27 Chemicals Listed Effective May 15, 1998 as Known to the State to Cause Cancer or Reproductive Toxicity
The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency has added the 27 chemicals named below 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 or the Act). These chemicals are listed effective May 15, 1998. These chemicals were included in the notice of intent to list published on December 5, 1997 in the California Regulatory Notice Register. Benzo(a)pyrene, technical grade DDT and zearalenone were also included in the December 1997 notice but it was subsequently determined that the criteria specified in Section 12306(d), Title 22 of the California Code of Regulations (22 CCR) were not met for these chemicals. Consequently, benzo(a)pyrene, technical grade DDT and zearalenone will be referred to the Developmental and Reproductive Toxicant (DART) Identification Committee for their consideration for listing. Metham sodium has been added to the May 15, 1998 chemical list on the basis of its reproductive toxicity. Information supporting inclusion of an additional endpoint (cancer) for metham sodium is currently under review.
The 27 chemicals are listed pursuant to the administrative mechanisms provided under the Act, based upon either (1) a formal identification by an authoritative body that the chemical causes cancer or reproductive toxicity; or, (2) a formal requirement by a state or federal agency that the chemical be identified or labeled as causing cancer or reproductive toxicity. The table below indicates documents in which authoritative bodies formally identified chemicals as causing cancer or reproductive toxicity or agencies of state or federal government formally required that a chemical be identified or labeled as causing cancer or reproductive toxicity. Regulations governing the listing of chemicals under the “authoritative bodies” mechanism and the “formally required to be labeled or identified” mechanism are published in 22 CCR, Sections 12306 and 12902, respectively.
The 27 chemicals listed effective May 15, 1998, and the mechanism under which each is listed, are shown below:
Carcinogens
|
Chemical |
CAS No. |
Listing Mechanism1 |
Reference |
|---|---|---|---|
|
Aniline hydrochloride |
142-04-1 |
AB |
US EPA (1989) |
|
C.I. Solvent Yellow 14 |
842-07-9 |
AB |
NTP (1982) |
|
p-Chloroaniline hydrochloride |
20265-96-7 |
AB |
NTP (1989a) |
|
p-Chloro-o-toluidine, strong acid salts of |
--- |
AB |
IARC (1990) |
|
Cytembena |
21739-91-3 |
AB |
NTP (1981) |
|
3,3'-Dichlorobenzidine dihydrochloride |
612-83-9 |
AB |
NTP (1994) |
|
Methyl carbamate |
598-55-0 |
AB |
NTP (1987) |
|
Nalidixic acid |
389-08-2 |
AB |
NTP (1989b) |
|
o-Nitrotoluene |
88-72-2 |
AB |
NTP (1996a) |
|
Phenolphthalein |
77-09-8 |
AB |
NTP (1996b) |
|
o-Phenylenediamine and its salts |
95-54-5 |
AB |
US EPA (1985) |
|
Salicylazosulfapyridine |
599-79-1 |
AB |
NTP (1997) |
Developmental and Reproductive Toxicants
|
Chemical |
CAS No. |
Toxicological Endpoint |
Listing Mechanism1 |
Reference |
|---|---|---|---|---|
|
Amoxapine |
14028-44-5 |
developmental toxicity |
FR |
FDA (1988a) |
|
Beclomethasone dipropionate |
5534-09-8 |
developmental toxicity |
FR |
FDA (1988b) |
|
Clobetasol propionate |
25122-46-7 |
developmental toxicity |
FR |
FDA (1995a) |
|
Codeine phosphate |
52-28-8 |
developmental toxicity |
FR |
FDA (1989) |
|
o,p'-DDT |
789-02-6 |
developmental toxicity |
AB |
NIOSH (1988) |
|
p,p'-DDT |
50-29-3 |
developmental toxicity |
AB |
NIOSH (1988) |
Developmental and Reproductive Toxicants (continued)
|
Chemical |
CAS No. |
Toxicological Endpoint |
Listing Mechanism1 |
Reference |
|---|---|---|---|---|
|
Endrin |
72-20-8 |
developmental toxicity |
AB |
US EPA (1980, 1992) |
|
Ethylene dibromide |
106-93-4 |
developmental toxicity |
AB |
NIOSH (1977) |
|
Flunisolide |
3385-03-3 |
developmental toxicity |
FR |
FDA (1984) |
|
Fluticasone propionate |
80474-14-2 |
developmental toxicity |
FR |
FDA (1995b) |
|
Histrelin acetate |
--- |
developmental toxicity |
FR |
FDA (1991) |
|
Levonorgestrel implants |
797-63-7 |
female reproductive toxicity |
FR |
FDA (1995c) |
|
Metham sodium |
137-42-8 |
developmental toxicity |
AB |
US EPA (1994a,b) |
|
Oxadiazon |
19666-30-9 |
developmental toxicity |
AB |
US EPA (1994a,b) |
|
Vinclozolin |
50471-44-8 |
developmental toxicity |
AB |
US EPA (1988b, 1994a,b) |
1Listing mechanism:
AB - “authoritative bodies” mechanism (Section 12306)
FR - “formally required to be labeled or identified” mechanism (Section 12902)
A complete, updated chemical list is published elsewhere in this issue of the California Regulatory Notice Register.
Chemical Reference
- Ethylene dibromide
- DDT (Dichlorodiphenyltrichloroethane)
- Endrin
- o-Phenylenediamine and its salts
- Methyl Carbamate
- Nalidixic Acid
- p-Chloroaniline Hydrochloride
- C.I. Solvent Yellow 14
- 3,3'-Dichlorobenzidine Dihydrochloride
- Cytembena
- Clobetasol Propionate
- Beclomethasone Dipropionate
- Aniline Hydrochloride
- Amoxapine
- Codeine Phosphate
- Histrelin Acetate
- Flunisolide
- Metham Sodium
- Fluticasone Propionate
- o,p'-DDT
- Oxadiazon
- Levonorgestrel Implants
- o-Nitrotoluene
- Phenolphthalein
- Vinclozolin
- p-Chloro-o-toluidine, strong acid salts of
- Sulfasalazine (salicylazosulfapyridine)
Related Notices
Footnotes and References
References
Food and Drug Administration (FDA, 1988a). Final printed labeling for the drug amoxapine. FDA approved 1988.
Food and Drug Administration (FDA, 1988b). Final printed labeling for the drug beclomethasone dipropionate. FDA approved 1988.
Food and Drug Administration (FDA, 1995a). Final printed labeling for the drug clobetasol propionate. FDA approved 1995.
Food and Drug Administration (FDA, 1989). Final printed labeling for the drug codeine phosphate. FDA approved 1993.
Food and Drug Administration (FDA, 1984). Final printed labeling for the drug flunisolide. FDA approved 1984.
Food and Drug Administration (FDA, 1995b). Final printed labeling for the drug fluticasone propionate. FDA approved 1995.
Food and Drug Administration (FDA, 1991). Final printed labeling for the drug histrelin acetate. FDA approved 1991.
Food and Drug Administration (FDA, 1995c). Final printed labeling for the drug levonorgestrel implants. FDA approved 1995.
Food and Drug Administration (FDA, 1997). Minutes from the Carcinogenicity Assessment Committee (CAC) Meeting, April 30, 1997, US Department of Health and Human Services, Public Health Service, Food and Drug Administration.
International Agency for Research on Cancer (IARC, 1990). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 48: 123-137. Some Flame Retardants and Textile Chemicals, and Exposures in the Textile Manufacturing Industry. IARC, Lyon, France.
National Institute for Occupational Safety and Health (NIOSH, 1988). Occupational Safety and Health Guideline for DDT. US Department of Health and Human Services, NIOSH.
National Institute for Occupational Safety and Health (NIOSH, 1977). Criteria for a recommended standard . . . Occupational Exposure to Ethylene Dibromide. DHEW (NIOSH) Publication No. 77-221. US Department of Health and Human Services, NIOSH.
National Toxicology Program (NTP, 1997). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 457. NTIS Publication No. 97-3373. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1996a). NTP Technical Report on Comparative Toxicity and Carcinogenicity Studies of o-Nitrotoluene and o-Toluidine Hydrochloride (CAS Nos. 88-72-2 and 636-21-5). Administered in Feed to Male F344/N Rats. NTP Toxicity Report Series No. 44. NTIS Publication Number 96-3936. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1996b). Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS No. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 465. NTIS Publication No. 97-3390. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1994). Seventh Annual Report on Carcinogens: 1994. Volume 1: 357-362. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1989a). Toxicology and Carcinogenesis Studies of para-Chloroaniline Hydrochloride (CAS No. 20265-96-7) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 351. NTIS Publication No. 89-2806. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1989b). Toxicology and Carcinogenesis Studies of Nalidixic Acid (CAS No. 389-08-2) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 368. NTIS Publication No. 90-2823. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1987). Toxicology and Carcinogenesis Studies of Methyl Carbamate (CAS No. 598-55-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 328. NTIS Publication No. 88-2584. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1982). Carcinogenesis Bioassay of C.I. Solvent Yellow 14 (CAS No. 842-07-9) in F344/N Rats and B6C3F1 Mice (Feed Study). NTP Technical Report Series No. 226. NTIS Publication No. 82-1782. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 1981). Carcinogenesis Bioassay of Cytembena (CAS No. 21739-91-3). NTP Technical Report Series No. 207. NTIS Publication No. 81-1763. US Department of Health and Human Services, NTP, Research Triangle Park, NC.
US Environmental Protection Agency (US EPA, 1994a) Proposed Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59 FR 1788).
US Environmental Protection Agency (US EPA, 1994b) Final Rule: Addition of Certain Chemicals; Toxic Chemical Release Reporting; Community Right to Know. Federal Register (59(229) FR 61432).
US Environmental Protection Agency (US EPA, 1992) Drinking Water Criteria Document for Endrin. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment.
US Environmental Protection Agency (US EPA, 1989) Integrated Risk Information System (IRISâ): Aniline. CASRN 62-53-3. Environmental Criteria and Assessment Office, US EPA, Cincinnati, OH.
US Environmental Protection Agency (US EPA, 1988a). Updated Health Effects Assessment for DDT. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Office of Research and Development, US EPA, Cincinnati, OH.
US Environmental Protection Agency (US EPA, 1988b) Proposed Rule for Pesticide Tolerances for 3-(3,5-Dichlorophenyl)-5-Ethenyl-5-Methyl-2,4-Oxazolidinedione. Federal Register (53 FR 41209).
US Environmental Protection Agency (US EPA, 1987a). Health Effects Assessment for Ethylene Dibromide. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Office of Research and Development, US EPA, Cincinnati, OH.
US Environmental Protection Agency (US EPA, 1987b). Drinking Water Criteria Document for Ethylenedibromide (EDB). Office of Drinking Water, US EPA, Washington, D.C.
US Environmental Protection Agency (US EPA, 1985). Health and Environmental Effects Profile for Phenylenediamines. Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, Office of Research and Development, US EPA, Cincinnati, OH.
US Environmental Protection Agency (US EPA, 1980) Ambient Water Quality Criteria for Endrin. Office of Water Regulations and Standards Criteria and Standards Division.