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Teratogenicity of D-allulose
Soonok Sa1, Yunji Seol2, Albert W Lee2
1Samyang Corporation, Seongnam-si, Gyeonggi-do, Republic of Korea.
Toxicology Reports
|December 15, 2022
Summary
D-allulose showed no teratogenic effects in pregnant rats during a prenatal developmental toxicity study. This sugar substitute is safe for prenatal development, with a no observed adverse effect level (NOAEL) of 5000 mg/kg/day.
Area of Science:
- Toxicology
- Reproductive Toxicology
- Food Science
Background:
- D-allulose is a rare sugar with potential health benefits.
- Assessing its safety during pregnancy is crucial for consumer confidence and regulatory approval.
Purpose of the Study:
- To evaluate the potential teratogenic effects of D-allulose in Sprague-Dawley (SD) rats.
- To determine the prenatal developmental toxicity of D-allulose.
Main Methods:
- A prenatal developmental toxicity test (modified OECD guideline 414) was performed on pregnant SD rats.
- Rats received daily oral doses of D-allulose (1250, 2500, or 5000 mg/kg) or vehicle control from gestational day (GD) 6 to 15.
- Fetuses were examined on GD 20 for external, soft tissue, and skeletal malformations.
Main Results:
- No treatment-related abnormalities or malformations were observed in fetuses exposed to D-allulose.
- D-allulose did not affect general signs, body weight, food consumption, or reproductive parameters.
- The no observed adverse effect level (NOAEL) for prenatal developmental toxicity was determined to be 5000 mg/kg/day.
Conclusions:
- D-allulose does not exhibit teratogenic effects in rats.
- The study supports the safety of D-allulose during prenatal development.
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