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EC number: 947-340-4 | CAS number: -
Skin irritation: Under the present test conditions, Ukanol FR 70 tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period, was non-cytotoxic and, hence, predicted to be non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin. Hence, the test item did not show irritant properties and is therefore not classified as irritant (UN GHS no category).
Eye irritation: Under the present test conditions Ukanol FR 70 tested in the in vitro BCOP test method, had an IVIS value of 0.807, which is below the cut-off value of 3 (UN GHS no category) and consequently it is not classified as a severe irritant and is not corrosive according to UN GHS classification.
The purpose of this study was to determine cytotoxic properties of Ukanol FR 70 to skin cells, which might lead to irritation of human skin, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.
Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
As the test item is highly viscous, Ukanol FR 70 was applied to a nylon mesh prior to application to the skin surface. The nylon mesh loaded with 25 mg of test item was applied to the skin model which was moistened with Dulbecco’s phosphate buffered saline (D-PBS).D-PBS was used as the negative control.5% aqueous sodium dodecyl sulphate (SDS)was used as the positive reference item. An exposure time of 60 minutes was employed followed by a 42-hour post-treatment incubation period in fresh medium. The mean viability of cells exposed to Ukanol FR 70 was 98.3% of the negative controls and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%. Ukanol FR 70 was considered to be non-cytotoxic and predicted to be non-irritant to skin.
The mean optical density (OD) of 3 negative control tissues was 1.472 and was well within the acceptable range of ≥ 1.0 to ≤ 2.5.The viability of cells treated with the positive reference item, 5% SDS, was 7.2 of the negative control and fulfilled the acceptance criterion of ≤20%.
The standard deviation of all triplicates determined was below the limit of acceptance of 18%.Hence, all acceptance criteria were fulfilled.
The purpose of this study was to determine a possible potency of Ukanol FR 70 of being 'ocular corrosive and severe irritant 'employing an in vitro system.The Bovine Corneal Opacity and Permeability Assay (BCOP) test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro.In this test method, possible damage by the test item was assessed by quantitative measurements of changes in corneal opacity and permeability inisolated corneas from bovine eyes.
Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea, as detected in the medium in the posterior chamber.The measurements were used to calculate an in vitro irritancy score (IVIS), which was used to assign an in vitro irritancy hazard classification category for prediction of the in vivo ocular irritation potential of the test item.
Three corneas were used for each treatment group (test item, solvent control and positive control). In a preliminary study, no homogeneous suspension of the test item could be achieved in a 0.9% sodium chloride solution due to the high viscosity of the test item. Hence, the test item was applied directly to the epithelial surface of the cornea. 150 mgUkanol FR 70 (corresponding to 750 µL of the recommended concentration of 20% (w/v) by thetest guideline 437 for non-surfactant solids) were applied to a plastic sheet prior to application to the cornea.The cornea was moistened with 600 µL0.9% NaCl solutionprior to application.0.9% NaCl solution was used as the solvent control and 20% Imidazole in0.9% NaCl solution as the positive control item.
750 µL of the control items as recommended as suitable test volume according to OECD TG 437 were added to completely cover the cornea’s epithelium. The exposure time for the test item and the controls was 240 minutes. The optical density (OD) was measured at a wavelength of 490 nm.The open-chamber method was used.
The acceptance criteria of validity were fulfilled in this test.
Following treatment with Ukanol FR 70 a mean opacity of 0.942±0.738 and a mean permeability value of <0.01compared to the negative control were determined. The calculated IVIS of 0.807±0.590 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.
The GHS criteria are not met. The substance is therefore not classified for skin- or eye irritating properties.
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