Exploring the safety parameters of ethanolic extract: a step towards harnessing its medicinal potential.

(Sendtn.) D'Arcy, a native plant of the Brazilian Atlantic Forest, has exhibited potential pharmacological effects due to the presence of withanolides with anti-cancer and anti-inflammatory activities. However, there is a lack of research on the safety and toxicity of this plant species. This study aimed to assess the safety of the ethanolic extract of leaves (Av-E) through toxicity and phytochemical analysis. Acute [1000 mg kg body weight (BW)] and subacute (250, 500, and 1000 mg kg BW) toxicity tests were conducted on female Wistar rats, along with an evaluation of the toxic reversal effect. HPLC-HRMS revealed the presence of withanolide steroids in Av-E. Reduced alanine aminotransferase (ALT), bilirubin levels, and increased calcium concentrations were observed after the acute toxicity test. Subacute toxicity demonstrated lowered ALT (250 and 1000 mg kg BW) and aspartate aminotransferase (AST) (250 and 500 mg kg BW) levels and increased sodium concentration (250 mg kg BW). No fatalities or clinical signs of toxicity occurred, and histological and biochemical analysis revealed no apparent liver or kidney toxicity. In conclusion, Av-E exhibited no toxicity in the experiments, encouraging further research to develop new herbal medicines.