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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 422-310-9 | CAS number: 114772-53-1
Endpoint summary
Administrative data
Description of key information
Oral subacute toxicity studies give conflicting results. One study (performed at 15, 50 and 150 mg/kg) did not identify a NOEL nor a NOAEL. The second study (performed at 40, 200 and 1000 mg/kg) identified a NOAEL and a NOEL of 40 mg/kg. Laboratory abnormalities as well as macroscopic and microscopic changes in reproductive organs were observed in the first study.
Key value for chemical safety assessment
Additional information
The reliability of the studies was judged as not assignable (score 4) because of the lack of study details. This would represent an obstacle to use the studies results for the classification and labelling (C&L) of the substance. However, the studies were previously presented within the context of a regulatory framework and the lack of details available to us does not necessarily mean that these studies have to be discarded. Moreover, the little data available for this substance suggest the possibility of some kind of harm, that should not be disregarded while waiting for more robust information.
Therefore, even with the above mentioned limitations, the studies were considered in order to define the C&L of the substance.
Justification for classification or non-classification
In absence of criteria for choosing the most reliable study for C&L, in case of conflicting results the study providing data of higher concern was used to provisionally define the C&L of the substance.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should be classified as following for its effects after repeated exposure:
- DSD: T R48/25, Xn R62
- GHS: STOT RE 1 H372, Repr 2 H361
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.
