Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:

No antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 50% 4 -84 -Nitrophenyl)-3 -morpholinon. No indication for a non-specific (irritating) activation was detected, too. A slight statistically significant increase compared to vehicle treated animals regarding ear weight was detected in the low dose group. However, this change was within the normal variance of this parameter, and thus to be judged of no biological relevance.

Therefore, the study does neither point to a non-specific (irritating) nor to a specific immunostimulating (sensitising) potential of the test item.


Migrated from Short description of key information:
Skin Sensitisation, LLNA/IMDS (NMRI mice, GLP, OECD TG 429, 406 and EPA OPPTS 870.2600): no non-specific (irritating) or specific immunostimulating (sensitising) properties
[Bayer AG, Report No. PH-34724, 2007-01-11]

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.