Registration Dossier
Registration Dossier
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EC number: 204-876-7 | CAS number: 128-04-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genotoxicity was evaluated in bacterial and mammalian cell assays. Both, the Ames test and the DNA damage assay performed with SDDC yielded a clear positive result. In contrast, the HPRT assay with SDDC showed no genotoxic effects.
The chromosomal aberration assay with SDDC did not show a clastogenic effect. Both tests were performed in mammalian cells and in the presence and absence of metabolic activation.
The appraisal that SDDC should not be classified as genotoxic is confirmed by two in-vivo assays, a micronucleus assay in murine bone marrow and a UDS assay in primary rat hepatocytes. Both assays were clearly negative.
Classification for mutagenicity: None.
Justification for selection of genetic toxicity endpoint
SDDC was mutagenic in bacteria but negative in mammalian in vitro and in vivo test systems.
Short description of key information:
In vitro:
Ames (OECD 471): positive
Chromosome Aberration (OECD 473): negative
HPRT (OECD 476): negative
In vivo:
MNT in mouse (OECD 474): negative
UDS in rat (OECD 486): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on a weight of evidence approach no classification regarding genotoxicity is needed.
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