Chemical Characterization and In Vivo Safety Assessment of Aqueous Extract From Anacardium occidentale L. (Anacardiaceae) Leaves.

Anacardium occidentale L. leaves are used in traditional medicine for allergies, pain, and diabetes, for example; however, the safety and composition of aqueous preparations remain insufficiently characterized. This study aimed to evaluate the phytochemical profile, acute toxicity, and genotoxicity of an aqueous extract from leaves of this plant (AoLE). AoLE contained total phenolic content of 266.1 mg pyrogallol equivalents/g dry weight (DW), total tannin content of 32.2 mg tannic acid equivalents/g DW, 14.58 mg/mL proteins, and lectin activity. HPLC analysis revealed gallic acid and rutin presence. LC-ESI-MS identified 13 flavonoids, 6 phenolic acids, and 4 gallotannin derivatives. For toxicological evaluation, mice received a single oral dose of 2000 mg/kg. No mortality, behavioral alterations, or changes in body weight, food/water intake, hematological parameters, or biochemical markers were observed over 14 days. Organ weights and histology of the liver, kidneys, and spleen remained normal, indicating an LD50 > 2000 mg/kg. Genotoxicity assays showed no increase in micronucleate cells or DNA damage in the comet assay. The presence of polyphenols, tannins, flavonoids, and lectins, together with no evidence of acute toxicity under the tested conditions, supports the development of AoLE as a standardized phytopharmaceutical. Future studies should investigate chronic toxicity and long-term stability to advance preclinical and clinical applications.