Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was shown to be clastogenic in chromosome aberration assays but was not mutagenic in the AMES assay. An in vivo rat micronucleus test showed no effect after IV dosing but was weakly positive following oral dosing. An additional in vivo rat micronucleus and comet assay was negative following both IV and oral dosing.


Short description of key information:
Negative with and without metabolic activation (AMES –test)
In vitro cell: strains of Salmonella typhimurium and Escherichia coli
Method AMES test

Positive (Chromosome aberration test)
In vitro cell: cultured peripheral human lymphocytes

Negative (micronucleus test)
In vivo, Species: rat, Cell: Bone marrow

Negative (comet assay)
In vivo, Species: rat, Cell: Bone marrow

Negative (Chromosome aberration test)
In vitro cell, V79 cells (embryonic lung fibroblasts) of the Chinese hamster

Endpoint Conclusion:

Justification for classification or non-classification

The substance was shown to be clastogenic in chromosome aberration assays but was not mutagenic in the AMES assay. An in vivo rat micronucleus test showed no effect after IV dosing but was weakly positive following oral dosing. An additional in vivo rat micronucleus and comet assay was negative following both IV and oral dosing.