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EC number: 500-092-7
CAS number: 36890-68-3
The following test item concentrations
showed a viability ≥ 70 %, were declared as valid and could therefore be
evaluated for luciferase induction:
Experiment I: 269µg/mL, 323 µg/mL, 338
µg/mL, 465 µg/mL, 558 µg/mL.
Experiment II: 269µg/mL, 323 µg/mL, 338
µg/mL, 465 µg/mL.
Experiment III: 269µg/mL, 323 µg/mL, 338
A substantial and reproducible
dose-dependent and a statistically significant increase in luciferase
induction was measured in the test item concentrations 323 µg/mL to 558
µg/mL in experiment I, 269 µg/mL to 465 µg/mL in experiment II and 269
to 388 µg/mL in experiment III. Here, the induction was equal or above
threshold of 1.5 fold in comparison to the solvent control.
An in vitro study (conducted
according to OECD Test Guideline 422D) has been carried out to evaluate
the potential of the test item ε-Caprolactone, oligomeric reaction
products with 2,2'-oxydiethanol to activate
the Nrf2 transcription factor (sensitizing potential) by
using the LuSens cell line. This test is part of a tiered strategy for
the evaluation of skin sensitization potential. Thus, data generated
with the present Test Guideline should be used to support the
discrimination between skin sensitizers and non-sensitizers in the
context of an integrated approach to testing and assessment.
The LuSens test is an ARE Reporter Gene
Assay that was developed by the BASF SE (Ludwigshafen, Germany) and is
based on the OECD 442D Guideline (KeratinoSens Assay). Since July
2017 a reviewed version of the OECD 442D is available, which includes
the LuSens test. Therefore this study is performed in accordance to this
draft OECD 442D with the title “In Vitro Skin Sensitisation
assays addressing the AOP Key Event on: Keratinocyte activation”.
The assay included a cytotoxicity
range finder test (CRFT) and two independent experiments (experiment I
and II) with a treatment period of 48 h. The CRFT was performed to
detect a potential cytotoxic effect of the test item. Based on the
results of this test the concentrations for the two experiments were
In the experiments, the highest
nominal applied concentration (2000 µg/mL) was chosen based on the
results obtained in the CRFT.A geometric series (factor 1.2) of eleven
dilutions thereof was prepared. Precipitation of the test item was not
visible in any of the experiments.
concentration: 1 %) was
used as solvent control and medium no. 3 as growth control. Lactic acid
(5000 µM) was used as negative control and EGDMA (120 µM) as positive
A substantial and reproducible
dose-dependent increase in luciferase induction above 1.5 fold in more
than two non-cytotoxic consecutive test item concentrations was observed
in both experiments.
the experimental conditions of this study, the test item,ε-Caprolactone,
oligomeric reaction products with 2,2'-oxydiethanol,
was positive in the LuSens assay and is therefore considered to have the
potential to activate the Nrf2
transcription factor (sensitizing
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