Acute and repeated dose oral toxicity study of AYUSH SG-5 in Sprague Dawley rats

Background: AYUSH SG-5 is a coded polyherbal formulation developed by the Central Council for Research in Ayurvedic Sciences for the treatment of arthritis. The safety evaluation of the test drug has not been established yet. Aim: The aim of this study was to evaluate the acute and repeated dose toxicity by following the Organization for Economic Cooperation and Development (OECD) 423 and 408 guidelines. Materials and Methods: Acute oral toxicity was performed in Sprague Dawley rats with a limit test dose of 2000 mg/kg as per OECD guideline No. 423 and changes in feed intake, body weight, and clinical signs were recorded for a duration of 14 days. The animals were sacrificed post treatment period and subjected to gross necropsy. Similarly, the 90-day repeated dose oral toxicity study was carried out with three different test doses. Clinical signs, weekly body weight, and feed intake were recorded. Post 90-day period, blood was withdrawn from the retro-orbital plexus and subjected to biochemical and hematological investigations. Urine analysis was carried out. Animals were subjected to necropsy and organs were excised and processed for histopathological examination. Results: Treatment with AYUSH SG-5 did not show any change in clinical signs, body weight, and feed intake in both the studies. Gross morphology and necropsy findings were found to be normal. Urine analysis and hematological and biochemical parameters were not significantly affected with AYUSH SG-5 treatment. Further, the histopathological analysis of major organs showed no major lesions and treatment-related changes. Conclusions: The findings of the current study established the approximate LD 50 of AYUSH SG-5 is >2000 mg/kg and no observed adverse effect level up to 1500 mg/kg.