Registration Dossier

Administrative data

Description of key information

Regarding skin irritation, in the in vitro human epidermis model assay (OECD 439) the test item was considered to possess an irritant potential. However, on their own these data were not sufficient to resolve between category 1 and 2. In the in vitro skin corrosion test (OECD 431) the test item was identified as not corrosive to skin.

Therefore, overall a classification of skin irritant Category 2 'Causes skin irritation', H315 is considered appropriate.

Regarding eye irritation, in a Bovine Corneal Opacity and Permeability test, BCOP (OECD 437), the test item was not identified to be Eye Damage Category 1. However, relative to the negative control the test item caused a slight increase of the corneal opacity. Therefore the hazard for eye damaging could not be predicted and the possibility of requiring classification under CLP could not be excluded based on this test alone. In a Reconstructed human Cornea-like Epithelium Test, RhCE (OECD 492), the test item was found to possess an eye irritating potential.

Therefore, the test item has to be classified as Eye irritant Category 2 'Causes serious eye irritation', H319.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data, the substance does require classification for skin irritation Category 2,'Causes skin irritation', H315, and classification for eye irritation Category 2,'Causes serious eye irritation', H319, according to Regulation (EC) No 1272/2008.