Registration Dossier

Administrative data

Description of key information

Skin irritation study

The test item was not irritating to the skin of rabbits, under the test conditions chosen.

 

Eye irritation study

The test item was not irritating to the eyes of rabbits, 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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Key study: Skin irritation study_2009/1130544

In a primary dermal irritation study, three albino female New Zealand White rabbits were exposed by the dermal route to 0.5 g test substance for 4 hours. Neither erythema nor oedema was observed 1, 24, 48 or 72 hours after exposure.

Therefore, the test substance was not irritating to the skin of rabbits.

 

Key study: Eye irritation study_ 2009/1130543

In an eye irritation study, the eyes of six New Zealand White rabbits were exposed to 0.1 g of the test substance. The treated eyes in the main study (3 animals) were not rinsed. The eyes were then examined over the course of the following week(s) for signs of irritation.

Mean scores over 24, 48 and 72 hours for each animal were 0 for cornea opacity, iris lesions and conjunctiva edema. The 24, 48 and 72 hour mean score for conjunctiva redness was 0.9.

Therefore, the test substance was not irritating to the eye of rabbits.

Justification for classification or non-classification

Skin irritation

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The mean score for erythema/ oedema over 24, 48, 72 hours for each animal was 0. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.

 

Eye irritation

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Mean scores over 24, 48 and 72 hours for each animal were 0 for cornea opacity, iris lesions and conjunctiva redness/edema. As a result the substance is not considered to be classified for eye irritation under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.