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.


    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

    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).


    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.


    Not possible on the data available.


    Bär, F. & Griepentrog, F. (1960) Med. u. Ernâhr., 1, 99

    Deutsche Forschungsgemeinschaft (1957) Fabstoff Komission, Mitteilung,

    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