Safety of AYUSH OSTO in experimental animals

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Background: AYUSH OSTO is a coded formulation developed by the Central Council for Research in Ayurvedic Sciences for the treatment of bone-related disorders. Aim: The present study focused on evaluating the safety of AYUSH OSTO through acute, 28-day sub-acute, and 90-day sub-chronic repeated dose toxicity studies. Materials and Methods: Acute oral toxicity was tested with doses of 260, 1300, and 2600 mg/kg, and sub-acute, sub-chronic studies were performed with doses of 180, 900, and 1800 mg/kg. During the acute toxicity, the evaluation test compound was administered once orally, whereas in the sub-acute toxicity and sub-chronic studies, the test compound was administered daily for 28 days and 90 days, respectively. Clinical signs of toxicity and mortality were observed in all three studies. Feed intake, changes in body weight, hematological, clinical biochemistry, urine analysis, gross necropsy, and histopathological analysis were performed in sub-acute, sub-chronic studies. Results: There was no mortality, and no clinical signs of toxicity were observed in all three toxicity studies. The weekly feed intake and body weight changes were found to be nonsignificant when compared to the control. The clinical chemistry and hematological profiles of the animals were not altered with the treatment. The histopathological analysis of vital organs at the tested dose levels did not show any organ damage. Conclusions: The findings of the acute toxicity study established the approximate LD50 of >2600 mg/kg and the repeated dose toxicity studies established the no-observed-adverse-effect level of AYUSH OSTO is up to 1800 mg/kg.