Registration Dossier

Administrative data

Description of key information

The test item was tested for skin irritation in rabbit according to a BASF testing method which in principle was similar to the OECD TG 404 (1981). The test item was tested for eye irritation in rabbit according to the Fed. Reg. 38, No. 187, 1973 (Draize test); the test conduct was in principle similar to the OECD TG 405(1981).

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

Skin irritation:

Three Vienna White rabbits received application of about 0.5 g test item (test patch with 0.5 mm thick film of the 80% test substance) onto the shaved skin for 4 hours under occlusive conditions (BASFAG81/366); the animals were observed for skin reaction during 8 days. Readings were done at time point 24 and 48 hours, but not at 72 hours. Scoring of the skin findings was based on the Draize system. Slight erythema (score 1) was seen in 1 animals after 24 hours, but was completely reversible within 48 hours. Thus, the mean score for erythema based on the 2 available time points was 0.15. No edema was seen. Thus, the test item was not irritating to the skin of rabbit under the test conditions used.

Eye irritation:

Each of 6 Vienna White rabbits received single instillation of 0.1 mL of crushed test item (corresponding to approx. 71 mg) into the conjunctival sac of the right eye; the left one remained untreated and served for control (BASFAG81/366). The eyes were examined after 24, 48 and 72 hours. The observation lasted until 72 hours. The findings were scored according to Draize.

Neither corneal opacity nor inflammation of the iris was seen.

Erythema was observed in 4/6 animals after 24 hours (4 animals with erythema scores of 1 and one of erythema score 2) and persisted in 3 animals (including the one with the most marked response after 24 hours) after 48 hours (score of 1 for each). The finding was fully reversible within 72 hours. The mean score for 24, 48 and 72 hours was 0.5. Only one animals displayed chemosis scored 1 after 24 hours, which disappeared within 48 hours. The mean score for 24, 48 and 72 hours was therefore about 0. Thus, the test item was not irritating to the eye of rabbit under the test conditions used.

Justification for classification or non-classification

Since the test item was neither irritant to the skin nor to the eye according to current scoring criteria, there is no need for classification according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008 .