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. BRILLIANT BLACK BN Biological Data Biochemical aspects At concentrations of 2-400 mg/litre the colour inhibits pepsin but not lipase (Diemair & Häusser, 1951) and at 12.5 mg/1itre it inhibits trypsin inconsistently (Diemair & Boeckhaff, 1953). Intravenous injection into rabbits and dogs of 50 mg/kg produced only small amounts in the urine (Hecht, 1960). Heated in the presence of reducing sugars the colour is partially decomposed and gives an orange derivative, isolated by paper chromatography, which is the disodium salt of 4'(4-sulfo-1-phenylazo) 1'amino 7'sulfonaphtalene (Saent Lascano Ruiz, Laroche, 1960). Acute toxicity Animal Route LD50 Reference mg/kg body weight Oral >5 000 DFG, 1957 >2 000 Gaunt et al., 1967 I.P. 500-1 000 Gaunt et al., 1967 Oral >5 000 Gaunt et al, 1967 Rat I.P. 1 100 Gaunt at al., 1967 >2 000 DFG, 1957 I.V. 2 500 DFG, 1957 approx. Five rats were given 1.5 g/kg body weight orally for 22 days. No Heinz bodies were found (DFG, 1957). In an experiment with guinea-pigs it was found that this colour had no sensitization activity (Bar & Griepentrog, 1960). A cat fed 0.1 g/kg body weight per day for seven days developed no Heinz bodies (DFG, 1957). Special studies The colour was tested for mutagenic effect in a concentration of 0.5 g/100 ml in cultures of Escherichia coli. No mutagenic effect was found (Lück & Richerl, 1960). Short-term studies Rat: Groups of 16 male and 16 female weanling rats were fed diets containing 0, 0.3 per cent., 1.0 per cent. and 3.0 per cent. colour for 90 days. Growth retardation associated with diminished food intake was evident only in males at the three per cent. level. This was shown by a paired feeding test. Haematological examination, liver and kidney function tests were normal. Organ weight of testes and kidneys increased in males at the three per cent. level only. No untoward histopathological findings were seen (Gaunt et al., 1967). Long-term studies Fifty rats were given 0.5 per cent. of the colour in drinking water for 337 days. The tumours found at 740 days were of the same distribution as in 50 controls. Another 10 rats received the colour for 543 days and were observed for 822 days. No tumours were noted. Another group of 15 rats were fed the colour at 0.5 per cent. in the drinking water for 360 days and developed no tumours by 800 days. Fifty animals of the second generation continued with 0.5 per cent. in the drinking water and had developed no tumours after 425 days (Hecht, 1960). Ten rats were fed the colour at 0.1 per cent. of the diet for 410 days and were observed for 761 days. One animal died prematurely. No tumours were observed (Hecht & Wingler, 1952; DFG, 1957). Another group of 10 rats were given twice weekly subcutaneous injections of a one per cent. solution of the colour for 365 days. Animals were observed for 816 days. Two rats died but no tumours were observed (DFG, 1957). Another group of 25 rats received twice weekly subcutaneous injections of a two per cent. solution of the colour for 280 days. No tumours had appeared by 525 days (Hecht, 1960). Comments Little is known of the metabolism and only a long-term study on tumour incidence in one species is available. A two-year study in a non-rodent mammalian species is also required. Parenteral administration does not appear to induce any local neoplastic changes. EVALUATION Not possible on the data available. REFERENCES Bär, F. & Griepentrog, F. (1960) Med. u. Ernâhr., 1, 99 Deutsche Forschungsgemeinschaft (1957) Fabstoff Komission, Mitteilung, 6 Diemair, W. & Häusser, H. (1951) Z. Lebensmitt.-Untersuch., 92, 165 Diemair, W. & Boekhoff, K. (1953) Z. Analyt. Chem., 139, 35 Gaunt, I. F. et al. (1967) Fd. Cosmet. Toxicol., 5, 171 Hecht, G. & Wingler, A. (1952) Arzneimittel-Forsch., 2, 192 Hecht, G. (1960) Unpublished report to Farbenfabriken Bayer, dated 1 December 1960 Lück, H. & Richerl E. (1960) Z. Lensmitt.-Untersuch., 112, 157 Saenz Lascano Ruiz, I. & Laroche, C. (1960) Ann. Fals. Exp. Chim., 53, 581
See Also: Toxicological Abbreviations