Results published in Food and Chemical Toxicology indicated that the no-observed-adverse-effect level (NOAEL) for reproductive and developmental toxicity was determined to be 50,000 ppm, which was equivalent to between 4 to 6 grams per kilogram of body weight per day.
The study, performed by Japan-based Ajinomoto scientists, reportedly adds to data from “several Good Laboratory Practices (GLP)-compliant toxicological studies, including those recommended by the FDA Redbook, and some human studies”.
Very high intensity sweetener
Advantame is a high intensity sweetener derived from the same amino acids as aspartame, and vanillin. While aspartame is around 200 times sweeter than sugar, Advantame is said to be “thousands of times” sweeter. In general this means less would be required in formulations, although actual food sweetness levels would depend upon specific applications.
The Ajinomoto Company has filed petitions in countries such as the US, Australia and New Zealand to approve the sweetener.
In February of this year, approval moved a step closer in Australia and New Zealand, as the Food Standards Australia New Zealand (FSANZ) published its preferred option that the Food Standards Code be amended to approve the intense sweetener for sale and use.
The Ajinomoto scientists fed two generation of rats diets containing 0, 2000, 10,000, or 50,000 ppm advantame, which equated to daily intakes of 164, 833, and 4,410 mg per kg of body weight for males, and 204, 1,036, and 5,431 mg per kg of body weight for females.
Results presented indicated no effects on “mortality, body weights, reproduction, litter observations, or postnatal offspring development”, wrote the scientists.
A slight increase in food consumption was observed in the animals, particularly males, receiving the highest dose, but this was “considered to be a secondary response to the high levels of non-nutritive material in the diet”, they added.
The results led the scientists to conclude that the NOAEL for reproductive and developmental toxicity was 50,000 ppm.
Source: Food and Chemical Toxicology
Published online ahead of print, doi: 10.1016/j.fct.2011.07.002
“A two-generation reproductive toxicity study of the high-intensity sweetener advantame in CD rats”
Authors: A. Otabe, T. Fujieda, T. Masuyama