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Description of key information

Skin: not irritating, CIBA, 1975
Eye: irritating, CIBA 1991, OECD TG 405

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

Skin: A skin irritation test was performed with three male and three female rabbits from the Russian breed (CIBA, 1975). A 24-hour occlusive exposure to the test material, produced no effects during the whole observation period on the treated sites (intact skin) of the animals. The mean score for the 24, 48 and 72 h reading for erythema and edema, respectively was 0. It has to be stressed that the test material was somehow diluted or moistened because the gauze patches were soaked with test substance before treatment. But taking into account that there where no marked local reactions during acute dermal toxcitiy tests in rabbits and rats (see acute dermal toxicitiy study, Ciba-Geigy AG 1990) it can be stated that the test substance is not irritating to skin.

Eye:

An eye irritation test was performed with two male and one female New Zealand White rabbits acc. to OECD 405 (CIBA 1991). Eyes were left unwashed after application of 0.1 g test substance and the animals were observed 21 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 2.0, 0.3, 1.4, and 1.6 respecitvely. A slight yellowish staining of the lid hairs of the treated eyes by pigment or coloring of the test article was observed (at 1 hour reading). Generally slight diffuse opacity of the cornea was observed in all animals within 1 hour to 72 hours or 14 days after test article treatment. In addition blood vessels on the sclera were visible within 1 hour to 7 or 21 days after treatment. There was a clear tendency for reversibility and findings were almost completely healed at the last observation time point, except for conjunctivae redness. This effect is not considered to be a severe ocular lesion or indicative of severe ocular damage.

In addition, another eye irritation test (CIBA, 1980) indicated full reversibility of all ocular effects within 7 days when rabbit eyes were treated with 0.1 g of the test substance. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 1.78, 0, 0.22, and 1.78 respecitvely when eyes were not washed.

Taken the result of both studies together, the substance is an eye irritant but does not produce irreversible effects on the eye.


Effects on eye irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC (R36).

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The average scores are below the threshold of classification as a severe irritant. Reversibility generally within 21 days is indicated. As a result the substance is considered to be classified as an irritant of Category 2 for eye irritation under Regulation (EC) No. 1272/2008.

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