INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF SOME FOOD COLOURS, ENZYMES, FLAVOUR ENHANCERS, THICKENING AGENTS, AND CERTAIN FOOD ADDITIVES WHO FOOD ADDITIVES SERIES 6 The evaluations contained in this publication were prepared by the Joint FAO/WHO Expert Committee on Food Additives which met in Rome, 4-13 June 19741 World Health Organization Geneva 1975 1 Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 557. FAO Nutrition Meetings Report Series, 1974, No. 54. CANTHAXANTHINE* Explanation This compound has been evaluated for acceptable daily intake by the Joint FAO/WHO Expert Committee on Food Additives (see Annex I, Ref. No. 10) in 1966. Since the previous evaluation no additional data have become available. The previously published monograph has been reproduced in its entirety below. BIOLOGICAL DATA BIOCHEMICAL ASPECTS Canthaxanthine does not exhibit provitamin A activity (Anonymous, 1966). TOXICOLOGICAL STUDIES Acute toxicity LD50 Animal Route mg/kg bw Reference Mouse Oral 10 000 Anonymous, 1966 Short-term studies Dog Groups of three male and three female dogs received 0, 100 and 400 mg/kg daily of canthaxanthine for 15 weeks. No significant effect was noted on body weight of control or test groups or on their general health (Anonymous, 1966). * This substance was detected for the first time in an edible mushroom, the chanterelle (Cantharellus cinnabarinus). It was subsequently shown to be present in the plumage and organs of flamingoes and various exotic birds such as the scarlet ibis (Guara rubra) and the roscato spoonbill (Ajaja ajaja). It has recently been detected in various crustacea and fish (trout, salmon) (Haxo. 1950; Fox, 1962a and b; Thommen & Wackernagel, 1963). Long-term studies Rat A three-generation study using 0 ppm and 1000 ppm in the diet revealed no adverse effect in any generation (Anonymous, 1966). In another experiment, 25-30 male and 25-30 female rats received 0%, 0.5%, 2% and 5% canthaxanthine in their diet for 93-98 weeks. No adverse effect was noted on food consumption and weight gain. Mortality and tumour incidence were not increased (Anonymous, 1966). Comments: This compound has been adequately tested in the rat and has no provitamin A activity. Evaluation is therefore based on the toxicological information provided. EVALUATION Level causing no toxicological effect Rat: 5% (= 50 000 ppm) in the diet equivalent to 2500 mg/kg bw Estimate of acceptable daily intake for man 0-25 mg/kg bw. REFERENCES Anonymous (1966) Hoffmann-La Roche, Unpublished report submitted to WHO Fox, D. L. (1962a) Comp. Biochem. Physiol., 6, 1 Fox, D. L. (1962b) Comp. Biochem. Physiol., 6, 305 Haxo F. (1950) Botan. Gaz., 122, 228 Thommen, H. & Wackernagel, H. (1963) Biochem. Biophys. Acta., 69. 387
See Also: Toxicological Abbreviations