Chemicals Listed Effective December 2, 2005 as Known to the State of California to Cause Reproductive Toxicity

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding butyl benzyl phthalate (BBP) (CAS No. 85 68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of the three phthalates is effective December 2, 2005.

Butyl benzyl phthalate (BBP) (CAS No. 85-68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) are being listed as chemicals known to the State of California to cause reproductive toxicity for one or more endpoint (see table below.) The listing of these chemicals is based on formal identification by an authoritative body, in this case, the National Toxicology Program, in final reports of the National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (“NTP-CERHR”) which conclude that the chemicals cause reproductive toxicity. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 22, Cal. Code of Regs., section 12306.

The reader is directed to the Notice of Intent to List butyl benzyl phthalate (BBP) (CAS No. 85-68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) and di-isodecylphthalate (DIDP) (CAS Nos. 68515-49-1 and 26761-40-0) published in the March 4, 2005, issue of the California Regulatory Notice Register (Register 2005, No. 9-Z) for the documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for these chemicals. The listing of the chemical di-isodecyl phthalate, which was included in the March 4 Notice of Intent to List, is still under consideration and will be the subject of a future public notice. Three public comments were received on the proposed listing of the phthalates during the 30-day comment period that closed on April 4, 2005.

OEHHA analyses of dose-response data to establish the maximum allowable dose levels (MADLs) for butyl benzyl phthalate (BBP) (CAS No. 85-68-7), di-n-butyl phthalate (DBP) (CAS No. 84-74-2), and di-n-hexyl phthalate (DnHP) (CAS No. 84-75-3) under Proposition 65 have not yet been conducted. The priority status for the development of such analyses will be announced in a future OEHHA Proposition 65 Status Report for Safe Harbor Levels.

A complete, updated Proposition 65 list is published elsewhere in this issue of the California Regulatory Notice Register.

¹ Listing mechanism:
AB – “authoritative bodies” mechanism (Title 22, Cal. Code of Regs. Section 12306)