Sucralose: Assessment of teratogenic potential in the rat and the rabbit

The teratogenic potential of sucralose was examined following gavage admini stration to pregnant rats and rabbits during organogenesis, Groups of 20 ma ted rats mere dosed on days 6-15 of gestation inclusive at 500, 1000 or 200 0 mg/kg/day; groups of 16 to 18 inseminated rabbits mere dosed on days 6 to 19 of gestation inclusive at 175, 350 or 700 mg/kg/day following prelimina ry studies at higher doses. Concurrent control groups received vehicle alon e. Rats were killed on day 21 and rabbits on day 29 of gestation. Foetuses were evaluated at necropsy and after processing for possible soft tissue an d skeletal alterations. There,vas no evidence of teratogenicity for either species. The only observed response to treatment in rats was a slight incre ase in water intake. Some adult rabbits receiving 700 mg/kg/day exhibited m arked gastrointestinal disturbance, also seen at higher doses in preliminar y studies. Gastrointestinal effects such as these occur non-specifically in response to high doses of poorly absorbed compounds, and in the present st udy mere considered to be responsible for two maternal deaths and four abor tions. Full evaluation of rabbit foetuses in the main study (up to 700 mg/k g/day) and necropsy of foetuses in a preliminary study with pregnant animal s (up to 1000 mg/kg/day) showed no evidence of adverse foetal response to s ucralose. These teratology studies in both pregnant rodent and non-rodent a nimal models demonstrate that maternal consumption of high levels of sucral ose during the period of organogenesis has no effect on normal foetal devel opment in the rat or rabbit. (C) 2000 Elsevier Science Ltd. All rights rese rved.