Registration Dossier

Administrative data

Description of key information

The key study for skin irritation found very slight irritant effects to the skin of rabbit, below the EU threshold for classificaton (Asta-Werke AG, 1987). The study was conducted according to an appropriate guideline and in compliance with GLP. 
The key study eye irritation found the test material non-irritating when applied undiluted to the eyes of rabbits (Asta-Werke AG, 1987). The study carried out to OECD Test Guideline 405 and in compliance with GLP.

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

The key study for skin irritation found the test material slightly irritating to rabbit skin (Asta-Werke AG, 1987). Very slight erythema was observed in all test animals, starting within 24 hours of patch removal (in two animals, an immediate reaction was observed). In one rabbit, erythema became well-defined at 24 hours, and was accompanied by very slight oedema. Oedema was not seen in any other animal, or at any other time point. All signs of irritation were fully reversible within 6 days of application. There were no signs of systemic toxicity, or mortality throughout the study.

The key study for eye irritation found no apparent effect on the cornea or iris (Asta-Werke AG, 1987) . Conjunctival redness and hyperaemia was observed in all treated animals within 24 hours, and was fully resolved within 48 hours. Slight swelling and discharge was seen in the treated eye of one animal, and swelling with partial eversion of lids was seen in another. These effects were only evident during the first 24 hours following application. There were no overt signs of systemic toxicity or mortality throughout the course of the study.


Justification for selection of skin irritation / corrosion endpoint:
The selected study is the only available skin irritation study. It was conducted according to an appropriate OECD test guideline and in compliance with GLP

Justification for selection of eye irritation endpoint:
The selected study is the only available eye irritation study. It was conducted according to an appropriate OECD test guideline and in compliance with GLP

Justification for classification or non-classification

Based on the available information, no classification is required for skin or eye irritation in accordance with Regulation (EC) No 1272/2008.