Acute and repeated dose oral toxicity study of Ayurvedic coded formulation Ayush SL

Abstract

The present investigation was conducted to evaluate the safety profile Ayush SL, a polyherbal Ayurvedic formulation indicated for the management of lymphatic filariasis (LF), through acute, 28-day, and 90-day toxicity studies. In the acute oral toxicity study, the test drug was administered at a single dose of 3250 mg/kg to Swiss albino mice. For the 28-day and 90-day repeated-dose studies, rats were administered Ayush SL at doses of 225, 1125, and 2250 mg/kg. No abnormal behavioural signs and mortality were observed in the mice that received 3250 mg/kg of the test drug during the acute toxicity study. Similarly, no pre-terminal death and no significant changes in hematological and biochemical parameters were observed in rats that received three doses for 28 & 90 days during sub-acute and sub-chronic toxicity studies. Histopathological examination of major organs also did not show any treatment-related pathological changes. These studies revealed that Ayush SL was safe at a dose of 3250 mg/kg in mice upon single-dose administration. In repeated dose studies, the drug was found to be safe up to 2250 mg/kg and no adverse effects were observed.