Single Oral Dose Toxicity Evaluation of the Aqueous Extract of Bombycis Faeces in Sprague-Dawley Rats Adaptability and Ginsenoside Compositional Stability of Acclimatized Panax ginseng Plantlets Derived from Somatic Embryogenesis under Field Conditions
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Background: Bombycis feces (dried feces of silkworms; Bombyx mori L.) are traditionally used in Korean and East Asian medicine to treat conditions including sensory disturbances, itching, and headaches. Recent studies have demonstrated pharmacological activities including anti-inflamma- tory, antioxidant, and neuroprotective effects. However, toxicological evidence supporting its safety is currently sparse. We aimed to evaluate the acute oral toxicity of an aqueous extract of Bombycis feces in Sprague-Dawley rats, following OECD guidelines. Methods and Results: Forty rats (20 males and 20 females) were randomly assigned to receive a single oral dose of the extract at 0 (control), 500, 1000, or 2000 mg/kg. The animals were observed for 14 days to assess clinical signs, mortality, body weight changes, and hematological parameters. No mortality or clinical signs of toxicity were observed in any group. Normal body weight gain occurred in both sexes, and macroscopic examination revealed no treatment-related organ abnormalities. Hematological parameters remained within physiological ranges in males. Although not clinically relevant, monocyte counts increased significantly in female rats in all treated groups (p < 0.01). Conclusions: Aqueous extract of Bombycis Faeces was well tolerated at doses up to 2000 mg/kg, indicating negligible acute toxicity. Collectively, these findings provide foundational safety data to support further development of Bombycis Faeces-based pharmaceutical and nutraceutical products.
Abstract
Background: Bombycis feces (dried feces of silkworms; Bombyx mori L.) are traditionally used in Korean and East Asian medicine to treat conditions including sensory disturbances, itching, and headaches. Recent studies have demonstrated pharmacological activities including anti-inflamma- tory, antioxidant, and neuroprotective effects. However, toxicological evidence supporting its safety is currently sparse. We aimed to evaluate the acute oral toxicity of an aqueous extract of Bombycis feces in Sprague-Dawley rats, following OECD guidelines. Methods and Results: Forty rats (20 males and 20 females) were randomly assigned to receive a single oral dose of the extract at 0 (control), 500, 1000, or 2000 mg/kg. The animals were observed for 14 days to assess clinical signs, mortality, body weight changes, and hematological parameters. No mortality or clinical signs of toxicity were observed in any group. Normal body weight gain occurred in both sexes, and macroscopic examination revealed no treatment-related organ abnormalities. Hematological parameters remained within physiological ranges in males. Although not clinically relevant, monocyte counts increased significantly in female rats in all treated groups (p < 0.01). Conclusions: Aqueous extract of Bombycis Faeces was well tolerated at doses up to 2000 mg/kg, indicating negligible acute toxicity. Collectively, these findings provide foundational safety data to support further development of Bombycis Faeces-based pharmaceutical and nutraceutical products.