Registration Dossier

Administrative data

Description of key information

- skin: mild irritant (OECD 404)
- eye: not irritant (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin: The cutaneous irritation that was induced by the test substance 2,6 -dichloro-4 -trifluoromethylaniline (DCPTFMA) was evaluated in rabbits according to the OECD Guideline No. 404. A Single dose of 500 mg of the test substance in its original form was prepared on a moistened compress and this was then applied to the skin of 3 male New Zealand White rabbits. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. Moderate cutaneous reactions were observed for up to 72 hours after removal of the dressing. They consisted of erythema (scores of 1 to 2 in 3 animals) and edema (score of 2 in 3 animals). The mean score over 24, 48 and 72 hours for individual animals was 1.7, 2.0 and 2.0 for erythema and 2.0. 2.0 and 2.0 for edema. Between days 5 and 15 a dryness of the skin was observed at the treatment site. No ulceration or necrosis was noted.

Eye: The ocular irritation that could be induced by the test substance 2,6 DCPTFMA was evaluated in rabbits according to the OECD Guideline No. 405. A single introduction of 100 mg of the test substance in its original form was placed into the conjunctival sac of the left eye of 3 male New Zealand White rabbits. Slight to moderate chemosis and redness of the conjunctiva (individual scores of 1 or 2) were observed for 48 hours after sample introduction in two animals and for 72 hours in one animal. Iris congestion (score of 1) was noted in 1 animal after 24 hours. A slight opacity of the cornea was noted in two animals after 24 hours and persisted in one animal after 48 and 72 hours. The mean scores over 24, 48 and 72 hours for individual animals were 0.0 to 1.3 for chemosis, 0.7 to 1.3 for redness, 0.0 or 0.3 for iris lesions, and 0.0 to 1.3 for corneal opacity. All ocular lesions reversed between days 4 and 5.


Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

The available data for 2,6 -dichloro-4 -trifluoromethylaniline (DCPTFMA) indicate a potential for skin irritation. Therefore, 2,6 DCPTFMA has to be classified as Xi; R38 according to Directive 67/548/EEC and as Cat.2; H315 according to Regulation (EC) No. 1272/2008.

2,6 DCPTFMA does not have to be classified for eye irritation according to Directive 67/548/EEC and according to Regulation (EC) No. 1272/2008.