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    WORLD HEALTH ORGANIZATION






    Toxicological evaluation of some food colours, thickening
    agents, and certain other substancse



    WHO FOOD ADDITIVES SERIES NO. 8





    The evaluations contained in this publication were prepared
    by the Joint FAO/WHO Expert Committee on Food Additives which
    met in Geneva, 14-23 April 19751



    World Health Organization, Geneva 1975



    1 Nineteenth Report of the Joint FAO/WHO Expert Committee on Food
    Additives, Wld Hlth Org. techn. Rep. Ser., 1975, No. 576;
    FAO Nutrition Meetings Report Series, 1975, No. 55.

    The monographs contained in the present volume are
    also issued by the Food and Agriculture Organization
    of the United Nations, Rome, as
    FAO Nutrition Meetings Report Series, No. 55A



















    ISBN 92 4 166008 2

    (C) FAO and WHO 1975

    FERROUS GLUCONATE

    Explanation

         Gluconic acid has been evaluated for acceptable daily intake by
    the Joint FAO/WHO Expert Committee on Food Additives (see glucono-
    delta-lactone, Refs No. 13 and No. 35) in 1966 and 1974; iron ion has
    been evaluated in the context of the evaluation of iron oxides and
    hydrated iron oxides (Ref. No. 35) in 1974.

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         See reference 13, page 139; reference 35, pages 100 and 182.

    TOXICOLOGICAL STUDIES

    Acute toxicity
                                                                        

                                   LD50
    Species        Route      mg/kg body weight    Reference
                                                                        

    Mouse          Oral        3 700  145         Hoppe, 1955
                               6 600               Anonymous, 1967

    Rat            Oral        4 600  560         Hoppe, 1955

    Guinea-pig     Oral        2 100               Anonymous, 1967

    Rabbit         Oral        3 500               Anonymous, 1967

    Dog            Oral       >2 200               Hoppe, 1955
                                                                        

         Cats given doses of 100-1600 mg/kg for five days per week for two
    weeks showed no toxic effects.

         The therapeutic dose for the treatment of anaemia is 1.2-2.4 g
    per day, long-term treatment is given at doses of 1 g/day.

    Short-term studies   )
                         )  none available
    Long-term studies    )

    Comments:

         Although there are no specific short-term and long-term studies 
    available on ferrous gluconate, the knowledge of its conversion into 
    ferrous iron and gluconate ion together with the observations from the 
    long-standing therapeutic use of ferrous gluconate in man at doses of 
    1 g or more per day, constitute a basis for evaluation. Nutritional
    supplementation with iron has not been included in the consideration
    of this compound.

    EVALUATION

    Estimate of acceptable daily intake for man

         Acceptable daily intake not specified. 1*

    REFERENCES

    Anonymous (1967) Unpublished report submitted to the World Health
         Organization by Pfizer, Ltd.

    Hoppe, J. O., Agnew-Marcelli, G. M. & Tainter, M. L. (1955) An
         experimental study of the toxicity of ferrous gluconate,
         Am. J. Med. Sci., 230, 491-498

              

    1    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 an acceptable
    daily intake (ADI) in mg/kg bw is not deemed necessary.

    *      However the contribution from ferrous gluconate to the total
    dietary gluconic acid intake from all sources should be included in
    the ADI of gluconic acid.


    See Also:
       Toxicological Abbreviations
       FERROUS GLUCONATE (JECFA Evaluation)