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.

    BEET RED

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         No information available.

    TOXICOLOGICAL STUDIES

    Special studies on reproduction

    Rat

         From the 32 rats treated with betanin to a level of 17 g/animal
    was produced an F2 generation of 24 pups. These received a total of
    25 g betanin per animal and showed a mean life span of 800 days. Only
    2 mammary fibro adenomata and no other adverse effects were seen in
    the test group (Druckrey, 1959).

    Acute toxicity

         No death could be obtained on oral administration of high doses
    (Druckrey, 1959).

    Short-term studies

         None available.

    Long-term studies

    Rat

         A group of 32 male and female rats received betanin in their
    drinking water to a total dose of 17 g per animal. The mean life span
    was 845 days, the last animal dying at 1220 days. A group of 56 rats
    acted as controls. In the test group occurred 1 intraperitoneal
    sarcoma and 1 mammary fibro adenoma, in the controls 2 sarcomas and 2
    fibro adenomata (Druckrey, 1959).

         A group of 27 male and female rats received s.c. injections of
    betanin (concentration not stated) and a control group of 56 rats was
    also studied. The mean life span of the test animals was similar to
    that of controls at 800 days, the maximum life span 1250 days. The
    test animals developed 5 fibro adenomata of the breast and 2
    unidentified tumours, the controls had 4 fibro adenomata of the
    breast, 1 renal adenoma, 1 sarcoma and 3 unidentified tumours
    (Druckrey, 1959).

    Comments:

         There is no information available on the metabolism of this
    naturally occurring betanin. The available long-term and reproduction
    studies are inadequate because only a few parameters were examined and
    many other essential observations have not been reported. No specific
    information is available on embryotoxicity including teratogenicity.
    This colour is, however, a normal constituent of food. Although the
    primary criteria are the same for evaluating the safety of food
    colours whether of natural or synthetic origin, consideration must be
    given to the quantities of food colour ingested as a result of
    technological use relative to its ingestion as an ingredient of food.
    This and the availability of an adequate specification permits
    evaluation in the absence of a full range of toxicological
    investigations.

    EVALUATION

         ADI not specified.*,**

    FURTHER WORK OR INFORMATION

         Required by June 1978

         (a)  metabolic studies preferably including man;

         (b)  adequate long-term study in one acceptable species.

    REFERENCE

    Druckrey, H. (1959) Personal communication

              

    *    The statement "ADI not specified" means that, on the basis of the
    available data (toxicological, biochemical, and other), the total
    daily intake of the substance, arising from its use or uses at the
    levels necessary to achieve the desired effect and from its acceptable
    background in food, does not, in the opinion of the Committee,
    represent a hazard to health. For this reason, and for the reasons
    stated in individual evaluations, the establishment of any acceptable
    daily intake (ADI) in mg per kg of body weight is not deemed
    necessary.

    **   Temporary.
    

    See Also:
       Toxicological Abbreviations
       Beet red (WHO Food Additives Series 22)
       BEET RED (JECFA Evaluation)