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Key value for chemical safety assessment

Additional information

Ames Assay

From the results, it was concluded that DEGMEE was not mutagenic under the conditions employed in this study.

In the main test I, the number of revertant colonies induced by the test substance was less the twice of that of the corresponding negative control value for any tester strains with or without S9 mix. The same result was obtained also in the main test II, and the reproducibility of the test results was confirmed. Furthermore, both tests were performed accurately because the acceptable criteria were satisfied.

In Vitro Chromosome Aberration Test

In the main and confirmation test, the highest concentration was determined at 1500 μg/mL (about 10 mM) in either the absence (S9-) or presence (S9+) of metabolic activation system, because no growth inhibition more than 50 % was observed in the concentration range-finding test.

Five groups were included in both main and confirmation test, 3 dose levels (375, 750 and 1500 ug/mL), negative and positive groups.

As the result of main and confirmation tests, the frequency of structural aberrant cells was less than 5 % at all test concentrations, and there was no increase of chromosome aberrations according to the concentration dependent manner compared with the negative control.

Therefore, the test substance, DEGMEE, was determined not to induce chromosome aberration in the CHL cell under the experimental condition.


Short description of key information:
Ames Assay: Negative with and without metabolic activation in S. typhimurium strains TA 1535, TA 1537, TA 98 & TA 100 and E.Coli strain WP2.
In Vitro Chromosome Aberration Test: Negative with and without metabolic activation using Chinese hamster lung cells (CHL).

Endpoint Conclusion:

Justification for classification or non-classification