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Rebaudioside A: two-generation reproductive toxicity study in rats
Leslie L Curry1, Ashley Roberts, Nigel Brown
1Cargill, Incorporated, 15407 McGinty Road W. MS 163, Wayzata, MN 55391, United States. Leslie_Curry@cargill.com
Summary
Rebaudioside A, a stevia sweetener, showed no toxicity or adverse reproductive effects in rats across two generations. The highest dose tested did not impact offspring development or survival, establishing a high NOAEL.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Food Science
Background:
- Rebaudioside A is a major sweet glycoside found in Stevia rebaudiana.
- Understanding the safety profile of food additives like Rebaudioside A is crucial for consumer protection.
Purpose of the Study:
- To evaluate the reproductive and developmental toxicity of Rebaudioside A in a two-generation rat study.
- To determine the No Observed Adverse Effect Level (NOAEL) for reproductive and developmental endpoints.
Main Methods:
- Male and female Han Wistar rats were fed diets containing Rebaudioside A at concentrations of 0, 7500, 12,500, and 25,000 ppm for two generations.
- Reproductive parameters, offspring survival, development, and general condition were assessed.
Main Results:
- No clinical toxicity, adverse effects on body weight, or food consumption were observed.
- No treatment-related effects on reproductive performance (fertility, gestation, estrous cycles, sperm parameters) were found in F0 or F1 generations.
- Offspring survival, development, and sexual maturation were not adversely affected at any dose, including the highest level.
Conclusions:
- Rebaudioside A is not associated with reproductive or developmental toxicity in rats.
- The NOAEL for reproductive effects and offspring survival/development was determined to be 25,000 ppm (2048-2273 mg/kg bw/day).
- These findings support the safety of Rebaudioside A as a food ingredient.
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