Registration Dossier

Administrative data

Description of key information

The key studies (Hooiveld, 2003) and (Hooiveld, 2003) report that the registered substance is not irritating to the skin or eye.

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

The key study for skin irritation (Hooiveld, 2003) was conducted according to the OECD 404 guideline under GLP conditions. The study was perfomed on male New Zealand White rabbits using watery ethanol (50%) in a 4 hour semi-occlusive exposure. After four hours of exposure very slight oedema was noted in one animal however this was reversed at the 24 hour observation. As this was the only sign of irritation it was concluded that the registered substance does not cause irritation.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

The key study for eye irritation (Hooiveld, 2003) was conducted according to the OECD 405 guideline under GLP conditions. The study was performed on male New Zealand White rabbits. Approximately 24.9 mg of the unchanged registered substance was applied to the conjunctival sac of one eye with the untreated eye serving as a control. The registered substance caused slight redness and discharge in the conjunctivae, however no other signs of irritation were noted. No significant irritation lasted for 24 hours or more. Based upon these results the registered substance was considered not to be irritating to the eye.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

Justification for classification or non-classification

Based upon the key information for skin and eye irritation the registered substance does not meet the criteria for classification as an irritant to either the skin or eye according to EC Regulation 1272/2008 and directive 67/548/EEC.