Registration Dossier

Administrative data

Description of key information

In a primary skin irritation study, no skin irritating effects were observed in three New Zealand rabbits.

The substance is considered to be non irritating to eyes in a weight-of evidence approach based on valid studies with two related substances and the BfR eye irritation rules.

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

Skin irritation

In a primary eye irritation study according to OECD guideline 404, 0.5 g of the test substance moistened with 0.5 mL of distilled water were applied to the intact skin of three New Zealand White rabbits for four hours. A semi occlusive dressing was used. After the exposure period residual test substance was removed. Animals were observed for 72 hours.

The test substance did not produce any evidence of skin irritation. The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.

Eye irritation

It is referred the attached document. As it contains chemical structures, it was technically not possible to include it in this freetext field.


Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.