Acute and subchronic toxicity studies of cryogenically-frozen, cryomilled, Pelodiscus sinensis (Japanese soft-shelled turtle—suppon) powder administered to the rat

Sprague–Dawley rats received “cryogenically-frozen suppon” (CFS), a cryomilled product derived for the Japanese soft-shelled turtle (Pelodiscus sinensis), widely consumed for its nutritious value and medicinal properties, especially for the maintenance of normal blood pressure and insulin levels, and in women for the treatment of menopausal symptoms. In this acute study, a single limit dose of 2.0 g/kg was given po. common to 10 male and 10 female rats. No adverse effects or mortality were observed during a 14-day period and at gross pathological examination. In the subchronic study, CFS was administered as oral daily doses of 100, 350, and 1000 mg/kg administered for 97 days, resulting in no mortality, no changes in body weight, food and water consumption, hematological and serum chemistry parameters, organ weights, or gross pathology or histopathology. The only treatment related finding was a characteristic excited behavior observed in several male rats from the second or third week of treatment, distributed evenly in all male treatment groups but not affecting all males. The number of excited animals did not change over time, the syndrome occurred in all test item treated male groups with similar incidence. None of the females was so affected.