Single oral toxicity assessment and phytochemical analysis of the Ficus erecta Thunb. Leaves extract

Ficus erecta Thunb. is a traditional medicinal plant used to treat various diseases in Asian countries. We recently reported the potential of the ethanol extract of F. erecta Thunb. leaves (EEFE) as a source of functional foods for cognitive improvement. However, there is insufficient scientific evidence supporting the safety of EEFE. In this study, we performed an acute oral toxicity test using Sprague–Dawley rats following Good Laboratory Practice regulations to assess the possible toxicity of EEFE. After single oral administration of EEFE at a maximum dose of 5000 mg/kg, the mortality, clinical signs, body weight changes, and gross findings were monitored for 2 weeks. No mortality was observed, and EEFE had no adverse effects on body weight or gross findings in all EEFE-administered rats. On the first day after administration, EEFE-colored stool was observed in both male and female groups. However, these symptoms were considered to be transient, caused by the color of the test substance. Overall, the approximate lethal dose of EEFE was determined to be over 5000 mg/kg in the acute toxicity test. Additionally, we established and validated a high-performance liquid chromatography-diode array detector-based analytical method for the quality control of EEFE using rutin as a marker compound. The method showed excellent linearity, accuracy, repeatability, and precision. The findings of this study could serve as fundamental data for ensuring the safety and standardization of EEFE.