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    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.


    STEARYL CITRATE

    Explanation

         This substance has been evaluated for acceptable daily intake by
    the Joint FAO/WHO Expert Committee on Food additives (see Annex 1,
    Ref. No. 20) in 1969.

         Since the previous evaluation, additional data have become
    available and are summarized and discussed in the following monograph.
    The previously published monograph has been revised and is reproduced
    in its entirety below.

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         Stearyl citrate upon enzymic hydrolysis could give rise to
    stearyl alcohol, and citric acid. There is evidence that this
    hydrolysis readily occurs in the dog, and to a lesser extent in the
    rat (Calbert, C. E. et al., 1951).

         The effect of stearyl citrate on fat absorption and digestibility
    and the digestibility of the compound itself were studied in rats and
    dogs. Four groups of eight to 10 female rats were given 15% margarine
    in the diet with or without addition of stearyl citrate at a rate of
    5% of margarine. Fat absorption after four and six hours was
    unaffected by the presence of the additive. Three groups of nine to
    10 female rats were fed 0.13%, 2.5% and 10% stearyl citrate, margarine
    being added to bring the total level of fat plus test substance to 25%
    of the diet. Digestibility of fat was determined by eight-day balance
    studies; the normal value of 95% was reduced respectively to 77% and
    71% at 2.5% and 10% level. The digestibility of stearyl citrate was
    55%, 6% and 20%, at 0.13%, 2.5% and 20% level respectively.
    Digestibility of fat in dogs was studied over 12 days in two groups of
    three, one as control, the other with 3% stearyl citrate in the diet.
    Normal fat digestibility was 95% in the controls and 80% in the test
    diet, the digestibility of stearyl citrate was 52% at 3% level
    (Calbert et al., 1951).

    TOXICOLOGICAL STUDIES

    Acute toxicity
                                                              
    Animal    Route     LD50 mg/kg bw       Reference
                                                              
    Rat       oral      > 5 400            Deuel et al., 1951

    Dog       oral      > 5 000            Deuel et al., 1951
                                                              

    Short-term studies

    Rat

         Groups of 10 male and 10 female rats were fed diets containing
    0%, 1.3%, 2.5%, 5% and 10% stearyl citrate for six weeks. There was no
    demonstrable effect on growth (Deuel et al., 1951). In another
    experiment four groups, of 19 male and female weanling rats each, were
    fed for 10 weeks on a diet containing unheated margarine, margarine
    heated continuously for eight hours to 205C, 0.86% stearyl citrate in
    similarly treated margarine and 0.68% stearyl citrate potato chips
    fried in margarine with this additive. Growth rates were identical in
    all four groups (Deuel et al., 1951).

         Three groups of 14 to 15 weanling rats were kept for 10 weeks on
    a diet containing 0%, 1.9% and 9.5% stearyl citrate, mated when 13
    weeks old and continued on the same diet throughout pregnancy and
    lactation. The second generation was weaned at three weeks and treated
    like the parent generation. Studies were continued to the weaning of
    the fifth generation. No deleterious effects on litter size,
    fertility, lactation and body weight on growth of progeny were noted
    (Deuel et al., 1951).

    Rabbit

         Groups of eight rabbits received diets containing 0%, 2% and 10%
    stearyl citrate for six weeks. There was no demonstrable effect on
    growth except for one animal which lost weight during the early test
    when it failed to eat; this rabbit began to regain its weight during
    the last week of the test. A complete histopathological examination
    made on all eight rabbits of the control and 10% stearyl citrate group
    showed no pathological findings (Deuel et al., 1951).

    Dog

         Two groups of four animals each were fed 0% and 3% stearyl
    citrate in the diet for 12 weeks. No difference in weight gain was
    noted between controls and treated animals at four, eight and 12
    weeks. Haemoglobin levels at the end of the period were practically
    identical for the two groups. Histopathological examination of the
    livers and kidneys showed no pathological findings (Deuel et al.,
    1951).

    Long-term studies

    Rat

         Groups of 10 male and 10 female rats were fed for two years on
    diets containing 0%, 0.5%, 2% and 10% stearyl citrate. From 55% to 65%
    survived in the test groups compared with 44% in the control group. No

    variations in weight gains were noted between test animals and
    controls. A complete histopathological examination was carried out in
    the animals which received 10% stearyl citrate. No specific
    pathological findings were seen; there were metastatic calcification
    and tumours not significantly different from the controls (Deuel et
    al., 1951).

    Comments:

         Addition of this material to the diet reduces absorption of fat
    in the rat and to a lesser extent in the dog. The 10% level appears to
    provide no adverse effects in the long-term studies in the rat. The
    further work desirable is adequate short-term studies in two species
    (one a non-rodent mammalian species); some of these studies should use
    combinations with hard fats. Emphasis should be placed on evaluation
    of kidney function.

    EVALUATION

    Level causing no toxicological effect

         Rat: 100 000 ppm (10%) in the diet equivalent to 5000 mg/kg bw
    per day.

    Estimate of acceptable daily intake for man

         0-50 mg/kg bw.

    FURTHER WORK OR INFORMATION

    Desirable

         Short-term studies in two species (one a non-rodent mammalian
    species); some of these studies should use combinations with hard
    fats. Emphasis should be placed on evaluation of kidney function.

    REFERENCES

    Calbert, C. E. et al. (1951) Food Res., 16, 294

    Deuel, H. J. jr et al. (1951) Food Res., 16, 258


    See Also:
       Toxicological Abbreviations
       Stearyl citrate  (FAO Nutrition Meetings Report Series 46a)
       STEARYL CITRATE (JECFA Evaluation)