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EC number: 221-178-8 | CAS number: 3025-30-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The provided collection of tests represents a complete Integrated Approach to Testing and Assessment (IATA). Although the individual tests on their own may be insufficient for classification, the combined weight of evidence concludes that there is no risk of sensitisation for ethyl (2E,4Z)-decadienoate.
Three OECD skin sensitisation tests demonstrate that no evidence of potential sensitising effects were observed when assessing the first key event of protein reactivity (OECD 422C, in chemico direct peptide reactivity assay), the second key event of activation of keratinocytes (OECD 422D, in vitro luciferase activity test) and the third key event of dendritic cell activation (OECD 422E, in vitro human cell line activation test). Taken together, these tests support that ethyl (2E,4Z)-decadienoate is not sensitising to the skin.
In addition, a patch test conducted on human volunteers in 1982 found that ethyl decadienoate is not sensitising. This test did not include a positive control, however this is typical of a human "patch test"; it would not be ethical to intentionally induce an allergic reaction in human volunteers.
Finally we note that ethyl (2E4Z)-decadienoate is intended for use solely in cosmetic products, an application for which animal testing is strictly forbidden.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- March 8-April 20, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: JID 47: 393-409, 1966
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- A LLNA test was not performed as this in vivo study using humans was already available.
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: volunteers
ENVIRONMENTAL CONDITIONS
- IN-LIFE DATES: From: March 8, 1982 To: April 20, 1982 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- other: a pre-test showed the test substance showed no significant evidence of irritation, so test subjects were pretested with 3% SLS.
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 48 hrs
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 27 (Originally 30, but 3 volunteers did not complete the study.)
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 exposures for 48 hrs
- Exposure period: 10 days total
- Site: forearms
- Frequency of applications: every other day
- Duration: 48 hrs
B. CHALLENGE EXPOSURE
- No. of exposures: 27
- Day(s) of challenge: After a 10-14 day rest from the induction
- Exposure period: 48 hrs
- Control group: SLS and petrolatum were used as controls on the same volunteers
- Site: forearms
- Evaluation (hr after challenge): 48 hrs
OTHER: Prior to the induction, patch sites were pretreated with 5% SLS. For the challenge test, 5% SLS was applied 30 minutes prior to the challenge exposure on the left side, and no SLS was used on the right side. - Challenge controls:
- SLS and petrolatum were used as controls on the same volunteers.
- Positive control substance(s):
- yes
- Remarks:
- SLS
- Positive control results:
- 5% SLS produced very little reactivity.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 27
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 27
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 27
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No significant irritant or allergic reactions were noted.
- Executive summary:
The skin sensitization of ethyl decadienoate was tested in a maximization test using 27 human volunteers. No volunteers showed significant reactions during the challenge phase. The test had significant methodoligical deficiencies, most notably, the test substance concentration and scoring system was not reported.
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- January 25-March 1, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- An in chemico method was chosen to see if the skin sensitization potential of the test substance could be determined without the use of vertebrate animals.
- Details on the study design:
- Skin sensitisation (In chemico test system) - Details on study design:
Preparation: A stock solution of 100 mM was prepared.
Reference controls: Yes, reference control A was used to verify the accuracy of the calibration curve for peptide quantification. Reference control B was used to verify the stability of the peptides over the analysis time. Reference control C was used to verifty that the solvent does not impact the percent peptide depletion (PPD). Each of the reference control solutions contained acetonitrile.
Solvent: acetonitrile
Proteins used: cysteine (amino acid sequence Ac-RFAACAA) 0.667 mM and lysine (amino acid sequence Ac-RFAAKAA) 0.667 mM, prior to use the peptides were stored at -80 degrees C and protected from light
Raio test item/protein: 1:10 cysteine, 1:50 lysine
Co-elution control: Prepared similarly to the test substance sample preparations but without peptide solution to determine if the test substance absorbs at 220 nm.
Postitive control: cinnamic aldehyde dissolved in acetonitrile
Incubation time: 24 hrs
Temperature: 25 degrees C
Detection method: HPLC, 220 nm for quantitation, 258 nm for co-elution; 100 mm x 2.1 mm, 3.5 um
Injection volume: 10 uL
Column temperature: 30 degrees C
Run Time: 20 minutes
Mobile phase A: 0.1% v/v trifluoroacetic acid in water
Mobile phase B: 0.085% v/v trifluoroacetic acid in acetonitrile
Replicates: 3
Acceptance criteria:
1) standard calibration curve with r2 > 0.99
2) mean PPD for postive control for cysteine is between 60.8-100%, and the maximum standard deviation is < 14.9%
3) mean PPD for positive control for lysine is between 40.2-69.0%, and the maximum standard deviation is < 11.6%
4) the mean peptide concentration for reference control A is 0.50 +/- 0.05 mM
5) coefficient of variation of the peptide peak areas for reference control B and C in solvent is < 15.0% - Run / experiment:
- other: Mean of three replicates
- Parameter:
- other: Percent peptide depletion
- Value:
- 0
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- Due to phase separation, the skin sensitization potential could not be predicted.
- Other effects / acceptance of results:
-
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: Yes, the reactivity of the postitive control to the peptides was 70.65%.
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Prediction of skin sensitivity could not be made due to the observed phase separation.
- Executive summary:
The skin sensitization potential of the test substance was determine in a peptide reactivity assay. The test evaluates the reactivity of the test sustance to peptides containing lysine and cysteine. Although the control show the test to be valid, phase seperation of the test substance means a prediction of sensitivity cannot be made.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- April 12-May 4, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 422E (In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation)
- Version / remarks:
- Adopted 9 October 2017
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of dendritic cells
- Justification for non-LLNA method:
- An in vitro method was chosen to see if the skin sensitization potential of the test substance could be determined without the use of vertebrate animals.
- Details on the study design:
- 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.
In the present study ETHYL 2,4-DECADIENOATE was dissolved in DMSO. Due to a lack of cytotoxicity, no CV75 could be derived. Therefore, the main experiment was performed covering the following concentration steps:
1000, 833.33, 694.44, 578.70, 482.25, 401.88, 334.90, 279.08 µg/mL
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.
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:
1000, 500, 250, 125, 62.50, 31.25, 15.63, 7.81 µg/mL
main experiment 1 and 2:
1000, 833.33, 694.44, 578.70, 482.25, 401.88, 334.90, 279.08 µg/mL - Positive control results:
- The positive controls 2,4-dinitrochlorobenzene and NiSO4 led to upregulation of the cell surface markers CD54 and CD86. The negative control lactic acid did not induce an upregulation of CD54 and CD86.
The cell batch was accepted for further testing. - Key result
- Run / experiment:
- other: Relative Fluorescence Intensity of CD86
- Parameter:
- other: RFI
- Value:
- 90
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: Relative Fluorescence Intensity of CD54
- Parameter:
- other: RFI
- Value:
- 71
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
Thein vitrohuman 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.
In the presentstudy ETHYL 2,4-DECADIENOATE was dissolved in DMSO.Due to a lack of cytotoxicity, no CV75 could be derived. Therefore, the main experiment was performed covering the following concentration steps:
1000, 833.33, 694.44, 578.70, 482.25, 401.88, 334.90, 279.08 µg/mL
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.
No cytotoxic effects were observed for the cells treated with the test item. Relative cell viability at the highest test item concentration was reduced to 94.1% (CD86), 94.1% (CD54) and 94.4% (isotype IgG1 control) in the first experiment and to 79.1% (CD86), 79.0% (CD54) and 78.5% (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.
In theory, the test item is considered to be no skin sensitiser. However, since the log KOW is higher than 3.5, the results must be considered as inconclusive.
The controls confirmed the validity of the study for all experiments.
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. However, since the log KOW is higher than 3.5, the results must be considered as inconclusive.
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- January 23-March 16, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- An in vitro method was chosen to see if the skin sensitization potential of the test substance could be determined without the use of vertebrate animals.
- Details on the study design:
- The in vitro KeratinoSens™ assay enables detection of the sensitising potential of a test item by addressing the second molecular key event of the adverse outcome pathway (AOP), namely activation of keratinocytes, by quantifying the luciferase activity in the transgenic cell line KeratinoSens™. The luciferase activity, assessed by luminescence measurement, compared to the respective solvent controls is used to support discrimination between skin sensitisers and
non-sensitisers.
In the present study ETHYL 2,4-DECADIENOATE was dissolved in DMSO.
Based on a molecular weight of 196.28 g/mol a stock solution of 200 mM was prepared.
Based on the stock solution a set of twelve master solutions in 100% solvent was prepared by serial dilution using a constant dilution factor of 1:2. These master solutions were diluted 1:100 in cell culture medium. The following concentration range was tested in the assay:
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. - Positive control results:
- Cinnamic aldehyde (CA, (2E)-3-phenylprop-2-enal; CAS 104-55-2; >98%; Alfa Aesar; Lot No.: 10176010) was used as positive control. CA was dissolved in DMSO (AppliChem; Lot No.: 0001055932) at a concentration of 6.4 mM and was further diluted four times with a constant dilution factor of 1:2 resulting in a concentration range of 0.4 mM – 6.4 mM. The following preparation of the positive control was carried out analogous to the preparation of the test item, resulting in a final concentration range of 4 µM – 64 µM. The final concentration of the solvent DMSO was 1% (v/v) for all wells.
Fold induction of positive control at 64 uM was > 1.5 in all experiments. - Key result
- Parameter:
- other: Luciferase activity (fold induction)
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In this study under the given conditions the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered as non sensitiser.
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:
Thein vitroKeratinoSens™ assay enables detection of the sensitising potential of a test item by addressing the second molecular key event of the adverse outcome pathway (AOP), namely activation of keratinocytes, by quantifying the luciferase activity in the transgenic cell line KeratinoSens™. The luciferase activity, assessed by luminescence measurement, compared to the respective solvent controls is used to support discrimination between skin sensitisers and
non-sensitisers.In the present study ETHYL 2,4-DECADIENOATE was dissolved in DMSO.
Based on a molecular weight of 196.28 g/mol a stock solution of 200 mM was prepared.
Based on the stock solution a set of twelve master solutions in 100% solvent was prepared by serial dilution using a constant dilution factor of 1:2. These master solutions were diluted 1:100 in cell culture medium. The following concentration range was tested in the assay:
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 the first experiment, nosignificant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5value could be calculated.
In the second experiment,nosignificant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5value 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 this study under the given conditions the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered asnonsensitiser.
The data generated with this method may not be 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.
Referenceopen allclose all
Test Substance Challenge Results
Subject No. | With SLS at 48 hrs | With SLS at 72 hrs | Without SLS at 48 hrs | Without SLS at 72 hrs |
1 | N | N | N | N |
2 | N | N | N | N |
3 | N | N | N | N |
4 | N | N | N | N |
5 | N | N | N | N |
6 | N | N | N | N |
7 | -- | -- | -- | -- |
8 | N | N | N | N |
9 | N | N | N | N |
10 | N | N | N | N |
11 | N | N | N | N |
12 | N | N | N | N |
13 | N | N | N | N |
14 | N | N | N | N |
15 | -- | -- | -- | -- |
16 | -- | -- | -- | -- |
17 | N | N | N | N |
18 | N | N | N | N |
19 | N | N | N | N |
20 | N | N | N | N |
21 | N | N | N | N |
22 | N | N | N | N |
23 | N | N | N | N |
24 | N | B | N | N |
25 | N | N | N | N |
26 | N | N | N | N |
27 | N | N | N | N |
28 | N | N | N | N |
29 | N | N | N | N |
30 | -- | -- | -- | -- |
Control Challenge Results
Subject No. | With SLS at 48 hrs | With SLS at 72 hrs | Without SLS at 48 hrs | Without SLS at 72 hrs |
1 | N | N | N | N |
2 | N | N | N | N |
3 | N | N | N | N |
4 | N | N | N | N |
5 | N | N | N | N |
6 | N | N | N | N |
7 | -- | -- | -- | -- |
8 | N | N | N | N |
9 | N | N | N | N |
10 | N | N | N | N |
11 | N | N | N | N |
12 | N | N | N | N |
13 | N | N | N | N |
14 | N | N | N | N |
15 | -- | -- | -- | -- |
16 | -- | -- | -- | -- |
17 | N | N | N | N |
18 | N | N | N | N |
19 | N | N | N | N |
20 | N | N | N | N |
21 | N | N | N | N |
22 | N | N | N | N |
23 | N | N | N | N |
24 | N | B | N | N |
25 | N | N | N | N |
26 | N | N | N | N |
27 | N | N | N | N |
28 | N | N | N | N |
29 | N | N | N | N |
30 | -- | -- | -- | -- |
No turbidity or precipitation was observed in the test solutions. Phase separation was noted after incubation. Minimal reactivity of the test item to the peptides was seen. The co-elution controls were valid. The mean depletion of both cysteine and lysine was 0.0%. Since a phase separation was observed, the concentration of 100 mM of test item, and full contact between the peptides and test item could not be guaranteed. No prediction of skin sensitization could therefore be made.
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. In theory, the test item is considered to be no skin sensitiser. However, since the log KOW is higher than 3.5, the results must be considered as inconclusive.
Table4: CD54 and CD86 Expression Experiment 1
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Flourescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
CD86 |
CD54 |
||
Medium Control |
- |
95.2 |
93.3 |
95.1 |
3235 |
1599 |
831 |
2404 |
768 |
105 |
149 |
389 |
192 |
Solvent Control |
0.20% |
94.8 |
94.1 |
95.1 |
3266 |
1483 |
969 |
2297 |
514 |
100 |
100 |
337 |
153 |
DNCB |
4.00 |
84.3 |
84.9 |
84.3 |
8562 |
2099 |
875 |
7687 |
1224 |
335 |
238 |
979 |
240 |
ETHYL 2,4-DECADIENOATE |
1000 |
94.1 |
94.1 |
94.4 |
3871 |
1500 |
1079 |
2792 |
421 |
122 |
82 |
359 |
139 |
833.33 |
94.1 |
93.9 |
93.6 |
4078 |
1636 |
1036 |
3042 |
600 |
132 |
117 |
394 |
158 |
|
694.44 |
93.7 |
93.7 |
93.8 |
4052 |
1611 |
1036 |
3016 |
575 |
131 |
112 |
391 |
156 |
|
578.70 |
93.4 |
94.0 |
92.7 |
3880 |
1546 |
1000 |
2880 |
546 |
125 |
106 |
388 |
155 |
|
482.25 |
94.3 |
94.2 |
94.1 |
4062 |
1580 |
1003 |
3059 |
577 |
133 |
112 |
405 |
158 |
|
401.88 |
94.1 |
94.5 |
94.1 |
4222 |
1693 |
1101 |
3121 |
592 |
136 |
115 |
383 |
154 |
|
334.90 |
94.4 |
94.7 |
94.8 |
4077 |
1515 |
1005 |
3072 |
510 |
134 |
99 |
406 |
151 |
|
279.08 |
95.2 |
95.1 |
94.7 |
3738 |
1526 |
991 |
2747 |
535 |
120 |
104 |
377 |
154 |
Table5: CD54 and CD86 Expression Experiment 2
Sample |
Conc. |
Cell Viability [%] |
Mean Fluorescence Intensity |
corrected Mean Fluorescence Intensity |
Relative Flourescence Intensity (RFI) |
Ratio Isotype IgG1 to [%] |
|||||||
CD86 |
CD54 |
IgG Isotype |
CD86 |
CD54 |
Isotype IgG1 |
CD86 |
CD54 |
CD86 |
CD54 |
C86 |
CD54 |
||
Medium Control |
- |
93.3 |
91.8 |
92.8 |
5237 |
1393 |
701 |
4536 |
692 |
106 |
111 |
747 |
199 |
Solvent Control |
0.20% |
93.1 |
92.6 |
92.4 |
4963 |
1303 |
679 |
4284 |
624 |
100 |
100 |
731 |
192 |
DNCB |
4.0 |
84.3 |
83.3 |
83.1 |
10948 |
2051 |
747 |
10201 |
1304 |
238 |
209 |
1466 |
275 |
ETHYL 2,4-DECADIENOATE |
1000.00 |
79.1 |
79.0 |
78.5 |
5511 |
1479 |
807 |
4704 |
672 |
110 |
108 |
683 |
183 |
833.33 |
83.3 |
84.2 |
83.6 |
5025 |
1428 |
823 |
4202 |
605 |
98 |
97 |
611 |
174 |
|
694.44 |
85.9 |
85.6 |
85.8 |
4889 |
1723 |
803 |
4086 |
920 |
95 |
147 |
609 |
215 |
|
578.70 |
90.8 |
91.1 |
90.9 |
4749 |
1433 |
870 |
3879 |
563 |
91 |
90 |
546 |
165 |
|
482.25 |
92.7 |
91.5 |
92.2 |
4438 |
1371 |
813 |
3625 |
558 |
85 |
89 |
546 |
169 |
|
401.88 |
90.8 |
91.2 |
90.8 |
4520 |
1306 |
866 |
3654 |
440 |
85 |
71 |
522 |
151 |
|
334.90 |
90.8 |
91.0 |
90.6 |
4666 |
1334 |
770 |
3896 |
564 |
91 |
90 |
606 |
173 |
|
279.08 |
90.0 |
90.3 |
90.4 |
4627 |
1311 |
790 |
3837 |
521 |
90 |
83 |
586 |
166 |
In this study under the given conditions the test item did not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered asnonsensitiser.
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.
Cytotoxicity
Table1: Results of the Cytotoxicity Measurement
|
Concentration [µM] |
Cell Viability [%] |
|||
Experiment 1 |
Experiment 2 |
Mean |
SD |
||
Solvent Control |
- |
100 |
100 |
100 |
0.0 |
Positive Control |
4.00 |
94.3 |
96.5 |
95.4 |
1.6 |
8.00 |
97.1 |
99.2 |
98.1 |
1.5 |
|
16.00 |
96.6 |
96.2 |
96.4 |
0.3 |
|
32.00 |
94.3 |
101.4 |
97.8 |
5.0 |
|
64.00 |
93.7 |
88.3 |
91.0 |
3.8 |
|
Test Item |
0.98 |
97.7 |
90.1 |
93.9 |
5.3 |
1.95 |
102.4 |
93.1 |
97.8 |
6.6 |
|
3.91 |
100.8 |
94.7 |
97.8 |
4.3 |
|
7.81 |
97.4 |
98.3 |
97.8 |
0.7 |
|
15.63 |
94.8 |
93.2 |
94.0 |
1.1 |
|
31.25 |
81.3 |
83.5 |
82.4 |
1.6 |
|
62.50 |
6.1 |
7.6 |
6.9 |
1.1 |
|
125.00 |
0.7 |
1.6 |
1.1 |
0.7 |
|
250.00 |
0.7 |
0.1 |
0.4 |
0.4 |
|
500.00 |
0.5 |
0.1 |
0.3 |
0.3 |
|
1000.00 |
3.7 |
2.8 |
3.3 |
0.6 |
|
2000.00 |
15.4 |
4.7 |
10.0 |
7.6 |
Luciferase Activity
Table2: Induction of Luciferase Activity Experiment 1
Experiment 1 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.16 |
1.21 |
1.05 |
1.14 |
0.08 |
|
8.00 |
1.19 |
1.25 |
1.13 |
1.19 |
0.06 |
|
|
16.00 |
1.68 |
1.45 |
1.38 |
1.50 |
0.16 |
* |
|
32.00 |
1.80 |
1.81 |
2.03 |
1.88 |
0.13 |
* |
|
64.00 |
5.22 |
4.72 |
4.96 |
4.97 |
0.25 |
* |
|
Test Item |
0.98 |
1.23 |
1.17 |
0.95 |
1.12 |
0.15 |
|
1.95 |
1.12 |
1.11 |
0.85 |
1.03 |
0.15 |
|
|
3.91 |
1.00 |
0.95 |
0.96 |
0.97 |
0.03 |
|
|
7.81 |
1.06 |
1.09 |
1.01 |
1.05 |
0.04 |
|
|
15.63 |
0.92 |
1.06 |
0.91 |
0.96 |
0.09 |
|
|
31.25 |
1.17 |
1.35 |
0.95 |
1.16 |
0.20 |
|
|
62.50 |
0.09 |
0.06 |
0.38 |
0.18 |
0.18 |
|
|
125.00 |
0.00 |
0.00 |
0.03 |
0.01 |
0.01 |
|
|
250.00 |
0.00 |
0.02 |
0.02 |
0.01 |
0.01 |
|
|
500.00 |
0.00 |
0.04 |
0.05 |
0.03 |
0.03 |
|
|
1000.00 |
0.11 |
0.06 |
0.45 |
0.21 |
0.21 |
|
|
2000.00 |
0.43 |
0.16 |
0.07 |
0.22 |
0.19 |
|
* = significant induction according to Student’s t-test, p<0.05
Table3: Induction of Luciferase Activity Experiment 2
Experiment 2 |
Concentration [µM] |
Fold Induction |
Significance |
||||
Rep. 1 |
Rep. 2 |
Rep. 3 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.04 |
1.11 |
0.99 |
1.05 |
0.06 |
|
8.00 |
1.17 |
1.33 |
1.02 |
1.18 |
0.15 |
|
|
16.00 |
1.24 |
1.29 |
1.22 |
1.25 |
0.03 |
|
|
32.00 |
1.70 |
1.71 |
1.65 |
1.69 |
0.03 |
* |
|
64.00 |
3.08 |
2.66 |
3.11 |
2.95 |
0.25 |
* |
|
Test Item |
0.98 |
1.13 |
1.16 |
1.10 |
1.13 |
0.03 |
|
1.95 |
0.82 |
0.96 |
1.08 |
0.96 |
0.13 |
|
|
3.91 |
0.95 |
0.95 |
0.91 |
0.94 |
0.02 |
|
|
7.81 |
0.90 |
1.00 |
0.98 |
0.96 |
0.05 |
|
|
15.63 |
1.17 |
1.10 |
0.92 |
1.06 |
0.13 |
|
|
31.25 |
0.93 |
0.94 |
0.92 |
0.93 |
0.01 |
|
|
62.50 |
0.21 |
0.27 |
0.59 |
0.36 |
0.21 |
|
|
125.00 |
0.02 |
0.00 |
0.38 |
0.13 |
0.21 |
|
|
250.00 |
0.00 |
0.00 |
0.29 |
0.10 |
0.17 |
|
|
500.00 |
0.00 |
0.00 |
0.29 |
0.10 |
0.17 |
|
|
1000.00 |
0.28 |
0.46 |
0.52 |
0.42 |
0.12 |
|
|
2000.00 |
0.38 |
0.00 |
0.55 |
0.31 |
0.28 |
|
* = significant induction according to Student’s t-test, p<0.05
Table4: Induction of Luciferase Activity – Overall Induction
|
Concentration [µM] |
Fold Induction |
Significance |
|||
Experiment 1 |
Experiment 2 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.14 |
1.05 |
1.09 |
0.06 |
|
8.00 |
1.19 |
1.18 |
1.18 |
0.01 |
|
|
16.00 |
1.50 |
1.25 |
1.38 |
0.18 |
|
|
32.00 |
1.88 |
1.69 |
1.78 |
0.14 |
* |
|
64.00 |
4.97 |
2.95 |
3.96 |
1.43 |
|
|
Test Item |
0.98 |
1.12 |
1.13 |
1.12 |
0.01 |
|
1.95 |
1.03 |
0.96 |
0.99 |
0.05 |
|
|
3.91 |
0.97 |
0.94 |
0.95 |
0.03 |
|
|
7.81 |
1.05 |
0.96 |
1.01 |
0.06 |
|
|
15.63 |
0.96 |
1.06 |
1.01 |
0.07 |
|
|
31.25 |
1.16 |
0.93 |
1.04 |
0.16 |
|
|
62.50 |
0.18 |
0.36 |
0.27 |
0.13 |
|
|
125.00 |
0.01 |
0.13 |
0.07 |
0.09 |
|
|
250.00 |
0.01 |
0.10 |
0.05 |
0.06 |
|
|
500.00 |
0.03 |
0.10 |
0.06 |
0.05 |
|
|
1000.00 |
0.21 |
0.42 |
0.31 |
0.15 |
|
|
2000.00 |
0.22 |
0.31 |
0.27 |
0.06 |
|
* = significant induction according to Student’s t-test, p<0.05
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
OECD 422 tests confirm that ethyl (2E,4Z)-decadienoate does not display the potential for activation of the first, second, and third key events for sensitisation. A human patch test confirms that ethyl (2E,4Z)-decadienoate does not cause an allergic reaction.
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