The data contained in this document were examined by the
    Joint FAO/WHO Expert Committee on Food Additives*
    Geneva, 18-27 April 1977

    Food and Agriculture Organization of the United Nations
    World Health Organization

    * Twenty-first Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Geneva, 1977, WHO Technical Report Series No. 617

    30 BLACK 7984




         The dye is poorly absorbed from the gastrointestinal tract after
    oral administration to rats. Up to 5 g/kg body weight leaves the rat
    carcass unstained but faeces are black. When given parenterally to
    mice the whole animal is coloured intensely, this being fully
    reversible after 12 hours. After i.v. injection of 50 mg/kg body
    weight into dogs up to 10% is excreted unchanged in the urine some
    13% appears as a coloured metabolite (monoazo naphthyl-amino
    disulfonic acid) while 80% are not accounted for. Only traces of
    p-sulfanilic acid appear in the urine. Rapid reductive splitting of
    the azo linkages between the two naphthalene rings occurs (Hecht,

    Acute toxicity


    Animal    Route          LD50 mg/kg       Reference
                             body weight

    Mouse     intravenous    1 000 mg         Hecht, 1960a
    Rat       oral           5 000 mg         Hecht, 1960a

         Rats given 1.5 g/kg body weight orally for 19 days showed no
    Heinz bodies (Hecht, 1960a). Cats given 100 mg/kg body weight/day for
    eight days and 5 mg/kg body weight/day for 31 days showed no increase
    in Heinz bodies (Hecht, 1960a).

    Special tests


         When given s.c. 10 doses of 1 ml of a 0.05-0.1% isotonic saline
    solution of the colour for a period of 21 days no intolerance was
    noted. A challenge test for sensitization after 14 days was negative
    (Hecht, 196Oa).


         Repeated intracutaneous injections of 0.1 ml of a 5% aqueous
    solution over a few days produced no skin abnormalities (Hecht,

    Short-term studies


         The dye was fed to 10 rats for 200 days at a level of 0.1% in the
    diet. The animals grew normally and no toxic effects were noted
    (Hecht, 1960a).

    Long-term studies


         Two groups of 10 male rats were given 0 or 0.5% of the dye in
    their drinking water (0.038 g/kg body weight) for 543 days. After this
    period animals continued on normal diet for up to 822 days. The total
    intake of colour was approximately 53 g/animal. No abnormalities as
    regards growth, survival or histopathology were seen and no tumours
    were found (Hecht, 1960a).

         In another experiment two groups of 25 male and 25 female rats
    were given 0 or 0.5% of the colour (average 600 mg/kg body weight) in
    their drinking water for 337 days and observed for up to 1184 days.
    Controls were observed up to 1013 days. After 337 days the animals
    received normal drinking water. Mortality of males only was greater in
    the test group after 24 months compared with male controls. At 30
    months six test females and one control female survived. Nine mammary
    fibro-adenomas of the breast and one ovarian tumour occurred in female
    test animals, one sarcoma and five breast fibroadenomas in control
    females. No extensive pathology was done (Hecht, 1960b).

         One group of 10 male rats was given twice a week 0.5 ml of a 1%
    solution (5 mg) s.c. After 105 injections (365 days) the
    administration was stopped and the last animal died on the six hundred
    and twenty-seventh day. Average survival was 600 days. No subcutaneous
    tumours were found (Hecht, 1960). In another experiment a group of 25
    male rats were given s.c. 0.5 ml of 2% solution (equiv. 10 mg) for 72
    administrations (280 days). The last animal died on the one thousand
    and twenty-seventh day (average 525 days). No subcutaneous or other
    tumours were found (Hecht, 1960a).

         A more recent study (Gangolli et al., 1972), in which Black 7984
    was compared with other dye-stuffs for protein binding and their
    ability to produce subcutaneous sarcomas, showed that Black 7984

    produced very mild, self-limiting local reactions although its ability
    to bind to serum proteins was high. This work supported the conclusion
    that food colourings which can firmly bind to proteins influence the
    rate of absorption from the site of subcutaneous injection which leads
    to the eventual production of local sarcomas.

    Reproduction studies


         Four females and one male from each group of the second rat study
    were used as parent generation to breed an F1 generation after eight
    months on 0.5% Black 7984 in their drinking water. The F1 pups were
    kept for 110 days, after weaning on 0.5% dye in their drinking water
    and killed after 146 days. From 19 F1 females an F2 generation was
    bred. Twenty-three F2 females were kept on 0.5% dye in their drinking
    water after weaning for 360 days and then continued on normal drinking
    water up to 800 days. A similar group of 18 F2 male and 25 F2 female
    controls were observed for a similar period of 28 months. No
    abnormalities were noted regarding growth, reproduction or any other
    effects (Hecht, 1960b).


    Gangolli, S. D., Grasso, P., Goldberg, L. and Hooson, J. (1972)
    Protein binding by food colorings in relation to the production of
    subcutaneous sarcoma, Fd. Cosmet. Toxicol, 10, 449-462

    Hecht, G. (1960a) quoted in R. Truhaut (1962), Estratto dei Rendiconti
    dell' Instituto Superiore di Sanita, XXV, 796-920 (Quotation in text

    Hecht, G. (1960b) Private communication to WHO. Typewritten
    unpublished document from Forbenfebrik Bayer AG. Paper transmitted to
    the Subcommittee on the Health Control of Foodstuffs of the Council of

    See Also:
       Toxicological Abbreviations
       BLACK 7984 (JECFA Evaluation)