Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents WHO FOOD ADDITIVES SERIES NO. 5 The evaluations contained in this publication were prepared by the Joint FAO/WHO Expert Committee on Food Additives which met in Geneva, 25 June - 4 July 19731 World Health Organization Geneva 1974 1 Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 539; FAO Nutrition Meetings Report Series, 1974, No. 53. DISTARCH GLYCEROL Explanation Treatment with epichlorhydrin under alkaline conditions up to 0.3% tends to produce cross-linking at a rate of one glycerol diether linkage per 220 - glycopyranose units. BIOLOGICAL DATA BIOCHEMICAL ASPECTS Much evidence in the literature points to etherified starches being somewhat resistant to enzymic degradation. Probably small fragments containing the ether linkage will remain and will not be absorbed readily. Any material absorbed is likely to be excreted by the kidney. Ne direct experimental evidence exists for this particular hypothesis (French, 1960). The metabolic fate of methyl-glucose is cited as collateral evidence. Although methylglucose is absorbed by rats (Sols, 1956) no demethylation is believed to occur (Csáky & Wilson, 1956) and excretion is essentially quantitative (Csáky & Glenn, 1957). The in vitro digestibility by amyloglucosidase of distarch glycerol (0.3% epichlorhydrin) was shown to be 98.3% of that of unmodified starch (Kruger, 1970). The caloric values of two starches treated at levels of 0.07% and 0.50% epichlorhydrin were estimated in groups of 10 weanling male rats by comparing the weight gain obtained after feeding for 28 days a basal diet supplemented with 3 g of each starch against a dose-response curve obtained by feeding daily sucrose supplements of 0, 1.5 g, 3 g, 4.5 g and 6 g equivalent to approximately 0, 6, 12, 18 and 24 calories. Distarch glycerols were only slightly lower in caloric value than unmodified starch, the differences not being significant (Oser, 1961). TOXICOLOGICAL STUDIES Short-term studies Rat Three groups of 10 male and 10 female rats were fed for 90 days unmodified starch or starch treated with 0.07% or 0.50% epichlorhydrin at 71% of their diet. Growth rate, appearance, behaviour and food intake were similar in all three groups. Haematological investigations showed no abnormalities related to the feeding of modified starches. Non-protein nitrogen blood levels and blood sugar levels remained normal in all groups. The weights of all major organs were normal and no abnormal gross or histopathological changes related to treatment were seen (Oser, 1961). Long-term studies None available. Comments: The feeding studies with rats show that the modified starch is well utilized. The available evidence for the group of modified starches considered indicate that caecal enlargement without associated histopathological changes is without toxicological significance. The short-term rat study shows no adverse effects at the high dietary level used. No long-term study on this modified starch is available and collateral evidence from the long-term and reproduction studies with hydroxypropyl distarch glycerol, a more highly modified starch, indicates that the glycerol linkage is causing no adverse effects. EVALUATION Estimate of acceptable daily intake for man Not limited.* REFERENCES Csáky, T. Z. & Glenn, J. E. (1957) Amer. J. Physiol., 188. 159 Csáky, T. Z. & Wilson, J. E. (1956) Biochim. Biophys. Acta., 22, 185 French, D. (1960) Unpublished report Kruger, L. (1970) Unpublished reports Nos 405 & 406 submitted by National Starch and Chemical Corporation Oser, B. L. (1961) Unpublished report of Food and Drug Research Laboratories Inc., submitted by National Starch and Chemical Corporation Sols, A. (1956) Rev. esp. Fisiol., 12, 17 * See relevant paragraph in the seventeenth report, pages 10-11
See Also: Toxicological Abbreviations Distarch glycerol (FAO Nutrition Meetings Report Series 46a) Distarch glycerol (WHO Food Additives Series 1) DISTARCH GLYCEROL (JECFA Evaluation)