Genotoxicity and 28-day oral toxicity studies of a functional food mixture containing maltodextrin, white kidney bean extract, mulberry leaf extract, and niacin-bound chromium complex
Journal
Regulatory toxicology and pharmacology : RTP
Journal Volume
92
Pages
67
Date Issued
2018-02
Author(s)
Abstract
Steady-fiber granule (SFG) is a functional food mixture that is composed of four major ingredients, resistant maltodextrin, white kidney bean (Phaseolus vulgaris) extract, mulberry leaf (Morus alba L.) extract, and niacin-bound chromium complex. This study focused on determining the safety of SFG. Genotoxicity and 28-day oral toxicity were evaluated. SFG did not induce mutagenicity in the bacterial reverse mutation assay using five Salmonella typhimurium strains (TA98, TA100, TA102, TA1535, and TA1537) in the presence or absence of metabolic activation (S9 system). SFG also did not induce clastogenic effects in Chinese hamster ovary cells with or without S9 treatment. Similarly, SFG did not induce genotoxicity in a micronucleus test conducted with mice. A dose-dependent 28-day oral toxicity assessment of SFG for rats revealed no significant effects on mortality, body weight, selected organ weights, and behavior. Evaluations of hematology, clinical biochemistry, and histopathology showed no adverse effects in rats treated with SFG. These results suggest that SFG has no significant mutagenic or toxic properties, and the no observed adverse effect level of SFG was defined as at least 5000 mg/kg/day orally for 28 days for male and female rats.
Subjects
Evaluation; Food; Functional; Genotoxicity; Safety; Toxicity
SDGs
Other Subjects
chromium derivative; mulberry extract; plant extract; unclassified drug; white kidney bean extract; chromium nicotinic acid complex; maltodextrin; nicotinic acid; nicotinic acid derivative; organometallic compound; plant extract; polysaccharide; animal cell; animal experiment; animal model; animal tissue; Article; behavior change; CHO cell line; chromosome aberration; controlled study; cytotoxicity; female; food composition; genotoxicity; histopathology; male; metabolic activation; micronucleus test; mortality; mouse; mulberry; mutagenicity; nonhuman; Phaseolus vulgaris; plant leaf; priority journal; rat; revertant; Salmonella enterica serovar Typhimurium; toxicity testing; weight change; animal; body weight; Cricetulus; drug effect; functional food; Institute for Cancer Research mouse; Morus; mutagen testing; mutation; oral drug administration; Phaseolus; procedures; Wistar rat; Administration, Oral; Animals; Body Weight; CHO Cells; Cricetulus; Female; Functional Food; Male; Mice; Mice, Inbred ICR; Morus; Mutagenicity Tests; Mutation; Niacin; Nicotinic Acids; Organometallic Compounds; Phaseolus; Plant Extracts; Plant Leaves; Polysaccharides; Rats; Rats, Wistar
Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
Type
journal article