Registration Dossier
Registration Dossier
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EC number: 204-875-1 | CAS number: 128-03-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The in-vitro test battery was conducted with SDDC and KDDC, both as aqueous solution of 41% and 50% respectively.
Neither the chromosomal aberration assay with SDDC nor a sister-chromatid exchange assay with KDDC induced clastogenic effects. Both tests were performed in mammalian cells and in the presence and absence of metabolic activation.
Genotoxicity was evaluated in bacterial and mammalian cell assays. Both, the tests conducted with KDDC and SDDC and the DNA damage assay performed with SDDC yielded a clear positive result. In contrast, the UDS test with KDDC and the HPRT assay with SDDC, both carried out in mammalian cells, showed no genotoxic effects. Sole exception is the positive HPRT assay with KDDC. However, this result is not toxicologically significant because an increased mutant frequency occurred only at cytotoxic concentrations.
The appraisal that KDDC should not be classified as genotoxic is confirmed by two in-vivo assays conducted with SDDC, a micronucleus assay in murine bone marrow and a UDS assay in primary rat hepatocytes. Both assays were clearly negative.
Classification for mutagenicity: None.
Short description of key information:
see study records
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
see discussion
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