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.

    PONCEAU 6R

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         No information available.

    TOXICOLOGICAL STUDIES

    Special studies on mutagenicity

         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 et al., 1960).

    Acute toxicity
                                                                        

    Animal     Route             LD50                 References
                                 per kg bw
                                                                        

    Rat        Intraperitoneal         > 2.0 g        Deutsche Forsch.
                                                      (1957)

    Rat        Intravenous       approx. 2.5 g         "          "
                                                                        

    Short-term studies

    Rat

         Ten rats were given subcutaneous twice weekly 0.5 ml of a 1%
    solution of the colour for 365 days. Total administrated quantity of
    the colour was 0.5 g/animal. Observation period 521 days. Two animals
    died during the experiment. No tumours were found (Deutsche Forsch.,
    1957).

    Guinea-pig

         In experiments with guinea-pigs it was found that this colour had
    no sensitization activity (Bär et al., 1960).

    Cat

         Nine cats were subjected to doses of a 5% aqueous solution 
    orally of 1 g on the first day and 0.1 g on the eighth and on the 
    nineteenth day. A negative test for Heinz bodies was obtained. There
    was no appearance of Heinz bodies (Deutsche Forsch., 1957).

    Long-term studies

    Rat

         This colour was fed to 10 rats at a level of 0.2% in the diet for
    417 days. The average daily dose was 0.1 g/kg bw and the total intake
    11 g/animal and the total intake about 51 g per animal. Nine of the 10
    animals lived to the end of the experiment, a total of 770 days. A
    carcinoma possibly originating from the pancreas was observed in one
    animal (Deutsche Forsch., 1957).

         Thirteen rats were fed this colour at a level of 1% in the
    drinking water for 176 days. The average daily dose was 1.4 g/kg bw.
    The animals were kept under observation for 861 days. No tumours were
    observed (Deutsche Forsch., 1957).

         Eleven rats received subcutaneous injections twice weekly of
    0.5 ml of a 1% solution for a period of 365 days, total administered
    0.5 g/animal. The animals were kept under observation for 784 days.
    Two died before the end of the experiment. A sarcoma in the
    mediastinum was found in one animal (Deutsche Forsch., 1957).

         Twelve rats were injected subcutaneously 40 mg of this colour
    as a 4% solution thrice monthly until a total of 1.8 g had been
    administered in 830 days. The animals were kept under observation for
    840 days. A benign sweat-gland adenoma was observed in one animal
    (Deutsche Forsch., 1957).

    OBSERVATIONS IN MAN

         Sensitivity reactions in people allergic to benzoates and aspirin
    have been reported (Michaelson & Juhlin, 1973).

    Comments:

         No information on metabolism is available on this colour. The
    long-term studies with this colour aimed solely at discovering
    potential carcinogenicity and therefore did not include the detailed
    observations usually made in these tests. Only small numbers of
    animals were used so that these tests are inadequate to assess long-
    term toxicity. Information on reproductive effects and embryotoxicity
    including teratogenicity is absent except for a teratology study in
    mice. Sensitization in man has been reported after oral intake.
    Adequate long-term studies in two species as well as reproduction,
    embryotoxicity including teratogenicity studies would be needed before
    this colour could be evaluated.

    EVALUATION

         Not possible on the data provided.

    REFERENCES

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

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

    Lück, H. & Rickerl, E. (1960) Zeitschr. Lebensmittel-Untersuch., 112,
         157

    Michaelson, G. & Juhlin, L. (1973) Brit. J. Derm., 88, 525

    See Also:
       Toxicological Abbreviations
       PONCEAU 6R (JECFA Evaluation)