3-Pyridinecarbonitrile, 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-[2-[2-(trifluoromethyl)phenyl]diazenyl]-

Endpoint summary

Description of key information

The test item as described in section 1.2 was tested for skin irritation/corrosion in a GLP compliant study with rabbits according to OECD guideline No. 404. The test item did not induce significant inflammation or corrosive effects to the skin (RCC 2003)
The test item was tested for eye irritation/corrosion in a GLP-compliant study with rabbits according to OECD guideline No. 405. The test item  did not induce significant or irreversible damage to the rabbit eye. Mild findings were reversible within 7 days (RCC 2003).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

The primary skin irritation potential of the test item was investigated by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits according to EU method B.4 and OECD guideline 404. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0), except red staining which persisted in all animals up to 14 days after treatment, the end of the observation time. The erythema was not assessable in all animals at the 1-hour reading due the marked red staining produced by the test item. At the other evaluation time points the individual mean score for erythema/eschar and oedema for each of the three animals was 0. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals. Thus, the test item did not induce significant inflammation or corrosive effects to the skin.

Eye irritation:

The primary eye irritation potential of test item was investigated by instillation of approximately 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.00, 1.00 and 0.67 for reddening and 0.00, 0.00 and 0.00 for chemosis, respectively. The instillation of test item into the eye resulted in mild to moderate, early onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Light orange staining of the treated eyes produced by the test item was observed in all animals at the 1-hour examination and persisted in two animals up to 24 hours and in one animal up to 48 hours after treatment. Orange remnants of the test item were observed in the eye or conjunctival sac of all animals one hour after treatment. Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Experimental data on respiratory irritation is not available.

Justification for classification or non-classification

Based on the available data, the test item does not need to be classified or labelled for skin and eye irriation according to Directive 67/548/EEC (DSD) and Regulation 1272/2008 EC (CLP).