title: Evaluation of the mutagenic potential and acute oral toxicity of standardized extract of Ocimum sanctum (OciBest™).
abstract: Ocimum sanctum L. (Lamiaceae) is found throughout India and in many parts of world. O. sanctum is used for the treatment of various health indications. In this lieu, it is of prime importance to investigate the safety aspects of the plant. Hence, the present study was conducted to investigate the possible genotoxic potential and acute oral toxicity of the extract of O. sanctum (OciBest™). The standard battery of in vitro genotoxicity tests, namely bacterial reverse mutation, chromosome aberration and micronucleus (MN) tests were employed to assess the possible mutagenic activity. The results showed that OciBest™ (7.9-2500.0 µg/mL) did not increase the number of histidine revertant colonies in Salmonella typhimurium strains (TA98 and TAMix) with and without exogenous metabolic activation (S9). OciBest™ (10.0-100.0 µg/mL) did not show structural chromosomal aberrations or increase in MN induction, with and without S9, at the tested dose range in both 4-h and 18-h exposure cell cultures. Thus, OciBest™ is not genotoxic in bacterial reverse mutation, chromosomal aberration and MN tests. In an acute oral toxicity test, rats were treated with 5 g/kg of OciBest™ and observed for signs of toxicity for 14 days and the results did not show any treatment-related toxic effects to Wistar rats.
authors: R&D centre, Natural Remedies Pvt Ltd, Bangalore, Karnataka, India. cvc@naturalremedy.com
authors: C V
authors: CV
authors: Chandrasekaran
authors: H S
authors: HS
authors: Srikanth
authors: M S
authors: MS
authors: Anand
authors: J Joshua
authors: JJ
authors: Allan
authors: M M Hipolith
authors: MM
authors: Viji
authors: A
authors: A
authors: Amit
mesh_terms: D000818:Animals; D016466:CHO Cells; D002460:Cell Line; D002869:Chromosome Aberrations / Q000139:chemically induced; D003412:Cricetulus; D004305:Dose-Response Relationship, Drug; D005260:Female; D008515:Medicine, Ayurvedic; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D009152:Mutagenicity Tests / Q000379:methods; D031339:Ocimum / Q000737:chemistry*; D010936:Plant Extracts / Q000302:isolation & purification / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D023382:Toxicity Tests, Acute / Q000379:methods
chemical_list: D010936:Plant Extracts
keywords: OciBest™; Ocimum sanctum; acute oral toxicity; bacterial reverse mutation test; chromosomal aberrations; micronucleus