Registration Dossier
Registration Dossier
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EC number: 282-617-7 | CAS number: 84281-74-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
in vitro gene mutation in bacteria, OECD 471: positive
in vitro gene mutation in mammalian cells: waiving
in vitro cytogenicity in mammalian cells: waiving
Genetic toxicity in vivo
Description of key information
in vivo micronucleus OECD 474: negative
in vivo gene mutation, OECD 486: negative
in vivo gene mutation, OECD 489: TPE
Additional information
Justification for classification or non-classification
Classification for mutagenicity under Regulation 1272/2008 is warranted for substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. The classification in Category 2 is based on:
— positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:
— 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.
The test item is positive to the in vitro gene mutation in bacteria which triggers some tests at Annex IX level. A reliabale and adequate in vivo genetic toxicity test, OECD 486 UDS Assay, is available showing negative results that will be supported by the results of a testing proposal for a Comet Assay OECD 489 on the substance itself.
Also an in vivo micronucleus OECD 474 is available on the analogue substance showing negative results.
Based on the current available information, the substance is not considered mutagenic and a review of the classification will be performed once the OECD 489 results are available.
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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