Registration Dossier

Administrative data

Description of key information

Available studies gave the following results:
p-TFMA is slightly irritating to the skin but not classified for this endpoint, and highly irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

Only one study was available (Hazleton, 1985), with reliability 2 and was selected as key study. Its summary was the following:

In a primary dermal irritation study (Hazleton, 1985), 6 rabbits were dermally exposed to p-trifluoromethylaniline (>=98.5%) for 4 hours to 6.25 cm2 of dorsal/flank skin. Test site was covered with a semi-occlusive patch for 4 hours. Animals then were observed 1, 24, 48 an 72 hours after removal the substance.
Irritation was scored following the erythema and oedema scale of EU guideline.

The mean value of erythema score was 0.44 without complete reversibility after 72h. No oedema effects were observed.
In this study, p-trifluoromethylaniline (>=98.5%) is slightly irritating but not a dermal irritant to the skin based on EU classification criteria (67/548/EC diective ) and CLP criteria.

Eye irritation:

Only one study was available (Hazleton, 1985), with reliability 2 and was selected as key study. Its summary was the following:

In a primary eye irritation study (Hazleton, 1985), 0.1 ml of undiluted paratrifluoromethylaniline (>98.5) was instilled into the conjunctival sac of one eye of 6 New Zealand White rabbits. Animals then were observed for 3 days. Irritation was scored by the method according to criteria of directive EC 67/548.
After 72 hours, the overall irritation was Chemosis: 2.34; Conjonctiva: 1.5; Iris: 1; Cornea: 2, were not fully reversible within 72 h.
Based on this study, p-trifluoromethylaniline (>=98.5%) is considered severely irritating to the eye and was classified XI R41 according to the Annex VI of the directive 67/548/EC, and Eye damage Cat. 1 H318 according to the CLP criteria.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on results of these available studies, p-TFMA could be considered as not irritating to the skin and highly irritating to the eyes, according to the EC classification criteria.