Registration Dossier
Registration Dossier
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EC number: 205-153-9 | CAS number: 134-71-4
Endpoint summary
Administrative data
Description of key information
The test substance is not irritating or corrosive to the skin and eye determined in an OECD 404 and 405 guideline study, respectively.
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
The potential to cause acute dermal irritation or corrosion was assessed, in a OECD 404 guideline study, by a single topical application of an amount of 0.5 mL of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing (BASF 2012). After removal of the patch, the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch and approximately 24, 48, 72 hours after removal. No effects were observed. It was concluded that the test substance was not irritating to the skin.
Eye irritation
The potential to cause damage to the conjunctiva, iris and cornea was assessed in an OECD 405 guideline study in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL (approx. 44 mg) of the test substance on day 0 (BASF 2012). The mean score (24 to 72 hours) for irritation was calculated to be 0.3, 0, and 0 for corneal opacity, 0, 0, and 0 for iritis, 1, 1, and 1.3 for chemosis, and 0, 0.3, and 0.7 for conjunctivae redness, for animal 1, 2, and 3 respectively. Findings were reversible within 72 hours after application. It was concluded that the test substance was not irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
One skin irritation / corrosion study is available. This study is adequate for covering this endpoint.
Justification for selection of eye irritation endpoint:
One eye irritation study is available. This study is adequate for covering this endpoint.
Justification for classification or non-classification
Based on the fact that no effects were observed after skin exposure and very limited effects were observed after ocular application, classification for skin irritation / corrosion and eye irritation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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