Notice of Intent to List Chemicals: 18 Chemicals

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. The following have been identified as authoritative bodies for purposes of the Act: the United States Environmental Protection Agency (USEPA), 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). The criteria for listing chemicals through the authoritative bodies mechanism are set forth in Title 22, California Code of Regulations (22 CCR), Section 12306.

The Act also provides another mechanism for the administrative listing of a chemical, that is if 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 of 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 notice dated March 28, 1997, OEHHA announced that these chemicals were under consideration for 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 commenced on March 28, 1997, and closed on, May 28, 1997. A public forum was held on April 24, 1997 to provide an opportunity for oral comments. No comments were received during the public comment period. OEHHA has determined that the chemicals identified below meet the criteria for listing under either 22 CCR, Section 12306 or Section 12902.

Anyone objecting to the listing of the chemicals identified under Section A below as carcinogens on the basis that there is no substantial evidence that the criteria of sufficiency of evidence of carcinogenicity identified in 22 CCR, Section 12306 have been satisfied, or to the listing of the carcinogens and reproductive toxicants identified in Section B below on the basis that the criteria in 22 CCR, Section 12902 have not been met, should provide written comments, along with supporting documentation, by mail or by fax to:

Office of Environmental Health Hazard Assessment
1001 I Street,
Sacramento, CA 95814
Fax No.: (916) 327-1097

Comments may also be hand-delivered to Sam Delson at the Office of Environmental Health Hazard Assessment, at the same address.

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, July 28, 1997.

A. The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12306 for listing as carcinogens under the authoritative bodies mechanism:

[Chemical CAS No. Reference]
1-Amino-2,4-dibromoanthraquinone 81-49-2 NTP (1994a; 1994c)

C.I. Direct Blue 15 2429-74-5 IARC (1993)

C.I. Direct Blue 218 28407-37-6 NTP (1994b)

3,7-Dinitrofluoranthene 105735-71-5 IARC (1996a)

3,9-Dinitrofluoranthene 22506-53-2 IARC (1996a)

Nitrobenzene 98-95-3 IARC (1996b)

B. The following chemicals have been determined by OEHHA to meet the criteria set forth in 22 CCR, Section 12902 for listing based on a formal requirement for labeling or identification as causing cancer or reproductive toxicity:

Carcinogens [Chemical CAS No. Reference]
Estropipate 7280-37-7 FDA (1994)

Ganciclovir sodium 82410-32-0 FDA (1995a)

Reproductive toxicants [Chemical CAS No. Reference]
Amiodarone hydrochloride 19774-82-4 FDA (1995c)

Atenolol 29122-68-7 FDA (1996a)

Estropipate 7280-37-7 FDA (1994)

Ethionamide 536-33-4 FDA (1969)

Ganciclovir sodium 82410-32-0 FDA (1995a)

Goserelin acetate 65807-02-5 FDA (1995d)

Leuprolide acetate 74381-53-6 FDA (1996b)

Paclitaxel 33069-62-4 FDA (1996c)

Quazepam 36735-22-5 FDA (1991)

Trimetrexate glucuronate 82952-64-5 FDA (1993)

One of the chemicals which appeared in the March 28, 1997 notice is not included in this Notice of Intent to List. Premarin was under consideration for possible listing through the formally required to be labeled or identified mechanism. In a notice published on April 18, 1997, OEHHA announced that no further action towards the listing of Premarin was appropriate at this time, since it was already covered by previous listings of conjugated estrogens as carcinogens and reproductive toxicants.

Chemical Reference

• C.I. Direct Blue 218
• 1-Amino-2,4-dibromoanthraquinone
• 3,9-Dinitrofluoranthene
• C.I. Direct Blue 15
• 3,7-Dinitrofluoranthene
• Amiodarone Hydrochloride
• Atenolol
• Ethionamide
• Estropipate
• Goserelin Acetate
• Ganciclovir Sodium
• Leuprolide Acetate
• Quazepam
• Nitrobenzene
• Trimetrexate Glucuronate
• Paclitaxel
• Premarin

Related Notices

• Request for Information, Chemicals Under Consideration for Possible Listing Via Administrative Mechanisms: 20 Chemicals

  Mar 28, 1997
• Chemicals Under Consideration for Possible Listing Via Administrative Mechanisms: Revision of the March 28, 1997 Notice (withdrawal of Premarin from consideration)

  Apr 18, 1997

Footnotes and References

References
Food and Drug Administration (FDA, 1994). Final printed labeling for the drug estropipate. FDA approved June 1994.

Food and Drug Administration (FDA, 1995a). Final printed labeling for the drug ganciclovir sodium. FDA approved October 1995.

Food and Drug Administration (FDA, 1995c). Final printed labeling for the drug amiodarone hydrochloride. FDA approved October 1995.

Food and Drug Administration (FDA, 1996a). Final printed labeling for the drug atenolol. FDA approved February 1996.

Food and Drug Administration (FDA, 1969). Final printed labeling for the drug ethionamide. FDA approved February 1969.

Food and Drug Administration (FDA, 1995d). Final printed labeling for the drug goserelin acetate. FDA approved December 1995.

Food and Drug Administration (FDA, 1996b). Final printed labeling for the drug leuprolide acetate. FDA approved April 1996.

Food and Drug Administration (FDA, 1996c). Final printed labeling for the drug paclitaxel. FDA approved April 1996.

Food and Drug Administration (FDA, 1991). Final printed labeling for the drug quazepam. FDA approved August 1991.

Food and Drug Administration (FDA, 1993). Final printed labeling for the drug trimetrexate glucuronate. FDA approved December 1993.

International Agency for Research on Cancer (IARC, 1993). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 57: 235-245. Occupational Exposures of Hairdressers and Barbers and Personal Use of Hair Colourants; Some Hair Dyes, Cosmetic Colourants, Industrial Dyestuffs and Aromatic Amines. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1996a). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 65: 297-307. Printing Processes and Printing Inks, Carbon Black and Some Nitro Compounds. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1996b). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 65: 381-408. Printing Processes and Printing Inks, Carbon Black and Some Nitro Compounds. IARC, Lyon, France.

National Toxicology Program (NTP, 1992). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 15 (CAS No. 2429-74-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 397. NTIS Publication No. 92-2852. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1994a). Toxicology and Carcinogenesis Studies of 1-amino-2,4-dibromoanthraquinone (CAS No. 81-49-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). Board Draft. NTP Technical Report Series No. 383. NTIS Publication No. 94-2838. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1994b). Toxicology and Carcinogenesis Studies of C.I. Direct Blue 218 (CAS No. 28407-37-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 430. NTIS Publication No. 94-3161. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1994c). Summary Minutes from Peer Review of Draft Technical Reports of Long-Term Toxicology and Carcinogenesis Studies by the Technical Reports Review Subcommittee on June 21, 1994. NTP, Research Triangle Park, NC.