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:

The sensitization potential of the test substance 2,6 -dichloro-4 -trifluoromethylaniline (DCPTFMA) was evaluated in guinea-pigs by intradermal injection and cutaneous application, according to the maximization method of Magnusson and Kligman , O.E.C.D. Guideline No. 406 and the Principles of GLP. Thirty guinea-pigs (15 males and 15 females) were allocated to 2 groups: a control group (5 males and 5 females) and a treated group (10 males and 10 females). The sensitization potential of the test substance was evaluated after a 10 -day induction period during which time the animals were treated with the vehicle (control group) or the test substance (treated group). On day 1, in presence of Freund's adjuvant 0.1 ml of the test substance at a concentration of 10% in corn oil was administered by intradermal route. On day 8, 500 mg of the test substance in its original form was prepared on a dry compress and then applied by cutaneous route. After a period of 12 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) and 0.5 ml of the test substance at a concentration of 20% in the vehicle (right flank) were administered on all animals. The substance and the vehicle were prepared on a dry compress then applied to the skin and held in place for 24 hours by means of an occlusive dressing. Cutaneous reactions on the challenge application site were then evaluated 24 and 48 hours after removal of the dressing. During the study, no clinical signs or deaths were observed. After the challenge application of the test substance, a positive response characterised by a well-defined or moderate to severe erythema (scores of 2 to 4) was observed on the right flank of 15/20 animals of the treated group. No oedema was noted. In 5/20 animals of the treated group and 1/10 animals of the control group, a very slight erythema (score of 1) caused by a slightly irritant primary effect of the test substance was noted. In addition, a dryness of the skin was noted in 17/20 animals of the treated group.

Migrated from Short description of key information:
Maximization test (OECD 406): positive in guinea pigs

Justification for classification or non-classification

The test substance 2,6 -dichloro-4 -trifluoromethylaniline (DCPTFMA) induced positive skin sensitization cutaneous reaction in 15/20 guinea-pigs. The allergenicity level of the test substance 2,6 DCPTFMA was strong in 75% guinea-pigs. Therefore, the test substance has to be classified as Xi; R43 according to Directive 67/548/EEC and as Cat. 1B; H317 according to Regulation (EC) No. 1272/2008.