INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF SOME FOOD COLOURS, EMULSIFIERS, STABILIZERS, ANTI-CAKING AGENTS AND CERTAIN OTHER SUBSTANCES FAO Nutrition Meetings Report Series No. 46A WHO/FOOD ADD/70.36 The content of this document is the result of the deliberations of the Joint FAO/WHO Expert Committee on Food Additives which met in Rome, 27 May - 4 June 19691 Food and Agriculture Organization of the United Nations World Health Organization 1 Thirteenth report of the Joint FAO/WHO Expert Committee on Food Additives, FAO Nutrition Meetings Report Series, in press; Wld Hlth Org. techn. Rep. Ser., in press. ACETYLATED DISTARCH GLYCEROL Modification is carried out with epichlorhydrin to a maximum of 0.3 per cent. and acetic anhydride to a maximum of five per cent. The amount of acetyl groups introduced does not exceed 2.5 per cent. Further treatment, such as bleaching, is often carried out. Biological Data Biochemical aspects No separate tests on enzymic hydrolysis are available but it is very likely that this modified starch behaves like starch acetate and distarch glycerol, both of which are somewhat less accessible to enzymic degradation. The caloric value was determined by reference to a dose-response curve established in groups of 10 male rats given a basic diet with graded supplements of 0, 0.075 g, 1.5 g, 3.0 g and 4.5 g sucrose equivalent to 0, 3, 6, 12 and 18 calories per day. Starches modified by the use of 0.1 per cent. epichlorhydrin + 5.5 per cent. acetic anhydride and 0.3 per cent. epichlorhydrin + 5.5 per cent. acetic anhydride were tested against native starch at levels of supplementation of 1.5 g and 3.0 g per day for 28 days. Weight gain on modified starch supplement was slightly reduced compared with that on unmodified starch. All rats remained normally active and healthy. The caloric estimates were similar for both levels of epichlorhydrin treatment (Oser, 1961). Acute toxicity None available. Short-term studies Rat. Groups of 15 male and 15 female rats were fed for 90 days on diets containing 50 per cent. either normal or modified starch (0.3 per cent. epichlorhydrin + 10.5 per cent. acetic anhydride). Two modified starches of this sort were tested, each containing 3.1 per cent acetyl. There were no deaths. The growth rate of male rats was significantly lower compared with controls on unmodified starch. The full and empty casual weights of both male and female rats in the test groups were significantly greater than in controls. Haematology, blood chemistry, urinalysis, organ weights and gross as well as histological examination were normal (Oser, 1964). Comments The available data do not permit the establishment of a no-effect level. The interpretation of increased caecal weights is discussed in the thirteenth report (see Annex 1, Ref. 18). Adequate metabolic studies preferably in man and 90-day studies in two species (one a non-rodent mammal) are required. EVALUATION Not possible on the data available. REFERENCES Oser, M. (1961) Unpublished report by Food & Drug Research Laboratories Inc. No. 81774, 1st June 1961, submitted by the National Starch and Chemical Corporation Oser, B. L. (1964) Unpublished report by Food & Drug Research Laboratories Inc. No. 85554, 16th October 1964, submitted by the National Starch and Chemical Corporation
See Also: Toxicological Abbreviations Acetylated distarch glycerol (WHO Food Additives Series 1) Acetylated distarch glycerol (WHO Food Additives Series 5) Acetylated distarch glycerol (WHO Food Additives Series 17) ACETYLATED DISTARCH GLYCEROL (JECFA Evaluation)