Registration Dossier

Administrative data

Description of key information

Skin Irritation: not irritating; OECD Guideline Study, 2002
Eye Irritation: not irritating; OECD Guideline Study, 2002

 

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

A GLP-compliant skin irritation test was performed with three New Zealand White rabbits according to OECD 404. A 4-hour semiocclusive exposure to approximately 0.5 mL of the unchanged test material produced no effects during the observation period of 3 days on the treated sites of the animals. The mean scores for the 24, 48 and 72 h reading for erythema and edema, respectively was 0.

This finding is supported by an additional irritation study performed with one New Zealand White rabbit. Here, 0.5 mL of the test article was administered occlusively for 4 hours to the flank of the animal. Very slight erythema (score 1) was recorded in the single rabbit one hour after gauze patch removal. Observed skin reactions were fully reversed in the animal by day 1 after removal of the gauze patches.

Based on the results of these studies, the test article is considered to be not irritating to the rabbit skin.

Eye

A GLP-compliant eye irritation test was performed with three New Zealand White rabbits according to OECD 405. The eyes were left unwashed after application of 0.1 mL test substance and the animals were observed for 72 h. Only minimal redness of the conjunctivae and discharge was observed in all animals after 1 hour; this finding was reversed to normal after 24 hours. The mean scores for the 24, 48 and 72 h reading for iritis, cornea opacity as well as conjunctivae chemosis and redness were 0.

This finding is supported by an additional study performed with one New Zealand White rabbit. Here, 0.1 mL of the test article was instilled unchanged into the conjunctival sac of the animal and the eye remained unwashed. Slight conjunctival redness was noticed 1 hour after instillation of the test article. Mean scores of 24 through 72 hours after ocular administration were below irritant levels for all parameters.

Based on the results of these studies, the test article is considered 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.As a result the substance is not considered to be classified as irritant or corrosive under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.