An escalating dose oral gavage study of 3 beta-acetoxyandrost-5-ene-7, 17-dione (7-oxo-DHEA-acetate) in Rhesus monkeys

To test the effects of 7-oxo-dehydroepiandrosterone-3 acetate (hereafter 7- ODA) in Rhesus macaques the steroid was administered by oral gavage to two male and two female monkeys. Dose levels of 250, 500, and 1,000 mg/kg body weight (BW)/day were administered on days 1, 3, and 5 respectively, and 1,0 00 mg/kg on days 7 through II. Each group received the dose in a volume of 10 ml/kg BW. All animals survived to the scheduled sacrifice on day 12. No adverse clinical effects of 7-ODA were observed at the 250 or 500 mg/kg dos es. Females vomited on non-treatment days and all animals vomited on some d ays after being given the 1000 mg/kg dose. Excessive salivation was observe d before or immediately after dosing on days 9 through 11, Appearance, beha vior and body weights were not altered by the treatments. Visual examinatio n of all body cavities, and macroscopic and microscopic examination of 42 d ifferent organs and tissues found no lesions or abnormalities. (C) 1999 Aca demic Press.