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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 604-102-1 | CAS number: 13893-53-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Acute dermal toxicity studies indicate that 2 -amino-2,3 -dimethylbutanenitril has a very low LD50 and warrants classification as "very toxic" according to 67/548/EEC and Category 1 for acute dermal toxicity according to the CLP regulation (EC) 1272/2008. Furthermore, 2 -amino-2,3 -dimethylbutanenitril has been shown to be moderately toxic in rats by ingestion as well as toxic by eye contact in rabbits. In consequence, single exposure of test animals to 2 -amino-2,3 -dimethylbutanenitril is more likely to cause lethality than skin sensitisation.
Thus, for animals welfare reasons testing on animals has been avoided and skin sensitisation has been adressed in a weight of evidence approach by using both, data from a validated (Q)SAR model as well as animal data from publicly available information on a substance with a similar chemical structure (2 -amino-2 -methylbutanenitrile; CAS 4475 -95 -0) to fulfill the standard information requirements of the Annex VII to REACH.
Taken together the information from both data sources there is no indication for a skin sensitising potential of 2 -amino-2,3 -dimethylbutanenitril.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
This information is not available.
Justification for classification or non-classification
Data available for skin sensitisation are conclusive but not sufficient for classification according to the criteria outlined in both, 67/548/EEC and 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.
