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Abstract

ACUTE AND 28 DAY REPEATED ORAL TOXICITY STUDY OF SATHAKUPPAI CHOORANAM- A SIDDHA POLY HERBAL FORMULATION IN WISTAR ALBINO RATS

A. Vasanth Milton Raj*, S. Vanathi, N. J. Muthukumar and V. Banumathy

ABSTRACT

Sathakuppai chooranam(SC) is the poly herbal formulation mentioned in ancient Siddha literature, Agathiyar attavanai vagadam. To evaluate it safety, acute and 28-day repeated oral toxicity studies were performed following OECD test guidelines 423 and 407, respectively. In acute study, SC was administered orally at 5, 50, 300, and 2000 mg/kg body weight. Animals were observed for toxic signs for 14 days. Gross pathology was performed at the end of the study. In 28 day repeated dose toxicity study, SC was administered at 200 and 400 mg/kg body weight daily, for 28 days. Animals were observed for mortality, behavioral changes, body weight, feed and water intake, hematology, biochemical parameters, gross pathology, relative organ weight and histopathological examination were performed. In acute toxicity study, no treatment related death or toxic signs were observed. It revealed that the LD50 cut-off value of SC is greater than 2000 mg/kg body weight. The 28 day repeated dose study did not show evidence of any treatment related changes in all observations up to the high dose level. There is no significant differences in organ weight, haematological and biochemical parameters of treated animals when compared with the control. Histopathological examination revealed no abnormalities. It revealed that the NOAEL > 400mg/kg/day in Wistar albino rats.

Keywords: Siddha medicine, Sathakuppai chooranam, Poly herbal, Acute toxicity study.


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