Abstract

Punarnava Mandur is an iron containing classical Ayurvedic formulation which was studied for repeated dose oral toxicity study in Wistar rats for 90 days. Total 48 Wistar rats (24 male and 24 female) were selected based on the body weight and were randomly distributed into four groups followed by administration of Punarnava Mandur at the dose of 0, 90, 450, 900 mg/kg body weight for 90 consecutive days. Body weight, Weekly Feed and Water consumption, Clinical Chemistry, Hematology, Differential leukocyte Count, Reticulocyte count and Organ weights were recorded and analyzed statistically. At termination, rats were sacrificed, examined for gross pathological changes, organs were collected, weighed and processed for histopathological evaluation. There was no effect on body weights and feed consumption, no abnormal findings in the histopathological evaluation of high dose group animals but there was significant increase in weight of liver in females of high dose group as compared to control. Hence, the dose level 450 mg/kg of Punarnava Mandur was found as NOAEL (No Observable Adverse Effect Level). However, the NOEL (No Observed Effect Level) could not be established. It was suggested to carry out a toxicity study at possible higher doses so as to establish target organ of toxicity.

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