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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 203-615-4 | CAS number: 108-78-1
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:
A very old human patch test (Hollander 1940) reports 1 positive case out of 208 tested volunteers. From the age of the study and the available data, it is concluded that this study is not reliable or adequate. A second observation (Fassett 1981) is also considered to be not reliable because possibly not even a primary report exists, only an entry in the secondary literature.
The study of Weiss 2010 is a guideline study with GLP.
Migrated from Short description of key information:
Melamine is not a skin sensitizer. This is the result of a Guinea Pig Maximization test, modified according to Maurer & Hess. No animal showed a positive reaction.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
No information is available and no human case report was detected in literature search.
Justification for classification or non-classification
No animal in a guideline study with GLP had positive reactions after melamine induction and challenge procedure.
No information on respiratory sensitisation is available and no human case report on respiratory sensitisation was detected in literature search.
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.
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