Assessment of Acute and 28-Day Sub-Acute Oral Toxicity of a Polyherbal Formulation in Rats

Abstract

Purpose: Most of these studies are conducted to assess the degree to which substances are toxic (poisonous) for humans, animals or the environment, to investigate the mechanism of toxic chemicals, or to develop new or improved tests for specific types of chemically induced effects. The present study was designed to evaluate the acute and 28 days repeated oral toxicity study of Polyherbal formulation according to OECD guidelines. Materials and Methods: In acute oral toxicity study, Herbal mixture was administered at 2000mg/kg orally and animals were observed for toxic signs at 30 min, 1, 2 and 4 hrs and thereafter once a day for the next 14 days. In repeated dose-28-day oral toxicity study, the animals were divided into four groups of 6 animals each. Group-1 animals served as a control. Group II animals received low dose of herbal mixture 50 mg/kg, Group III animals received middle dose 100 mg/kg and Group IV animals received high dose of 200 mg/kg (orally) once daily for 28 days respectively. Results: The assessment study results showed that neither the acute toxicity study of herbal mixture at the dose level of 2000mg/kg nor the 28 days repeated oral toxicity study produced any toxic signs or mortality during study. In 28 days repeated oral toxicity study, no significant changes were observed in the haematological and biochemical parameters, relative organ weight, gross necropsy and histopathological examination with herbal mixture treatment. Conclusion: The results of the present study suggest that LD50 of newly developed Polyherbal formulation was >2000 mg /kg and the mixture is completely safe and non-toxic for therapy.