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). Occlusive application of the test material to intact rabbit skin for 24 hours resulted in transient slight reactions on animals skin which recovered within 72h. A single instillation of the test material into the eye of the rabbit elicited slight, transient chemosis and redness of conjunctiva which was fully reversible within three days. The test substance is therefore not considered to be irritant.

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

Procedure and observation

Two studies were performed to evaluate irritating potential of the test material to skin or eyes. In the first study, four female rabbits were each administered a single dermal dose of 0.5 ml. Occlusive application of the test material to intact rabbit skin for 24 hours resulted in transient slight reactions on animal skin which recovered within 72h.

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

Discussion

Application of the test substance onto skin or installation into eyes did not cause corrosion or irritation. The test substance is therefore not considered to be irritant.

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 as amended for the fifth time in Directive EC 944/2013.