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Key value for chemical safety assessment

Additional information

The following information was taken into account for any hazard / risk assessment:

i) the ability to induce mutations in bacterial (AMES, OECD 471)

ii) in mammalian cells (in vitro point mutation assay using BALB/3T3 cell line, similar to OECD 476);

iii) transformation assay (in vitro transformation assay using BALB/3T3 cell line;

iv) chromosome aberration (in vivo mouse micronucleus assay, OECD 474)

Negative results were obtained both with this substance and an analog, EC 283-392-8, in the AMES assay. 

Positive results were obtained in the presence of an exogenous metabolic activation system in the mammalian cell point mutation assay.

Negative results were obtained from the in vitro transformation test

Negative results were obtained from the in vivo micronucleus tests.

The weight of evidence suggests that the test material is non-clastogenic and non-mutagenic.


Short description of key information:
EC 218-679-9:
in-vitro: negative in SALMONELLA reverse mutation TEST (with and without metabolic activation)
in-vitro: positive in point mutation assay in the presence of metabolic activation using 3T3 cell line.
in-vivo: there was no evidence of increase in the number of micronuclei per 1000 polychromatic erythrocytes in Mammalian Erythrocyte Micronuclues Test in BS-1 mice.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with EU CLP (Regulation (EC) No. 1272/2008) classification is not required for genotoxicity.

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