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EC number: 947-350-9 | CAS number: -
The potential of the test item to induce skin irritation was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EpiSkin™ according to the OECD Guideline 439 (2015). Ability of the test item to impair cell viability following an exposure period of 15 minutes and a subsequent 42 ± 1 hour recovery period was tested. A colorimetric measurement of MTT reduction (blue formazan salt) was used as an index for cell viability. A preliminary test was carried out to evaluate the compatibility of the test item with the test system. Firstly, the test item was assayed for the ability of reducing MTT per se. No colour change was noted in the MTT solution at the end of the incubation period, indicating that the test item could not direct interact with MTT. Secondly, the test item was assayed for its ability to colour water per se. A colourless solution was observed, indicating that the test item does not have potential interfering ability. Based on these results, no additional control was added in the Main Assay. In the Main Assay, the test item was applied as supplied in three replicates at the treatment level of 20 ± 2 mg/epidermis unit, each measuring 0.38cm2 (treatment level: 53 mg/cm2). A positive control (5% (w/v) sodium dodecyl sulphate solution in water) and a negative control (Dulbecco’s phosphate buffered saline (D-PBS)) were concurrently tested.
The negative control provided the expected baseline value (Optical Density values of the three replicates higher than 0.6) and variability (Standard Deviation (SD) of % viability lower or equal to 18), as indicated in the guideline, representing 100 % cell viability. The positive control caused the expected cell death (2% cell viability compared to the negative control) and variability (SD of % viability equal to 1.0). Based on the stated criteria (mean viability ≤ 40% and SD of % viability ≤ 18), the assay was regarded as valid. The test item did not induce cell death in any replicate. The mean cell viability after subtraction of the blank solution was 95% compared to the negative control. Intra-replicate variability was acceptable (SD of % viability value equal to 8.5 (lower than the maximum of 18)). Based on these results, the test item is not classified as irritating to the skin (UN GHS No Category).
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