Registration Dossier

Administrative data

Description of key information

For investigating skin irritation potential, the test article was applied to the un-abraded skin under a semi-occlusive dressing in contact with the skin for 4 hours. Erythema or edema were not evident at 60 minutes, or at 24, 48 and 72 hours after patch removal. The test article was considered to be non-irritant to skin.
In a BCOP study, the test article was applied to five bovine corneas within a MEM, Minimum Essential Medium with the determination of Opacity measurements and sodium fluorescein permeability. The in vitro score in this BCOP study was calculated as 119.0. The test article was considered to be a very severe irritant to eyes.

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

Skin Irritation:

A test article was applied to the un-abraded skin of 3 female New Zealand White rabbits under a semi-occlusive dressing. The test article was kept in contact with the skin for 4 hours. Residual test article was removed with distilled water prior to scoring. Erythema or edema were not evident at 60 minutes, or at 24, 48 and 72 hours after patch removal. The mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.

Eye Irritation:

A test article was applied to five bovine corneas within a 20% solution (MEM, Minimum Essential Medium). Opacity measurements and sodium fluorescein permeability were determined. The in vitro score in this BCOP study was calculated as 119.0 and, accordingly, the test item was classified as a very severe irritant in agreement with supporting literature.


Effects on eye irritation: highly irritating

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for skin irritation.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin irritation.

The substance meets classification criteria under EU Directive 67/548/EEC for eye irritation.

The substance meets classification criteria under Regulation (EC) No 1272/2008 for Eye Damage, Category 1.