Draft and FINAL Hazard Identification Documents for Chloral Hydrate

Jul 25, 2003

[Document finalized on 11/21/03]

The California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The Carcinogen Identification Committee (CIC) of OEHHA's Science Advisory Board advises and assists OEHHA in compiling the list of chemicals known to the State to cause cancer, which is mandated by Health and Safety Code Section 25249.8. The Committee serves as the State's qualified experts for determining whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer.

The possible listing of chloral hydrate was discussed at the May 11, 1995 meeting of the CIC. At this meeting the CIC concluded that the available evidence did not, at that time, support a finding that chloral hydrate was clearly shown through scientifically valid testing according to generally accepted principles to cause cancer. However, the CIC expressed serious concern about the extensive use of chloral hydrate especially in pediatric medicine, and lack of adequate carcinogenicity testing of the chemical. On behalf of the CIC, OEHHA urged the National Toxicology Program (NTP) and the National Center for Toxicological Research to give chloral hydrate carcinogenicity bioassays those agencies were planning the highest priority. These studies have been completed and results released. OEHHA has revised the hazard identification document on chloral hydrate originally released in March 1995 to incorporate the results of these studies. Additional studies published since 1995 and relevant to the carcinogenicity of chloral hydrate have also been incorporated into the revised hazard identification document. Today OEHHA announces the availability of the revised document, entitled: "Evidence on the Carcinogenicity of Chloral Hydrate." Copies of the document are available from the Proposition 65 Implementation Office and may be requested by calling (916) 445-6900. The document is also available for download below. This notice marks the beginning of a 60-day public comment period.

Cynthia Oshita
Office of Environmental Health Hazard Assessment
Proposition 65 Implementation
P.O. Box 4010
1001 I Street, 19th floor
Sacramento, California 95812-4010

FAX (916) 323-8803

P65Public.Comments@oehha.ca.gov

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 5:00 p.m. on Tuesday, September 23, 2003.

OEHHA will organize and index the comments received and forward the information to the CIC members prior to the meeting at which the candidate chemical will be considered. The next meeting of the CIC is scheduled for Friday, October 17, 2003. The meeting will be held at the California Environmental Protection Agency Headquarters Building, Sierra Hearing Room, at 1001 I Street, Sacramento, California. The meeting will begin at 10:00 a.m. and will last until all business is conducted or until 5:00 p.m. The agenda for the meeting will be provided in a future public notice published in advance of the October 17 meeting.