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EC number: 949-790-7 | CAS number: -
The objective of this study was to evaluate Esacure 3644 for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of Esacure 3644 was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch M7-238-1807001 of Esacure 3644 was a light yellow solid. Skin tissue was moistened with 25 µL of Milli-Q water and at least 25 mg of Esacure 3644 was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 13% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤14% for the negative control and test item. For the positive control, the Coefficient of Variation between tissue replicates at the 3-minute exposure was 36%. Since both individual tissues were clearly positive it was concluded 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 Esacure 3644 compared to the negative control tissues was 87% and 77%, respectively. Because the mean relative tissue viability for Esacure 3644 was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Esacure 3644 is considered to be not corrosive.
In conclusion, Esacure 3644 is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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