Acute and Subchronic Toxicity Study of the Ethanol Extracts from Ficus deltoidea Leaves in Male Mice

BACKGROUND: Ficus deltoidea Jack. leaves have a great potential as traditional medicine, but the safety level of its use is still unknown. AIM: This study aimed to determine the phytochemical contents of the ethanol extract of F. deltoidea leaves and evaluate the level of safety and toxicity through acute and subchronic toxicity tests in mice (Mus musculus). METHODS: The ethanol extract of F. deltoidea leaves was determined for phytochemical contents such as alkaloids, phenolics, flavonoids, coumarin, steroids, saponins, carotenoids, and tannins. In the acute toxicity test, 10 male mice were divided into a control group and the extract treatment group with 2000 mg/kg body weight (BW) dose for 14 days to identify signs of toxicity and mortality. Meanwhile, in the subchronic toxicity test, 25 male mice were divided into control and four treatment groups with various doses (125, 250, 500, and 1000 mg/kg BW), respectively, for 28 days. The toxicological effect was evaluated by observing behavior, signs of toxicity, and changes in BW. At the end of the treatment, hematological and biochemical evaluations were also measured. RESULTS: The results showed that the ethanol extract of F. deltoidea Jack leaves qualitatively contains alkaloids, phenolic, flavonoids, coumarin, and steroids, whereas quantitatively total phenolics, flavonoids, and IC50 were 107.6583211 μg GA/mg, 175.9103641 μg CE/mg, and 103.7484 μg/mL. Moreover, 2000 mg/kg BW dose resulted in no symptoms of toxicity and mortality, indicating that the 50% lethal dose (LD50) was above 2000 mg/kg BW. Meanwhile, there were no behavioral changes, significant differences in weight changes, hematological parameters, and serum biochemistry of mice in subchronic toxicity tests. CONCLUSION: The present study shows that acute and subchronic oral administration of the ethanol extract of F. deltoidea leaves for male mice does not induce clinical symptoms of toxicity or mortality. The LD50 of the ethanol extract of F. deltoidea leaves for mice >2000 mg/kg is considered as practically non-toxic