Registration Dossier
Registration Dossier
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EC number: 248-370-4 | CAS number: 27253-29-8
Endpoint summary
Administrative data
Description of key information
Skin irritation: not irritating (OECD 404, GLP)
Eye irritation: not irritating (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:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
One reliable in vivo study described by Hansen (2013)(OECD 404; GLP compliant) is considered to be reliable without restrictions.The substance was determined not to be irritating to the skin.
Eye irritationOne reliable in vivo study described by Sanders (2013) (OECD 405; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not irritating to the eye.
Furthermore, a reliable in vitro study described by Heppenheimer (2012)(OECD 437; GLP compiant) is considered to be reliable without restrictions. The substance was determined not to be corrosive nor severely irritating to the eyes.
Justification for selection of skin irritation / corrosion endpoint:
Key study
Justification for selection of eye irritation endpoint:
Key study
Justification for classification or non-classification
Skin irritation
Reference Hansen (2013) 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 toDirective 67/548 EC.
Eye irritationReference Sanders (2013) is considered as the key study for in vivo eye irritation and will be used for classification. During the study the test item was applied to one eye of two animals each and the eye irritation was scored according to the Draize scale. The following mean scores (24, 48 and 72 hours) were obtained for the two animals:
cornea: 0 for both animals
iris: 0 and 0.67
conjunctival redness: 1.67 and 1.33
chemosis: 1.67 and 1.33
The ocular effects were fully reversible within 7 days. Thus, according to Regulation (EC) 1272/2008 and subsequent amendments the substance will not be classified as irritating to the eyes. Furthermore, the substance has not to be classified as eye irritant according to Directive 67/548 EC.
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