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.


    HYDROXYPROPYL DISTARCH GLYCEROL

    Modification is performed by the use of 0.1 per cent. epichlorhydrin
    and 10 per cent. propylene oxide. Cross-linkage would be no greater
    than expected on edification with 0.1 per cent. epichlorhydrin.
    Substitution by treatment with 10 per cent. propylene oxide would
    probably add no more than 15-20 ether linkages per 100 glucopyranose
    units.

    Biological Data

    Biochemical aspects

    None available.

    Acute toxicity

    None available.

    Short-term studies

    Rat. Groups of 25 male and 25 female rats were fed for 13 weeks on a
    diet containing one per cent. and five per cent. of modified starch or
    five per cent. of native starch. The general appearance and behaviour
    of test rats was comparable with the controls. One male and one female
    rat died at the lowest test level. Growth, feed consumption,
    bodyweight haematology at one and three months, urinalysis at one and
    three months, gross and histopathological findings were comparable in
    all groups (Knapp, 1967a).

    Dog. Three groups of four male and four female beagle dogs were
    given in their diet one per cent, and five per cent. of modified
    starch or five per cent. of native starch for 13 weeks. Haematological
    studies, blood sugar, blood urea, serum GPT and alkaline phosphatase
    as well as urinalysis were comparable for all groups. Appearance and
    behaviour were normal. Body weight changes were unrelated to the
    administration of the test substance. Gross and histopathology showed
    no consistent abnormalities. Organ weights of thyroid, heart, liver,
    spleen, kidneys, adrenals and testes showed no test-related changes
    (Knapp, 1967b).

    Long-term studies

    None available.

    Comments

    No biochemical data are available on enzymatic hydrolosis or the fate
    of the moiety containing propylene glycol radical. Metabolic studies
    in man are desirable. The 90-day tests reveal no significant
    abnormalities and are used as a basis for evaluation.

    EVALUATION

    Level causing no toxicological effect in the rat

    Five per cent. (= 50 000 ppm) in the diet equivalent to 2500 mg/kg
    body weight/day.

    Estimate of acceptable daily intake for man

    Temporary acceptance                    mg/kg body weight

                                                0 - 12.5

    Further work required by June 1972

    Metabolic studies in several species.

    REFERENCES

    Knapp, W. A. jr (1967a) Report by Hazleton Laboratories Inc., 14th
    April 1967 submitted by the International Latex and Chemical
    Corporation

    Knapp, W. A. jr (1967b) Report by Hazleton Laboratories Inc., 28th
    February 1967 submitted by the International Latex and Chemical
    Corporation
    

    See Also:
       Toxicological Abbreviations
       Hydroxypropyl distarch glycerol (WHO Food Additives Series 1)
       Hydroxypropyl distarch glycerol (WHO Food Additives Series 5)
       Hydroxypropyl distarch glycerol (WHO Food Additives Series 17)
       HYDROXYPROPYL DISTARCH GLYCEROL (JECFA Evaluation)