Mutagenicity assessment of by bacterial reverse mutation assay using histidine dependent tester strains.

BACKGROUND AND OBJECTIVE

Genotoxicity analysis is one of the most important non-clinical environmental safety investigations required for pharmaceutical and agrochemical product registration. Any medicinal product must undergo a risk evaluation to determine its mutagenicity and carcinogenicity.

MATERIALS AND METHODS

The Ames test is a commonly used test for determining a test chemical's mutagenic activity. Histidine-dependent strains with a defective gene that causes the bacteria to synthesis the necessary amino acid histidine for life were tested for mutagenic potential. In order to reveal pro-mutagens and mutagens, the mutagenic potential of both plate integration and pre-incubation techniques was examined in the presence and absence of metabolizing system. has been widely used in ayurveda to treat various ailments. However, the information of mutagenicity of is scarce as per available literature.

RESULTS

The mutagenicity of a root extract was investigated utilizing the Ames assay with plate incorporation and pre-incubation protocols using the appropriate tester strains: TA98, TA100, TA1537, TA1535, and TA102 in the presence and absence of S9. The concentrations used were 0.3123, 0.625, 1.25, 2.5 and 5 mg/plate. The extract of root did not show any mutagenic effect in any of the strains at the concentrations tested in the absence or presence of metabolic activation.

CONCLUSION

The root of was hence confirmed to be non-mutagenic and at least according to the results of this genotoxicity evaluation can be regarded as being safe for human use.