Registration Dossier

Administrative data

Description of key information

Skin: OECD 404; rabbit, no irritation. Reliability = 1
Eye: OECD 405; rabbit, slight irritation, cleared by 48 hours. Reliability = 1

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

After application of a single 0.5 mL dermal dose to the shaved intact skin of rabbits for 4 hours, no dermal irritation was observed at any time point evaluated.

After instillation of 0.1 mL of test substance into the lower conjunctival sac of the eye of 3 rabbits, slight conjunctival redness (score of 2), chemosis (score of 2), and discharge (score of 2) were observed in 3 rabbits one hour after test substance instillation. The overall incidence of irritation decreased with time and all animals were free of ocular irritation by 48 hours.

Justification for classification or non-classification

The test substance produced slight eye irritation which cleared within 48 hours, but no skin irritation. The substance does not need to be classified for skin or eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.