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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The results of three performed in vitro tests for genetic toxicity were negative.


Short description of key information:
Three tests in vitro for the determination of genetic toxicity were performed:
The tests were performed according to the following methods:
1/ EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
2/ EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
3/ EU Method B.17 (Mutagenicity - In vitro Mammalian Cell Gene Mutation Test)

The obtaining of information concerning of mutagenicity in the tests in vitro are in accordance with reccomendations stated in Annexes VII - X of the Regulation (EC) No 1907/2006.

All testst were carried out in accordance with internationally valid GLP principles.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Because the results of all performed genotoxicity tests are negative, the test item could not be clasiffied as mutagenic.