Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test substance.

The test substance is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.


Migrated from Short description of key information:
Skin sensitizing (contact allergenic) effect in Guinea pigs, August 26, 1980
Optimization test performed without GLP (GLP were not in place at that time), according to Maurer et al.

Justification for selection of skin sensitisation endpoint:
Optimizing test performed in albino-guinea pigs. Animals were exposed to an induction period followed by a challenge injection and application. Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test material
The test material is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results, p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline should be classified as skin sensitizer (Category 1B) and labeled as H317: May cause an allergic skin reaction according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.