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EC number: 686-241-8 | CAS number: 81058-27-7
In a GLP compliant K1 in vitro skin irritation study conducted according to OECD Guideline 439 and EU Method B.46, T003421 was observed to be non-irritating to skin. Based on these results, T003421 should not be classified as a skin irritant according the criteria of the CLP regulation (EC) No 1272/2008.
In a K1 Bovine Corneal Opacity and Permeability (BCOP) test, performed according to OECD guideline 437, T003421 did not induce occular irritation. No classification is required for eye irritation or serious eye damage.
Eurlings (2016) investigated skin irritation in a Reconstructed Human Epidermis Test (OECD 439 and EU Method B.46). 18.4 to 19.1 mg of test item was applied directly on top of the tissue for 15 minutes. Cell viability was calculated for each tissue as a percentage of the mean optical density of the negative control tissues. Based on the results, 1.007 mean optical density and 101% mean tissue viability, the test item is a not irritating to the skin.
In addition, Hubbard (2012) investigated skin irritation in a Reconstructed Human Epidermis Test according to OECD Guideline 439. After 15 minutes of exposure to 10 ± 2 mg of test item, 0.788 mean optical density and 109% mean tissue viability was observed. Based on the results, the test item was predicted as a non-irritant to the skin.
The skin irritation study of 2016 is considered the key result for assessing the skin irritation endpoint. According to the REACH legislation (art 13.4) new tests (since 2008) must be performed in compliance with GLP. As the result of the non-GLP Reconstructed Human Epidermis Test performed in 2012 was negative, this study was added to the dossier as supporting evidence and the GLP-compliant Reconstructed Human Epidermis Test performed in 2016 is selected as key study for classification purposes.
Eurlings (2016) investigated eye irritation in an in vitro bovine corneal opacity-permeability (BCOP) assay. 320 to 339 mg of test item was applied on the top of 3 corneas for 240 minutes. Both opacity and permeability were measured and the resulting objective values were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas were clear after the 240 minutes of treatment with the test item. The test item did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.7 (-1.9 to 0.6) after 240 minutes. Since the test item induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
In addition, an in vitro bovine corneal opacity-permeability (BCOP) assay was performed by Verheyen (2012). 20% (w/w) suspension of test item was applied on the top of 3 corneas in such a way that the complete cornea was covered, for 240 minutes. Both opacity and permeability were measured and the resulting objective values were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). After 240 minutes of exposure to test item T003421 a mean IVIS of 4.7 (0.5 to 7.1) was recorded. Based on the results, the test item is classified as a mild eye irritant when tested in vitro under the conditions of the test. However, according to criteria of the CLP Regulation, no prediction can be made on the classification of the test item, since the test item induced an IVIS of 4.7, which is >3 and ≤55.
Although the IVIS score in the BCOP performed in 2012 is between 3 and 55, the substance is considered non-irritating to eye based on the result (IVIS < 3) from the more recent study (Eurlings, 2016) performed under GLP according to the OECD guideline.
According to the in vitro skin irritation study of 2016, T003421 is not a skin irritant. The test item did not meet the criteria for classification as irritant according to the criteria of the CLP regulation (EC) No 1272/2008.
According to the in vitro eye irritation study (BCOP) of 2016, T003421 is not an eye irritant or corrosive to eyes and should not be classified for eye irritation or serious eye damage according to the criteria of the 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.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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