[Study on the toxicity of SF-1008C (II): Subacute toxicity study in rats]

The toxicity of an elemental diet (SF-1008C) for hepatic failure and recovery after administration were investigated in Sprague-Dawley rats. The rats were orally administered the drug in doses of 10, 20 and 30 g/kg/day for five weeks, after which, recovery was studied for five weeks. The results were summarized as below: In the 30 g/kg/day group, decreases in food and water consumption were observed, while the body weight gain and the rate of body weight gain were high compared to the treated control group. In addition, urinary pH and serum total protein were lower, and serum glucose and calcium levels were higher than in the treated control group, but these results were not considered to be due to the drug's toxicity. In the 20 and 10 g/kg/day groups, a slight decrease in food consumption was observed, though the rate of body weight gain was higher than in the treated control group. Slight decreases in urinary pH and serum total protein were observed, but were not considered to be due to the toxic effect of the drug. From the above results, it was concluded that the maximal non-effect dose of SF-1008C in oral administration was 30 g/kg/day, which was the maximally applicable dose in rats.