Nghiên cứu độc tính cấp và tác dụng hỗ trợ sinh sản của myo-inositol và các thành phần phối hợp trên mô hình động vật thực nghiệm

Abstract

This study evaluated the acute toxicity and reproductive-enhancing effects of a myo-inositol-based combination formulation (S-FEMME) in experimental animals. Acute toxicity was assessed in Wistar rats according to OECD 423 guidelines. The reproductive effects were evaluated in female Swiss mice over 30 days. The assessed parameters included pregnancy rate, number of implanted embryos, and serum estrogen levels. The results showed that S-FEMME did not produce acute toxicity at the limit dose of 5000 mg/kg. In mice, serum estrogen levels in the S-FEMME groups showed an increasing trend compared to the control group. The total numbers of implanted embryos in the treated groups (52 and 65 embryos - 6 mice each group) were higher than in the control group (50 embryos - 6 mice), with mean embryo numbers per animal of 8.50 (control), 8.67 ( low dose S-FEMME -0.32 g/kg/day), and 9.27 ( high dose S-FEMME -0.64 g/kg/day), respectively. In conclusion, oral administration of S-FEMME demonstrated a favorable safety profile in Wistar rats. S-FEMME is classified as unclassified for acute toxicity under the GHS, with an estimated LD₅₀ exceeding 5000 mg/kg body weight. and showed a tendency to improve reproductive performance in mice by increasing pregnancy rate, embryo implantation, and serum estrogen levels.