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.


    ASCORBYL STEARATE

    Biological Data

    Biochemical aspects

    No information available.

    Special studies

    No information available.

    Acute toxicity

                                                                

    Animal    Route          LD50           References
                        (kg body-weight)
                                                                

    Mouse     oral            25 g          Tokita
                                            (undated)
                                                                

    Short-term studies

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

    Long-term studies

    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
    per cent. or 0.25 per cent. 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

    For the assessment of this substance collateral evidence is provided
    by the long-term study on the ascorbyl palmitate reviewed in the
    evaluation of ascorbyl palmitate.1 The material investigated
    contained 5-20 per cent. stearate. The adverse effects in relation to
    bladder stone formation then observed (as reflected in the previous
    lower ADI of ascorbyl palmitate) have been shown more recently to be
    associated with the presence of claculi in the bladder of rodents. It
    is therefore reasonable to allocate a higher ADI for both the ascorbyl
    palmitate and ascorbyl stearate. Long-term studies in the rat using
    well-defined individual compounds are desirable.

    EVALUATION

    Level causing no significant toxicological effect in the rat

    0.25 per cent. (= 2500 ppm) in the diet equivalent to 125 mg/kg
    body-weight/ day.

    Estimate of acceptable daily intake for man

                                            mg/kg body-weight

    Unconditional acceptance                    0 - 1.25a

    REFERENCES

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

    Tokita (undated) Unpublished report from Toho University, submitted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



                   

    1 See 6th Report of the Joint FAO/WHO Expert Committee on Food
    Additives (1962) Wld Hlth Org. techn. Rep. Ser., 228.

    a As the sum of ascorbyl stearate or ascorbyl palmitate or both.

    

    See Also:
       Toxicological Abbreviations
       ASCORBYL STEARATE (JECFA Evaluation)