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Embryotoxicity and teratogenicity study with erythritol in rats

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Author: Smits- Prooije, A.E. van · Waalkens-Berendsen, D.H. · Bär, A.
Source:Regulatory Toxicology and Pharmacology, 2 II, 24
Identifier: 233711
doi: doi:10.1006/rtph.1996.0103
Keywords: erythritol · animal experiment · animal model · article · embryo · embryotoxicity · female · fetotoxicity · fetus · male · nonhuman · priority journal · rat · teratogenicity · Abnormalities, Drug-Induced · Animals · Body Weight · Diet · Embryo · Erythritol · Female · Fertility · Male · Pregnancy · Rats · Rats, Wistar · Sweetening Agents · Teratogens · Animalia


The embryotoxicity/teratogenicity of erythritol, a low-calorie polyol sugar substitute, was examined in Wistar Crl:(WI) WU BR rats. Erythritol was fed at dietary concentrations of 0, 2.5, 5, and 10% to groups of 32 female rats from Day 0 to 21 of gestation. The treatment was generally well tolerated and no mortality occurred in any group. Weight gain during gestation, food consumption, and food efficiency were similar in all groups except for a significantly reduced weight gain in the 10% erythritol group in Week 2 of gestation. Reproductive performance was not affected by the treatment but the fertility index was generally rather low (69% in both control and high-dose group). Examination of the fetuses for external, visceral, and skeletal alterations did not reveal any fetotoxic, embryotoxic, or teratogenic effects. The slightly lower maternal body weight in the high-dose group was interpreted as a trivial result of the consumption of a low-calorie test substance in high amounts. In conclusion, no adverse effects were observed at erythritol doses of up to about 6.6 g/kg body wt/day, i.e., the highest dose tested.