Registration Dossier

Administrative data

Description of key information

Only one acute oral toxicity study (BASF Co, 1998, report no. 80203065; conducted according to the EPA guideline 870.1200; 24 hours treatment, occlusive coverage of test sites) is available, where the skin irritation potency was evaluated 30 minutes after removal of the test material according to the Draize technique (recorded as the Day 1 score) and subsequently days 3, 7, 10, and 14. The test substance was corrosive to the rabbit skin under the conditions of the study.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In the acute dermal study 5 young adult Hra:(NZW)SPF rabbits (2013-2562 g; 14-15 weeks) per sex per dosed were used (except the 3000 mg/kg dose group, where the treatment was interrupted for humane reasons, after 3 males were treated). Unchanged test substance was applied to approximate 180 cm2 of a shaved area at the back of test animals under occlusive conditions and washed out with after 24 hours. The initial dermal irritation reading was made in this acute dermal study 30 minutes after removal of the test material according to the Draize technique (recorded as the Day 1 score). Subsequent readings of dermal irritation were made on Days 3, 7, 10, and 14.

 

The erythema score was 4 in all animals until the end of the observation period (14 days). All animals showed eschar formation (generally from day 3 to the end) or possible necrotic areas (generally at day 1). At necropsy, the treated skin of each animal was observed to be variable dark-brown or red, with or without crusted areas. The treated skin was also thickened in some animals. The underlying muscle in some animals was also dark-brown or tan. These findings are attributed to the irritation/injury caused by the test material.


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based to the gravity of the erythema scores, as well as crusted areas, eschar, discoloration of the underlying muscle and necrosis, and although the treatment period was 24 hours instead of 4 hours and the coverage of test sites occlusive instead of semi-occlusive, the test substance should be considered corrosive to the rabbit skin (worst case consideration giving the 24 hours treatment and the occlusive coverage of test sites; R34 according to the EU and Category 1C according to GHS).