Acute and Delayed Oral Toxicity Studies and Observations on Pregnancy, Gestation and Reproductive Performance of Wistar Rats Administered Limit Dose of Purified Extract from Stem Bark of Antidiabetic Anogeissus leiocarpus (African Birch Tree)

Abstract

Objectives: The maximum purification of the extracts of antidiabetic Anogeissus leiocarpus stem bark led to a quest for its lethal dose (LD50) and effects on pregnancy, gestation, pups (kitten) and reproductive performance of Wistar rats.
 Design: Extracts of A. leiocarpus were subjected to column and thin layer chromatography until final purification.
 Five (5) each of adult male and female rats were used for the study. The revised limit test dose of 2000mg/kg.bd.wt. was used to evaluate the acute oral toxicity and effects on reproductive characteristics of the purified extracts on Wistar rats. The rats were monitored for instant death and 24hours later, 3 each of male and female rats were humanely sacrificed. On day 0 and 24hours later biomarkers of liver damage, AST, ALT, and ALP and that of kidney, urea, were assayed. The remaining 4 rats (2 males and 2 females) were monitored for additional 14days and thereafter for any effect of the limit dose on reproductive activities.
 Results: The limit dose caused no death within the first 24hours and no hepato-renal damages. Pregnancy, gestation, parturition, pups (kitten) and reproductive performance were normal. The median lethal Dose (LD50) is > 2000mg/kg./bd.wt.
 Conclusion: Animal experimentation, using Wistar rats showed that purified extracts of A. leiocarpus stem bark as a non-conventional drug for diabetes mellitus, has no effects on pregnancy and reproductive performance. There was no teratogenic effect on pups. The compound has a wide range of safety value.
 Keywords: Oral Toxicity, Pregnancy, Gestation, Reproductive Performance, Wistar Rats, Anogeissus leiocarpus, Purified Extract