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Dr. Rathinam J.*, Dr. Murugavel R., Dr. Anbarasan B., Dr. Kingsley J. and Dr. M. Murugesan


Evaluation of toxicity is important before starting clinical trial of any drug. Need for traditional medicines have been increasing in the recent past, so it is necessary to ensure that the medicine prescribed are safe. Aim of the study is to evaluate the safety profile of Dhadhu Virthi Kuligai (DVK) through Acute Oral Toxicity study, 28-Day Repeated Dose Oral Toxicity Study and 90-Day Repeated dose oral toxicity as per OECD guidelines. In Acute study, Animals were divided into groups. Three Female animals are used for each group. The dose level of 5, 50, 300 and 2000 mg/kg body weight was administered stepwise. Animals were observed for toxic signs for 14 days and gross pathology was performed at the end of the study. In repeated dose toxicity study, the animals were divided into four groups. The first group was treated as control (milk) and second, third, fourth groups were treated with Low dose 11.7mg/kg/ b. wt, Mid dose 58.5mg/kg/b. wt, High dose 117mg/ kg/ b. wt of DVK. 80 Wistar Albino Rats (40M + 40F) were selected and divided into 4 groups. First group treated as a control (milk) and other three group were treated with test drug (Low dose 11.7 mg/kg/ b. wt, Mid dose 58.5 mg/kg/ b.wt and High dose 117mg/kg/ b. wt) for 90 days. In acute oral toxicity study, no treatment related death or toxic signs were observed. 28-day repeated dose study and 90 day repeated dose oral toxicity, did not show evidence of any significant treatment related changes in all observations from low dose to the high dose level, when compared with the control. Histopathological examination also revealed that no abnormalities. This study ensures that the drug is safe.

Keywords: Dhadhu Virthi Kuligai, Toxicity, OECD guidelines.

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