Acorus calamus is widely used in traditional medicine in various ailments. However, there is no toxicological information available regarding its safety after exposure. The present study was designed to evaluate potential toxicity of an ethanolic extract of Acorus calamus Linn. rhizomes after acute and chronic administration in Wistar rats. In the acute toxicity study, female Wistar rats were treated with ethanolic extract by oral gavage at dose levels of 175, 550, 1750 and 5000 mg/kg body weight according to OECD 425. Animals were observed periodically during the first 24 h after administration of the extract, and daily thereafter for 14 days. In the chronic toxicity study, the ethanolic extract of Acorus calamus was administered orally at doses of 0, 200, 400 and 600 mg/kg body weight daily for 90 days in Wistar rats. The effects on clinical signs, body weight, food consumption, organ weight, haematology, clinical biochemistry, as well as histology, were studied. No mortality was observed, but clinical signs like abdominal breathing, piloerection and tremors were observed for 30 min in rats dosed with 1750 mg and 5000 mg/kg body weight of extract. No statistical significant data in body weight and feed consumption were observed. Haematological and biochemical analysis showed no marked differences in any of the parameters. Pathologically, neither gross abnormalities nor histopathological changes were observed. The ethanolic extract of A. calamus does not appear to have toxicity on acute and chronic administration in Wistar rats.
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