Request for Relevant Information on the Carcinogenic Hazards of Diaminotoluenes

Oct 23, 2014

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of Proposition 65¹. The Carcinogen Identification Committee (CIC) of OEHHA’s Science Advisory Board serves as the state’s qualified experts and renders an opinion about whether a chemical has been clearly shown to cause cancer. The chemicals identified by the CIC are added to the Proposition 65 list.

Diaminotoluene (mixed) was added to the Proposition 65 list of chemicals known to the state to cause cancer on January 1, 1990, under the authoritative bodies provision of Proposition 65.² It was formally identified by the US Environmental Protection Agency (US EPA) as causing cancer (US EPA, 1988)³.

OEHHA received a petition from Big Lots Stores, Inc. (petition can be found here) for reconsideration of listing for diaminotoluene (mixed) on October 21, 2014. While the US EPA (1988) basis document indicates that the hazard ranking of diaminotoluene (mixed) “is applicable to all isomers of diaminotoluene”, and that the “evidence on potential carcinogenicity from animal studies is “sufficient””, the US EPA document also indicates that “this evidence is based on the carcinogenic properties of the isomer 2,4-diaminotoluene”. No other information on the mixture or individual isomers is included in the US EPA document.

In order to clarify the scope of the listing, OEHHA is referring diaminotoluene (mixed) to the CIC for a determination as to whether the chemical should continue to be included on the list of chemicals known to the state to cause cancer pursuant to Title 27, Cal. Code of Regs., section 25306 (j).

At a future meeting, the committee will consider the available scientific evidence on the chemical group diaminotoluene (mixed) as well as on the individual isomers in that group, and make a determination on whether diaminotoluenes as a group, the mixtures or any of five individual isomers named in the table below should be listed under Proposition 65. 2,4-Diaminotoluene will not be re-considered, as it was individually added to the list by the Science Advisory Panel (the predecessor entity to the CIC) on January 1, 1988.

Chemicals for Preparation of Cancer Hazard Identification Materials

Chemicals	CAS No.
Diaminotoluene(mixed)	---
Diaminotoluenes	---
2,3-Diaminotoluene	2687-25-4
2,5-Diaminotoluene	95-70-5
2,6-Diaminotoluene	823-40-5
3,4-Diaminotoluene	496-72-0
3,5-Diaminotoluene	108-71-4

By this notice, OEHHA is giving the public an opportunity to provide information relevant to the assessment of the evidence of carcinogenicity for diaminotoluene (mixed), diaminotoluenes, 2,3 diaminotoluene, 2,5-diaminotoluene, 2,6-diaminotoluene, 3,4-diaminotoluene, and 3,5-diaminotoluene. Relevant information includes but is not limited to:

Cancer bioassays
Cancer epidemiology studies
Genotoxicity testing
Other pertinent data on:
- Pharmacokinetics, biomarkers
- Effects on biochemical and physiological processes in humans

Interested parties or members of the public wishing to provide such information should send it to the address given below.

The publication of this notice marks the start of a 45-day data call-in period, ending on Monday, December 22, 2014. The information received during this period will be reviewed and considered by OEHHA as it prepares the cancer hazard identification materials on these chemicals.

Hazard identification materials are made available to the public for comment prior to the CIC’s consideration of the chemical for possible listing. Their availability for comment will be announced in the California Regulatory Notice Register and on OEHHA’s website. Public comments received on these materials are sent to the CIC for its consideration prior to the CIC meeting at which the chemicals will be considered for listing. The time, date, location, and agenda of the CIC meeting will also be published in the California Regulatory Notice Register and posted on OEHHA’s website.

We encourage you to submit relevant information responsive to this request in electronic form, rather than in paper form. Submissions transmitted by e-mail should be addressed to P65Public.comments@oehha.ca.gov. Please include “Diaminotoluenes” in the subject line. Submissions in paper form may be mailed, faxed, or delivered in person to the addresses below:

Mailing Address:
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010
Fax: (916) 324-6511
Street Address: 1001 I Street
Sacramento, California 95814

In order to be considered at this point in the process, the relevant information must be received at OEHHA by 5:00 pm on Monday, December 22, 2014.

Comment Period

Link to Public Comments

Footnotes and References

Safe Drinking Water and Toxic Enforcement Act of 1986, Health and Safety Code section 25249.5 et seq.
Title 27, Cal. Code of Regs., section 25306
US Environmental Protection Agency (EPA, 1988). Methodology for Evaluating Potential Carcinogenicity in Support of Reportable Quantity Adjustments Pursuant to CERCLA Section 102. Office of Health and Environmental Assessment, Washington DC 20460, EPA/600/8-89/053, June 1988, including Appendix: Hazard Ranking of Potential Carcinogens, and Appendix: Evaluation of the Potential Carcinogenicity of Diaminotoluene (Mixed) (95-80-7). In Support of Reportable Quantity Adjustments Pursuant to CERCLA Section 102, Carcinogen Assessment Group, Office of Health and Environmental Assessment Washington, DC, 20460 EPA/600/8-91/103 June 1988.