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Administrative data

Description of key information

This substance is not irritating to skin or eye. 

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)

Additional information

In a key study the undiluted substance was applied to New Zealand white rabbits under semi-occlusive dressing for four hours. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes following patch removal, were also made after 24, 48 and 72 hours and on days 7 and 14. In this study, slight irritation was seen which resolved within 14 days of exposure. The primary irritation index was calculated to be 1.7 for sites treated with the test material.

In a supporting study the undiluted substance was applied to New Zealand white rabbits under semi-occlusive dressing for four hours. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes following patch removal, were also made after 24, 48 and 72 hours and on days 7 and 14. ThePrimaryIrritation Index was calculated to be 1.8 for sites treated with the test material.

 

In a key study, the undiluted substance was instilled into the conjunctival sac of New Zealand White rabbits (6 animals). The test material produced mild to moderate conjunctival irritation in the albino rabbit eyes which fully reversed in all animals by Day 14. Corneal involvement was observed in 5/6 animals however it was not evident at day 7. No iritis was noted during the 14 day observation period.

Justification for classification or non-classification

This substance is not considered to cause skin irritation according to EU CLP (Regulation (EC) No. 1272/2008)

This substance is not considered to cause eye irritation according to EU CLP (Regulation (EC) No. 1272/2008)

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