Acute and repeated dose (28 day) oral toxicity study of a polyherbal drug (smartlean^®) in wistar rats

The study was conductedto evaluate the acute and repeated dose 28-day oral toxicity study of Smartlean^®. According to OECD Test No. 420 guideline the acute oral toxicity study was conducted in four groups of five animals each. Control group received 2% gum acacia 10ml/kg; second, third & fourth groups received one dose each of 54, 540 & 1080mg/kg smartlean^®. The animals were observed for clinical signs of toxicity and/or mortality at 10-15min, 30-40min, 1, 2, 4 and 6hours on day one and thereafter once daily for 14 days. Four groups of animals with ten animals each were used for repeated dose 28-day oral toxicity study. The groups received 2% gum acacia 10ml/kg, 54, 540 & 1080mg/kg of smartlean^®respectively,daily for 28 days. On 29^th day blood was sent for biochemical, haematological investigation and histopathological examination of organs was done.None of the animals revealed any clinical signs of toxicity/mortality nor biochemical, haematopoetic or histopathological abnormalities in both acute and repeated dose 28-day oral toxicity study.The test item smartlean^® is non-toxic up to and at 1080 mg/kg body weight which is 20 times higher than the recommended dose, in acute and repeated dose 28-day oral toxicity study.