In vivo assessment of chronic, genotoxic, and reproductive toxicity of a combination of Termitomyces schimperi (Pat.) R. Heim (Lyophillacea) and kaolin

Ethnopharmacological relevance: Termitomyces schimperi (Pat.) R. Heim (family Lyophyllaceae) is a widely used mushroom in traditional medicine in West Africa, often combined with kaolin, to manage various diseases, including cancers. Despite its ethnopharmacological use, scientific data on its long-term safety, genotoxicity, and effects on male reproductive health remain limited, necessitating rigorous toxicological evaluation. Aim of the study: This study aimed to assess the chronic toxicity, genotoxic potential, and reproductive effects of T. schimperi and kaolin (TSK). Materials and methods: Sprague-Dawley rats were randomly assigned to three groups and orally administered with distilled water (control) or TSK at doses of 200 and 500 mg/kg daily for 180 days. Biochemical, haematological and histopathological parameters were analysed to detect toxicological effects. The genotoxic potential of TSK was evaluated using the mouse micronucleus assay while reproductive toxicity was assessed through sperm count, motility, viability, and morphology in male rats. Statistical analyses were performed using one-way analysis of variance (ANOVA) and Tukey's post hoc test with significance set at p < 0.05. Results: Chronic administration of TSK at 200 and 500 mg/kg showed no significant adverse effects on body weight, organ-to-body weight ratios, histopathological evaluations, biochemical and haematological parameters. The micronucleus assay demonstrated no significant increase in micronuclei count in polychromatic erythrocytes (MNPCE), confirming the absence of genotoxic potential. Reproductive toxicity assessments also showed no significant changes in sperm parameters at therapeutic doses. Conclusion: This study establishes that the combination of T. schimperi and kaolin is safe at therapeutic doses (200 mg/kg and 500 mg/kg) during prolonged administration, with no evidence of chronic toxicity or genotoxicity. However, mild cytotoxic effects and potential reproductive toxicity at higher doses (1000 mg/kg) warrant further investigation. Additionally, the lipid-lowering and fertility-enhancing potential of TSK observed in this study suggests promising therapeutic applications that merit further pharmacological exploration.