[Study on the toxicity of SF-1008C (I): Acute toxicity study in mice and rats]

The oral acute toxicity studies of SF-1008C, an elemental diet for hepatic failure, and its components (peptide and rice oil) were evaluated in ICR mice and Sprague-Dawley rats. The following results were obtained. Mortality; The minimum lethal doses for SF-1008C in male and female mice and rats were higher than 40 g/kg. The minimum lethal doses for peptide in male and female mice and rats were higher than 6 g/kg. The minimum lethal doses for rice oil in male and female mice and rats were higher than 20 ml/kg. General symptoms; the major signs observed were loose stool in the mice treated with SF-1008C, yellowish brown urine in the rats treated with SF-1008C or peptide and diarrhea in the rats treated with rice oil. Body weight and food consumption; decrease in food consumption and slight decrease in body weight gain were observed in the female mice treated with SF-1008C, peptide and rice oil, but the decrease was not dose-dependent. Decrease in food consumption was also observed in the male and female rats treated with of SF-1008C and rice oil, but the decrease was not dose-dependent. Body weight, however, did not show significant change in any group of rats. Gross pathology; no drug-related changes in organs and tissues were observed by necropsy in any group of mice or rats. Based on these results, the acute toxicities of SF-1008C and its components were low, respectively.