Registration Dossier

Administrative data

Description of key information

Two studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or eyes (OECD guideline 404 and 405). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight, transient conjuctival irritation. All reaction resolved within 72h. Therefore, the substance is not considered to be irritating.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Method and observations

Two studies were performed to evaluate irritating potential of the test material to skin or eyes. In the first study, six rabbits (3/sex/dose) were each administered a single dermal dose of 0.5 g of the test substance. Semiocclusive application of the test material to intact rabbit skin for four hours did not cause any reaction on animals skin.

In a second study, three female rabbits were each administered a single ocular dose of 0.1 g of the test substance and observed for 72h after instillation. A single instillation of the test material into the eye of the rabbit elicited slight, transient redness of the conjunctiva which was fully reversible within 72h.

There are no data available about irritation to the respiratory system.

Discussion

Application of the test substance onto skin did not cause corrosion or irritation. Appllication into the conjunctival sac of the eye caused slight, transient conjuctival irritation which recoverd within 72h.

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 not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC.

                                             

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 not considered to be classified for irritation under Regulation (EC) No. 1272/2008.