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Abstract

Pirandai uppu (PU) a herbo mineral formulation has been employed as a traditional siddha remedy for diarrhea since long time. Diarrheal diseases remain one of a leading cause of morbidity and mortality in the world, particularly in developing countries. As a mandate, steps were taken to evaluate safety profile of PU in animal model under OECD guidelines. Acute toxicity studies done on female wistar albino rat under OECD guidelines 423 and 28 days repeated oral toxicity studies done on both sex of wistar albino rat under OECD guidelines 407. Acute oral toxicity study of PU revealed no mortality at the dosage of 2000 mg/kg body weight and the median lethal dosage of PU is estimated above 2000 mg/kg body weight. Repeated oral toxicity study of PU does not exhibit mortality at the high dosage of 200 mg/kg body weight given up to the period of 56 days including 28 days of drug administered. At the end of 28 days no specific changes are observed in hematological, hepatic, renal and other biochemical parameters. No gross morphological and histological changes are observed in the organs. The above studies recommend that PU is a safest drug under intended human adult dosage (500 mg) as illustrated in the literature.