A two-generation reproductive and developmental toxicity study of sucrose polyester |
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| Authors: | G A Nolen F E Wood T A Dierckman |
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| Affiliation: | 1. Department of Chemical Engineering, Faculty of Engineering, Chulalongkorn University, Patumwan, Bangkok 10330, Thailand;2. Department of Chemistry and Center of Excellence in Biomaterials, Faculty of Science, Naresuan University, Phitsanulok 65000, Thailand;1. School of Pharmacy, University of Nottingham, University Park, Nottingham NG72RD, UK;2. School of Engineering and Physical Sciences, Nano Safety Research Group, Heriot-Watt University, Edinburgh EH14 4AS, UK;3. School of Chemistry, University of Nottingham, University Park, Nottingham NG72RD, UK;4. Department of Chemical and Environmental, Faculty of Engineering, University of Nottingham, University Park, Nottingham NG7 2RD, UK;5. Institute of Pharmaceutical Technology and Biopharmaceutics, Martin-Luther-University Halle-Wittenberg, Wolfgang-Langenbeck-Str. 4, D-06120 Halle/Saale, Germany;1. Science Strategies, LLC, 1001 East Market Street, Suite 202, Charlottesville, VA 22902, USA;2. Department of Pharmacology, UMDNJ-Robert Wood Johnson Medical School, 661 Hoes Lane, Piscataway, NJ 08854, USA;3. CeeTox, Inc., 4717 Campus Drive, Kalamazoo, MI 49008, USA |
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| Abstract: | 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. |
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