Evaluation of acute and sub-chronic oral toxicity study of Baker Cleansers Bitters - a polyherbal drug on experimental rats

Abstract

Baker Cleanser Bitters (BCB) - a polyherbal formula commonly used in the treatment of diabetes, liver cirrhosis, kidney failure, rheumatism and arthritis was evaluated in an acute and sub-chronic toxicity study in Wistar albino rats. A single administration of BCB was given orally at the highest dose level of 2000 mg/kg body weight in the acute toxicity study. Signs of toxicity were observed every hour for the first 6 h and every day for 7 days. In the subchronic oral toxicity study, BCB was administered to rats at doses of 50, 100 and 200 mg/kg body weight for 28 days. Mortalities, clinical signs, body weight changes, biochemical and haematological parameters were monitored during the study period. There were no mortalities or clinical signs observed in rats in the acute toxicity study. In the sub-chronic study in rats, daily oral administration of BCB at the dose of 200 mg/kg body weight resulted in a drop in percentage increase in body weight at the end of the 4th week. Alanine amino transferase (ALT), aspartate amino transferase (AST), fasting blood sugar and packed cell volume (PCV) decreased significantly (p≤0.05) whereas alkaline phosphatase (ALP), lactate dehydrogenase (LDH) and platelets increased significantly (p≤0.05) when compared to control. The high no-observed adverse effects level (NOAEL) value of 2000 mg/kg body weight implies that the drug could be safe. The study also revealed that the polyherbal drug may have good hypoglycemic effects and favourable reducing effects on the cardiovascular risk factors and explains the basis for the continual use of this plant by traditional medical practitioners.