Toxicological evaluation of some food
    additives including anticaking agents,
    antimicrobials, antioxidants, emulsifiers
    and thickening agents



    WHO FOOD ADDITIVES SERIES NO. 5







    The evaluations contained in this publication
    were prepared by the Joint FAO/WHO Expert
    Committee on Food Additives which met in Geneva,
    25 June - 4 July 19731

    World Health Organization
    Geneva
    1974

              

    1    Seventeenth Report of the Joint FAO/WHO Expert Committee on
    Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 539;
    FAO Nutrition Meetings Report Series, 1974, No. 53.

    TARTARIC ACID AND ITS POTASSIUM, POTASSIUM-SODIUM AND
    SODIUM SALTS

    Explanation

         These compounds have been evaluated for acceptable daily intake
    by the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1,
    Refs Nos. 6, 7 and 8) in 1961, 1963 and 1964.

         Since the previous evaluation, additional data have become
    available and are summarized and discussed in the following monograph.
    The previously published monographs have been expanded and are
    reproduced in their entirety below.

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         Tartaric acid is metabolically inert in the human body (Underhill
    et al., 1931a, b, c; Finkle, 1933).

         When taken by mouth, only about 20% of ingested tartrate is
    eliminated in the urine; the remainder is not absorbed as such since
    it is destroyed in the intestinal tract by bacterial action.

         Sodium tartrate in daily doses of up to 10 or even 20 g has been
    used in medical practice as a laxative. It has been tested for this
    action in a clinical study involving the application of daily doses of
    10 g of sodium tartrate to 26 patients for an average of 11.8 doses,
    giving laxative responses in 66% of the subjects. The only side
    effects noticed were nausea or vomiting (1.6%) and abdominal cramps
    (2.1%).

         Renal damage has been observed only after the intravenous
    administration of tartaric acid in doses of 0.2 to 0.3 g in rabbits
    and rats (Bodansky et al., 1942; Gold & Zahm, 1943).

    TOXICOLOGICAL STUDIES

    Acute toxicity

         In the mouse, the LD50 of the sodium salt administered by mouth
    was found to be 4360 mg/kg bw (Locke et al., 1942).

         Tartaric acid administered by stomach tube in a dose of
    5000 mg/ kg was fatal to a dog (Sourkes & Koppanyi, 1950).

         Three out of seven male rabbits died following oral
    administration of disodium tartrate in an average dose of 5290 mg/kg;
    while six male rabbits survived an average oral dose of 3680 mg/kg
    (Locke et al., 1942).

    Short-term studies

    Rabbit

         Three rabbits survived 17 consecutive daily feedings of disodium
    tartrate in an average dosage of 1150 mg/kg; whereas average dosages
    of 3680 mg/kg killed three out of six rabbits in six to 19 consecutive
    daily feedings (Locke et al., 1942).

    Dog

         Tartaric acid was administered in daily oral doses of 990 mg/kg
    to each of four dogs for 90 to 114 days. Casts appeared in the urine
    of three dogs; the blood chemistry remained normal except in one dog
    in which azotaemia developed with death in 90 days. Weight changes
    varied from a gain of 30% to a loss of 32% (Krop & Gold, 1945).

    Long-term studies

    Rat

         Groups of 24 rats (12 of each sex) were fed diets containing
    0.1%, 0.5%, 0.8% and 1.2% of tartaric acid for a period of two years.
    A group of 48 rats served as controls. No significant toxic effects
    were observed in any of the groups as determined by growth rate (for
    the first year), mortality throughout the experiment, and gross and
    microscopic findings at the end of the two-year period. An
    exceptionally thorough microscopic pathological examination was
    carried out (Fitzhugh & Nelson, 1947).

    Comments:

         The long-term study in rats showed no adverse effects at the
    highest level tested and they have been used medicinally for long
    periods. The evaluation is, therefore, based on the metabolic
    inertness of three tartrates and the fact that they are normal
    constituents of food.

    EVALUATION

    Estimate of acceptable daily intake for man

         0-30* mg/kg bw.

              
    *    Calculated as L(+)-tartaric acid.

    REFERENCES

    Bodansky, O., Gold, H. & Zahm, W. (1942) J. Amer. pharm. Ass,,
         sci. Ed., 31, 1

    Finkle, P. (1933) J. biol. Chem., 100, 349

    Fitzhugh, O, G. & Nelson, A. A. (1947) J. Amer. pharm. Ass., sci. Ed.,
         36, 217

    Gold, H. & Zahm, W. (1943) J. Amer. pharm. Ass., sci. Ed., 32, 173

    Krop, S. & Gold, H. (1945) J. Amer. pharm. Ass., sci. Ed., 34, 86

    Locke, A., Locke, R. B., Schlesinger, H. & Carr, H. (1942) J. Amer.
         pharm. Ass., sci. Ed., 31, 12

    Sourkes, T. L. & Koppanyi, T. (1950) J. Amer. pharm. Ass., sci. Ed.,
         39, 275

    Underhill, F. P., Leonard, C. S., Gross, E. G. & Joleski, T. C.
         (1931b) J. Pharmacol. exp. Ther., 43, 359

    Underhill, F. P., Peterman F. I., Joleski, T. C. & Leonard, C. S.
         (1931c) J. Pharmacol. exp. Ther., 43, 381

    Underhill, F. P., Peterman, F. I. & Krause, A. G. (1931a)
         J. Pharmacol. exp. Ther., 43, 351

    See Also:
       Toxicological Abbreviations