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The mean OD570 of the negative control, sterile, Dulbecco’s Phosphate Buffered Saline, was 2.193. The mean viability of the positive control, SDS, was 8.5%. The standard deviation calculated from individual percent tissue viabilities of the 3 identically treated replicates was < 18% for the test substance, positive and negative control. Since the mean positive control result was an R38 classification (i.e. viability ≤ 50%) and the mean OD570 value of the negative control was greater than 1.000 and less than 2.500, the assay results were considered valid.
The Skin Irritation Test using the EpiDerm™ Skin Model was used to predict the skin irritation potential of the test substance in the context of classification of skin irritation hazard according to the EU classification system (R38 or No Label). The test substance, positive control (5% Sodium Dodecyl Sulfate), and negative control (Dulbecco’s Phosphate Buffered Saline) were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT. Based upon the results of this assay, the test substance was not predicted to be a skin irritant.
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