Registration Dossier

Administrative data

Description of key information

Not irritating on rabbit skin (OECD 404)

Not irritating in rabbit eyes (OECD 405)

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:
Reliable data from several studies on skin irritation are available for the test substance. These data reveal a very low skin irritation potential of the test substance.
In a patch test with the test substance 0.5 g of the test substance was applied under occlusive conditions to the intact and abraded skin of 6 rabbits (3/sex). The gauze patches were removed 24 hours after application and the skin reaction was observed according to the Draize method after 24, 48 and 72 hours, 4 days and 7 days. No signs of irritation were evident on abraided and intact skin of the rabbits. The average scores (animal 1-6, 24/48/72 h) for erythema and edema were 0. Similar results were found in the supporting study. In this study the skin reactions were only scored after 24 and 72 hours, but no skin reactions were found after 24 and 72 hours.

 

Eye:

The eye irritation potential of the test substance was assessed in two studies similar to OECD guideline 405. In the key study (Ciba-Geigy Ltd., 1975) the test substance was tested in 6 rabbits (3 per sex) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye. The right eye was left empty and served as a control. The eye of 3 animals were rinsed 1 minute after application with physiologic saline. The reaction was scored after 1 and 6 hours and 1, 2, 3, 6 and 8 days. Under the conditions of this experiment, the test substance was found to cause minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of little but assessable effect. No classification according to CLP requirements is necessary.

This conclusion was supported by another eye irritation study with 6 rabbits (3 per sex) of the English Silver breed (Ciba-Geigy Ltd., 1974). After application of 0.1 g of the test substance into the conjunctival sac of the left eye of the rabbits no effect were observed with or without washing within an observation periode of 7 days.

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. Based on available data on skin irritation/corrosion and eye irritation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP),
as amended for the thirteenth time in Regulation (EC) No. 2018/1480.