An acute oral gavage study of 3 beta-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-acetoxyand rost-5-ene-7,17-dione (7-oxo-DHEA-acetate,7-ODA) when administered as a sin gle oral gavage dose. Five groups of Sprague-Dawley rats (Crl:CD (SD) BR VA F/Plus) (five/sex/group) were treated with 7-ODA at a dose level of 0 (cont rol), 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 goo d health to the scheduled sacrifice on Day 15. The single oral administrati on of 7-ODA had no apparent effects on body weight. Food consumption was si gnificantly higher for all female treated groups during week two; however, the statistically significant differences were not considered to be of clin ical consequence. Treatment caused no apparent changes of gross or microsco pic anatomical structures of nine different organs. This study demonstrated that the no-observable adverse effect level for a single oral dose of 7-OD A in male and female rats was 2,000 mg/kg. (C) 1999 Academic Press.