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.

    ASCORBYL PALMITATE AND STEARATE

    Explanation

         Ascorbyl palmitate was evaluated for acceptable daily intake by
    the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1,
    Ref. No. 6) in 1961 and ascorbyl stearate in 1969 (see Annex 1, Ref.
    No. 20).

         The previously published monographs are reproduced in their
    entirety below.

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         No information available.

    TOXICOLOGICAL STUDIES

    Special studies

         No information available.

    Acute toxicity
                                                                        

    Animal          Route          LD50               References
                                   (kg bw)
                                                                        

    Mouse           oral           25 g               Tokita
                                                      (undated)
                                                                        

    Short-term studies

    Rat

         Groups of 10 young rats were fed diets containing L-ascorbyl
    stearate in concentrations providing 100, 200, 500, 1000 and
    3000 mg/kg bw for six months. No adverse effects were noted (Tokita).

         Groups of 10 rats each were fed for nine months on normal diets 
    and diets containing 2% and 5% of ascorbyl palmitate. At the 5% level
    the growth rate was significantly retarded, and two of the 10 rats had
    numerous bladder stones and hyperplasia of the bladder epithelium.
    Another rat in this group showed an inflammatory condition in the
    kidney. There was a slight retardation of growth in the rats on the

    diet containing 2% of ascorbyl palmitate, but there were no
    significant differences between these rats and the controls in respect
    of mortality and histopathology (Fitzhugh & Nelson, 1946).

    Long-term studies

    Rat

         Heat-treated lard containing 1% or 5% of L-ascorbyl palmitate
    (0.05% or 0.25% of the total diet) was fed for two years to groups of
    10 rats each. No adverse effects were observed in any of the
    experimental animals as determined by growth rate, mortality and
    pathological examination (Fitzhugh & Nelson, 1946).

         No direct evidence is available on the long-term effects of
    L-ascorbyl stearate. However, L-ascorbyl palmitate was fed to rats for
    two years (Fitzhugh & Nelson, 1946), no adverse effects being noted at
    the 0.5% or 0.25% levels as determined by growth rate, mortality and
    pathological examination. Food grade palmitic acid of that time period
    normally contained significant amounts of stearic acid as evidenced by
    a statement from a major United States producer of fatty acids. It is
    a reasonable inference that the L-ascorbyl palmitate used in the
    feeding study probably contained L-ascorbyl stearate.

    Comments:

         Since the material tested contained 5 to 20% stearate and 80 to
    95% palmitate, the study of commercial ascorbyl palmitate can be used
    for evaluation. The adverse effect in rodents of bladder stone
    formation are not considered significant for man.

    EVALUATION

    Level causing no toxicological effect

         2500 ppm (0.25%) in the diet equivalent to 125 mg/kg bw

    Estimate of acceptable daily intake for man

         0-1.25* mg/kg bw

    REFERENCES

    Fitzhugh, O. G. & Nelson, A. A. (1946) Proc. Soc. exp. Biol., 61, 195

    Tokita (undated) Unpublished report from Toho University, submitted
         1968

              

    *    As ascorbyl stearate or ascorbyl palmitate, or the sum of both.

    See Also:
       Toxicological Abbreviations