Registration Dossier

Administrative data

Description of key information

In an in vivo skin irritation study performed according to OECD/EC guideline and GLP principles, the substance was not irritating.
In an in vivo eye irritation study performed according to OECD/EC guideline and GLP principles, the substance was not irritating.

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/corrosion

In an in vitro skin corrosion test performed according to OECD 431 and GLP principles, the substance was not corrosive. In the subsequently performed in vivo skin irritation test in rabbits performed according to OECD 404 and GLP principles, the substance was not irritating.

Eye irritation/corrosion

In the Bovine Corneal Opacity and Permeability test performed according to OECD/EC guideline, the substance showed a mean irritancy score of 0.1 after 240 minutes of treatment, which means the substance is not an ocular irritant in this test. In the subsequently performed in vivo eye irritation test in rabbits performed according to OECD/EC guideline, instillation of the substance in the eye resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation has completely resolved within 48 hours and the substance was considered to be slightly irritating to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study performed according to guideline (Klimisch criterium 1).

Justification for selection of eye irritation endpoint:
Reliable in vivo study performed according to guideline (klimisch criterium 1).

Justification for classification or non-classification

Based on these results the substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.