Registration Dossier

Administrative data

Description of key information

Jud & Cagen (1982): The test material, Crude Catalyst 32899, was found to be non-irritant to rabbit skin.
Jud & Cagen (1982): The test material, Crude Catalyst 32899, was found to be non-irritant to rabbit eyes.

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

Both studies were evaluated for suitability, based on this evaluation, it was established that the studies were niether GLP compliant or conducted according to standard guidelines. Despite this, they were considered to be acceptable for the purposes of classification and labelling and assigned a Klimisch rating of 2.

Skin Irritation

Jud & Cagen (1982)

The objective of the study was to evaluate the primary skin irritation potential of Crude Catalyst 32899 in six New Zealand white rabbits. The rabbits' backs were shaved 24 hours prior to exposure. There were two intact and two abraded skin test sites per animal. Each test site was treated with 500 milligrams of actual undiluted test material, moistened with deionized water. The test sites were occluded for 24 hours, Observations for dermal irritation were made at 24 and 72 hours after treatment. Crude Catalyst 32899 was "minimally irritating" to the rabbit skin, with a primary irritation score of 0.021 (maximum of 8.0).

Eye Irritation

Jud & Cagen (1982)

The objective of the study was to evaluate the eye irritation potential of Crude Catalyst 32899 in nine New zealand white rabbits. One tenth gram of actual undiluted material was placed into the right eye of 3 male and 3 female rabbits. The eyes of an additional group of 3 male rabbits were flushed with tap water 30 seconds after exposure. The eyes were examined and scored for irritation one hour and 1, 2, 3, 7, and 14 days after treatment. Crude Catalyst 32899 was found to be "moderately irritating" to the nonwashed rabbit eye with a maximum mean irritation score of 18.8 (maximum of 110) seen 24 hours after exposure. The maximum mean irritation score for washed eyes was 10.0 seen 24 hours after exposure, washing the eyes with water therefore provided slight protection against irritation.

Justification for classification or non-classification

Based on current classification and labelling guidelines, the test material was considered to be non-irritant to skin and eyes according to Regulation (EC) No 1273/2008.