Evaluation of Acute and Sub-chronic toxicities of a Nigeria polyherbal formulation

Abstract

This study was carried out to evaluate safety profile of a commercial polyherbal product Washing and setting that is highly consumed in South-Eastern Nigeria. Qualitative phytochemical analysis was conducted. Acute toxicity test on selected doses of the polyherbal formulation was carried out in mice and rats. In sub-chronic toxicity study, animals were exposed to the polyherbal product daily for 90 days at 1, 5 and 10 ml/kg. Five rats from each dose level were selected on the 31st, 61st and 91st days for the determination of biochemical and haematological indices. Histology of the liver and kidney were also carried out. A 28 days post-treatment study was conducted to determine reversibility in toxicological changes. From results of the study, alkaloids were observed to be the most abundant phytocompound in the polyherbal formulation. No sign of acute toxicity was observed. No mortality was observed in the treated groups throughout the 90 days study. At the tested doses, there was significant (p<0.05) increase in both alanine aminotransferase and aspartate aminotransferase and blood urea nitrogen at the 91st day at 10 ml/kg group compared with the vehicle treated group. Significant (p<0.05) elevations were observed in serum creatinine on the 61st day at the highest dose (10 ml/kg) and on the 91st day for 5 and 10 ml/kg compared to vehicle-treated control group. All toxicological effects were reversible on withdrawal of administration in post treatment studies. The polyherbal formulation may be nephrotoxic and hepatotoxic especially at high doses on long term exposure.