Mutagenic, Genotoxic and Sub Chronic Oral Safety Analysis of Boswellia Serrata Extract (Boswellin® Super)

Though there are several studies on efficacy of Boswellia serrata on various indications, safety studies of the extract are very few or inadequate.Also, Boswellia serrata extract is usually intended for long term use so potential cytotoxic, genotoxic or mutagenic activity testing of the extract is important.Further, mutagenicity tests help to reduce the genetic or carcinogenetic hazards to humans as several studies showed the connection between mutagenicity and carcinogenicity 13 .In the present study, we have conducted the in vivo acute toxicity study, 90 days sub chronic study, Mammalian Bone Marrow Chromosome Aberration Test and Mammalian Bone Marrow ABSTRACT Boswellia serrata is a branching tree found abundantly in India, Boswellic acids extracted from resin of plant is used in inflammatory conditions, arthritis and hyperlipidaemia.However, any supplement used for long term use needs to be tested for potential mutagenicity and toxicity.Thus, we assessed the mutagenicity of Boswellia serrata extract by Mammalian Bone Marrow Chromosome Aberration Test and Mammalian Bone Marrow Micronucleus Test and in vitro Bacterial Reverse Mutation Test.Further we assessed in vivo toxicity by acute toxicity study and 90 days sub chronic toxicity study of Boswellia serrata extract.None of the mutagenic assays showed any increase in mutagenicity above background.Also, the acute oral toxicity and sub chronic toxicity study revealed that Boswellia serrata extract was not lethal to animals up to 2000mg/kg/day when observed for 14 days and 600mg/kg/day when observed for 90 days.Therefore, these data provide evidence that the Boswellia tested have no cytotoxic potency and are not mutagenic.Thus, our findings contribute to the risk assessment of preparations containing Boswellia serrata extract.