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
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).
None of the diagnosed changes in the eyes of rat, reported in the
two year feeding study, are compound related.
* Monograph addendum
Level causing no toxicological effects
Rat: 1,58% (= 15,800 ppm) in the diet, equivalent to
800 mg/kg bw., (based on a multigeneration
Estimate of acceptable daily intake for man
0 - 8 mg/kg bw.
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Unpublished study by Hazleton Lab.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 Unpublished report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.