INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    SUMMARY OF TOXICOLOGICAL DATA OF CERTAIN FOOD ADDITIVES



    WHO FOOD ADDITIVES SERIES NO. 12






    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

    CHRYSOINE

    EVALUATION FOR ACCEPTABLE DAILY INTAKE

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         No data available.

    Acute toxicity

                                                          

    Animal    Route          LD50 mg/kg       Reference
                             body weight
                                                          
    Rat       i.p.           >1.0 mg          Hecht, 1955
    Rat       i.v.           >1.0 mg          Hecht, 1955
                                                          

    Special studies

         The colour was tested for mutagenic effect in a concentration of
    0.5 g/100 ml in cultures of E. coli. No mutagenic effect was seen
    (Lück and Rickerl, 1960).

    Guinea-pig

         In studies with guinea-pigs no sensitization was seen (Bär and
    Griepentrog, 1960).

    Short-term toxicity

         Ten rats were given the colour at a level of 2% in drinking-water
    for 171 days, with an observation period of 350 days. No tumours were
    observed (Hecht, 1955).

    Long-term toxicity

    Mouse

         A total of 64 male and female mice produced by mixed breeding
    from five different strains were given a diet containing 1 mg per
    animal per day of the food colour. Mice at the age of 50 to 100 days
    were used. A number of the animals were sacrificed after an
    observation period of 500 days and the survivors of the rest after
    700 days. A total of 168 mice were used as negative controls.

    Positive control groups which were given o-aminoazotoluene and
    dimethylaminoazobenzene, were also included. In these groups the
    formation of liver tumours was noted after approximately 200 days.
    The incidence of tumours in mice receiving the colour was not
    significantly greater than in the negative controls (Waterman and
    Lignac, 1958).

    Rat

         Ten rats received a diet containing 2% of the colour in the diet
    for 171 days. The daily intake was 1.5 g per kg body weight and the
    total intake 51 g per animal. The observation period was 819 days. One
    subcutaneous fibrosarcoma was found (Hecht, 1955).

         Ten rats were given the colour at a level of 0.2% of the diet for
    417 days. The average daily intake was 0.1 g/kg body weight and the
    total intake amounted to 11 g per animal. The animals were kept under
    observation for a total of 989 days. No tumours were observed (Hecht,
    1955).

         No tumours were induced when 10 rats were given subcutaneous
    injections twice weekly of 0.5 ml of a 1% aqueous solution of this
    colour for one year. These animals were kept under observation for
    855 days (DFG, 1957).

    REFERENCES

    Hecht (1955) In: DFG - Deutsche Forschungsgemeinschaft, Bad Godesberg,
    Federal Republic of Germany, Farbstoff Kemmission (1957) Mitteilung 6
    (unpublished report)

    Lück, H. and Rickerl, E. (1960) Z. Lebensmitt.-Untersuch., 112,
    157

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

    Waterman, N. and Lignac, G. O. E. (1958) as summarized by H. van
    Genderen, Acta physiol, pharmacol, nerrly., 7, 35

    See Also:
       Toxicological Abbreviations
       CHRYSOINE (JECFA Evaluation)