Notice of Intent to List Bromochloroacetic Acid and Cumene
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list the chemicals bromochloroacetic acid and cumene as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986. This action is being taken under the authoritative bodies mechanism.
Notice of Intent to List Bromochloroacetic Acid And Cumene
| Chemical | CAS No. | Endpoint | Reference | Chemical Use |
|---|---|---|---|---|
| Bromochloroacetic acid | 5589-96-8 | Cancer | NTP (2009a) | Water disinfection by-product |
| Cumene | 98-82-8 | Cancer | NTP (2009b) | Used in the production of numerous chemicals, especially phenol and acetone; used as a thinner, a solvent, and in some fuels; occurs naturally in petroleum and some foods |
OEHHA requested information relevant to the possible listing of bromochloroacetic acid and cumene in a notice published in the California Regulatory Notice Registry on October 16, 2009 (Register 2009, No. 42-Z). OEHHA received no public comments.
Background on listing via the authoritative bodies mechanism: A chemical must be listed under Proposition 65 when two conditions are met:
- An authoritative body formally identifies the chemical as causing cancer (Section 25306(d)).
- The evidence considered by the authoritative body meets the sufficiency criteria contained in the regulations (Section 25306(e)).
However, the chemical is not listed if scientifically valid data which were not considered by the authoritative body clearly establish that the sufficiency of evidence criteria were not met (Section 25306(f)).
The National Toxicology Program (NTP) is one of several institutions designated as authoritative for the identification of chemicals as causing cancer (Section 25306(m)). OEHHA is the lead agency for Proposition 65 implementation. After an authoritative body has made a determination about a chemical, OEHHA evaluates whether listing under Proposition 65 is required using the criteria contained in the regulations.
OEHHA’s determination: Bromochloroacetic acid and cumene each meet the criteria for listing as known to the State to cause cancer under Proposition 65, based on findings of the National Toxicology Program (NTP, 2009a; NTP, 2009b).
Formal identification and sufficiency of evidence for bromochloroacetic acid: In 2009, the NTP published a report on bromochloroacetic acid, entitled Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). This report concludes that the chemical causes cancer, which satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.
OEHHA is relying on the NTP’s discussion of data and conclusions in the report that bromochloroacetic acid causes cancer. The NTP (2009a) report concludes:
“Under the conditions of these 2-year studies, there was clear evidence of carcinogenic activity of bromochloroacetic acid in male F344/N rats based on increased incidences of malignant mesotheliomas and adenomas of the large intestine. There was clear evidence of carcinogenic activity of bromochloroacetic acid in female F344/N rats based on increased incidences of adenomas of the large intestine; increased incidences of multiple fibroadenomas of the mammary gland in female rats were also considered to be exposure related. Increased incidences of pancreatic islet adenomas in male rats and of hepatocellular adenomas in male and female rats may have been related to bromochloroacetic acid exposure. There was clear evidence of carcinogenic activity of bromochloroacetic acid in male and female B6C3F1 mice based on increased incidences of hepatocellular neoplasms and hepatoblastoma (males only).” (Emphasis in original)
Thus, the NTP (2009a) has found that bromochloroacetic acid causes increased incidences of malignant mesotheliomas in male rats, and malignant liver tumors in male and female mice.
Formal identification and sufficiency of evidence for cumene: In 2009, the NTP published a report, entitled Toxicology and Carcinogenesis Studies of Cumene (CAS No. 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). The report concludes that cumene causes cancer, which satisfies the formal identification and sufficiency of evidence criteria in the Proposition 65 regulations.
OEHHA is relying on the NTP’s discussion of data and conclusions in the report that cumene causes cancer. The NTP (2009b) report concludes:
“Under the conditions of these 2-year inhalation studies, there was clear evidence of carcinogenic activity of cumene in male F344/N rats based on increased incidences of respiratory epithelial adenoma in the nose and renal tubule adenoma or carcinoma (combined). Increased incidences of interstitial cell adenoma of the testis may have been related to exposure to cumene. There was some evidence of carcinogenic activity of cumene in female F344/N rats based on the incidences of respiratory epithelium adenoma in the nose. There was clear evidence of carcinogenic activity of cumene in male B6C3F1 mice based on increased incidences of alveolar/bronchiolar neoplasms. The increased incidences of hemangiosarcoma in the spleen and follicular cell adenoma in the thyroid gland in male mice may have been related to cumene exposure. There was clear evidence of carcinogenic activity of cumene in female B6C3F1 mice based on increased incidences of alveolar/bronchiolar neoplasms. Increased incidences of hepatocellular adenoma or carcinoma (combined) in female mice were also considered to be related to exposure to cumene.” (Emphasis in original)
Thus, the NTP (2009b) has found that cumene causes increased incidences of combined benign and malignant kidney tumors in male rats, and malignant lung tumors in mice of both sexes.
Request for Comments: OEHHA is committed to public participation in its implementation of Proposition 65. OEHHA wants to ensure that its regulatory decisions are based on a thorough consideration of all relevant information. OEHHA is requesting comments as to whether these two chemicals meet the criteria set forth in the Proposition 65 regulations for authoritative bodies listings. In order to be considered, the OEHHA must receive comments by 5:00 p.m. on Monday, March 8, 2010. We encourage you to submit comments in electronic form, rather than in paper form. Comments transmitted by e-mail should be addressed to P65Public.Comments@oehha.ca.gov. Comments submitted in paper form may be mailed or delivered in person in triplicate, or faxed, to the addresses below:
Mailing Address:
Ms. Cynthia Oshita
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 323-8803
Street Address: 1001 I Street
Sacramento, California 95814
If you have any questions, please contact the Proposition 65 Office at coshita@oehha.ca.gov or at (916) 445 6900.
- Bromochloroacetic Acid
- Cumene
Chemical Reference
Related Notices
Footnotes and References
National Toxicology Program (NTP, 2009a). Toxicology and Carcinogenesis Studies of Bromochloroacetic Acid (CAS No. 5589-96-8) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 549. NIH Publication No. 09-5890. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.
National Toxicology Program (NTP, 2009b). Toxicology and Carcinogenesis Studies of Cumene (CAS No. 98-82-8) in F344/N Rats and B6C3F1 Mice (Inhalation Studies). NTP Technical Report Series No. 542. NIH Publication No. 09-5885. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.