Toxicology studies with N-acetylglycine

Area of Science:

• Toxicology
• Food Science
• Genetics

Background:

• N-acetylglycine (NAGly) is a naturally occurring compound found in various food sources.
• Understanding the safety profile of food constituents like NAGly is crucial for food safety and regulatory assessment.

Purpose of the Study:

• To evaluate the genotoxic potential of N-acetylglycine (NAGly) using in vitro and in vivo assays.
• To determine the acute oral and repeated dose toxicity of NAGly in rodent models.
• To establish the no-observed-adverse-effect level (NOAEL) for NAGly.

Main Methods:

• In vitro bacterial reverse mutation assays (Ames test) and in vivo mouse micronucleus tests were performed for genotoxicity assessment.
• Acute oral toxicity studies involved single gavage administration of NAGly to Sprague-Dawley rats (up to 2000 mg/kg).
• Repeated dose dietary toxicity studies exposed rats to NAGly (100, 500, 1000 mg/kg/day) for 28 days, monitoring clinical signs, body weight, feed consumption, and clinical pathology.

Main Results:

• N-acetylglycine (NAGly) demonstrated no evidence of genotoxicity in bacterial assays or in vivo micronucleus tests.
• No mortality or adverse effects were observed in rats following acute oral exposure to 2000 mg/kg NAGly.
• Repeated dose studies showed no significant adverse effects, with NOAELs established at 898.9 mg/kg/day for male rats and 989.9 mg/kg/day for female rats.

Conclusions:

• N-acetylglycine (NAGly) is not genotoxic and exhibits low acute oral toxicity.
• The established NOAELs indicate a favorable safety profile for NAGly following repeated dietary exposure.
• These findings support the safety of NAGly as a food constituent.