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The mean absorption at 540 nm measured after treatment with PF-00346643 and controls are presented in Table 1 (see attached background information). The individual OD540 measurements are presented in Appendix l (see attached background information).
Table 2 (see attached background information) shows the mean tissue viability obtained after 3 minutes and 1 hour treatment with PF-00346643 compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3 minutes and 1 hour treatment with PF-00346643 compared to the negative control tissues was 106% and 108% respectively. Since the mean relative tissue viability for PF-00346643 was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment PF-00346643 is considered to be not corrosive.
The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range (See appendix ll in attached background information). The mean relative tissue viability of the 3 minutes exposure of the positive control was 7%. The maximum inter tissue variability in viability between two tissues treated identically was less than 10% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 5%. It was therefore concluded that the test system functioned properly.
Historical control data for in vitro skin corrosion studies is given in Appendix II (see attached background information)
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