Registration Dossier

Administrative data

Description of key information

Based on key study results, the test item is not irritating to the rabbit skin and causes serious damage to the rabbit eye (OECD 404 and 405, GLP). After 21 days, slight corneal opacity and pannus were still present.

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:
adverse effect observed (irritating)

Additional information

In a primary skin irritation/corrosion study (RCC Notox BV, 1993), 3 young adult female New Zealand White rabbits were dermally exposed to 0.5 g of the moistened test item for a period of 4 hours. Animals then were observed for at least 72 hours after patch removal. Irritation was scored by the method of Draize (1959). In all animals, a mean score (24, 48 and 72 hours readings) of 0 for edema and 0.3 for erythema was noted. The very slight erythema (grade 1) observed in all animals at 24 hours resolved within 48 hours. In this study, the test item was no skin irritant.

In a primary eye irritation study (RCC Notox BV, 1993), approximately 55 mg of test item was placed in the conjunctival sac of each one eye of 3 young adult New Zealand White rabbits. The treated eyes were rinsed 24 hours after application. Animals were observed for 21 days following treatment. The scores of each animal (according to Draize, 1959) at the reading times 24, 48 and 72 hours after application were assessed for each type of lesion (corneal opacity, iris lesions, conjunctival redness and conjunctival chemosis). Under the conditions of this study, the treatment with the test item resulted in adverse effects on the cornea, iris and the conjunctivae in all animals. Corneal opacity (grade 1) and/or pannus was observed at termination in 2/3 animals. Also, the irritation of the conjunctivae had not completely resolved within the observation period of 21 days in any of the treated animals. Slight redness of the conjunctival tissues was still present in all animals at termination. Accordingly, under the conditions of this study, the test item was considered to cause serious damage to the rabbit eye.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The test item is not subject to classification for skin irritation according to Directive 67/548/EEC and Regulation 1272/2008/EC.

Due to the lack of full reversibility of cornea findings in 2/3 animals and conjunctival redness in 3/3 animals within the 21 -day observation period, the test item is subject to classification with Xi, R41 (risk of serious damage to eyes) according to Directive 67/548/EEC and Category 1, H318 (causes serious eye damage) according to Regulation 1272/2008/EC.