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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Poitn mutation and chromosomal aberration tests were negative, both in the presence and absence of a metabolic activation sytem.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Ames and Chromosome Aberration tests were negative for the induction of mutagenicity bot in the absence and presence of a metabolic activation system. An absence of genetic toxicity in mammalian cells is predicted in a weigh tof evidence approach using literature data reporting negative QSAR results for EBP and data of a worst case analogous substance that was clearly negative in a mouse lymphoma assay performed by NTP, 1986.


Short description of key information:
Guideline- and GLP-compliant Ames and Chromosome Aberration tests and weight of evidence for genotoxicity in mammalian cells all suggest that the substance is not genotoxic in the standard in vitro assays.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non-classification: Ames and Chromosome Aberration tests were negative for the induction of mutagenicity.