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






         The colour was injected intravenously into rats. The bile was
    collected for six hours and analysed. The recovery of the colour was
    an average of 23% (10-40%) of the administered quantity (Ryan and
    Wright, 1961).

    Effect on enzymes

         After a prolonged administration to two generations of rats with
    a daily dose of 50 mg/rat the vitamin A content of the liver showed a
    three-to four-fold decrease. The glutathione content of the spleen was
    increased in the first generation, not in the second (Galea et al.,

         At 6.66 mg dye/ml succinic acid dehydrase was inhibited and
    xanthine oxidase was weakly inhibited (Schormüller and Schulz, 1958).

         The products of air-oxidation or reduction and subsequent
    air-oxidation of Orange GGN inhibited lactic acid fermentation of milk
    (Eisenbrand and Lang, 1960; Lang, 1967).


    Special studies on carcinogenicity

         A group of 10 male rats was fed 1-(m-sulfophenylazo)-2-naphthol-
    6-sulfonic acid, disodium salt at 0.02-0.1% in food (10 mg/kg body
    weight per day) to assess carcinogenicity. After at least 410 days,
    there were nine survivors but no tumours were observed. There was no
    increase in Heinz bodies (Hecht and Wingler, 1952).

         Five male and five female rats were given in their drinking water
    0% or 1.0% of the colour for 266 days. The average daily intake was
    0.75 g/kg body weight. Total intake was 50 g/animal. Observation
    period was 545 days. No tumours were found (Deutsche Forsch., 1957).

         Five male and five female rats were given this colour at a level
    of 0% or 1% in the drinking water for 262 days. The average daily
    intake was 0.9 g/kg body weight. The total intake of the colour was
    52 g/animal. The animals were kept under observation for 832 days. Two
    of the animals died before the end of the experiment. No tumours were
    observed (Deutsche Forsch., 1957).

         Ten rats were fed at a level of 0.1% in the diet for a period of
    410 days. The average daily dose was 0.06 g/kg. The total intake
    6 g/animal. The animals were kept under observation for 761 days. One
    animal died before the end of the experiment. No tumours were observed
    (Deutsche Forsch., 1957; Hecht and Wingler, 1952).

         Two groups of 10 rats were subjected to subcutaneous injections
    of 0.5 ml of a 1% solution of the colour twice weekly for respectively
    364 and 365 days. Total intake in both groups of rats was
    0.5 g/animal. The animals were kept under observation for 521 and
    839 days. Two animals died before the end of the experiment. In one
    animal a poly-morphocellular tumour in the lung and in another rat a
    fibromyoma at the site of injection was observed (Deutsche Forsch.,

    Other special studies

         This 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 and Rickerl, 1960). Five rats were given 1.4 g of
    colour per kg body weight for 22 days. No Heinz bodies were found in
    the blood of the animals (Deutsche Forsch., 1957). In experiments with
    guinea-pigs it was found that this colour has no sensitization
    activity (Bär and Griepentrog, 1960). A negative test for Heinz bodies
    was obtained on a cat given 0.1 g/kg orally for seven days (Deutsche
    Forsch., 1957; Hecht and Wingler, 1952). In another test in cats given
    200 mg/kg orally for six days no Heinz bodies were found (Wingler,

    Acute toxicity


    Animal    Route     LD50 per kg       References
                        body weight

    Mouse     oral      >5.0 g            Deutsche Forsch, 1957

    Rat       i.p.      >2.0 g            Deutsche Forsch, 1957
                        >1.0 g            A.B. Shporn et al., 1958

    Rat       i.v.      Approx. 2.5 g     Deutsche Forsch, 1957

    Long-term studies

    Mouse, rat

         Mice and rats were treated with Orange GGN to assess chronic
    toxicity. No effects on haematology, clycaemia, or protein synthesis
    were observed (Sporn and Heilpern, 1958).


         Rats were treated with Orange GGN to assess chronic toxicity at
    about 125 mg/kg daily. After prolonged administration, vitamin A
    content of liver decreased three- to four-fold with parallel decrease
    in glutathione in liver and spleen (Galea et al., 1962).

         See also special studies on carcinogenicity.


    Bär F. and Griepentrog, F. (1960) Die Allergenwirkung von Fremden
    Stoffen in den Lebensmitteln, Med. u. Ernähr., 1, 99-104

    Deutsche Forschungsgemeinschaft (1957) Bad Godesberg, Federal Republic
    of Germany, Farbstoff Kommission, Mitteilung, 6, 32

    Eisenbrand, J. and Lang, E. (1960) Influence of azo dyes on acid
    production of lactic acid bacteria. V. Action of cleavage and air-
    oxidation products of Brilliant Black BN, Chrysoin, S., Echtgelb
    Extra, Yellow 27175 N, Yellow Orange S, Orange GGN and Tartrzine,
    Z. Lebensm.-Untersuch. u.-Forsch., 113, 48-52

    Galea, V., Ariesan, Maria and Luputiu, Georgeta (1962) Biochemical
    alterations in the liver of white rats under the influence of
    synthetic organic dyes, Orange GGN and Amaranth, Farmacia
    (Bucharest), 10, 531-533

    Hecht, G. and Wingler, A. (1952) Biological study and suitable
    chemical constitution of some azo dyes for food colouring,
    Arzneimittel-Forsch., 2, 192-196

    Lang, E. (1967) Cleavage products of the azo dyes, Brilliant Black BN,
    Yellow Orange S, Orange GGN and their effect on acid production by
    lactic acid bacteria, Z. Lebensm.-Unters. Forsch., 132, 363-367

    Lück, H. and Rickerl, E. (1960) Lebensmittelzusatzstoffe und mutagene
    Wirkung, Z. Lebensmitt.-Untersuch. u.-Forsch., 112, 157-174

    Ryan, A. J. and Wright, S. E. (1961) The excretion of some azo dyes in
    rat bile, J. Pharm. Pharmac., 13, 492-495

    Schormüller, J. and Schulz, W. B. (1958) Action of food colour on the
    succinic acid dehydrase and xanthine oxidase in vitro, Z. Lebensm.
    -Untersuch. u.-Forsch., 108, 9-17

    Shporn, A. B., Peretsiana, Zh. M. and Gal'perin, S. (1958) Studies on
    the toxicity of chemicals added to food, Voprosy Pitaniya, 17, No.
    4, 48-53

    Sporn, A. and Heilpern, J. (1958) The toxicity of the Orange GGN food
    colouring, Igiena, 7, 235-243

    Wingler, A. (1953) Über Farbstoffe zur Lebensmittelfärbung. Zur Frage
    der Krebsgefährdung, Z. Krebsforschung., 59, 134-155

    See Also:
       Toxicological Abbreviations
       ORANGE GGN (JECFA Evaluation)