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Administrative data

Description of key information

One skin irritation study (similar to OECD guideline 404) and one eye irritation study (similar to OECD guideline 405) are available. Test substance related findings were not observed.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

A possible irritating or corrosive potential to the skin was assessed in an OECD Guideline 404 study. Clipping of the fur was conducted at least 15 hours before the beginning of the study. The test substance was applied on the upper third of the back or flanks as 50 % aqueous formulation (w/w) (0.5 g test substance) for 4 hours under an occlusive dressing to the skin of 3 rabbits (White Vienna). At the end of the exposure period, the test substance was removed with Lutrol and Lutrol / water (1 : 1). 30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 72 h after the beginning of application readings were conducted. The untreated skin sites of the same animals were used as negative control. After sacrifice the animals were examined by gross pathology. The erythema as well as the edema scores for all three tested animals were 0 after 24, 48, and 72 hours. No symptoms were observed. Therefore, the test substance showed no skin irritating potential under the conditions of this test.

Eye irritation / corrosion

A possible irritating or corrosive potential to the eye was assessed in an OECD Guideline 405 study. The test substance (0.1 mL bulk volume, about 100 mg of the comminuted test substance) was applied to the conjunctival sac of the right eyelid of 3 rabbits (White Vienna) and not rinsed. The untreated eyes of the animals served as negative controls. Readings were conducted 1 h, 24 h, 48 h and 72 h after application. The primary irritation index was 0. Therefore, the test substance showed no eye irritation potential under the conditions of this test.

Justification for classification or non-classification

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. An OECD 404 study is available for skin irritation. An OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008.