Registration Dossier
Registration Dossier
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EC number: 943-389-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Not skin corrosive, not eye corrosive
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
Justification for classification or non-classification
Skin irritation
According to the interpretation of results and prediction model given in the OECD 431, a substance shall be considered as Non corrosive if the Mean cell viability is ≥ 50 % after 3 min exposure AND ≥ 15 % after 60 min exposure
The percentage of mean cell viability for treated cells resulted to be ≥ 50 % both after 3 minutes and after 60 minutes of exposure ( 105.1% and 122.5 % respectively), therefore the target substance shall be considered as non corrosive for skin.
Eye irritation
According to the classification scale for irritant effect of ICCVAM-Recommended Test Method Protocol, a substance shall be classified as Irritant if the Irritation Grade (N) is greater than 9, if 5 ≤ N < 9, the substance is considered as mildly irritant.
The Irritation Grade of the tested parent substance #1 is 6.8, therefore the substance is Mildly Irritant.
Based on the test results, the substance does not requires classification for serious eye damage. According to the ECHA Guidance R7.a, the HET-CAM test method were not sufficiently accurate for regulatory use especially for Category 2 chemicals, to make a final conclusion on their validity. Considering the test results, the variable evaluation of irritant categories, the false positive rate of the HET-CAM test and the chemical nature of the substance no conclusion on the eye irritation classification is reachable.
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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