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EC number: 202-160-9
CAS number: 92-50-2
The key information is based on three different in-vitro/in-silico tests
addressing different events of the adverse outcome pathway (AOP), namely
activation of keratinocytes (KeratinoSens™ assay), the molecular
initiating event being protein reactivity (in-chemico direct peptide
reactivity assay), and dendritic cell activation (h-CLAT).
In the in-vitro
KeratinoSens™ assay, the following concentration
range was tested: 2000, 1000, 500, 250, 125, 62.5, 31.25, 15.63, 7.81,
3.91, 1.95, 0.98 µM. Cells were incubated with the test item for 48 h at
37°C. After exposure cells were lysed and luciferase activity was
assessed by luminescence measurement. In two separate experiments, no
significant luciferase induction > 1.5 was found in the tested
concentration range. Therefore, no EC1.5 value could be calculated. No
dose response for luciferase activity induction was observed for each
individual run as well as for an overall luciferase activity induction.
Under the condition of this study the test item is therefore considered
as non sensitiser.
In the in-chemico direct peptide reactivity assay (DPRA), test
item solutions were tested by incubating the samples with
the peptides containing either cysteine or lysine for 24 ± 2 h at
25 ± 2.5 °C. Subsequently samples were analysed by HPLC. After
the 24 h±2 h
incubation period but prior to the HPLC analysis samples were inspected
for precipitation, turbidity or phase separation. No precipitation,
turbidity or phase separation was observed for any of the test item
samples. Sensitising potential of the
test item was predicted from the mean peptide depletion of both analysed
peptides (cysteine and lysine) by comparing the peptide concentration of
the test item treated samples to the corresponding reference control. The
100 mM stock solution of the test item showed minimal reactivity towards
the synthetic peptides. The mean depletion of both peptides was 6.38%
(1.06%). Based on the prediction model 1 the test item can be considered
as non-sensitiser. The 100 mM stock solution of the positive control
(cinnamic aldehyde) showed high reactivity towards the synthetic
peptides with a mean depletion of both peptides of 65.83%.
In the human cell line activation test (h-CLAT), 2-(n-ethylanilino)ethanol
was dissolved in DMSO.For the dose finding assay stock solutions with
concentrationsranging from 500 mg/mL to 3.91 mg/mLwere prepared by a
serial dilution of 1:2. Cells were incubated with the test item for 24 h
at 37°C. After exposure cells were stained with propidium iodide and
cell viability (CV) was measured by FACS analysis. A CV75 of
578.15 ± 15.95 µg/mL was derived in the dose finding assay. Based on the
CV75, the main experiment was performed covering the following
concentration steps: 693.77, 578.15, 481.79, 401.49, 334.57, 278.81,
232.34, 193.62 µg/mL In all experiments no precipitation or turbidity of
the test item was observed for all concentration steps when mixing the
test item stock solutions with cell culture medium. Cells were incubated
with the test item for 24 h at 37°C. After exposure cells were stained
and cell surface markers CD54 and CD86 were measured by FACS analysis.
Cell viability was assessed in parallel using propidium iodide staining.
Cytotoxic effects were observed for the cells treated with the test
item. Relative cell viability at the highest test item concentration was
reduced to 60.2% (CD86), 57.2% (CD54) and 56.7% (isotype IgG1 control)
in the first experiment and to 55.9% (CD86), 56.4% (CD54) and 55.6%
(isotype IgG1 control) in the second experiment. In the first experiment
the expression of the cell surface markers CD86 and CD54 was not
upregulated above the threshold of 150% and 200%. In the second
experiment the expression of the cell surface marker CD86 was
upregulated to 181% at a concentration of 693.77 µg/mL. This was the
only upregulation above the threshold of 150%, no other upregulation was
observed. Since there was no upregulation in the first and the one
upregulation in the second experiment, the outcome of the study must be
considered as inconclusive.
Based on the three guideline tests performed, 2-(n-ethylanilino)ethanol
did not appear to be a skin sensitizer.
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