<i>In vitro</i> and <i>in vivo</i> genotoxicity assessments of <i>Ficus erecta</i> Thunb. leaves extract support its functional and pharmaceutical potential

<i>Ficus erecta</i> Thunb. has been used to treat various inflammatory diseases owing to its anti-inflammatory and antioxidative properties. However, scientific evidence on the safety of <i>F. erecta</i> extract is limited. We evaluated the genotoxicity of ethanol extract of <i>F. erecta</i> (EEFE) using multiple tests. The bacterial reverse mutation (Ames) test showed that EEFE treatment of five bacterial strains (<i>Salmonella typhimurium</i> TA98, TA100, TA1535, TA1537, and <i>Escherichia coli</i> WP2<i>uvrA</i>) did not affect the number of revertant colonies in the absence or presence of S9 mix, a metabolic activator, up to a concentration of 312.5 µg/plate. The number of chromosomal aberrations associated with EEFE was similar to that in the negative controls, with no significant increase up to a concentration of 31.3 µg/mL EEFE. The chromosomal aberration assay showed that EEFE was not associated with any abnormalities in combination with or without S9 mix. The <i>in vivo</i> micronucleus test revealed that EEFE did not influence the frequency of bone marrow micronuclei up to 2000 mg/kg body weight of male ICR mice. Moreover, no changes in mouse body weight or mortality rates were observed. Our study demonstrates the safety of EEFE in genotoxicity tests, providing proof-of-concept for its use as a medicine and functional food.