Study of the Acute Oral Toxicity, 28-Day Subchronic Toxicity, and Cytotoxicity of a Herbal Antiviral Recipe Used in the Treatment of Hepatitis B in Togo

This study was conducted to evaluate the safety of a hydroethanolic extract from a herbal recipe composed of Bridelia ferruginea bark, Sansevieria liberica roots, and the whole plant of Phyllanthus amarus, which is traditionally used in the treatment of hepatitis B in Togo. Acute and subchronic toxicity tests were conducted following OECD guidelines 423 and 407, respectively. For the acute toxicity study, a single dose of 5000 mg/kg body weight (bw) of the recipe extract was administered. For the subchronic toxicity study, doses of 500 and 1000 mg/kg bw were used. Cytotoxicity was evaluated using the MTS assay, and normal human colon epithelial cells (NCM 356) were used. In the acute toxicity study, the recipe extract caused no deaths or signs of toxicity. In the subchronic study, administration of 500 and 1000 mg/kg bw over 28 consecutive days in Wistar rats caused no mortality. No macroscopic lesions attributable to treatment were observed in either male or female rats. At a dose of 500 mg/kg bw, the extract significantly reduced the relative weight of the testes (p = 0.013) and liver (p < 0.001) in male rats. In female rats, a significant increase in creatinine was observed at 500 mg/kg (p = 0.0083), and alanine aminotransferase levels increased significantly at 1000 mg/kg bw (p = 0.002) compared to the control group. The extract showed no cytotoxicity in the MTS assay.