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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 436-230-7 | CAS number: 359406-89-6
Endpoint summary
Administrative data
Description of key information
Based on a maximisation test according to the method of Magnusson and Kligman ITC 826 concentrate, elicited a 30% sensitisation response and is considered to be sensitizing to the skin. By analogy with ITC 826, THPC-urea-amine is considered as a skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No sensitisation studies have been carried out on the registered THPC-urea-amine. The studies submitted are for a closely related substance ITC 826. Read-across is considered justified since the only differences between ITC 826 and the current product are in amine carbon chain length (C16 -18for ITC 826 and C14for the registered THPC-urea-amine).
One study was available for this endpoint and considered as the key study (Lees, 1996).The sensitisation potential of ITC 826 concentrate was assessed using a method based on the maximisation test of Magnusson and Kligman (1970).The test substance was ITC 826 Concentrate.
Challenge of previously-induced guinea pigs with a 30% w/v preparation of the test sample elicited a 30% sensitisation response (6/20 animals) with an intradermal induction at 0.03%. Challenge of previously-induced guinea pigs with a 10% w/v preparation of the test sample elicited a 10% sensitisation response (2/20 animals). The control animals showed the anticipated reactions.
By analogy with ITC 826 concentrate, THPC-urea-amine is considered as a skin sensitizer.
Justification for selection of skin sensitisation endpoint:
Only one study was available for this endpoint (Kr.2). This study was performed on ITC 826 concentrate.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Short description of key information:
No data available
Justification for selection of respiratory sensitisation endpoint:
No data available.
Justification for classification or non-classification
Skin sensitization:
Following a maximisation test according to the method of Magnusson and Kligman ITC 826 concentrate, elicited a 30% sensitisation response (intradermal induction at0.03%) and should be classified into Category 1A, H317 (may cause an allergic skin reaction) according to theCLPregulation (1272/2008) and as sensitising (Xi; R43) according to the Directive 67/548/EEC criteria.By analogy with ITC 826 concentrate, THPC-urea-amine is considered as a skin sensitizer ans has the same classification.
Respiratory sensitization:
No data available, therefore no classification is 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.
