The safety assessment of N-trans-feruloyltyramine using In vitro genotoxicity studies and 90-day toxicity study in rats.

Abstract

IntroductionN-trans-feruloyltyramine (NFT) is a bioactive compound present in many plant sources. The purpose of the studies was to investigate adverse effects, if any, of NFT produced through precision fermentation.MethodsAn in vitro Ames test was performed with NFT using bacterial strains at concentrations up to 1580 µg/plate with and without S9. The in vitro micronucleus assay was performed in human peripheral blood cells in culture, with and without, metabolic activation at three different doses. In the subchronic toxicity study, adult Sprague Dawley rats (10/sex/group) were fed diets prepared with target doses of 0, 5000, 10,000 or 20,000 ppm of NFT for 90 days.ResultsIn the Ames assay, there were no NFT-related or concentration dependent increases in revertant colony numbers in any of the tester strains. In the in vitro micronucleus assay, there was no statistically significant increase in the number of binucleated cells with micronuclei compared to the vehicle control. NFT was found to be non-genotoxic when evaluated in the in vitro Ames and micronucleus assays. In the 90-day rodent study, NFT was well tolerated, with no related adverse findings observed at any of the dose levels tested. There were no NFT related adverse histopathological changes observed in the high dose group of both the sexes.ConclusionThe No observed adverse effect level of NFT was determined as 1474 mg/kg body weight/day in males and 1958 mg/kg body weight/day in females based on the actual intake at the dose levels tested and under the experimental conditions employed.