Vol. 7, Issue 2, Part A (2025)

This study investigates the acute oral toxicity of a polyherbal formulation with immunomodulatory properties in female Wistar Albino rats. The formulation, comprising Asparagus racemosus, Withania somnifera, Andrographis paniculata, Ocimum sanctum, and Piper nigrum, was prepared using a decoction method. The polyherbal formulation was prepared by the decoction method of extraction with the excipients to extend the shelf life. The acute toxicity study, conducted following OECD guidelines, involved administering single doses (0 mg/kg, 300 mg/kg, and 2000 mg/kg) and observing the rats for 14 days. The findings showed the polyherbal formulation, at a dose of 2000 mg/kg, exhibited no signs of toxicity or mortality. Body weight, behavioral patterns, and hematological parameters remained unaffected. Gross pathological examination revealed no internal organ lesions. The LD₅₀ was determined to be over 2000 mg/kg, classifying it as GHS category 5. The polyherbal formulation, consisting of Asparagus racemosus, Withania somnifera, Andrographis paniculata, Ocimum sanctum and Piper nigrum, was found to be safe at the maximum tested dose of 2000 mg/kg in acute oral toxicity study, demonstrating its potential for further exploration as an immunomodulatory agent.