Rebaudioside A: Two-generation reproductive toxicity study in rats

Rebaudioside A was administered via the diet to male and female Han Wistar rats at 0, 7500, 12,500, and 25,000 ppm for two generations. Rebaudioside A treatment was not associated with any signs of clinical toxicity or adverse effects on body weight, body weight gain, or food consumption. No treatment-related effects of rebaudioside A were observed in either the F0 or F1 generations on reproductive performance parameters including mating performance, fertility, gestation lengths, oestrous cycles, or sperm motility, concentration, or morphology. The survival and general condition of the F1 and F2 offspring, their pre-weaning reflex development, overall body weight gains, and the timing of sexual maturation, were not adversely affected by rebaudioside A treatment.The NOAEL for reproductive effects was 25,000 ppm and the NOAEL for the survival, development, and general condition of the offspring also was considered to be 25,000 ppm or 2048–2273 mg/kg body weight/day.