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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-281-1 | CAS number: 17243-69-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Limited information is provided in a patient leaflet on mutagenicity studies of tilidine hydrochloride, which is a structural analogue of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate. An Ames and a cytogenetics study with bone marrow cells of rats were negative. In this leaflet limited information is also provided that studies with a combination of tilidine and naloxon did not provide evidence of mutagenicity.
Endpoint Conclusion:
Justification for classification or non-classification
Based on the limited information available, classification in accordance with Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 is not possible.
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.
