ACUTE AND SUB-ACUTE ORAL TOXICITY ASSESSMENT OF THE POLYHERBAL FORMULATION IN ALBINO WISTER RATS

Objective: Polyherbal formulation (PHF) is prepared from five herbs; these herbs are well-known and widely used in the traditional system of medicine for the treatment of diabetes and various diseases. Individually, each herb is completely safe, but the combined effects of these herbs are not known. Thus, the main objective of the present study was to assess the toxicological profile of PHF by acute and sub-acute oral toxicity in rats.Methods: The acute and sub-acute oral toxicity study was carried out as per OECD guidelines 423 and 407 respectively. In the acute toxicity study female albino Wistar rats administered single oral dose (2000 mg/kg) of PHF, while in sub-acute toxicity study male and female albino Wistar rats administered daily oral doses (100, 200 and 400 mg/kg) of PHF for 28 d. At the end of the study, the animals were humanely sacrificed and assessed for the effect of PHF on body weight and relative organ weights and hematological, biochemical and histopathological parameters.Results: In the acute toxicity study no mortality or behavioral changes were observed in rats treated with a single dose of PHF (2000 mg/kg) indicating that the LD50 is higher than 2000 mg/kg. In the sub-acute toxicity study, PHF was administered at three dose levels (100, 200 and 400 mg/kg), showed no significant changes in body weight and relative organ weights and hematological, biochemical and histopathological parameters.Conclusion: These results exhibit the absence of acute and sub-acute oral toxicity after treatment of PHF in rats. However, further studies in animals and in humans are needed in order to have sufficient safety evidence for its use in humans.Keywords: Polyherbal formulation, Acute and sub-acute toxicity, Hematology, Biochemistry, Histopatholog