Request for Information, 46 Chemicals Under Consideration for Possible Listing Via The Authoritative Bodies Mechanisms

The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act) requires the Governor to publish, and update at least annually, a list of chemicals known to the State to cause cancer or reproductive toxicity.

The Act provides two mechanisms for administratively listing chemicals as 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 (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). 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 second mechanism for the administrative listing of a chemical applies 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 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 is investigating the possible listing of the chemicals identified below, based upon information in the references cited. Documentation summarizing the rationale for considering the evaluation of these chemicals for possible administrative listing is available from OEHHA’s Proposition 65 Implementation Office at the address and telephone number indicated below, or from the Internet.

OEHHA is committed to public participation and external scientific peer review in its implementation of Proposition 65, and welcomes public input on this listing process. As part of its efforts to ensure that regulatory decisions are based upon a thorough consideration of all relevant information, OEHHA is soliciting information which may be relevant to the evaluation of these chemicals in the context of the Proposition 65 administrative listing regulatory criteria (22 CCR Section 12306 or Section 12902, as appropriate).

A public forum will be held on Wednesday, October 1, 1997 to provide an opportunity for interested parties to present oral comments and to discuss the scientific data and other information relevant to a determination as to whether these chemicals meet the criteria for listing set forth in 22 CCR Section 12306 or Section 12902. The public forum will be conducted at 10:00 a.m. in the Auditorium at 714 P Street, Sacramento, California, and will last until all business has been conducted or until 5:00 p.m.

Written comments, along with supporting information, may also be submitted to:

Proposition 65
Office of Environmental Health Hazard Assessment
1001 I Street,
Sacramento, CA 95814

FAX: (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 October 21, 1997.

Following the review of all comments received, OEHHA will announce its intention to proceed with the listing of those candidate chemicals that meet the regulatory criteria for administrative listing in a Notice of Intent to List Chemicals.

A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies" mechanism:

Chemical

CAS No.

Reference

Aniline hydrochloride

142-04-1

US EPA (1989b)
C.I. Solvent Yellow 14

842-07-9

NTP (1982a)
Carbon black (by inhalation)

1333-86-4

IARC (1996)
p-Chloroaniline hydrochloride

20265-96-7

NTP (1989a)
p-Chloro-o-toluidine and its strong acid salts

95-69-2

IARC (1990)
Cytembena

21739-91-3

NTP (1981)
3,3-Dichlorobenzidine dihydrochloride

612-83-9

NTP (1994)

 

A. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as carcinogens via the "authoritative bodies" mechanism (continued):

Chemical

CAS No.

Reference

Metham sodium1

137-42-8

US EPA (1995a)
Methyl carbamate

598-55-0

NTP (1987)
Nalidixic acid

389-08-2

NTP (1989b)
o-Nitrotoluene

88-72-2

NTP (1996)
o-Phenylenediamine and its salts

95-54-5

US EPA (1985)
Salicylazosulfapyridine

599-79-1

NTP (1997)

B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as reproductive toxicants via the "authoritative bodies" mechanism:

Chemical

CAS No.

Reference

Acrylamide

79-06-1

NIOSH (1991, 1992) NTP (1993a)
Benzo[a]pyrene

50-32-8

IARC (1983)
Boric Acid1,2

10043-35-3

US EPA (1993a, b)
1,3-Butadiene

106-99-0

NIOSH (1984) US EPA (1989a) NTP (1993b)
Carbon dioxide
(by inhalation)1,2

124-38-9

US EPA (1991a, b)
o,p-DDT

789-02-6

IARC (1991) NIOSH (1988) US EPA (1988a)
p,p-DDT

50-29-3

IARC (1991) NIOSH (1988) US EPA (1988a)
DDT, technical grade

---

IARC (1991) NIOSH (1988) US EPA (1988a)
(2,4-dichlorphenoxy) acetic acid

94-75-7

US EPA (1988c)
2,4-D n-butyl ester

94-80-4

US EPA (1988c)
2,4-D isopropyl ester

94-11-1

US EPA (1988c)
2,4-D isooctyl ester

25168-26-7

US EPA (1988c)
Propylene gylcol butyl ether ester (of 2,4-D)

1928-45-6

US EPA (1988c)
2,4-D butoxyethanol ester

1929-73-3

US EPA (1988c)

B. Chemicals which may meet the criteria set forth in 22 CCR Section 12306 for listing as reproductive toxicants via the "authoritative bodies" mechanism (continued):

Chemical

CAS No.

Reference

2,4-D dimethylamine salt

2008-39-1

US EPA (1988c)
2,4-D butyric acid1

94-82-6

US EPA (1988c, 1994a, b)
Endrin

72-20-8

US EPA (1980, 1992b)
Ethylene dibromide

106-93-4

NIOSH (1977)
US EPA (1987a, b)
Linuron1

330-55-2

US EPA (1994a, b)
Metham Sodium1

137-42-8

US EPA (1994a, b)
Oxadiazon1

19666-30-9

US EPA (1994a, b)
Tetraborate and its salts (including Sodium Borate)1,2

---

US EPA (1993a, b)
Vinclozolin1

50471-44-8

US EPA (1988b, 1994a, b)
Zearalenone

17924-92-4

NTP (1982b) IARC (1993)

1On July 21, 1997 and August 4, 1997, letters were sent to the U.S. Environmental Protection Agency seeking clarification on its determination that the chemical had been identified as causing reproductive toxicity (see attached letters).

2On August 4, 1997, a letter was sent to the US Food and Drug Administration seeking clarification on its determination that the chemical had been identified as causing reproductive toxicity (see attached letter).

 

C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as reproductive toxicants via the "formally required to be labeled or identified" mechanism:

Chemical

CAS No.

Reference

Amoxapine

14028-44-5

FDA (1988a)
Beclomethasone dipropionate

5534-09-8

FDA (1988b)
Clobetasol propionate

25122-46-7

FDA (1995a)
Codeine phosphate

52-28-8

FDA (1989)

 

C. Chemicals which may meet the criteria set forth in 22 CCR Section 12902 for listing as reproductive toxicants via the "formally required to be labeled or identified" mechanism (continued):

Chemical

CAS No.

Reference

Flunisolide

3385-03-3

FDA (1984)
Fluticasone propionate

80474-14-2

FDA (1995b)
Histrelin acetate

---

FDA (1991)
Levonorgestrel implants

797-63-7

FDA (1995c)
Pravastatin sodium 81131-70-6 FDA (1996)

Footnotes and References

California Department of Food and Agriculture (CDFA, 1987) Summary of Toxicology Data: Oxadiazon. Medical Toxicology Branch. Last updated, 4/11/90.

California Department of Food and Agriculture (CDFA, 1986) Summary of Toxicology Data: Metam-Sodium. Medical Toxicology Branch. Last updated, 6/15/92.

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, 1996). Final printed labeling for the drug pravastatin sodium. FDA approved 1996.

International Agency for Research on Cancer (IARC, 1996). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 65: 149-262. Printing Processes and Printing Inks, Carbon Black and Some Nitro Compounds. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1993). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 56:397-444. Some Naturally Occurring Substances: Food Items and Constituents, Heterocyclic Aromatic Amines and Mycotoxins. IARC, Lyon, France.

International Agency for Research on Cancer (IARC, 1991). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Volume 53: 179-249. Occupational Exposures in Insecticide Application, and Some Pesticides. DDT and Associated Compounds. IARC, Lyon, France.

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.

International Agency for Research on Cancer (1983). IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Volume 32. Polynuclear Aromatic Compounds, Part 1, Chemical, Environmental and Experimental Data. IARC, Lyon, France.

National Institute for Occupational Safety and Health (NIOSH, 1992). Occupational Safety and Health Guideline for Acrylamide. US Department of Health and Human Services, Public Health Service, Centers for Disease Control, NIOSH, Division of Standards Development and Technology Transfer.

National Institute for Occupational Safety and Health (NIOSH, 1991). NIOH and NIOSH basis for an occupational health standard - Acrylamide: A review of the literature. Centers for Disease Control, Public Health Service, US Department of Health and Human Services in cooperation with the National Institute of Occupational Health, Solna, Sweden. DHHS/PUB/NIOSH-91-115.

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, 1984). Current Intelligence Bulletin 41. 1,3-Butadiene. 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, 1996). 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, 1995a). Toxicology and Carcinogenesis Studies of Salicylazosulfapyridine (CAS No. 599-79-1) in F344/N Rats and B6C3F1 Mice (Gavage Studies). Board Draft. NTP Technical Report Series No. 457. NTIS Publication No. 95-3373. US Department of Health and Human Services, NTP, Research Triangle Park, NC.

National Toxicology Program (NTP, 1995b). Summary Minutes from Peer Review of Draft Technical Reports of Long-Term Toxicology and Carcinogenesis Studies Including the Effects of Dietary Restriction on Feed Studies and a Short-Term Toxicity Study by the Technical Reports Review Subcommittee and NTP Toxicology and Collaborative Carbon Disulfide (CS2) Inhalation Studies on June 20-21, 1995. 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, 1993a). Final report on the reproductive toxicity of acrylamide (ACRL) (CAS No. 79-06-1) in CD-1 (trade name) Swiss mice. Government Reports Announcements & Index, Issue 10, reporting on NTIS/PB93-158285.

National Toxicology Program (NTP, 1993b). Toxicology and Carcinogenesis Studies of 1,3-Butadiene (CAS No. 106-99-0) in B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 434. NTIS Publication No. 93-3165. 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, 1982a). 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, 1982b). Carcinogenesis Bioassay of Zearalenone in F344/N Rats and B6C3F1 Mice. NTP Technical Report Series No. 235. NTIS Publication No. 83-1791. 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.

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US Environmental Protection Agency (US EPA, 1995c). Health Test Guidelines. OPPRS 870.3700; Prenatal Developmental Toxicity Study. Public Draft.

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).

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