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Key value for chemical safety assessment

Additional information

In vitro studies were GLP compliant and of high quality (Klimisch score = 1). Therefore there is no reason to believe that these results would not be applicable to humans.

Justification for selection of genetic toxicity endpoint
No study was selected as all three in vitro studies were used as a weight of evidence for this endpoint.

Short description of key information:
Ames test (OECD guideline 471): negative with and without metabolic activation
In vitro chromosome aberration test performed with cultured human lymphocytes: negative with and without metabolic activation
In vitro mammalian cell gene mutation test with mouse lymphoma L5178Y tk +/- cells: negative with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance was negative in three in vitro studies : gene mutation in bacteria, chromosome aberration test and gene mutation in mammalian cells. Therefore the substance is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.