INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF SOME
    FOOD COLOURS, ENZYMES, FLAVOUR
    ENHANCERS, THICKENING AGENTS, AND
    CERTAIN FOOD ADDITIVES



    WHO FOOD ADDITIVES SERIES 6







    The evaluations contained in this publication were prepared by the
    Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
    4-13 June 19741


    World Health Organization     Geneva     1975






              

    1  Eighteenth Report of the Joint FAO/WHO Expert Committee on
    Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 557.
    FAO Nutrition Meetings Report Series, 1974, No. 54.

    MICROBIAL GLUCOSE OXIDASE* (Aspergillus niger)

    Explanation

         This enzyme preparation has been evaluated for acceptable daily
    intake by the Joint FAO/WHO Expert Committee on Food Additives (see
    Annex 1, Ref. No. 27) in 1971.

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

    BIOLOGICAL DATA

    BIOCHEMICAL ASPECTS

         No data available.

    TOXICOLOGICAL STUDIES

    Acute toxicity

         None available.

    Short-term studies

    Rat

         Three groups of 10 male and 10 female Charles River rats were fed
    0, 5 and 10% of Aspergillus niger mycelial preparation in their diet
    for 90 days. There were no overt signs of toxicity, and food
    consumption and growth were not affected. There was a drop in the
    efficiency of food utilization for all dosed groups, it was
    significant for the males in the high dose group. The haematological,
    the clinical and the ophthalmoscopic data revealed no significant
    differences between the groups. There were significant increases in
    the relative kidney weight of females in both dosage groups. The gross
    and microscopic findings were mostly related to chronic respiratory
    disease and kidney lesions including hydropelvis or hydronephrosis,
    which did not appear to be treatment-related (Swann & Cox, 1973).

              

    *    This enzyme preparation is prepared from some varieties of
    Aspergillus niger.

    Duckling

         Groups of five ducklings received in their diet either 0, 1, 5 or
    10% of enzyme for 29 days. Growth, feed efficiency, behaviour and
    survival were similar in all groups except the 10% level which showed
    some growth retardation. No gross liver lesions or differences in mean
    liver weight were noted. Histopathology was normal. No toxic element
    was noted (FDRL., 1963).

    Long-term studies

         None available.

    Comments:

         Aspergillus niger is a common contaminant of food. The
    available information indicates that it is not pathogenic to man. A
    duckling study was done and a 90-day study in rats is now available
    showing no toxicological effects at 10% in the diet. This meets the
    requirements as laid down by the Committee.

    EVALUATION

         Acceptable daily intake not specified.*

    REFERENCES

    FDRL (1963) Unpublished report No. 84600d of the Food and Drug
         Research Laboratories submitted by Miles Chemical Co.

    Swann, H. E. & Cox, G. E. (1973) Unpublished report la. No. 1223
         submitted by Searle Biochemicals

              

    *    The statement "ADI not specified" means that, on the basis of the
    available data (toxicological, biochemical, and other), the total
    daily intake of the substance, arising from its use or uses at the
    levels necessary to achieve the desired effect and from its acceptable
    background in food, does not, in the opinion of the Committee,
    represent a hazard to health. For this reason, and for the reasons
    stated in individual evaluations, the establishment of an acceptable
    daily intake (ADI) in mg per kg of body weight is not deemed
    necessary.

    See Also:
       Toxicological Abbreviations