Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404 & GLP): not irritating (rabbit, in vivo) (CIBA-GEIGY Ltd., 805042, 1985)
Eye irritation (OECD 405 & GLP): not irritating (rabbit, in vivo) (CIBA-GEIGY Ltd., 805041, 1985)

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

Skin irritation

The test article's potential to cause dermal irritation was assessed in a GLP-compliant study following OECD guideline 404 (CIBA-GEIGY Ltd., 850042, 1985). An amount of 0.5 g of the test substance was applied topically to the intact skin of 3 male rabbits for 4 hours under occlusive dressing. In two animals slight erythema reactions were observed one hour after removing of the dressing, reversible within 24 hours. All scores at the 24, 48 and 72 hour time points were zero. The third animal showed mild erythema and edema reactions, reversible after 72 and 48 hours, respectively. The mean scores over 24, 48 and 72 hour readings in this animal were 0.66 for erythema and 0.33 for edema. Overall, only minimal skin reactions could be observed and in conclusion, under the test conditions chosen, the test substance is not considered to be irritating to the skin.

 

Eye irritation

To assess the acute eye irritation potential of the test substance in vivo, a GLP-compliant study with three New Zealand white rabbits was performed according to OECD guideline 405 (CIBA-GEIGY Ltd., 850041, 1985). An amount of 0.1 g of the test substance was applied into the conjunctival sac of the right eye of each animal and the ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation. All animals displayed mild reactions to the conjunctivae (reddening) and minimal chemosis (after 1 hour of instillation only). The mean conjunctiva scores (24 - 72 hours) for each animal were 0.33, 0.33 and 1, all reactions were reversed to normal after 72 hours the latest. Since the observed reactions were minimal and below the regulatory threshold of significance, the test article is considered to be not irritating to the rabbit eye.

Respiratory Irritation

No data

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. 

Based on the data, the test substance is not classified as skin or eye irritant.

 

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, the test substance is not classified as skin or eye irritant.