Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The mutagenicity studies in bacteria and in mammalian cells in vitro as well as the chromosome aberration study performed in vitro were all negative. The substance is therefore considered to be non-mutagenic and non-clastogenic.
Justification for selection of genetic toxicity endpoint
Three standard mutagenicity / clastogenicity studies in vitro
Short description of key information:
Evaluation of the mutagenic activity in the bacterial reverse
mutation assay and in an in vitro mammalian cell gene mutation test as
well as in an in vitro chromosome aberration test in cultured peripheral
human lymphocytes.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the above stated assessment of the genotoxic potential (Ames test negative, in vitro mammalian cell gene mutation test negative, in vitro Chromosomme aberration mammalian cells negative) the substance is deemed non-genotoxic and accordingly does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according CLP (Regulation (EC) No 1272/2008 Of The European Parliament And Of The Council) as implementation of UN-GHS in the EU.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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