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EC number: 269-950-3 | CAS number: 68391-42-4
Gene mutation assay in bacteria (AMES test): positive.
Gene mutation assays in mammalian cells (HPRT test): negative.
Micronucleus assay in bone marrow cells of mouse: negative.
According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans are classified in Category 2. This classification is based on positive evidence obtained in:
— somatic cell mutagenicity tests in vivo, in mammals; or
— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Note: substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.
In vitro mutagenicity tests are the following:
— in vitro mammalian chromosome aberration test;
— in vitro mammalian cell gene mutation test;
— bacterial reverse mutation tests.
The overall assessement on the genotoxic potential was based on: positive outcome in bacterial reverse mutation assay (AMES test), negative outcomes in in vitro HPRT assays and negative result in in vivo micronucleus test in bone marrow cells of mouse.
All studies were conducted according to OECD guidelines and have a high reliability.
Based on these results, target susbstance was considered as non genotoxic and it was not classified within the CLP Regulation (EC 1272/2008).
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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