Toxicological evaluation of peptide compound TSC6: A 13-week subchronic toxicity and genotoxicity study.

TSC6-peptide is an 8-amino acid synthetic peptide compound that inhibits intestinal α-amylase upon oral administration to control the digestion and absorption of starchy foods. However, its toxicological safety and other scientific evidence remain to be established. Given the potential utility of TSC6-peptide as an α-amylase inhibitor, this study conducted in vivo and in vitro experiments to support its safety profile. In reverse mutation and mammalian micronucleus assays revealed no genotoxicity for TSC6-peptide. Meanwhile, in the 90-day dietary toxicity study in rats, the NOAEL was 500 mg/kg bw/day for male rats following TSC6-peptide administration and the LOAEL for female rats was 50 mg/kg bw/day. These results indicate that TSC6-peptide possesses controllable safety as an α-amylase inhibitor.