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EC number: 826-490-3 | CAS number: 1971906-58-7
The test item showed no non-specific MTT-reducing potential but it showed colouring after mixture with isopropanol. Therefore, NSClivingwas determined. No correction of results was necessary because NSClivingwas below 5% (3 min treatment: 0.3%; 60 min treatment: 0.6%).
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (104.7%) after 3 min treatment and³ 15% (93.8%) after 60 min treatment.
In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermÔ, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (104.2%) after 60 min treatment and 42 h post-incubation.
The controls confirmed the validity of the study. The mean absolute OD570of the two negative control tissues was > 0.8 and < 2.5 (1.661). The mean relative tissue viability (% negative control) of the positive control was < 50% (18.6%). The inter tissue difference of replicate tissues of all dose groups was < 20% (18.6%).
The In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) test and the In Vitro Skin Irritation: Reconstructed Human Epidermis Test has been performed.
The test item showed no corrosive or irritant effects.
The eye irritancy potential of YELLOW 2747 was investigated in the bovine corneal opacity and permeability assay.
The result ( Mean in vitro irritation score) has been 13.09 .
The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are:
> 3; ≤ 55
No prediction can be made
The substance does not require classification for serious eye damage (UN GHS No Category), but no prediction can be made and further testing is required.
The In vitro Eye Irritation: Ocular Irritation Assay using the EpiOcularTMHuman Tissue Model has been performed.
In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 2”.
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