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


    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


    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.



         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.



         Analyses of diets and faeces of rats maintained for one month in
    diets containing 5 to 15% oxystearin, showed that 70% of the ingested
    oxystearin was absorbed. Liver lipids remained normal, but carcass
    lipids showed decreasing iodine values, with increasing dietary
    oxystearin (Mattson, 1951). In another experiment, utilization of the
    ether soluble material at three and 15 months in rats maintained on a
    15% oxystearin diet was 61 to 83% (Hodge, 1954).


    Acute toxicity


         Per os, intraperitoneally, LD50 have not been established.
    Female rats were able to tolerate doses as high as 15 g/kg without any
    marked ill-effects (Hodge, 1952).

    Short-term studies


         Groups each of 20 rats (10 of each sex) were maintained for 30
    days on diets containing 0, 0.5, 2.0 and 20% oxystearin. No deaths
    occurred. Retarded growth rates were reported at the 20% level. Organ
    weights were normal (Hodge, 1952).

         In another study, groups of 20 rats (10 of each sex) were
    maintained on diets containing 0, 0.15, 5, 10 and 15% oxystearin for
    one month. There was no effect on weight gain or haematological
    indices of blood. The weights of all organs were normal (Hodge, 1952).


         A single female dog tolerated a diet containing 25% oxystearin
    for one month. Haematologic indices of blood were normal as were
    urine, sugar and protein. At autopsy, organ weights were within normal
    limits and there were no compound related histological changes (Hodge,

         Groups each of four dogs (two of each sex) were fed diets
    containing 0, 0.25 and 2.5% oxystearin for one year. Observations
    included general condition, growth rate, food intake, urine analyses,
    haematologic indices of blood, organ weight and histopathology. All
    findings were negative (Hodge, 1954).

    Long-term studies


         300 mg per week of oxystearin was administered to the skin of 38
    mice in three doses for 75 weeks. The tumour index (% - weeks) was
    negative for a cotton-seed oil control, a 40% solution of oxystearin
    in cotton-seed oil, and a 40% unsaponifiable fraction of oxystearin in
    cotton-seed oil. The positive control methylcholanthrene had a tumour
    index of 89% (Horton, 1956).


         Groups each of 100 rats (50 of each sex) were fed a diet
    containing 0, 0.5, 5.0 and 15.0% oxystearin for two years. There was
    no indication that oxystearin shortened the life span. Growth rate and
    food consumption was normal, with the exception of the 15% group,
    where there was a slight retardation in growth during the first 90
    days, but this difference had disappeared by the end of the first
    year. Urine analyses gave normal values for sugar and protein.
    Haematological indices of blood were normal, with the exception of
    females at the 15% level, where there was a slight depression in
    haemoglobin and red blood cell counts. At autopsy, organ weights were
    normal with the exception of liver weight, at the 5 and 15% level. No
    histological changes occurred in the liver or other organs and tissues
    examined that could be related to the test substances. A study of
    femur length and radiographs of these bones showed no effect on bone
    structure (Hodge, 1954).

         A three generation reproduction study in rats selected from the
    0, 0.5 and 5% groups (16 females and eight males), showed that there
    were no effects on reproductive performance as measured by number of
    pregnancies, rats born, pups per litter, mortality 0-5 days, 6-12
    days; and average weight at end of 21 days. Organ weights of the F3b
    generation were within normal range; although organ/body weight ratios
    of test groups were greater than control, because of slightly lower
    body weight of these groups (Hodge, 1954).


         Metabolic studies indicate that the fatty acids are absorbed and
    utilized and there are adequate short-term and long-term studies
    available for assessment. There is no evidence of accumulation of the
    saturated fatty acids in the liver cells, although compositional
    changes in body fat are reported. Provision is made in the
    specification for limitation of epoxide content.


    Level causing no significant toxicological effect

         Rat: 50 000 ppm (5%) in the diet equivalent to 2500 mg/kg bw.

    Estimate of acceptable daily intake for man

         0-25 mg/kg bw.


    Hodge, H. (1952) Unpublished report, Procter & Gamble Co.

    Hodge, H. (1954) Unpublished report, Procter & Gamble Co.

    Horton, A. W. (1956) Unpublished report, Procter & Gamble Co.

    Mattson, F. H. (1951) cited in Hodge, H. (1952) Unpublished report
         submitted by Procter & Gamble Co.

    See Also:
       Toxicological Abbreviations
       Oxystearin (FAO Nutrition Meetings Report Series 46a)
       OXYSTEARIN (JECFA Evaluation)