Registration Dossier

Administrative data

Description of key information

To evaluate the irritation potential of the test article, skin or eyes of New Zealand rabbits were treated with the test substance and reactions were observed and scored up to 72h (OECD guideline 404 and 405). Application onto skin did not cause irritation. In contact with eyes, irritation of the cornea, iris and conjunctiva were observed. The reactions were reversible until 10 days of installation.

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

Procedure and observations

 

The irritation potential of the test substance was evaluated in two studies.

In the first study, primary skin irritation properties of the test material were investigated by topical application of 0.5 g onto clipped skin of each of three young adultrabbits (OECD guideline 404). The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

Under the conditions of this experiment, the test substance did not cause irritation, erythema or oedema when applied to healthy intact rabbit skin.

 

In the course of the second study, the irritation potential of the test article was investigated by instillation of 61 mg into one eye of each of three young adultrabbits (OECD guideline 405). The treated eyes were not rinsed after application. Scoring of irritation effects were performed 1, 24, 48 and 72 hours after test article application.

Significant irritation of the cornea, iris and conjunctiva was observed 1h after removal of the bandage. The reactions resolved until day 10 after installation.

 

 

Discussion

Application of the test substance onto skin did not cause corrosion or irritation. Administration of the test article into the conjunctival sac of the rabbit eye induced irritation of cornea, iris and conjunctiva which were reversible after 10 days of installation.

Therefore, the test substance is considered to be as non-irritating to skin but irritating to eyes.


Effects on eye irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as an eye irritant under Regulation (EC) No. 1272/2008.

The substance is classified as "Irritating to eyes" and labeled with R 36 and H 320, respectively.