Registration Dossier
Registration Dossier
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EC number: 209-047-3 | CAS number: 553-72-0
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (OECD 404, GLP)
Eye irritation: corrosive (OECD 405; GLP)
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
One reliable in vivo study described by Hansen (2014)(OECD 404; GLP compliant) is considered to be reliable without restrictions. The substance was determined not to be irritating to the skin.
Eye irritation
One reliable in vivo study described by Hansen (2014)(OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be corrosive to the eye.
Furthermore, a reliable in vitro study described by Heppenheimer (2012) (OECD 437; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be neither corrosive nor severely irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Key study
Justification for selection of eye irritation endpoint:
Key study
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin irritation
Reference Hansen (2014) is considered as the key study for in vivo skin irritation and will be used for classification. The skin irritation was scored according to the Draize scale. The mean score (24, 48, 72 h) for erythema and oedema for all three animals were as follows:
Erythema: 0 for all animals
Oedema: 0 for all animals
Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the skin. Furthermore, the substance has not to be classified as skin irritant according to Directive 67/548 EC.
Eye irritation
Hansen (2014) is considered as the key study for in vivo eye irritation and will be used for classification. The eye irritation was scored according to the Draize scale. The following mean score (24, 48, 72 h) for three animals were as follows:
cornea: 1, 2, and 1.33
iris: 0 for all animals
conjunctival redness: 1.67 for all animals
chemosis: 0.67, 3 and 2.67
The effects were not fully reversible. All animals were euthanised by day 6 (one animal by day 6 and the other animals by day 5), since the animals showed continuing severe pain or distress. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will be classified as Category 1. Furthermore, the substance has to be classified as risk of serious damage to eyes according to Directive 67/548 EC.
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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