Toxicology and carcinogenesis studies of ginseng (CAS No. 50647-08-0) in F344/N rats and B6C3F1 mice (gavage studies)

CHEMICAL AND PHYSICAL PROPERTIES: Ginseng is a perennial aromatic herb widely used in herbal remedies, dietary supplements, cosmetics, and as a food additive. Ginseng was nominated for study by the National Cancer Institute based on significant human exposure through the uses described above and the lack of information on its toxicity. Male and female F344/N rats and B6C3F1 mice were administered extracts of ginseng root by gavage for 2 weeks, 3 months, or 2 years. Genetic toxicology studies were conducted in Salmonella typhimurium, Escherichia coli, and mouse peripheral blood erythrocytes. 2-WEEK STUDY IN RATS: Groups of five male and five female rats were administered ginseng in 0.5% aqueous methylcellulose by gavage at doses of 0, 125, 250, 500, 1,000, or 2,000 mg/kg, 5 days per week for 16 days. All rats survived to the end of the study. Mean body weight gain of 2,000 mg/kg males was significantly greater than that of the vehicle controls. There were no chemical-related gross or microscopic findings attributed to the administration of ginseng. 2-WEEK STUDY IN MICE: Groups of five male and five female mice were administered ginseng in 0.5% aqueous methylcellulose by gavage at doses of 0, 125, 250, 500, 1,000, or 2,000 mg/kg, 5 days per week for 17 days. All mice survived to the end of the study. The final mean body weight of 1,000 mg/kg males was significantly less than that of the vehicle controls. There were no significant chemical-related gross or histopathologic changes in dosed mice. 3-MONTH STUDY IN RATS: Groups of 10 male and 10 female rats were administered ginseng in sterile water by gavage at doses of 0, 1,000, 2,000, 3,000, 4,000, or 5,000 mg/kg, 5 days per week for 14 weeks. All rats survived to the end of the study. Mean body weights of all dosed groups were similar to those of the vehicle control groups. No lesions that were observed by gross or histopathologic examination were attributed to the administration of ginseng. 3-MONTH STUDY IN MICE: Groups of 10 male and 10 female mice were administered ginseng in sterile water by gavage at doses of 0, 1,000, 2,000, 3,000, 4,000, or 5,000 mg/kg, 5 days per week for 14 weeks. All mice survived to the end of the study. Mean body weights of all dosed groups were similar to those of the vehicle control groups. Although sporadic incidences of lesions were observed in the vehicle control and 5,000 mg/kg groups, there were no chemical-related gross or microscopic findings in dosed mice. 2-YEAR STUDY I