Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
In an in vivo skin irritation study performed according to OECD/EC guideline and GLP principles, the substance was not irritating.
In an in vivo eye irritation study performed according to OECD/EC guideline and GLP principles, the substance was not irritating.
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
In an in vitro skin corrosion test performed according to OECD 431 and GLP principles, the substance was not corrosive. In the subsequently performed in vivo skin irritation test in rabbits performed according to OECD 404 and GLP principles, the substance was not irritating.
Eye irritation/corrosion
In the Bovine Corneal Opacity and Permeability test performed according to OECD/EC guideline, the substance showed a mean irritancy score of 0.1 after 240 minutes of treatment, which means the substance is not an ocular irritant in this test. In the subsequently performed in vivo eye irritation test in rabbits performed according to OECD/EC guideline, instillation of the substance in the eye resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation has completely resolved within 48 hours and the substance was considered to be slightly irritating to the eyes.
Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study performed according to guideline (Klimisch criterium 1).
Justification for selection of eye irritation endpoint:
Reliable in vivo study performed according to guideline (klimisch criterium 1).
Justification for classification or non-classification
Based on these results the substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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