Registration Dossier

Administrative data

Description of key information

Skin irritation was tested in a guideline study according to OECD guideline 404 in 3 New Zealand White rabbits. With reference the absence of any effect the substance does not have to be classified as irritant to the skin.
The substance was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects onconjunctivae (redness and swelling) were observed in all animals one hour after application. These signs were fully reversible within 72 h.

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: 1 key study available: not irritating

Eye irritation: 1 key study available: not irritating

There is one reliable study on the skin irritancy potential. Skin irritation was tested in a guideline study according to OECD guideline 404 in 3 New Zealand White rabbits.

With reference the reported scores (edema (mean):0, erythema (mean): 0) The substance does not have to be classified as irritant to the skin.

There is one reliable study available on the eye irritancy potential. The substance was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405.

Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs were fully reversible within 72 hours.


Justification for selection of skin irritation / corrosion endpoint:
Guideline conform GLP study

Justification for selection of eye irritation endpoint:
Guideline conform GLP study

Justification for classification or non-classification

With reference the reported scores and the reversibility of the effects of effects within 72 h the substance does not have to be classified as irritant to the skin and eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).