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

D. Ullal Sheetal, Ramya, H. N. Gopalakrishna, Sahana D. Acharya, Belagali Yogesh, Menezes Vishma, Rai Amrita

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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 29th 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.

Original languageEnglish
Pages (from-to)879-883
Number of pages5
JournalResearch Journal of Pharmaceutical, Biological and Chemical Sciences
Issue number6
Publication statusPublished - 01-01-2015


All Science Journal Classification (ASJC) codes

  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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