INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF SOME
    FOOD COLOURS, EMULSIFIERS, STABILIZERS,
    ANTI-CAKING AGENTS AND CERTAIN
    OTHER SUBSTANCES



    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.


    INDANTHRENE BLUE

    Biological Data

    Biochemical aspects

    No data available

    Acute toxicity

                                                                     

    Animal    Route           LD50         Reference
                         mg/kg body weight 
                                                                     

    Rat       oral            2 000        Lu & Lavallée, 1964
                                                                     

    In experiments with guinea-pigs it was found that this colour has no
    sensitizing activity (Bär & Griepentrog, 1960). Cats received daily
    doses of 0.1 g/kg colour for seven days. No increase in Heinz bodies
    was noted in the blood of test animals (Oettel et al., 1965).

    Short-term studies

    Rat. This colour was fed to 21 rats at 0.1 per cent. in the diet for
    184 days. No increased tumour incidence was observed. Eight rats which
    survived for more than 400 days (432-683) showed no abnormality.
    Twelve rats also received monthly subcutaneous injections of 2 ml of a
    2.5 per cent. aqueous suspension of the colour. Six rats survived for
    417-570 days. No tumours were seen at the site of injection (Umeda,
    1956).

    Long-term studies

    Rat. Eighty-five rats received this colour at 0.1 per cent. in their
    diet. No increased tumour incidence was observed over their life-span.
    Twenty rats, given one per cent. of the colour in their diet for two
    years, showed no increased tumour incidence. Eleven animals died
    before the end of the experiment DFG, 1957).

    Groups of 20 male and 20 female rats or more were fed diets containing
    0 ppm and one per cent. of the colour for two years. A similar test
    group was formed from the first filial generation and was fed the one
    per cent. level for a similar period. No deleterious effects appeared
    in the test groups, and gross add microscopic examination of the
    animals disclosed no changes attributable to the test diet. There was
    no significant difference in tumour incidence between the groups
    (Oettel et al., 1965).

    Comments

    The available long-term study in rats provides useful information and
    does not indicate carcinogenic potential but the other toxicological
    data are rather sparse.

    EVALUATION

    One per cent. (= 10 000 ppm) in the diet equivalent to 500 g/kg
    bodyweight per day.

    Estimate of acceptable daily intake for man:

                                           mg/kg body-weight

    Temporary acceptance                         0 - 1

    Further work required by June 1974

    Metabolic studies in several species, preferably including man;
    two-year studies in a non-rodent mammalian species, and long-term
    studies in the rat or another species.

    REFERENCES

    Bär, F. & Griepentrog, F. (1960) Med. U. Ernär.,  1, 9

    Deutsche Forschungsgemeinschaft,.Farbstoff Kommission (1957)
    Mitteilung 6

    Lu, F. C. & Lavallée, A. (1964) Canad. pharm. J., 97, 30

    Oettel, H., Frohberg, H., Nothdurft, H. & Wilhelm, G. (1965) Arch.
    für Toxikol., 21, 9

    Umeda, M. (1956) Gann 47, 57
    

    See Also:
       Toxicological Abbreviations