Registration Dossier

Administrative data

Description of key information

The test article was not irritating to rabbit skin and not irritating to rabbit eyes.

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

The test substance was applied to the skin of rabbits as a 50% aqueous preparation (amount applied not specified) in an irritation study comparable to OECD guideline 404 (using 6 animals) and observed for 8 days. Dermal reactions were recorded according an internal system comparable to the Draize system on days 1, 2, 5, 6, 7 and 8. The application caused no erythema and no edema to the skin. Yellow substance residues were reported.

Eye irritation

In an ocular irritation study 50µg of the test substance was applied to the eyes of 6 rabbits. Reactions were scored according an internal system comparable to the Draize system 1, 3, 24, 48, 72 h and 4 d, 7 d and 8 days after instillation. The cornea, iris and chemosis scores were 0 at time points 24, 48 and 72 hours. The application caused a mean (24, 48 and 72 hours) conjunctivae redness score of 0.5 which was reversible within 48 hours. The test article was determined to be not irritating to the rabbit eye.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for irritation is not warranted under Regulation (EC) No.1272/2008.