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EC number: 210-638-3
CAS number: 620-40-6
Table 1: Results of the first run
MEAN cell viability (%)
S.I. CD86 -IgG1 (%)
InterferenceIgG1 FL1 Geo Mean S.I. (%)
C= test groups with cytotoxic effects (cell viability < 70%) were excluded from the assessment.
S= with S.I. values of ≥ 150% .
P= Precipitations were observed
Table 2: Results of the second run
Table 3: Historical Control Data
Mean relative viability [%]
Negative control (Lactic acid 200µg/mL)
Positive control TNBS 50µg/mL)
An in vitro skin sensitization test (U-SENS™) according to OECD TG 442E was performed to assess the skin sensitization potential of the test item dissolved in DMSO when administered to U937 cells for 45 ± 3 hours. This human cell line activation test can be used as part of a testing battery (including e.g. DPRA (Direct Peptide Reactivity Assay), and ARE-Nrf2 (luciferase test method)) based on the OECD adverse outcome pathway for the assessment of the skin sensitisation potential of chemicals. The highest test item concentration was 200 μg/mL in accordance to the OECD TG 442E. For CD86 expression measurement the following concentrations of the test item were tested in the main experiments (U-SENS™): 1, 10, 20, 50, 100 and 200 μg/mL in first experiment (run) and 1, 5, 10, 15, 20 and 30 μg/mL in the second experiment. In the first experiment, cytotoxic effects (cell viability < 70 %) were observed following incubation with the test item starting with a concentration of 50 μg/mL up to the highest test concentration of 200 μg/mL, and precipitation was observed at 100 and 200 μg/mL. Therefore, the concentrations from 50 μg/mL up to 200 μg/mL were excluded from the assessment. In the second experiment cytotoxic effects were observed in the flow cytometric evaluation following incubation with the test item starting with 20 μg/mL up to the highest test concentration of 30 μg/mL. Therefore, the concentrations 20 μg/mL and 30 μg/mL were excluded from the assessment. The CV70 value of the test item was 26.0 μg/ml in the first experiment and 18.5 μg/mL in the second experiment. The test item showed interference (defined as IgG1 FL1 Geo Mean S.I. ≥ 150 %) at 50 μg/mL and 100 μg/mL in the first experiment and at 30 μg/mL in the second experiment. This observation has no impact for the outcome of the study, since the concentrations which showed interference did not meet the cytotoxcitiy criterion and were excluded from the assessment. In the first experiment the CD86 stimulation index (S.I.) was higher or equal to 150 % after treatment with the test item between 10 μg/mL and the highest tested concentration of 200 μg/mL. Two of these concentrations (10 and 20 μg/mL) were non-cytotoxic (cell viability ≥ 70 %). In the second experiment the CD86 stimulation index (S.I.) was higher or equal to 150 % after treatment with the test item between 10 μg/mL and the highest tested concentration of 30 μg/mL. Two of these concentrations (10 and 15 μg/mL) were non-cytotoxic (cell viability ≥ 70 %). Therefore, the outcome of the U-SENS™ is considered positive for the test item. In conclusion, the test item activated U-937 cells under the test conditions of this study. Therefore, the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).
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