Registration Dossier

Administrative data

Description of key information

Both the skin and eye irritation key studies were available according to internationally acceptable testing and GLP guidelines demonstrating that the test material may be slightly irritating to the skin and but not to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results from a reliable study conducted under the GLP, from semiocclussive skin irritation study performed in rabbits with a single application of dioctyl maleate, indicated that the material is only mild irritant to the skin. The test material was considered slightly irritating but fully reversible within 8 days, therefore, labelling is not required.

Results from reliable studies conducted under the GLP for eye irritation showed that a dose of 0.1 cm³ of highly concentrated dioctyl maleate was slightly eye irritating but reversible within 72 hours after exposure. The test substance was considered not irritating.

Based on the skin/eye irritation scores determined in these studies, no classification is required.


Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

According to criteria in Regulation (EC) No 1272/2008, the substance is a mild or slightly skin irritating but does not required classification.

According to criteria in Regulation (EC) No 1272/2008, the substance is not classifiable as irritating to the eye.