Toxicology studies with N-acetylglycine.
N-acetylglycine (NAGly) has been identified as a minor constituent of numerous foods. The current paper reports the outcome of in vitro and in vivo genotoxicity, acute oral and repeated dose dietary toxicology studies conducted with NAGly. No evidence of genotoxicity was observed with NAGly in vitro bacterial tester strains or in vivo bone marrow micronucleus studies conducted in mice. No mortalities or evidence of adverse effects were observed in Sprague-Dawley rats following acute oral gavage with NAGly at a dose of 2000 mg/kg of body weight or following repeated dose dietary exposure to NAGly at targeted doses of 100, 500, or 1000 mg/kg of body weight/day for 28 days. No biologically significant or test substance related differences were observed in body weights, feed consumption, or clinical pathology response variables in any of the treatment groups. Based on these results it was concluded that NAGly is not genotoxic or acutely toxic. Further, the no-observed adverse-effect-level (NOAEL) for systemic toxicity from repeated dose dietary exposure to NAGly was 898.9 mg/kg of body weight/day for male rats and 989.9 mg/kg of body weight/day for female rats.
Harper
Marc S
MS
Pioneer Hi-Bred International, Inc., 2450 SE Oak Tree Court, Ankeny, IA 50021, USA.
Shen
Z Amanda
ZA
Barnett
John F
JF
Krsmanovic
Ljubica
L
Dakoulas
Emily W
EW
Delaney
Bryan
B
D000107:Acetylation; D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D001854:Bone Marrow Cells / Q000187:drug effects; D004247:DNA / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D004785:Environmental Pollutants / Q000633:toxicity*; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D005506:Food Contamination / Q000032:analysis*; D005998:Glycine / Q000031:analogs & derivatives* / Q000633:toxicity; D008136:Longevity; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009154:Mutation / Q000187:drug effects; D019055:No-Observed-Adverse-Effect Level; D011506:Proteins / Q000737:chemistry; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D023382:Toxicity Tests, Acute
D004785:Environmental Pollutants; D011506:Proteins; D004247:DNA; D005998:Glycine; C006368:aceturic acid