In this study, we assessed whether D-allulose was associated with reproductive toxicity in rats, assessing reproduction and offspring growth following gavage of parents with 0, 500, 1000, and 2000 mg/kg of this compound. Specifically, female rats were continuously dose from 2 weeks prior to mating until day 21 of lactation, while males were dose for the 10 weeks before mating. We did not observe any direct toxicity or mortality upon D-allulose administration, with no changes in body weight or eating behavior between study and control groups. We also did not observe any significant alterations in precoital time, copulation index, fertility index (male), or pregnancy index (male) between groups. Relative to controls, there was also no effect of D-allulose treatment on pregnancy rates, implantation, pregnancy length, gender ratios, viability indexes, lactation indexes, prenatal death rates, or number of live young at time of birth. Organ weights and indexes were also comparable between groups at time of sacrifice, and treatment was not linked to any obvious manifestations upon necropsy or histopathological examination. In the F1 offspring, the body weights of pups born to parents administered D-allulose (2000, 1000, and 500 mg/kg) were slightly higher on days 1-9 postnatally relative to controls (p < 0.05), however after day 9 these effects were no longer evident. Together, these results indicate a no-observed-adverse-effect level (NOAEL) of D-allulose of 2000 mg/kg, the highest dose tested, in parental animals and their offspring.
Keywords: D-allulose; One-generation reproductive toxicity; Rat.
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