Genotoxicity and mutagenicity assessment of a standardized extract (P2Et) obtained from Caesalpinia spinosa

[Display omitted] •The P2Et extract was assessed for genotoxicity and mutagenicity activity.•The P2Et extract showed no genotoxicity in Micronucleus assay.•The P2Et extract showed no mutagenicity in Ames test. The standardized P2Et extract obtained from Caesalpinia spinosa has shown antioxidant, and direct antitumor activity, but also activation of specific immune response through the induction of tumor immunogenic cell death in breast and melanoma cancer models. The present work evaluated the mutagenicity and genotoxicity profile of P2Et to continue the development of the P2Et. Genotoxicity was evaluated by OECD 1997 a guideline and mutagenicity by OECD 2016. At P2Et’s doses of 500, 1000, and 2000 mg/kg body weight in mice (Mus musculus), the difference between the number of micronuclei in PCE of the groups were not statistically significant (17 (negative control), 15 (500 mg/kg), 15 (1000 mg/kg), 19 (2000 mg/kg) and 271 (positive control). Similarly, P2Et did not induce gene mutations by base pair changes or frameshifts in the genome of Salmonella Typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 at the tested range of concentrations up to 5000 μg/plate in the absence and presence of metabolic activation. Therefore, the P2Et was considered as non- mutagenic and non-genotoxic at the conditions of the tests.