Registration Dossier

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.