“…To start the regulatory requirements, the genotoxic and mutagenic evaluation of an extract obtained from Caesalpinia spinosa called P2Et was performed. The Micronucleus assay is used for evaluation of the potential mutagenic activity of new substances in order to classify them by mutagenic hazard, besides is highly efficient as an indicator of induced chromosomal lesions for the substances tested [ 35 ], additionally the evaluation of mixtures like the ones found in extracts, it has to be tested because is clear that mixtures can induce genotoxic effects even if each of the compounds separately does not manifest such activity in testing. Therefore, it is necessary to evaluate the genotoxicity of herbal drugs to ensure the safety of patients who take these products [ 36 ].…”