An acute oral gavage study of 3beta-acetoxyandrost- 5-ene-7,17-dione (7-oxo-DHEA-acetate) in rats

The present study was done to assess the tolerance of rats for 3-acetoxyandrost-5-ene-7,17-dione (7-oxo-DHEA-acetate, 7-ODA) when administered as a single oral gavage dose. Five groups of Sprague-Dawley rats (Crl:CD (SD) BR VAF/Plus) (five/sex/group) were treated with 7-ODA at a dose level of 0 (control), 250, 500, 1000, or 2,000 mg/kg of body weight in a dose volume of 10 ml/kg. Food and water were provided ad libitum. All animals survived in good health to the scheduled sacrifice on Day 15. The single oral administration of 7-ODA had no apparent effects on body weight. Food consumption was significantly higher for all female treated groups during week two; however, the statistically significant differences were not considered to be of clinical consequence. Treatment caused no apparent changes of gross or microscopic anatomical structures of nine different organs. This study demonstrated that the no-observable adverse effect level for a single oral dose of 7-ODA in male and female rats was 2,000 mg/kg.