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EC number: 306-060-7 | CAS number: 95873-69-1
For each run, the test item was prepared in pre-warmed water for injections at 100 mM. The formulation was then heated at 60°C for up to 1h30 and sonicated for 10 minutes prior being filtered through a 0.22 μm filter.
Each run was considered to be valid since all acceptance criteria were fulfilled for the positive and negative controls. In the third run, an outlier luminescence value was removed from the data analysis of the negative control wells (the second replicate of the third plate), therefore 17 negative control values were taken into consideration for the analysis instead of 18.
This run was performed using the following concentrations: 0.49, 0.98, 1.95, 3.91, 7.81, 15.63, 31.3, 63, 125, 250, 500 and 1000 μM in culture medium containing 1% DMSO and 1% water.
At these tested concentrations:
. no precipitate/emulsion was observed in any test item-treated wells at the end of the 48-hour treatment period,
. no noteworthy decrease in cell viability was noted (i.e. cell viability > 70%), therefore no IC30 or IC50 was calculated,
. a statistically gene-fold induction above the threshold of 1.5 was noted at concentration of 1000 μM,
. the Imax was 2.19 and the calculated EC1.5 was 658.31 μM.
The evaluation criteria for a positive response are met in this run.
Due to results obtained in the first run (i.e. statistically significant gene-fold induction > 1.5 at the highest tested concentration only), a narrower range of concentrations was used in the second run (i.e. dilution factor of 1.41): 22.83, 32.20, 45.40, 64.01, 90.25, 127.26, 179.4, 253, 357, 503, 709 and 1000 μM in culture medium containing 1% DMSO and 1% water.
. a decrease in cell viability (i.e. cell viability < 70%) was noted at 1000 μM, the corresponding IC30 was 898.70 μM, no IC50 was calculated since the cell viability was > 50% in this run,
. no statistically significant gene-fold induction above the threshold of 1.5 was noted in comparison to the negative control at any tested concentrations. Moreover, the Imax value was < 1.5.
The evaluation criteria for a negative response are met in this run.
Since non-concordant results were obtained in the first two runs, a third run was performed.
The same concentrations as those used in the second run were used in this third run and the following results were obtained:
. no statistically significant gene-fold induction above the threshold of 1.5 was noted in comparison to the negative control at any tested concentrations. Moreover, the Imax value was 1.52.
No geometric mean IC30 or IC50 was calculated since the cell viability was > 70% in two out of three runs.
The evaluation criteria for a negative response are met in two out of three runs, the final outcome is therefore negative. This negative result can be used to support the discrimination between skin sensitizers and non-sensitizers in the context of an integrated approach to testing and assessment. It cannot be used on its own to conclude on a skin sensitisation potential.
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