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EC number: 807-040-5
CAS number: 4538-42-5
According to OECD TG 431 a chemical should be classified as
"corrosive" if the cell viability after a 3-min. treatment with a test
item is decreased by more than 50 %.
control NaCl 0.9 %
In this case the test item was characterized by having a
significant impact on cell viability after the 3 -min. or the 60-min.
An in vitro study according to OECD TG 431 for predicting a non
specific, corrosive potential of a substance was conducted. In that
study undiluted test item was applied topically on a reconstructed human
skin (50 µL; epiCS, CellSystems, Germany). After an exposure period of 3
minutes at room temperature and 60 minutes in an incubator (37 °C, 5 %
CO2, maximum humidity), the cell viability was 13 % and 2 %,
respectively, as measured by a MTT conversion assay. Based on OECD TG
431 the test substance should be therefore classified as corrosive.
An in vitro study according to OECD TG 431 for predicting a non-specific, corrosive potential of substances is available. In this study undiluted test item was applied topically on a reconstructed human skin (50 µL; epiCS, CellSystems, Germany). After an exposure period of 3 minutes at room temperature and 60 minutes in an incubator (37 °C, 5 % CO2, maximum humidity), the cell viability was 13 % and 2 %, respectively, as measured by a MTT conversion assay. Based on OECD TG 431 the test substance should be therefore classified as corrosive.
Further available is an in vitro skin irritation test according to OECD TG 439. In this study undiluted test item was applied topically on a reconstructed human epidermis (30 µL; epiCS, CellSystems, Germany). After an exposure period of 20 min. at room temperature and a post-exposure incubation of 42 hours in an incubator (37 °C, 5 % CO2, maximum humidity) the cell viability was 0.5 % as measured by a MTT conversion assay. Thus, also in this test with a 20 -min. exposure period it was demonstrated that the substance has a significant impact on cell viability.
Most recently, an in vivo skin irritation study was conducted according to OECD TG 404. Three male rabbits were occlusively exposed to the undiluted test substance for four hours. The skin reactions observed at 1 hour of initial and confirmatory tests were all recovered within 48 hours and reversibility was confirmed. No erythema were detected. The mean score of oedema was calculated as “0.3”, “0.3”, and “0.3” in the initial and confirmatory tests. The overall result of this in vivo study was “very slight irritating” to skin.
No in vivo eye irritation study was performed in accordance to REACH Annex VIII, 8.1.1. Column 2 (the substance is classified as Skin Corr. 1C (H314: Causes severe skin burns and eye damage.)).
Nevertheless, for eye irritation/corrosion three in vitro assays were performed.
At first, the test substance was investigated in the Bovine Corneal Opacity and Permeability (BCOP) test according to OECD TG 437. This in vitro test is used to identify chemicals with a potential for serious eye damage. In this study 750 µL of the unchanged test substance was applied to the extracted bovine cornea. Measurement of corneal opacity and permeability after a 10-minute exposure time and a 2-hour incubation time revealed an in vitro irritation score (IVIS) well below the cut-off value of 55, that is indicating a classification for serious eye damage according to the OECD TG 437. The positive (1 % sodium hydroxide solution) and negative (water) controls confirmed the validity of the test. Thus, under the conditions of this test no potential for serious eye damage can be concluded.
Secondly, an in vitro study for assessing ocular irritation was conducted in a human corneal epithelial (HCE) cell model. This model is recognized in the scientific community as a highly valuable model for the identification of substances that do not require classification for serious eye damage/eye irritancy (e.g. Cotovio et al., Toxicol. in Vitro, 24, 2010, 523 -537), and is routinely used by cosmetic and pharmaceutical companies. A recently conducted multi-laboratory validation study demonstrated the suitability for the assay to be used as part of a solid eye irritation risk assessment (Alépée et al., Toxicol in Vitro 31, 2016, 43–53). In this HCE-assay undiluted test item (30 µL) was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes (room temperature), followed by a 16 hours post-treatment incubation period (37 °C, 5 % CO2, maximum humidity), the cell viability was 2.7 % as measured by a MTT conversion assay. Since the cut-off for a non-irritant to the eye is 50 %, the test substance requires classification for eye irritation or eye damage based on this assay.
Thirdly, the HET-CAM (Hen's Egg Test on the Chorioallantoic Membrane) was conducted according to a protocol of the ICCVAM Test Method Evaluation Report 2010 in order to assess a potential for severe eye damage of the substance. In this test eight days incubated fertile hen eggs were opened and 300 µL of the test substance was applied onto the chorioallantoic membrane. The effects occurring during the first 300 seconds after application were measured and used to calculate the irritation score. Based on this irritation score, which was 1 of maximal 21, the test item was identified as having a slight irritant potential.
Overall, two of three in vitro assays indicate an adverse effect to the eye. Since the substance is corrosive to the skin the risk of severe damage to the eyes is considered implicit.
Respiratory Tract Irritation
With respect to respiratory irritation acute and repeated inhalation studies give evidence that the substance is a respiratory tract irritant (see endpoint summaries acute and repeated dose toxicity). Clinical observations in an acute inhalation toxicity study revealed signs reflective of respiratory tract irritation and in studies with repeated inhalation exposure irritant effect in the upper respiratory tract (epithelial alteration and inflammatory infiltrates in the nasal cavity) were histopathologically detected.
According to Regulation (EC) No 1272/2008, Annex I, classification is warranted for skin corrosion Cat. 1 (H314: Causes severe skin burns and eye damage). Based on the available in vitro and in vivo tests for skin irritation/corrosion (OECD TG 431, 439 and 404), Cat. 1C is most justified.
For substances assigned to skin corrosive Cat. 1, 1A, 1B or 1C, the risk of severe damage to eyes is considered implicit (serious eye damage Cat. 1 implicitly covered).
According to Regulation (EC) No 1272/2008, Annex I, classification is warranted for STOT SE 3 (H335: May cause 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.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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