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Advantame--an overview of the toxicity data
A Otabe1, T Fujieda, T Masuyama
1Ajinomoto Co., Inc., 15-1 Kyobashi 1-Chome, Chuo-ku, Tokyo 104-8315, Japan. akira_otabe@ajinomoto.com
Summary
Advantame, a derivative of aspartame, demonstrated excellent tolerability and no systemic toxicity in extensive animal and human studies. Safety assessments indicate it is safe for food use at anticipated intake levels.
Area of Science:
- Food Science
- Toxicology
- Pharmacokinetics
Background:
- Advantame is an N-substituted derivative of aspartame.
- It shares structural similarities with neotame.
Purpose of the Study:
- To evaluate the safety of Advantame through comprehensive toxicological and pharmacokinetic studies.
- To establish the relevance of animal models for human safety assessment.
- To determine human tolerability of Advantame.
Main Methods:
- Pharmacokinetic and metabolism studies in various species.
- Subchronic and chronic toxicity studies in rats and dogs.
- Carcinogenicity, genotoxicity, and reproductive/developmental toxicity assessments.
- Human tolerability trials.
Main Results:
- Advantame is well-tolerated in both animals and humans.
- No systemic toxicity was observed.
- Metabolic data confirmed the relevance of animal models for human safety.
- No-observed-adverse-effect levels (NOAELs) were high, with predicted human intake significantly lower than these levels.
Conclusions:
- Comprehensive toxicological and human data support the safety of Advantame for food applications.
- Advantame is deemed safe for consumption under anticipated use conditions.
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