© 1989 Oxford University Press
research-article |
Two-Year Toxicity and Carcinogenicity Studies of Ampicillin Trihydrate and Penicillin VK in Rodents
National Institute of Environmental Health Sciences Research Triangle Park, North Carolina 27709
Received November 20, 1987; accepted July 18, 1988
Toxicology and carcinogenesis studies of ampicillin trihydrate and penicillin VK, two widely used ß-lactam antibiotics, were performed in F344/N rats and B6C3F1 mice. In these studies ampicillin trihydrate was administered for 2 years to rats at doses of 0, 750, or 1500 mg/kg and to mice at doses of 0, 1500, or 3000 mg/kg, and penicillin VK was administered to rats and mice at doses of 0, 500, or 1000 mg/kg. Both drugs were administered by oral gavage in corn oil. Toxic lesions ofthe stomach were seen in rats and mice after ampicillin trihydrate administration and in mice after penicillin VK administration. In male rats that received ampicillin trihydrate there was a marginal increase in incidence of mononuclear cell leukemia and pheochromocytomas of the adrenal gland medulla. There was no evidence for carcinogenic activity in female rats or male and female mice after ampicillin trihydrate administration or in rats and mice after penicillin VK administration.