Registration Dossier
Registration Dossier
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EC number: 610-161-4 | CAS number: 4403-36-5
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: not corrosive and not irritating (OECD 431 and 439, GLP)
Eye irritation: not corrosive and not irritating (OECD 437, GLP)
Respiratory irritation: no study available
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
In vitro skin corrosion
The corrosive properties of of the test item to human skin was assessed in an experiment with an artificial three-dimensional model of human skin according to OECD Guideline 431 and under GLP conditions. The EpiDerm™model was employed.
In comparison to the negative control, the mean viability of cells exposed to the test item was 103.5% after a 3-minute exposure period and 92.9% after a 1-hour exposure. The 3-minute exposure and the 1-hour exposure values were above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of ≥ 50% and ≥ 15%, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
In vitro skin irritation
The substance was assessed for cytotoxic properties to skin cells, which might lead to irritation of human skin, by using an artificial threedimensional model of human skin in accordance with OECD Guideline 439 and GLP. The EpiDerm™ model was employed.
The mean viability of cells exposed to TA-2 was 102.9% of the negative control and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%. TA-2 was considered to be non-cytotoxic and predicted to be non-irritant to skin.
In vitro vivo eye corrosion/irritation
The possible potency of the substance of being 'ocular corrosive and severe irritant' was determined employing an in vitro system (Bovine Corneal Opacity and Permeability Assay (BCOP)) according to OECD Guideline 437 and under GLP conditions.
Following treatment with TA-2 a mean opacity of 0.570 ± 0.641 and a mean permeability value of -0.016 ± 0.008 compared to the negative control were determined. The calculated IVIS of 0.330 ± 0.622 is below the cut-off value of 3 (UN GHS no category). Hence, the test item did not show severely irritant or corrosive properties and consequently it is not classified as a severe irritant and is not corrosive according to UN GHS classification.
Justification for classification or non-classification
The available data indicate that the substance does not meet the classification criteria for skin corrosion/ irritation or eye corrosion/irritation in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
There is no information available on respiratory irritation.
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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