Acute and Repeated Dose (28 Day) Oral Toxicity Study of a Polyherbal Drug (Smartlean®) In Wistar Rats.

Ullal, Sheetal D and *, Ramya and *, Gopalakrishna HN and Acaharya, Sahana D and Belagali, Yogesh and Menezes, Vishma Hydie and Rai, Amrita (2015) Acute and Repeated Dose (28 Day) Oral Toxicity Study of a Polyherbal Drug (Smartlean®) In Wistar Rats. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 6 (6). pp. 879-883. ISSN 0975-8585

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Abstract

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.

Item Type: Article
Uncontrolled Keywords: Smartlean®, Acute oral toxicity study, Repeated dose 28-day oral toxicity study, wistar rats
Subjects: Medicine > KMC Mangalore > Pharmacology
Depositing User: KMCMLR User
Date Deposited: 06 Jan 2016 12:11
Last Modified: 06 Jan 2016 12:11
URI: http://eprints.manipal.edu/id/eprint/145001

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