Registration Dossier

Administrative data

Description of key information

OECD Guidelines for the Testing of CHemicals, TG 404 (2002), Acute dermal irritation/corrosion
OECD Guidelines for the Testing of CHemicals, TG 405 (2002), Acute eye irritation/corrosion

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

Acute Dermal irritation /corrosion

Single dermal application to male rabbit skin (no.3 animals).

After the exposure period (4 hours), clinical signs and skin reactions were monitored throughout the study and skin reactions were graded at 1, 24, 48 and 72 hours after patch removal.

Acute Eye irritation /corrosion

Single administration to the right eye of male healty rabbit (3 animals).

Clinical signs and ocular reactions were observed and graded at 1, 24, 48 and 72 hours after instillation.

Justification for classification or non-classification

Acute Dermal irritation /corrosion

On day 4, the keratinization was observed at whole clipped area including control area of two animals. There were no other significant clinical signs except these and body weight changes.

Very slight edema was observed at 1 hour after patch removal at one animal. There was no other significant skin irritancy.

The test article was considered to be non-irritant/non-corrosive substance.

Acute Eye irritation /corrosion

White colored wye discharge were observed slightly at all animals after day 1. However, these clinical signs were not observed anymore on day 3. no other unusual clinical signs and no significant body weight changes were noted.

Conjunctival redness (some body vessels definitely hyperemic) and slight to obvious swelling were observed on the right eye of all animals at 1 hour after instillation. After 24 hours after instillation, only slight conkunctival redness was observed on the right eye of all animals that were recovered within 72 hours after instillation. No evidence of ocular irritation in cornea and iris.

The test article was considered to be non-irritant/non corrosive substance.