Evidence on the Carcinogenicity of Estragole

PREFACE The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65, California Health and Safety Code 25249.5 et seq.) requires that the Governor cause to be published a list of those chemicals " known to the state " to cause cancer or reproductive toxicity. The Act specifies that " a chemical is known to the state to cause cancer or reproductive toxicity...if in the opinion of the state's qualified experts the chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity. " The lead agency for implementing Proposition 65 is the Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency. The " state's qualified experts " regarding findings of carcinogenicity are identified as the members of the Carcinogen Identification Committee of the OEHHA Science Advisory Board (22 CCR 12301). Estragole was assigned a final priority of 'high' carcinogenicity concern and placed on the Final Candidate list of chemicals for Committee review on June 12, 1998. A public request for information relevant to the assessment of the evidence on the carcinogenicity of this chemical was announced in the At their October 7, 1999 meeting the Committee found, by a vote of five in favor, one against, and one abstention, that estragole had been " clearly shown through scientifically valid testing according to generally accepted principles to cause cancer. " Estragole was added to the list of chemicals known to the State to cause cancer, for purposes of the Table 1. Hepatocellular carcinomas in newborn CD-1 mice administered estragole and other alkenylbenzenes via oral gavage (Miller et al., 1983). .. 6 Table 2. Hepatocellular carcinoma in CD-1 female mice fed diets containing estragole, safrole, or 1'-hydroxyestragole (Miller et al., 1983). .. 7 Table 3. Hepatocellular carcinomas in newborn male CD-1 mice administered intraperitoneal injections of estragole, other alkenylbenzenes, and their derivatives Table 4. Hepatocellular carcinomas in newborn male B6C3F 1 mice administered intraperitoneal injections of estragole, other alkenylbenzenes, and their derivatives (Miller et al., Table 5. Effect of the sulfotransferase inhibitor, pentachlorophenol (PCP), on the development of hepatocellular carcinomas in B6C3F 1 mice given an intraperitoneal injection of estragole or other alkenylbenzenes Table 6. Lung adenomas in female A/J mice treated with estragole, safrole and selected metabolites (Miller et al., Table 7. Hepatocellular carcinomas in newborn male CD-1 mice treated by subcutaneous injection with estragole, 1'-hydroxyestragole, …