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EC number: 955-078-7
CAS number: -
The objective of this study was to evaluate PF-07321332 MTBE Solvate for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)).The possible corrosive potential of the test item was tested through topical application for 3 minutes and | hour.The study procedures described in this report were based on the most recent OECD and EC guidelines.Batch 902/7321332/B/1/1 of the test item was a white to off-white solid. Skin tissue was moistened with 25 uL of Milli-Q water and at least 25 mg of the test item was applied directly on top of the skin tissue.The positive control had a mean relative tissue viability of 8.3% after the 1-hour exposure. The absolute mean OD570 of the negative control tissues of the 1-hour treatment was just above the laboratory historical control data range. Since the absolute mean OD570 values were the within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8), this minor deviation has no impact on the study results. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 7.2%, indicating that the test system functioned properly.Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 94% and 92%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.In conclusion, PF-07321332 MTBE Solvate is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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