Introduction: TR-Y017 is a phytomedicine widely used in Benin and which has been claimed effective against anemia, hepatitis, allergies, urinary infections and cancer by the manufacturer. In order to establish the safety use of TR-Y017, this study aims to evaluate the effects of its acute and sub-acute oral administration to Wistar albino rats.
Methods: Acute oral toxicity tests were performed on Wistar rats by oral forcefeeding with a single dose of 2000 mg/kg in accordance with the Organization for Economic Co-operation and Development (OECD) Guidelines and animals were observed for 14 days to record various clinical signs or death. In sub-acute toxicity study, female rats were divided into 4 groups of 5 animals each. Three doses 12.5; 25 and 37.5 mg/kg body weight for 28 days were received by groups 2 to 4. Physiological behavior and body weight were evaluated. Biochemical, haematological and histological Analysis were realized at the end of each study.
Results: Out of apathy, reduction in mobility and food rejection during the first hour after TR-Y017 acute administration, no mortality was observed. TR-Y017 was found to be non-toxic at high dose and itUY5s lethal dose was estimated to be superior to 2000 mg/kg body weight under present experimental conditions. On the 28th day of treatment, none of the three doses of TR-Y017 affected general behavior or caused death. However, significant differences in body weight, kidney (p = 0.0438) and liver (p = 0.00929) weights were observed in treated rats when compared to controls. No significant difference was observed on haematological and biochemical parameters. Between the beginning and the 28th day, there was no significant difference on haematological and biochemical parameters of treated animals comparing to the control group. Histopathological examination revealed no alteration in the morphological architecture of renal and hepatic tissues.
Conclusion: Acute and sub-acute oral administration of TR-Y017 to Wistar rat was not associated with any manifestation of toxicity such as global behavior changes, toxic lesions or death. These results suggest that prolonged administration of TRY017 did not cause functional or structural changes in rats and did not indicate any toxicity of this product.