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Key value for chemical safety assessment

Additional information

Short description of key information:
Two key in-vitro genotoxic experimental studies, Ames and chromosome aberration study, have been completed. One in-vivo study, mouse micronucleus study with reliability assigned a 1 has been completed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No dose-related and reproducible increases in revertant colony frequency were observed in any tester strains at any concentration, both with and without S9. The test substance was not genotoxic in the Ames test.

Chromosome Aberrations in Purified Human Lymphocytes: with and without exogenous metabolic activation with a confirmatory assay with multiple harvests. The test article is considered equivocal for inducing chromosomal aberrations under conditions of metabolic activation at extremely toxic dose levels and not clastogenic without metabolic activation.

Mouse Micronmucleus study: Test substance was considered non-clastogenic in this study.