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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Based on skin (OECD 404) and eye irritation (OECD 405) studies performed in vivo, it can be concluded that the test substance is not corrosive or irritating to the skin, but causes irreversible effects to the eye.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

The potential to cause acute dermal irritation of corrosion was assessed, in an OECD 404 guideline study (in compliance with GLP), by single topical application of an amount of 0.5 mL of the test substance for 4 hours to the intact skin of three Vienna White rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing (BASF1 989). After removal of the patch, the application area was washed off. The cutaneous reactions were assessed 30 - 60 minutes after removal of the patch and approximately 24, 48 and 72 hours after the beginning of application. No effects were observed. In another study (BASF 1976) two Vienna White rabbits were treated by application of the undiluted test substance, using a patch of 2.5 cm x 2.5 cm, on the back for 1, 5, and 15 minutes and 20 hours. Skin responses were read 24 hours and 8 days after beginning of application. Only questionable erythema was observed in one animal treated for 20 hours. Based on this it was concluded that the test substance was not irritating to the skin.

Eye irritation

The potential to cause damage to they eye was assessed in two studies. In one OECD 405 guideline study (in compliance with GLP) three Vienna White rabbits were subjected to a single ocular application of 0.1 mL of the undiluted test substance (BASF 1989). In another study (BASF 1976) two Vienna White rabbits were subjected to a single ocular application of 0.5 mL of the undiluted test substance. Effects on the cornea and conjuctivae were observed in both studies. In the first study effects were not reversible within 21 days in two animals. In the second study all effects were reversible within 7 days. Based on this it was concluded that the test substance may cause damage to the eyes.


Justification for selection of skin irritation / corrosion endpoint:
Two skin irritation studies are available. The study which was performed according an OECD 404 guideline was selected as key.

Justification for selection of eye irritation endpoint:
Two eye irritation studies are available. In one study a slight irritation was observed, while in the other study irreversible effects on the eye were observed. The latter study, which was performed according to OECD guideline 405 was selected as key.

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the two skin irritation studies, classification for skin irritation/corrosion is not warranted in accordance with Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008. Because effects after ocular application were not reversible in two animals within 21 days in one of the two studies performed, the test substance is classified as Xi:R41 Risk of serious damage to eyes in accordance with Directive 67/548/EEC (DSD) and Cat.1:H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.