Acute and sub-chronic toxicity study of traditional Indian medicine Manahshila (realgar)

Abstract

Objective: In the present scenario, interest and concerns are projected about arsenic and other heavy metal-containing formulations for their safety aspects. Although arsenical Ayurvedic formulations were used safely, on the other hand, it is not used as a single compound in the clinical practices that is why there is an importance to produce research-based confirmation that these compounds are safe. Manahshila (realgar) is one of the arsenical compounds which is widely used in preparation and practice of Ayurvedic medicine. The aim of the present study was to assess the safety profile of crude realgar (CR) and purified realgar (PR) in rats. Methods: The CR and PR were given to overnight starved animals at sorted doses by following the ‘Up and Down method’ with 2 g/kg for acute toxicity. In the sub-chronic toxicity, the CR and PR were given at the doses of 0.7, 3.5 and 7 mg/kg to rats for 28 days. Rats were slaughter after anaesthetized with an overdose of carbon dioxide on 29th day. The effects of both drugs were evaluated on body weight changes, food–water intake, changes in biochemical, haematological and histopathological parameters. Results: The PR-treated rats did not show any differences in gross behaviour up to 14 days, while CR-treated rats showed signs of toxicity like sedentary, trembling, piloerection, fore-limbs and body stretching through 14 days at the dose level of 2 g/kg. In the sub-chronic study, changes in weight, food–water intake, biochemical and cytoarchitecture in organs of CR and tenfold of a therapeutic dose of PR-treated rats were found. Conclusion: The obtained results showed that PR is safe at its effective dose for clinical practice. © 2020, Korean Society of Environmental Risk Assessment and Health Science.