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Key value for chemical safety assessment

Additional information

The GLP conform bacterial reverse mutation assay (key_bacterial reverse mutation assay_2008_Rel1) performed according to OECD 471 and

the GLP conform mammalian cell gene mutation assay (key_in vitro mammalian cell gene mutation assay_2014_RL1) performed according to OECD 476 showed that the test item did not induce gene mutations. In addition, the GLP conform in vitro mammalian cell micronucleus test (key_in vitro mammalian cell micronucleus test_2015_RL1) performed according to OECD 487 showed that the test item did not induce chromosome aberration.


Justification for selection of genetic toxicity endpoint
GLP guideline studies conducted with the test item

Short description of key information:
In vitro studies:
Bacterial reverse mutation assay/Ames test: negative (OECD 471; GLP compliant)
In vitro mammalian cell gene mutation assay: negative (OECD 476; GLP compliant)
In vitro mammalian cell micronucleus test: negative (OECD 487; GLP compliant)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the guideline-conform studies conducted under GLP, the test substance is considered void of genotoxicity. Thus, according to Directive 67/548 /EEC as amended and according to Regulation (EC) No 1272/2008 as amended, the test substance is not considered to be genotoxic, and hence no classification or labelling is required.

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