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. THIODIPROPIONIC ACID AND DILAURYL ESTER Explanation These substances have been evaluated for acceptable daily intake by the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1, Refs Nos 6 and 9) in 1961 and 1964. The previously published monographs have been revised and are reproduced in their entirety below. BIOLOGICAL DATA BIOCHEMICAL ASPECTS No information available. TOXICOLOGICAL STUDIES Acute toxicity THIODIPROPIONIC ACID Animal Route LD50 mg/kg bw Reference Mouse oral 2 000 Lehman et al., 1951 Mouse i.p. 250 Lehman et al., 1951 Mouse i.v. 175 Lehman et al., 1951 Rat oral 3 000 Lehman et al., 1951 Rat i.p. 500 Lehman et al., 1951 Rat i.v. > 300 Lehman et al., 1951 DILAURYL THIODIPROPIONATE Animal Route LD50 mg/kg bw Reference Mouse oral > 2 000 Lehman et al., 1951 Mouse i.p. > 2 000 Lehman et al., 1951 Rat oral > 2 500 Lehman et al., 1951 DISTEARYL THIODIPROPIONATE Animal Route LD50 mg/kg bw Reference Mouse oral > 2 000 Lehman et al., 1951 Mouse i.p. > 2 000 Lehman et al., 1951 Rat oral > 2 500 Lehman et al., 1951 Short-term studies Rat Mixtures of thiodipropionic acid and dilauryl thiodipropionate were heated with lard in concentrations at least 10 times that recommended for use and fed to rats. There was no detectable toxic effect (Lehman et al., 1951). Guinea-pig Thiodipropionic acid was fed to guinea-pigs at a level of 0.5% in the drinking-water for a period of 120 days. No significant effect was noted on weight or mortality (Lehman et al., 1951). Dog Dogs were fed a mixture of 10 parts by weight of dilauryl thiodipropionate and one part of thiodipropionic acid in the diet at concentrations of 0.1% and 3.0% of the acid-ester mixture. No untoward effects were noted over a period of 100 days (Lehman et al., 1951). Long-term studies Rat Thiodipropionic acid or its dilauryl or distearyl ester was fed to groups of 20 rats each at levels of 0%, 0.5%, 1.0% and 3.0% in the diet for a period of two years. No discernible adverse effects were observed in any of the experimental animals, as determined by growth rate, mortality, and pathological examination (Lehman et al., 1951). Comments: It would be desirable to have biochemical studies and observations on human subjects. EVALUATION Level causing no toxicological effect Rat: 30 000 ppm (3%) in the diet equivalent to 1500 mg/kg bw. Estimate of acceptable daily intake for man 0-3* mg/kg bw.** FURTHER WORK OR INFORMATION Desirable Biochemical studies and observation on human subjects. Specifications for the distearyl ester. REFERENCE Lehman, A. J. et al. (1951) Advanc. Food Res., 3, 197 * Calculated as thiodipropionic acid. ** The ADI does not apply to the distearyl ester as no specifications are available.
See Also: Toxicological Abbreviations