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Administrative data

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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

The skin irritation/corrosion study was performed in accordance with OECD 404 (Schüngel, 2004). The test substance was moistened with water and placed on a gauze patch. The gauze patch was applied to the intact skin of albino rabbits under semi-occlusive conditions for exposure periods of 3 min, 1 h or 4 h. After the respective treatment, the gauze patch was removed and the treated skin site was cleaned. Observation of the treated skin sites following 3 min or 1 h exposure was done immediately after patch removal. For the 4 h exposure, the evaluation of irritant effects was performed at 1, 24, 48 and 72 h after patch removal. There were no signs of skin irritation or corrosion at the treated skin sites. All scores at any observation time points were 0. Under the test conditions, the test substance was not irritating to the skin.

According to OECD 405, the unchanged test substance was applied in the conjunctival sac of one eye of each rabbit (Schüngel, 2005). The untreated eye served as the control. 1, 24, 48 and 72 h after test substance instillation, the grades of ocular reaction (conjunctivae, cornea, iris) were recorded. Conjunctival redness (score 1-2) was observed in all 3 animals, but was fully reversible within 48 h post application in 2 animals. The third animal recovered within 72 h post application. No other eye irritation effects were noted. Under the test conditions, the test substance was not irritating to the eyes.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

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