Registration Dossier
Registration Dossier
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EC number: 204-807-0 | CAS number: 126-83-0
Endpoint summary
Administrative data
Description of key information
Skin: OECD 439, in vitro reconstructed human epidermis test. Predicted to be a non-irritant. Reliability = 1
Eye: OECD 437, in vitro bovine corneal opacity and permeability test. Predicted to be a non-irritant. Reliability = 1
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
The skin irritation potential of the test substance was evaluated based upon measuring the relative conversion of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test article for a 60-minute exposure period, followed by a 42-hour post-exposure expression period in accordance with OECD guideline 439(In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method). Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The test article was not observed to directly reduce MTT in the absence of viable cells. The mean viability of the test substance was 105.1% and the test substance is predicted to be a non-irritant.
The potential ocular irritancy of the test substance, as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas was examined in accordance with OECD guideline 437. Bovine corneas were incubated in the presence of the test substance at 32 ± 1ºC for 4 hours. The test substance was determined to have an in vitro score of 1.6, indicating it is not an eye irritant.
Justification for classification or non-classification
Based on in vitro tests performed in accordance with OECD guidelines 439 and 437, the test substance is unlikely to be irritating to the skin or eyes, respectively. Therefore, the substance does not need to be classified for skin or eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) 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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