlor

Download a copy of the supporting document for Amantadine hydrochloride, Diazoxide, Dichlorphenamide, Diltiazem, hydrochloride, Filgrastim, Ribavirin*, Rifampin and Trientine hydrochloride.

 

 
 
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