Registration Dossier

Administrative data

Description of key information

In an OECD 404 compliant GLP study a skin irritating potential of the test item was not observed.

In an OECD 405 compliant GLP study the test item shows a slight eye irritation potential under the test conditions chosen.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 mL of the test substance for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with serniocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 1, 24, 48 and 72 hours after removal of the patch. Slight to moderate erythema was observed in all animals during the observation period. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch at latest. The individual scores (24 to 72 hours) for irritation of animal 1, 2, and 3 were 0.3, 0.3, and 0.7 for erythema, and 0.0 each for edema, respectivley. Considering the described cutaneous reactions as well as the average score for irritation, the test item does not show a skin irritation potential under the test conditions chosen.

Eye Irritation

The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL of the test substance to one eye of three White New Zealand 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 and on day 7. Slight corneal opacity, moderate iritis, moderate conjunctival redness, slight to moderate conjunctival chemosis and slight to moderate discharge were observed in the animals during the course of the study. Additional findings like contracted pupil and injected scleral vessels in a circumscribed area or circular were noted during the observation period. The ocular reactions were reversible in all animals within 7 days after application. The individual scores (24 to 72 hours) for irritation of animal 1, 2, and 3 were 1.0 each for corneal opacity, 0.7, 0.3, and 0.3 for iris, 2.0 each for conjunctival redness and 1.3, 1.0, and 1.7 for chemosis, respectively. Considering the described ocular reactions as well as the average score for irritation, the test item shows a slight eye irritation potential under the test conditions chosen.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The eye irritation scores were above trigger values, but findings were all reversible within 7 days. As a result the substance is considered to be classified as eye irritant category 2 (H319: " Causes serious eye irritation") under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.

Classification concerning skin irritation is not warranted.