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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
- Bacterial Reverse Mutation Assay (e. g. Ames test): Negative (TA98, TA100, TA1535, TA1537, WP2uvrA-), OECD 471, EU Method B.13/14;
- Mammalian C
The MeClas tool determined that there is no need to classify pNMC oxide (generic composition) for the Mutagenicity endpoint
The outcome of two genotoxicity tests with pNMC oxide (8:1:1:) (AMES test and the chromosomal aberration test) confirmed that there is no conclusive evidence to classify the tested substance for this specific endpoint.
hromosome Aberration Test: Negative, OECD 473, EU Method B.10.available for this endpoint.
There are currently no in vivo testing data available for this endpoint.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, an in vivo mutagenicity test is required to confirm that the substance should not be classified for this endpoint when no positive effects are observed in the in vitro mutagenicity test. No in vivo study is currently available, but application of the mixture rules using the hazard properties of the pNMC oxide properties (MeClas-calculation) shows that there is no requirement to classify pNMC oxide for the mutagenicity endpoint (no hazard identified).
Taking into account the MeClas-calculation and the negative response in the two in vitro mutagenicity tests with the substance, it is concluded that pNMC oxide should not be classified for this hazard endpoint.
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.
