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Key value for chemical safety assessment

Additional information

For the Ames study and the two of the three in vitro mammalian cell gene mutation tests the results are: negative with metabolic activation; negative without metabolic activation. One in vitro study indicated a positive result with and without activation; chromosome aberration study indicates a positive result with activation at the highest concentration tested due to polyploid cells, although there was no increase in frequency of chromosome aberrations.


Short description of key information:
For the Ames study and the two of the three in vitro mammalian cell gene mutation tests the results are: negative with metabolic activation; negative without metabolic activation. One in vitro study indicated a positive result with and without activation; chromosome aberration study indicates a positive result with activation at the highest concentration tested due to polyploid cells, although there was no increase in frequency of chromosome aberrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for genetic toxicity.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for genetic toxicity.