Registration Dossier

Administrative data

Description of key information

In an in vivo study according to OECD guideline 404 in rabbits, the test substance showed no skin irritating or corrosive properties (BASF SE, 2009).

In an in vivo study according to OECD guideline 405 in rabbits, the test substance showed no eye irritating properties (BASF SE, 2009).

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/corrosion

In the available BASF SE (2009) study conducted according to the OECD Guideline 404, the potential of test substance to cause acute dermal irritation or corrosion was assessed. A single topical application of 0.5 g of the test substance was applied for 4 hours onto the intact skin of three New Zealand White rabbits, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately, as well as approximately 1, 24, 48, and 72 hours after removal of the patch.

Slight or moderate erythema was observed in the animals during the course of the study. A slight yellow discoloration of the skin was also noted in all animals during the observation period. However, all cutaneous reactions were reversible in all animals within 72 hours after removal of the patch. Mean individual 24-48-72-hour scores were 0.3, 0.0 and 0.3 for erythema and 0.0 per animal for edema. Therefore, the test substance does not show a skin irritation potential under the test conditions chosen.

 

Eye Irritation

In the BASF SE (2009) study conducted according to the OECD Guideline 405, the potential of the test substance to cause eye damage was assessed. A single ocular application of 0.1 mL bulk volume (about 17 mg) of the test substance was applied to one eye of each 3 New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application, the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, and 72 hours after application.

Slight conjunctival redness and slight discharge were observed in the animals during the course of the study. In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period. The ocular reactions were reversible in all animals within 48 hours after application at latest.

Mean 24-48-72-hour scores for each of the 3 animals were 0.0 for corneal opacity, chemosis and iris lesions, and 0.0, 0.3 and 0.0, respectively for the 3 tested animals for redness of the conjunctiva. Therefore, the test substance does not show an eye irritation potential under the test conditions chosen.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

As a result the substance is not considered to be classified for skin or eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.