Registration Dossier

Administrative data

Description of key information

Not skin irritating

Eye irrit, 2 (H319), according to the CLP regulation (EC) 1272/2008

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:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In the key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.

According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.

Based on the review of all the experiments available, the substance seems to be able to cause eye irritation; however, effects can be recovered within 21 days.

In conclusion, the substance does not meet the criteria to be classified for the skin irritation; however, it should be classified as eye irritating, category 2 (H319), according to the CLP Regulation (EC) No 1272/2008.