Background: Majoon hajrul yahood is a polyherbomineral formulation commonly used in the Unani system of medicine for the management of urolithiasis. In this study safety of a hydroalcoholic extract of majoon hajrul yahood was evaluate in Wistar rats. Materials and Methods: The hydroalcoholic extract of the formulation were tested for acute and sub-acute toxicity study. The single-dose (300, 2000, and 5000 mg/kg) of the extract was administered orally to female rats. In the subacute study, the extract was given at doses of 1/5, 1/10, and 1/15 mg/kg (1000, 500, and 333.33 mg/kg) of maximum dose (5000 mg/kg) of acute toxicity study during 28 days orally. Mortality, changes in body weight and food consumption, organ weights, biochemical, hematological, and histopathology of the organs were performed. Results: In the acute study, the extract was classified as safe, according to the OECD guide in category 5. In the present study, results revealed that subacute treatment with test extract, there is no changes in biochemical, hematological, and histological changes in the tissues. Conclusion: The no-observed-adverse-effect level (NOAEL) was found 5000 mg/kg/day in this study for both the sexes. The hydroalcoholic extract of the majoon hajrul yahood did not show any signs of toxicity or changes in hematological, biochemical, and histological parameters in rats when different doses were administered for 28 days.
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