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EC number: 858-735-5 | CAS number: 2337348-25-9
- Life Cycle description
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-05-03 to 2021-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442E (In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT))
- Version / remarks:
- 23 July 2018
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- human Cell Line Activation Test (h-CLAT)
Test material
- Reference substance name:
- 1,3-bis[(3-methylbut-2-en-1-yl)oxy]propan-2-ol
- EC Number:
- 858-735-5
- Cas Number:
- 2337348-25-9
- Molecular formula:
- C13H24O3
- IUPAC Name:
- 1,3-bis[(3-methylbut-2-en-1-yl)oxy]propan-2-ol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Details of test system:
- THP-1 cell line [442E]
- Details on the study design:
- 442E
PREPARATION OF TEST SOLUTIONS
The test item was freshly prepared immediately prior to use. The test item was soluble in dimethyl sulfoxide (DMSO) at a concentration of 500 mg/mL.
Stock solutions were prepared by diluting the highest soluble concentration seven times with a constant dilution factor of 1:2 in the dose-finding assay and factor 1:1.2 in the main experiments.
The working stock solutions were prepared by diluting each stock solution 250 times with cell culture medium.
Only in the dose finding assay 2 phase separation was observed in the two highest concentrations when diluted 1:250 in cell culture medium. Sonication was used to aid solubilisation.
The working stock solutions were applied to the cells by adding equal volumes of each solution to prepared cells, resulting in a further 1:2 dilution of the working solutions. The solvent was present at a constant volume ratio of 0.2% (v/v) in all cultures, i.e. in all concentrations of the test item and the solvent control.
DOSE Groups:
1. Medium Control: cell culture medium
2. Solvent Control: 0.2% DMSO (v/v) in cell culture medium
3. Positive Control: 4 µg/mL DNCB
4. Test Item: 8 concentrations of the test item
(dose finding assay/ main experiment)
dose finding assay 1 and 2: 1000, 500, 250, 125, 62.50, 31.25, 15.63, 7.81 µg/mL - A CV75 of 358.04 ± 55.37 µg/mL was derived in the dose finding assay
Based on the CV75, the main experiment was performed covering the following concentration steps:
main experiment 1 and 2: 429.65, 358.04, 298.37, 248.64, 207.20, 172.67, 143.89, 119.91 µg/m
APPLICATION OF THE TEST CHEMICAL AND CONTROL SUBSTANCES
A medium control, a solvent control, and a positive control were set up in parallel in order to confirm the validity of the test.
Medium Control
A medium control was included in the test.
Solvent Controls
Solvent controls were included in the test. The solvent controls were set up depending on the appropriate solvent previously determined.
Since the test item was solubilized in DMSO, a DMSO control served as solvent control for the test item.
Since the positive control was solubilized in DMSO, a DMSO control was included and served as solvent control for the positive control.
The solvent controls were diluted, resulting in a final concentration of 0.2% (v/v) for DMSO.
Positive Control
2,4-dinitrochlorobenzene (DNCB) at a final concentration of 4 µg/mL (alternatively at the concentration of the CV75) was tested concurrently with the test item. DNCB was dissolved in DMSO and diluted, resulting in a final DMSO concentration of 0.2% (v/v).
MEASUREMENT OF CELL SURFACE EXPRESSION/LUCIFERASE ACTIVITY
For h-CLAT
Dose Finding assay:
The PI (propidium iodide) uptake of the cells and therefore cytotoxicity was analysed immediately after the staining procedure by flow cytometry using an excitation wavelength of lambda = 488 nm and an emission wavelength of lambda > 650 nm. A total of 10,000 living (PI negative) cells were acquired and cell viability was calculated for each test concentration.
Main experiment:
The expression levels of CD86 and CD54 as well as cell viability were analysed by flow cytometry using an excitation wavelength of lambda = 488 nm and an emission wavelength of lambda = 530 nm ± 15 nm for FITC and lambda > 650 nm for PI. Based on the geometric mean fluorescence intensity (MFI), the relative fluorescence intensity (RFI) of CD86 and CD54 were calculated.
Acceptance criteria
The test meets acceptance criteria if:
• the cell viability of the solvent controls is >90%,
• the cell viability of at least four tested doses of the test item in each run is >50%,
• the RFI values of the positive control (DNCB) is >=150% for CD86 and >=200% for CD54 at a cell viability of >50%,
• the RFI values of the solvent control is not >=150% for CD86 and not >=200% for CD54,
• the MFI ratio of CD86 and CD54 to isotype IgG1 control for the medium and DMSO control, is >105%.
DATA EVALUATION
- Cytotoxicity assessment
Cell viability were analysed by flow cytometry
- Prediction model used
For CD86/CD54 expression measurement, each test item was tested in at least two independent runs to derive a single prediction. Each independent run was performed on a different day or on the same day provided that for each run: independent fresh stock solutions and working solutions of the test chemicals and antibody solutions were prepared and independently harvested cells were used. Sensitising potential of the test item was predicted from the mean percentage expression of CD86 and CD54. Any test chemical tested by the h-CLAT was considered positive if the RFI of CD86 was equal to or greater than 150% at any tested dose at a cell viability = 50% in at least two independent runs or if the RFI of CD54 was equal to or greater than 200% at any tested dose at a cell viability = 50% in at least two independent runs or if the RFIs of both the CD86 and CD54 were equal to or are greater than 150% and 200% respectively at any tested dose at a cell viability = 50% in at least two independent runs. In case of not concordant results a third run should be conducted to make the final prediction. Otherwise the results were considered as inconclusive.
A negative test result of a test item was only accepted if the cell viability at a concentration of 1.2 x CV75 is <90%. In contrast, a positive test outcome was accepted irrespective of cell viabilities >90% at a concentration of 1.2 x CV75. If no CV75 could be derived negative test results can be accepted when the test item is tested at the highest soluble concentration (5000 µg/mL for 0.9% NaCl solution; 1000 µg/mL for DMSO or a different organic solvent) even if the cell viability is >90%.
A negative result for test items with a Log KOW > 3.5 should be considered as inconclusive. - Vehicle / solvent control:
- DMSO
- Negative control:
- other: Medium control
- Positive control:
- dinitrochlorobenzene (DNCB) [442E]
Results and discussion
- Positive control results:
- Refer to the result tables in 'Any other information on results incl. tables'
In vitro / in chemico
Resultsopen allclose all
- Group:
- test chemical
- Run / experiment:
- other: run/experiment 1 and 2
- Parameter:
- other: RFI CD54
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The expression of the cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments
- Remarks:
- Refer to the result tables in 'Any other information on results incl. tables'
- Group:
- test chemical
- Run / experiment:
- other: run/experiment 1 and 2
- Parameter:
- other: RFI CD86
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The expression of the cell surface marker CD86 was not upregulated above the threshold of 150% in any of the experiments.
- Remarks:
- Refer to the result tables in 'Any other information on results incl. tables'
- Outcome of the prediction model:
- negative [in vitro/in chemico]
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: see below table
Any other information on results incl. tables
Discussion
The in vitro human cell line activation test (h-CLAT) enables detection of the sensitising potential of a test item by addressing the third molecular key event of the adverse outcome pathway (AOP), namely dendritic cell activation, by quantifying the expression of the cell surface markers CD54 and CD86 in the human monocytic cell line THP-1. The expression of the cell surface markers compared to the respective solvent controls is used to support discrimination between skin sensitiser and non[1]sensitisers.
Prior to the main study the cell batch was checked for its reactivity towards known positive and negative controls and was found to be acceptable for further testing.
In the present study 1,3-di(3-Methyl-2-butenoxy)-2-hydroxypropane was dissolved in DMSO. For the dose finding assay stock solutions with concentrations ranging from 500 mg/mL to 3.91 mg/mL were 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 was measured by FACS analysis.
A CV75 of 358.04 ± 55.37 µg/mL was derived in the dose finding assay.
Based on the CV75, the main experiment was performed covering the following concentration steps: 429.65, 358.04, 298.37, 248.64, 207.20, 172.66, 143.89, 119.91 µg/mL
Phase separation of the test item was observed for the two highest concentration steps in the dose-finding study 2 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 35.4% (CD86), 38.0% (CD54) and 43.8% (isotype IgG1 control) in the first experiment and to 34.9% (CD86), 36.2% (CD54) and 47.3% (isotype IgG1 control) in the second experiment.
The expression of the cell surface marker CD86 was not upregulated above the threshold of 150% in any of the experiments. The expression of the cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments. Therefore, the test item was negative in this assay.
The controls confirmed the validity of the study for all experiments as shown in Table 6.
The data generated with this test should be considered in the context of integrated approached such as IATA, combining the result with other complementary information, e.g. derived from in vitro assays addressing other key events of the skin sensitisation AOP
Results
Reactivity Check of the Cell Stock
Doubling time of the cells was monitored and found to be 32.2 h which is within the doubling time range specified by the manufacturer (30 - 55 h).
Table 2: Results of the Cell Batch Activation Test
Sample |
Concentration |
CD86 |
CD54 |
Activated |
Pass /Fail |
||||
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
Cell Viability [%] |
RFI |
Threshold OECD TG 442E |
yes/no |
|||
DNCB |
4 µg/mL |
87 |
276 |
>150 |
86 |
413 |
>200 |
yes |
pass |
NiSO4 |
100 µg/mL |
88 |
351 |
>150 |
87 |
596 |
>200 |
yes |
pass |
LA |
1000 µg/mL |
97 |
103 |
=150 |
98 |
109 |
=200 |
no |
pass |
The positive controls DNCB and NiSO4 led to upregulation of the cell surface markers CD54 and CD86. The negative control LA did not induce an upregulation of CD54 and CD86.
The cell batch was accepted for further testing.
Solvent Finding
All test item solutions were freshly prepared immediately prior to use. The test item was soluble in DMSO at a concentration of 500 mg/mL.
Dose Finding Assay
The dose finding assay was performed using stock solutions with a concentration of 500 mg/mL (applied concentration 1000 µg/mL).
Table 3: Results of the Dose Finding Assay
Sample |
Experiment 1 |
Experiment 2 |
|||
Concentration applied [µg/mL] |
Cell Viability [%] |
Concentration applied [µg/mL] |
Cell Viability [%] |
||
Medium Control |
-- |
-- |
94.54 |
-- |
95.59 |
Solvent Control |
DMSO |
-- |
92.47 |
-- |
94.92 |
1,3-di(3-Methyl-2-butenoxy)-2-hydroxypropane |
C8 |
7.81 |
92.73 |
7.81 |
93.61 |
C7 |
15.63 |
93.79 |
15.63 |
93.08 |
|
C6 |
31.25 |
93.24 |
31.25 |
94.57 |
|
C5 |
62.50 |
92.72 |
62.50 |
95.86 |
|
C4 |
125.00 |
92.35 |
125.00 |
95.63 |
|
C3 |
250.00 |
91.21 |
250.00 |
93.70 |
|
C2 |
500.00 |
66.94 |
500.00 |
40.44 |
|
C1 |
1000.00 |
3.14 |
1000.00 |
1.95 |
|
Calculated CV75 [µg/mL] |
397.19 |
318.88 |
|||
Mean CV75 [µg/mL] |
358.04 |
||||
SD CV 75 [µg/mL] |
55.37 |
Results CD54 and CD86 Expression
For determination of the cell surface markers CD54 and CD86 two independent experiments were performed using separate cultivated cells at passage 19 (first experiment) and 25 (second experiment). For each experiment separately weighted samples and preparations were used.
Table 4: CD54 and CD86 Expression Experiment 1
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Fluorescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
CD86 |
CD54 |
||
Medium Control |
- |
96.0 |
93.9 |
92.0 |
1144 |
693 |
490 |
654 |
203 |
81 |
53 |
233 |
141 |
Solvent Control |
0.20% |
96.7 |
91.9 |
94.6 |
1211 |
780 |
400 |
811 |
380 |
100 |
100 |
303 |
195 |
DNCB |
4.00 |
85.4 |
73.8 |
87.9 |
2017 |
1180 |
395 |
1622 |
785 |
200 |
207 |
511 |
299 |
1,3-di(3-Methyl-2-butenoxy)-2-hydroxypropane |
429.65 |
35.4 |
38.0 |
43.8 |
852 |
783 |
494 |
358 |
289 |
44 |
76 |
172 |
159 |
358.04 |
74.7 |
64.8 |
80.5 |
952 |
806 |
411 |
541 |
395 |
67 |
104 |
232 |
196 |
|
298.37 |
85.9 |
86.9 |
90.5 |
1066 |
724 |
399 |
667 |
325 |
82 |
86 |
267 |
181 |
|
248.64 |
89.6 |
90.9 |
89.4 |
979 |
645 |
395 |
584 |
250 |
72 |
66 |
248 |
163 |
|
207.20 |
92.2 |
90.5 |
94.3 |
1005 |
703 |
397 |
608 |
306 |
75 |
81 |
253 |
177 |
|
172.67 |
92.9 |
92.9 |
93.9 |
905 |
658 |
393 |
512 |
265 |
63 |
70 |
230 |
167 |
|
143.89 |
93.7 |
91.6 |
94.1 |
967 |
639 |
396 |
571 |
243 |
70 |
64 |
244 |
161 |
|
119.91 |
94.8 |
93.9 |
90.3 |
972 |
605 |
393 |
579 |
212 |
71 |
56 |
247 |
154 |
Table 5: CD54 and CD86 Expression Experiment 2
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Fluorescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
CD86 |
CD54 |
||
Medium Control |
- |
91.2 |
93.0 |
93.0 |
1234 |
742 |
473 |
761 |
269 |
79 |
82 |
261 |
157 |
Solvent Control |
0.20% |
92.5 |
90.4 |
92.8 |
1387 |
753 |
425 |
962 |
328 |
100 |
100 |
326 |
177 |
DNCB |
4.0 |
80.3 |
77.1 |
76.9 |
3093 |
2070 |
725 |
2368 |
1345 |
246 |
410 |
427 |
286 |
1,3-di(3-Methyl-2-butenoxy)-2-hydroxypropane |
429.65 |
34.9 |
36.2 |
47.3 |
1503 |
1023 |
517 |
986 |
506 |
102 |
154 |
291 |
198 |
358.04 |
56.0 |
61.5 |
66.4 |
1587 |
994 |
426 |
1161 |
568 |
121 |
173 |
373 |
233 |
|
298.37 |
84.5 |
82.9 |
86.9 |
1540 |
1033 |
423 |
1117 |
610 |
116 |
186 |
364 |
244 |
|
248.64 |
88.2 |
89.3 |
91.3 |
1604 |
916 |
425 |
1179 |
491 |
123 |
150 |
377 |
216 |
|
207.20 |
91.6 |
90.9 |
93.1 |
1591 |
810 |
401 |
1190 |
409 |
124 |
125 |
397 |
202 |
|
172.67 |
92.2 |
92.2 |
94.0 |
1554 |
848 |
493 |
1061 |
355 |
110 |
108 |
315 |
172 |
|
143.89 |
88.9 |
92.7 |
92.7 |
1428 |
835 |
554 |
874 |
281 |
91 |
86 |
258 |
151 |
|
119.91 |
93.1 |
93.6 |
91.0 |
1427 |
979 |
401 |
1026 |
578 |
107 |
176 |
356 |
244 |
Acceptance Criteria
Table 6: Acceptance Criteria
Acceptance Criterion |
Range |
Experiment 1 |
pass/fail |
Experiment 2 |
pass/fail |
||||
cell viability solvent controls [%] |
>90 |
91.9 |
- |
96.7 |
pass |
90.4 |
- |
93.0 |
pass |
number of test dosed with viability >50% CD86 |
>=4 |
7 |
pass |
7 |
pass |
||||
number of test dosed with viability >50% CD54 |
>=4 |
7 |
pass |
7 |
pass |
||||
number of test dosed with viability >50% IgG1 |
>=4 |
7 |
pass |
7 |
pass |
||||
RFI of positive control of CD86 |
>=150 |
200 |
pass |
246 |
pass |
||||
RFI of positive control of CD54 |
=200 |
207 |
pass |
410 |
pass |
||||
RFI of solvent control of CD86 |
<150 |
124 |
pass |
126 |
pass |
||||
RFI of solvent control of CD54 |
<200 |
187 |
pass |
122 |
pass |
||||
MFI ratio CD86/IgG1 for medium control [%] |
>105 |
233 |
pass |
261 |
pass |
||||
MFI ratio CD86/IgG1 for DMSO control [%] |
>105 |
303 |
pass |
326 |
pass |
||||
MFI ratio CD54/IgG1for medium control [%] |
>105 |
141 |
pass |
157 |
pass |
||||
MFI ratio CD54/IgG1for DMSO control [%] |
>105 |
195 |
pass |
177 |
pass |
||||
Historical Data
Table 7: Historical Data
Criterion |
mean |
SD |
N |
cell viability solvent controls [%] |
96.3 |
1.5 |
1554 |
number of test doses with viability >50% |
- |
- |
4026 |
RFI of positive control of CD86 |
355.0 |
122.9 |
259 |
RFI of positive control of CD54 |
435.4 |
255.5 |
259 |
RFI of solvent control of CD86 |
111.1 |
31.3 |
259 |
RFI of solvent control of CD54 |
114.4 |
43.2 |
259 |
MFI ratio IgG1/CD86 for medium control [%] |
309.0 |
154.2 |
259 |
MFI ratio IgG1/CD86 for DMSO control [%] |
353.1 |
364.2 |
259 |
MFI ratio IgG1/CD54 for medium control [%] |
179.0 |
150.3 |
259 |
MFI ratio IgG1/CD54 for DMSO control [%] |
176.5 |
54.3 |
259 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item did not upregulate the expression of the cell surface markers in at least two independent experiment runs. Therefore, the test substance was negative in this study.
The data generated with this method may be not sufficient to conclude on the absence of skin sensitisation potential of chemicals and should be considered in the context of integrated approach such as IATA. - Executive summary:
The in vitro human cell line activation test (h-CLAT) enables detection of the sensitising potential of a test item by addressing the third molecular key event of the adverse outcome pathway (AOP), namely dendritic cell activation, by quantifying the expression of the cell surface markers CD54 and CD86 in the human monocytic cell line THP-1. The expression of the cell surface markers compared to the respective solvent controls is used to support discrimination between skin sensitisers and non-sensitisers.
Prior to the main study the cell batch was checked for its reactivity towards known positive and negative controls and was found to be acceptable for further testing.
In the present study 1,3-di(3-Methyl-2-butenoxy)-2-hydroxypropane was dissolved in DMSO. For the dose finding assay stock solutions with concentrations ranging from 500 mg/mL to 3.91 mg/mL were 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 was measured by FACS analysis.
A CV75 of 358.04 ± 55.37 µg/mL was derived in the dose finding assay.
Based on the CV75, the main experiment was performed covering the following concentration steps: 429.65, 358.04, 298.37, 248.64, 207.20, 172.66, 143.89, 119.91 µg/mL
Phase separation of the test item was observed for the two highest concentration steps in the dose-finding study 2 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 35.4% (CD86), 38.0% (CD54) and 43.8% (isotype IgG1 control) in the first experiment and to 34.9% (CD86), 36.2% (CD54) and 47.3% (isotype IgG1 control) in the second experiment.
The expression of the cell surface marker CD86 was not upregulated above the threshold of 150% in any of the experiments. The expression of the cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments. Therefore, the test item can be considered as “negative” in this assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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