Multigeneration reproduction study of policosanol in rats.

The hypocholesterolaemic drug policosanol was administered to Sprague-Dawley rats of both sexes throughout three successive generations at concentrations of 0, 5, 50 and 500 mg/kg bw/day by gavage. For each generation two litters were reared until they were at least 3 weeks old. No clinical signs which could be related to the administration of the test substance were observed in the F0, F1b and F2b parents. There were no differences among groups in the number of animals that conceived, the number of pups born live or dead, the rate of male to female pups, the number of pups that survived until weaning and the pups' body weights through the lactancy. The following test showed no treatment-related effects on F3b offspring: righting on a surface, air righting, corneal, pirmal and pain reflexes, auditory startle and visual placing. The results of the present study did not demonstrate any deleterious effects on the fertility, reproductive performance or development of rats administered policosanol at levels of up to 500 mg/kg bw/day over three successive generations.