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EC number: 947-393-3 | CAS number: -
For skin irritation:
The mean percent tissue viability of the treated tissues was 106.1%, versus 1.3% in the positive control (5% Sodium Dodecyl Sulfate).
Under these experimental conditions and in accordance with the Regulation (CE) No.1272/2008, the test item was classified as non-irritant.
For eye irritation:
A component is present at a content superior to 10 % and is classified H319. Thereore the substance is by default classified H319 in accordance with the regulation (CE) N°1272/2008.
Table 7.3.1/1: Reconstructed Human Epidermis (RHE) model – results
OD 570 nm
An in vitro skin irritation study was performed according to OECD Guideline 439 and in compliance with GLP to evaluate the possible irritating effects of the test item after topical application on in vitro human reconstructed epidermis (SkinEthic RHE model).
The test item was applied on three tissues replicates of Reconstructed Human epidermis during 42 minutes, followed by a rinse with PBS and 42 hours post-incubation period at 37 °C. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The mean percent tissue viabilities obtained with the negative control and positive controls were met the acceptance criteria and therefore validate the experiment.
The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the serious eye damage/ eye irritant hazard of the registered substance. The decision of classification as eye Damage category 2 was based on existing data on constituents (additivity principles) the registered substance has a constituent classified as Eye Damage Category 2 present at more than 10% and should be classified as a Eye damage category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.
The component alpha-guaiene (EC N°641 -402 -1) is present at a content superior to 10 % and is classified H319 (IFRA elbelling manual). Thereore the substance is by default classified H319.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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