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Administrative data

Description of key information

The test item did not reveal any irritating effects on the skin or the eye.

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

Test material was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits according to OECD TG 404. After the 4 h exposure to 0.5 ml of the undiluted test material under semi-occlusive conditions only minor effects were seen in all animals (erythema score: 0 -2; edema score: 0 -1). These effects were fully reversible until the 72 h reading.

This result was confirmed by another reliable study performed in a similar way.

The test material was furthermore subject to an acute eye irritation/corrosion test in 3 New Zealand White rabbits according to OECD TG 405. After the instillation of 0.1 ml of the undiluted test material into each rabbits left conjunctival sac only minor effects were seen in all animals (cornea score: 0; iris score: 0 -1; conjunctivae score (redness): 0 -2; chemosis score: 0 -2). These effects were fully reversible until the 7 d reading.

This negative finding was approved by another study of minor quality.

In summary, o-anisidine has not to be classified as irritating to skin or eye because only minor effects on skin or eye were observed in guideline studies which were fully reversible within a short period of time.

Justification for classification or non-classification

Based on the negative results in the above mentioned studies the test item has not to be classified as irritating to skin or eyes according to Regulation (EC) No. 1272/2008.