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:

The key study was a human two application patch test, in which 100 males and 100 female subjects were exposed twice (15 days rest period) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sensitasing potential of the test substance.

30 out of 200 subjects showed positive skin reactions at 1 of the 3 readings after induction. At the challenge phase, 29 out of 200 subjects showed a positive skin reaction at 1 of the 3 readings. Only 1 human subject showed an additional positive skin reaction at the challenge readings, while in 2 other subjects the reaction disappeared.

Under the conditions of this study, it was not possible to conclude on the sensitising potential of Santicizer 141, as the substance can be considered rather irritating than sensitising.


Migrated from Short description of key information:
Human (2-application) patch test: not sensitising

Justification for classification or non-classification

Based on the available data, no conclusion can be drawn considering the classification for skin sensitisation.