Registration Dossier

Administrative data

Description of key information

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

After application of a single 0.5 mL dermal dose to the shaved intact skin of rabbits for 4 hours, erythema (score of 1) was noted at the treated site of all 3 rabbits immediately following patch removal and/or at the 30-60 minute scoring interval. All animals were free of dermal irritation by 24 hours.

After instillation of 0.1 mL of test substance into the lower conjunctival sac of the eye of 3 rabbits, conjunctival redness (score of 1) and discharge (scores of 1, 2, or 3) were observed in the treated eye of all 3 rabbits at the 1-hour scoring interval. All animals were free of ocular irritation by 24 hours.


Justification for selection of skin irritation / corrosion endpoint:
OECD guideline, GLP study

Justification for selection of eye irritation endpoint:
OECD guideline, GLP study

Justification for classification or non-classification

Although skin and eye irritation were observed, all animals were free from dermal or ocular irritation within 24 hours. Therefore, 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.