Registration Dossier

Administrative data

Description of key information

Skin irritation: irritant category 2 (equivalent or similar to OECD 439, GLP compliant)
Eye irritation: not irritating (EU method B.5, GLP)

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)

Additional information

Skin irritation

One reliable in vitro study described in Heppenheimer (2009) (equivalent or similar to OECD 439, GLP compliant) is considered to be reliable without restrictions. The substance was determined to be irritant to skin.

Eye irritation

One reliable animal study described in Vaeth (2009) (EU method B.5, GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be an eye irritant.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Skin irritation

Reference Heppenheimer (2009) is considered as the key study for in vitro skin irritation and will be used for classification. The test method based on the EPISKIN™ assay allows the prediction of both irritant and non-irritant substances and can thus be considered as a stand alone method to be used as replacement for the animal test. According to Regulation (EC) 1272/2008 and subsequent amendments the substance will be classified as Category 2.

Eye irritation

Reference Vaeth (2009) is considered as the key study for eye irritation and will be used for classification. The eye irritation was scored according to the OECD 405. The mean scores (24, 48, 72h) for conjunctivae and chemosis were 0.33 in all of the three animals. No other effects were observed. The effects were fully reversible within 48 hours. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes.