Registration Dossier

Administrative data

Description of key information

The skin irritation/corrosion study was performed according to OECD Guideline 404 and GLP principles.
Three eye irritation studies were conducted with the substance.
The in vivo eye irritation/corrosion study was performed equivalent or similar to OECD Guideline 405 and GLP principles, but tested with a 50% dilution of the substance. An in vitro eye irritation/corrosion study (BCOP) was performed according to OECD Guideline 437 and GLP principles. And an in vitro eye irritation/corrosion study (EpiOcular)was performed according to GLP principles.

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)

Additional information

In the in vivo skin irritation test, the test substance is considered to be not irritating to rabbit skin.

In the in vivo eye irritation test, 50% substance was not irritating to eyes of rabbits. No conclusions can be drawn on 100% test substance.

In the in vitro eye irritation test (BCOP), the 100% substance was not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test. Also in the in vitro eye irritation test (EpiOcular), the 100% substance showed no irritation.

Justification for classification or non-classification

Based on the absence of skin irritation in a reliable in vivo study, the substance needs not to be classified and labelled for skin irritation according to CLP.

Based on the available information on eye irritation, two negative in vitro eye studies tested with 100% substance and a negative in vivo study tested with 50% substance, no conclusions can be drawn as negative in vitro data are not accepted for definite conclusion on classification and labelling. As in vivo data are only available for a 50% dilution of the substance, no conclusions can be drawn on 100% substance. As a result, the classification and labelling according to CLP for eye irritation is therefore inconclusive.