Registration Dossier

Administrative data

Description of key information

Skin Irritation: not irritant; OECD Guideline Study, RCC 1990
Eye Irritation: not irritant; OECD Guideline Study, RCC 1990

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

In a GLP-compliant primary dermal irritation study (OECD 404, RCC 1990), 3 female New Zealand White rabbits were exposed to 0.5 g of the test substance for 4 hours under semiocclusive conditions. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean scores for the 24, 48 and 72 h reading for erythema and edema were 0.00. In this study, the test substance was not a dermal irritant.

Eye

A GLP-compliant eye irritation test was performed with three New Zealand White rabbits according to OECD 405 (RCC 1990). Treated eyes were left unwashed after application of 0.1 g of the test substance and the animals were observed for 72 h. Under the conditions of this experiment, the test substance was found to cause mean scores for cornea, iris and conjunctivae of 0.00 and for chemosis of 0.33 when applied to the conjunctival sac of the rabbit eye (24 - 72 h observation period). The chemosis effects were reversible within 48 h. Blue staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed, in all animals. Due to the results described above, the test article is considered as not irritant to the eye of rabbits.

 

Respiratory system

No data available

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.