A two-generation reproductive and developmental toxicity study of sucrose polyester.

Sucrose polyester (SPE) is a mixture of hexa-, hepta- and octa-esters of fatty acids with sucrose, and has physical and organoleptic properties similar to those of conventional dietary fats. Because SPE is neither absorbed nor metabolized it forms a bulk lipid phase in the small intestine, resulting in effects on the absorption and enterohepatic circulation of lipid-soluble materials, such as cholesterol and fat-soluble vitamins. Such effects could potentially alter the physiology of animals to the extent of interfering with reproduction and/or the normal development of the embryo/foetus. To determine the likelihood of such phenomena, Sprague-Dawley rats were continuously fed SPE at dietary levels of 1, 5 or 10% along with controlled levels of vitamins A and E for two generations, with a reproductive and a teratogenic phase in each generation. Body-weight gain of rats fed SPE was comparable to that of the controls throughout the study, but feed consumption increased with increasing levels of SPE. Pregnancy or lactation had no effect on these growth patterns. Throughout the study, SPE had no deleterious effect on mating, conception, embryonic development, foetal or post-natal viability, or on post-natal growth. Nor was there any treatment-related histopathology. Thus, it is concluded that SPE would not represent a reproductive or teratogenic hazard to human consumers of products containing SPE.