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EC number: 815-031-2 | CAS number: 1411949-02-4
- 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
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 2017-04-25 to 2017-07-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- 2015-02-04
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- Replacement method for animals testing.
Test material
- Reference substance name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- EC Number:
- 815-031-2
- Cas Number:
- 1411949-02-4
- Molecular formula:
- C9H19O2
- IUPAC Name:
- 2-isobutyl-4-vinyl-1,3-dioxolane
- Test material form:
- liquid
Constituent 1
In vitro test system
- Details on the study design:
- Skin sensitisation (In vitro test system) - Details on 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.
Results and discussion
- Positive control results:
- Experiment 1: 32 µM, 1.91 (SD 0.45) fold induction; 64 µM, 3.26 (SD 0.79) fold Induction
Experiment 2: 32 µM, 1.76 (SD 0.21) fold induction; 64 µM, 2.81 (SD 0.64) fold Induction
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: test substance concentration 2000 µM
- Parameter:
- other: max. Luciferase activity induction (Imax)
- Value:
- 1.24
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: test substance concentration 2000 µM
- Parameter:
- other: Cell viability (%)
- Value:
- 86.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: test substance concentration 2000 µM
- Parameter:
- other: EC 1.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for solvent control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Induction of Luciferase Activity - Overall Induction:
|
Concentration [µM] |
Fold Induction |
|||
Experiment 1 |
Experiment 2 |
Mean |
SD |
||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
0.00 |
Positive Control |
4.00 |
1.10 |
1.10 |
1.10 |
0.00 |
8.00 |
1.15 |
1.34 |
1.24 |
0.13 |
|
16.00 |
1.39 |
1.35 |
1.37 |
0.03 |
|
32.00 |
1.61 |
1.91 |
1.76 |
0.21 |
|
64.00 |
2.36 |
3.26 |
2.81 |
0.64 |
|
Test Substance |
0.98 |
1.06 |
0.91 |
0.99 |
0.11 |
1.95 |
1.01 |
1.10 |
1.06 |
0.07 |
|
3.91 |
0.97 |
1.04 |
1.00 |
0.05 |
|
7.81 |
1.03 |
1.08 |
1.06 |
0.04 |
|
15.63 |
1.03 |
0.80 |
0.91 |
0.17 |
|
31.25 |
1.06 |
0.91 |
0.98 |
0.11 |
|
62.50 |
0.93 |
0.87 |
0.90 |
0.05 |
|
125.00 |
1.14 |
0.88 |
1.01 |
0.19 |
|
250.00 |
1.11 |
0.98 |
1.05 |
0.10 |
|
500.00 |
1.10 |
0.97 |
1.03 |
0.09 |
|
1000.00 |
1.17 |
0.96 |
1.06 |
0.15 |
|
2000.00 |
1.24 |
1.07 |
1.15 |
0.12 |
Acceptance Criteria:
Criterion |
Range |
Experiment 1 |
Pass/Fail |
Experiment2 |
Pass/Fail |
CV Solvent Control |
< 20 % |
7.0 |
Pass |
17.8 |
Pass |
No. of positive control concentration steps with significant luciferase activity induction > 1.5 |
≥1 |
2.0 |
Pass |
2.0 |
Pass |
EC1.5 PC |
7 < x < 34 µM |
23.95 |
Pass |
20.35 |
Pass |
Induction PC at 64 µM |
2.99 < x < 8.00 |
2.36 |
Pass |
3.26 |
Pass |
Applicant's summary and conclusion
- Interpretation of results:
- other: Under the condition of this study the test substance did not induce the luciferase activity and is threrefore considered as non sensitiser.
- Remarks:
- 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.
- Conclusions:
- In an in vitro ARE-Nrf2 Luciferase assay (KeratinoSens™) according to OECD Guideline 442D, the test substance did not induce luciferase activity and no EC1.5 could be determined and is threrefore considered as non sensitiser.
- Executive summary:
In the present study, the skin sensitising properties of 2-isobutyl-4-vinyl-1,3-dioxolane were determined in an in vitro ARE-Nrf2 Luciferase assay (KeratinoSens™) according to OECD Guideline 442D.
Based on a molecular weight of 156.22 g/mol a stock solution of 200 mM was prepared in water. Based on the stock solution a set of eleven 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, a max luciferase activity (Imax) induction of 1.24 was determined at a test item concentration of 2000 µM. The corresponding cell viability was 86.3 %. No significant luciferase induction >1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated. Furthermore, no cytotoxic effect was observed. In the second experiment, a max luciferase activity (Imax) induction of 1.1 was determined at a test item concentration of 1.95 µM. The corresponding cell viability was 119.5 %. No significant luciferase induction >1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated. Within the second experiment a cytotoxic effect was observed starting from 125 µM onward. 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 substance is therefore considered as non sensitiser.
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