Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation, OECD 476, negative
in vitro bacteria test, OECD 471: predicted positive
in vitro MNT, OECD 487: negative
Genetic toxicity in vivo
Description of key information
in vivo UDS, OECD 486: negative
in vivo Comet Assay, OECD 489: TPE
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
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 predicted positive to the traditional in vitro gene mutation study in bacteria which triggers first some potential elucidation of bacteria specific mechanisms. OECD 471 with nitro-reducatse deficient strains was performed with ifferent simialr substances containing nitro-geoups which showed a marked reduction of the mutagenic potential. However the trigger for some tests at Annex IX level is still valid. A reliable and adequate in vitro gene mutation OECD 476 and in vivo genetic toxicity test, OECD 486 UDS Assay, are available on analogue substances showing negative results. A read across from a further in vivo Comet Assay OECD 489 is proposed to completely assess and confirm the gene mutation toxicity behaviour of the substance.
Also an in vitro MNT OECD 487 is available 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.
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.
