Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The substane is not a skin or an eye irritant.

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

In a skin irritation study, 0.5 g of test substance (50% in propylene glycol/saline) was administered to the clipped skin of 3 male and 3 female New Zealand White rabbits. The test item was kept under occlusive conditions for 24 hours. Erythema and eschar formation and oedema formation were scored after 24, 48, and 72 hours, and after 4 and 7 days. No edema was observed. Due to intensive staining by the test compound erythema was not assessable, but erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). Therefore, under the conditions of this experiment, the test substance was found to cause no irritation when applied to rabbit skin.

In an eye irritation study, 0.1 g of test substance was administered to the eyes of 3 male and 3 female New Zealand White rabbits. The other eye served as an untreated control. In 3 out of 6 animals, the eyes were washed after 30 seconds of exposure. Observations were made on day 1, 2, 3, 4 and 7 after application. The substance was found to cause no irritation (washed or non-washed) when applied to the rabbit eye mucosa.

Justification for classification or non-classification

Based on the available information the test substance does not need to be classified for skin and eye irritation in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.