抄録
Glycine Soja (Soybean) Peptide-B is one of the black soybean extract as an amino acid complex. It has been used as a functional food for decomposition of body fat. However, there is insufficient background information on toxicological evaluation of Glycine Soja (Soybean) Peptide-B to support its safety for human use. The objective of this study was to characterize the repeated toxicity study of Glycine Soja (Soybean) Peptide-B in Sprague-Dawley rats for 13 weeks. The Sprague-Dawley rats were administered by oral gavage once daily at dose levels of 0, 500, 1500 and 5000 mg/kg/day for 13 weeks. The powder of Glycine Soja (Soybean) Peptide-B was suspended in distilled water to make each target concentration. The parameters including mortality, clinical signs, body weight, food consumption, ophthalmologic examination, urinalysis, hematology, clinical chemistry, gross findings at necropsy, organ weight and histopathologic examination were performed in the study. Based on the results from 13-Week treatment in Sprague-Dawley rats, there were no test article-related findings in both sexes at any doses. Therefore, the target organ was not determined and the NOAEL for Glycine Soja (Soybean) Peptide-B was established to be 5000 mg/kg/day in both sexes of rats.