ANOXOMER*

    Explanation

         This compound was reviewed at the 26th meeting of the Joint
    Expert Committee on Food Additives. (Annex 1, Ref. 59) A temporary ADI
    for man of 0-8 mg/kg b.w. was established. A toxicological monograph
    was published. (Annex 1, Ref. 60)

         Since the previous evaluation, additional data have become
    available and are summarized and discussed in the following monograph
    addendum.

    BIOLOGICAL DATA

    Special Studies

         Additional studies on the overall incidence of cataractous change
    and/or retinal degeneration in control and Anoxomer-treated rats in
    the two year feeding study (Anonymous, 1980) have been carried out.
    The overall incidence of animals with cataractous change and/or
    retinal degeneration was similar in control or Anoxomer treated rats.
    In addition the degree of severity of cataractous change and retinal
    degeneration, although varying in different animals was also similar
    in different groups (Sheikh and Dua, 1983).

         Another evaluation of the occurrence of senile cataracts in this
    study reported that the most frequently diagnosed changes were retinal
    degeneration and cataracts. Retinal degeneration occurred in control
    rats with approximately the same frequency as in the low, medium
    and high dose groups. Cataracts were present in controls with
    approximately the same frequency and severity as observed in the test
    animals. However, there was a high incidence of cataracts in all
    groups. The less frequently diagnosed effects namely synechia, 
    keratitis, uveitis, corneal subepithelial mineralization,
    dacryoadenitis were not compound related (Trucksa, 1983).

    Comments

         None of the diagnosed changes in the eyes of rat, reported in the
    two year feeding study, are compound related.

              

    *    Monograph addendum

    EVALUATION

    Level causing no toxicological effects

         Rat:      1,58% (= 15,800 ppm) in the diet, equivalent to
                   800 mg/kg bw., (based on a multigeneration
                   reproduction/teratology study).

    Estimate of acceptable daily intake for man

         0 - 8 mg/kg bw.

    REFERENCES

    ANONYMOUS (1980) Chronic toxicity study in rats, D00079, final report,
    Unpublished study by Hazleton Lab. of America, Inc. submitted to the
    WHO by Dynapol, Inc., Palo Alto, California, USA.

    SHEIKH, N.M. & DUA, P.N. (1983) Pathology Report Anoxomer (Pathology
    Profect No. -PR-53), Division of Pathology, Bureau of Foods, FDA,
    submitted to the WHO by USFDA.

    TRUCKSA, R.C. (1983) Observations and Interpretation of Microscopic
    Examination of 1018 Rat Eyes. Project No. 2006-105. Unpublished report
    prepared for Dynapol, US. Submitted to the WHO.
    

    See Also:
       Toxicological Abbreviations
       Anoxomer (WHO Food Additives Series 17)
       ANOXOMER (JECFA Evaluation)