Acute and 28-day subchronic oral toxicity study ofkadukkai maathirai, an iron based siddha herbal formulation in wistar albino rats

Background: Kadukkai maathirai(KM), an iron based polyherbal formulation widely used in India for the treatment of anaemia and liver disease by Siddha physicians. The toxicological profile of the drug was not reported. The present study was carried out to determine toxicity profile of KM by acute and subchronic oral toxicity studies in rats. Methods: Adult wistar albino rats of either sex weighing 150 - 200 g were used for the present study. In acute toxicity study, single oral dose of KM was administered and the animals were observed for 14 days. In 28-day sub chronic oral toxicity study, three doses (36, 180, 360mg/kg) of KM was administered orally for 28 days. Body weight, food intake and water intake were recorded at weekly interval. Hematological parameters like total RBC, total WBC count, WBC differential count and hemoglobin (Hb) were determined in whole blood. Biochemical parameters like, glucose, total protein, total bilirubin, total cholesterol, blood urea nitrogen (BUN), creatinine, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) were analyzed in serum. Histological changes were assessed in liver, kidney, lungs, heart, brain, ovary, testis and spleen. Results: There was no significant alteration in body weight, food intake, water intake, urine parameters, hematology parameters, liver function enzymes and kidney function parameters. Histopathological studies of stomach, heart and brain showed normal architecture. There were mild inflammatory changes seen in histology of spleen, liver, kidney and lung of KM treated groups. Conclusion: Kadukkai maathirai even at 10 times higher the therapeutic dose could be considered safe, thus having wide margin of safety.