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. DIACETYL TARTARIC AND FATTY ACID ESTERS OF GLYCEROL Explanation These emulsifiers have been evaluated for acceptable daily intake by the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1, Ref. No. 13) in 1966. The previously published monograph has been revised and is reproduced in its entirety below. BIOLOGICAL DATA BIOCHEMICAL ASPECTS Six male rats were fed 0.53 to 0.81 g/kg bw 14C-acetyltartaric acid ester of mono- and diglycerides (labelled in the two carboxyl groups of tartaric acid) as an oily solution. Within 24 hours only 26 to 31% of the radioactivity was absorbed. Twelve to 20% of the radioactivity was eliminated as 14CO2 and 8 to 13% was excreted in the urine; 2% was found in the carcass (Lang & Schmidt, 1965). The analysis of the depot fat of dogs fed up to 20% of the substance for 22 months showed no traces of either free or a fat soluble derivative of tartaric acid (Koppanyi & Dardin, 1950). The digestibility coefficient was over 90% of the substance or about the same as that of lard (Koppanyi & Dardin, 1950). In an aqueous medium diacetyl tartaric ester of mono- and diglycerides was hydrolyzed spontaneously to mono- and diglycerides and acetylated tartaric acid, the hydrolysis being somewhat accelerated by pancreatic lipase (Lang & Schmidt, 1965). There was some evidence that diacetyltartaric acid was also hydrolyzed in the body (Sourkes & Koppanyi, 1950). TOXICOLOGICAL STUDIES Acute toxicity No acute toxic effects at a practicable dose level have been demonstrated. Rats and rabbits tolerated intragastric doses of 30 g/kg bw and dogs 27 g/kg bw without any adverse effects. No diarrhoea was noted and autopsied animals showed no pathological changes. Histological examination of liver and kidneys of animals killed 10 days after the administration of the substance showed no abnormalities (Koppanyi & Dardin, 1950). Short-term studies Dog Thirteen dogs each received daily i.v. injections of 0.5% suspensions of the substance in isotonic glucose at a dose rate of 40 to 50 ml/kg bw for a total of up to 30 infusions. A fall in haemoglobin concentration occurred in 11 dogs and a pleural effusion in six. Groups of two three-year-old dogs were fed diets containing 0, 5, 10 and 20% of diacetyl tartaric esters of mono- and diglycerides for 25-1/2 months. No specific effects attributable to the test substance were seen (Hartwig et al., 1962). Long-term studies Rat Groups of eight rats were fed 0, 5, 10 and 20% diacetyltartaric esters of mono- and diglycerides, another two groups were fed 50% white bread (bread control group) and 50% bread which was baked with the addition of 10% of the emulsifier in terms of flour weight (bread test group) for two years. No difference was found between the groups regarding body weight, external appearance, liver and kidney weights and mortality rate. Autopsies and histological examination of the major organs showed no changes attributable to the test substance. A second generation was maintained on similar regimes for 22 months. There was no difference between the groups regarding body weight, mortality and results of gross and histological examination. All litters were normal (Koppanyi & Dardin, 1950). Comments: Diacetyltartaric acid is not a natural constituent for the diet, and its low rate of spontaneous hydrolysis possibly allows the absorption of some unhydrolyzed compound. The experimental results show that the ester has a very low toxicity when given orally and that the acetylated tartaric acid moiety is absorbed only to a small extent. Evaluation is based on the available toxicological information and the results of the biochemical and metabolic studies. EVALUATION Level causing no toxicological effect Rat: 100 000 ppm (10%) in the diet equivalent to 5000 mg/kg bw. Estimate of acceptable daily intakes for man 0-50* mg/kg bw. REFERENCES Hartwig, Q. L., Singleton, W. S. & Cotlar, A. M. (1962) Toxicol. Appl. Pharmacol. 4, 107 Koppanyi, T. & Dardin, V. (1950) Unpublished report to WHO Lang, K. & Schmidt, B. (1967) Unpublished report to WHO Sourkes, T. L. & Kappanyi, T. (1950) J. Amer. Pharm. Assoc., sci. Ed., 39, 275 * The total food additive intake of tartaric acid should not exceed 30 mg/kg bw per day.
See Also: Toxicological Abbreviations