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:

Only one study (Chrysalis, 1995) with reliability 1 was available and was selected as key study. The summary of this study is the following:

In a dermal sensitization study (Chrysalis, 1995) with p-trifluoromethylaniline in absolute ethanol, Hartley guinea pigs (10/sex in test groups and 5/sex in control group) were tested using the method of maximization. 

2/20 animals presented positive reaction. It is not sufficient to consider p-TFMA for sensitization. 30% of positive reaction is necessary to classify a test item as skin sensitizer.

Burnt appearance of the skin on a surface less than one quarter of the application area was noted for 2 males. 1 male and 2 females presented scratches to the application area.

At dose of 1%, p-trifluoromethylaniline was not considered as dermal sensitizer, according to the EC classification criteria (67/548/EC directive) and CLP criteria.


Migrated from Short description of key information:
p-TFMA is not sensitizing at 1% concentration in a maximization test.

Justification for classification or non-classification

Based on results of the available study, p-TFMA could be considered as not sensitizing.