In the safety evaluation of a test substance, determination of acute oral toxicity is generally the initial step and provides information on health hazards that may arise from an acute exposure by the oral route. It may also provide early information on the mode of toxic action of a substance. The study was aimed to assess the possible toxic effects and to identify the preliminary safety profile of Trasina®, a polyherbal capsule (M/S Deys Medical Stores Manufacturing Limited, Kolkata, West Bengal, India) after single oral administration in mice according to the OECD guidelines. In the present study, a single administration of the poly herbal extract at a dose of 2000 mg/kg, respectively, was given to the swiss albino mice. During the study period the mice were observed for general appearance, behavior, body weight, adverse effects, mortality and necropsy up to 14 days post-treatment. No toxicological changes or mortalities related to the test substance were also observed after the administration in experimental animals. No changes in general appearance and mortality was observed. Trasina was found to be safe at dose of 2000 mg/kg. In the conclusion these results demonstrate that the extract may not have any single dose toxicity.

Keywords: Acute Toxicity; Trasina; Ayurvedic Formulation; OECD Guidelines; Necropsy;