Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 608-659-1 | CAS number: 31692-85-0
- 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:
- 20 Oct - 10 Nov 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- adopted in 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- 2-[(oxolan-2-yl)methoxy]ethan-1-ol
- EC Number:
- 608-659-1
- Cas Number:
- 31692-85-0
- Molecular formula:
- C5H10O2[C2H4O]n, n = 0, 1, 2, 3, 4, ... (data given for max n of 4)
- IUPAC Name:
- 2-[(oxolan-2-yl)methoxy]ethan-1-ol
Constituent 1
In vitro test system
- Details on the study design:
- TEST METHOD
The in vitro KeratinoSens™ assay enables detection of the sensitising potential of a test substance 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 sensitiser and non-sensitisers.
TEST CELL LINE
- Type: KeratinoSens™
- Source: Givaudan, Switzerland
- Passage number: 8 (experiment 1), 12 (experiment 2)
CELL CULTURE CONDITIONS
- Type and identity of media:
Maintenance medium: Dulbecco’s Modified Eagle Medium (GlutaMAX TM) supplemented with 1.0 g/L D-glucose and Na-pyruvate, 10% fetal bovine calf serum and 1% geneticin (final concentration 500 μg/mL)
Assay medium: Dulbecco’s Modified Eagle Medium (GlutaMAX TM) supplemented with 1.0 g/L D-glucose and Na-pyruvate and 10% fetal bovine calf serum
Test substance exposure medium: Dulbecco’s Modified Eagle Medium (GlutaMAX TM) supplemented with 1.0 g/L D-glucose and Na-pyruvate and 1% fetal bovine calf serum
- Temperature (°C): 37 ± 1.0
- CO2 (%): 5.0
TEST CONCENTRATIONS
0.98, 1.95, 3.91, 7.81, 15.63, 31.25, 62.5, 125, 250, 500, 1000 and 2000 μM
CONTROLS
Vehicle control
- Substance: dimethyl sulfoxide (DMSO)
- Final concentration: 1%, in test substance exposure medium
Positive control
- Substance: cinnamic aldehyde
- Final concentration: 4 - 64 μM, in 1% DMSO
EXPOSURE CONDITIONS
- Exposure duration: 48 ± 1 h
NUMBER OF REPLICATIONS: two independent exp. with 3 replicates
DETERMINATION OF CELL VIABILITY
- Method: MTT assay
- MTT concentration: 5 mg/mL (stock solution) in DPBS
- Incubation time: 4 h at 37 ± 1°C
- Device: plate reader
- Wavelength: 600 nm
DETERMINATION OF LUMINESCENCE
- Luciferase reagent: Luciferase Assay Kit (Promega, Cat. no. E1531, Lot No. 0000246522)
- Device: plate reader
Results and discussion
- Positive control results:
- The positive control induced a significant increase in the luciferase activity at a concentration of 32 µM (2.09 and 2.03 in experiment 1 and 2, respectively) and 64 µM (3.95 and 3.24 in experiment 1 and 2, respectively). The EC 1.5 value of the positive control was found to be 16.09 and 17.22 µM in experiment 1 and 2, respectively.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: experiment 1, test substance
- Parameter:
- other: maximum luciferase activity induction (mean of 3 replicates)
- Value:
- 1.35
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: at 2000 µM
- Key result
- Run / experiment:
- other: experiment 2, test substance
- Parameter:
- other: maximum luciferase activity induction (mean of 3 replicates)
- Value:
- 1.21
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: at 2000 μM
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
not stated in the report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
The average coefficient of variation of the luminescence reading for the vehicle control DMSO was 7.8% in experiment 1 and 5.2% in experiment 2 and thus < 20%
- Acceptance criteria met for positive control: yes
The luciferase activity induced by the positive control at a concentration of 64 µM was 3.95 in experiment 1 and 3.24 in experiment 2 (range of acceptance criteria: 2 - 8).
The EC 1.5 value of the positive control was 16.09 µM in experiment 1 and 17.22 µM in experiment 2 and thus within two standard deviations of the historical mean of the test facility (7 - 34 µM)
Any other information on results incl. tables
Table 2: Results of the cytotoxicity measurement
|
Concentration [μM] |
Cell viability (%) |
||
Exp. 1 |
Exp. 2 |
Mean ± SD |
||
Vehicle control |
- |
100.0 |
100.0 |
100 ± 0.0 |
Positive control |
4.00 |
100.2 |
100.1 |
100.2 ± 0.1 |
8.00 |
112.2 |
103.5 |
107.9 ± 6.1 |
|
16.00 |
124.3 |
110.4 |
117.3 ± 9.8 |
|
32.00 |
129.6 |
113.7 |
121.7 ± 11.3 |
|
64.00 |
135.1 |
117.1 |
126.1 ± 12.8 |
|
Test substance |
0.98 |
87.7 |
96.9 |
92.3 ± 6.5 |
1.95 |
81.3 |
99.9 |
90.6 ± 13.2 |
|
3.91 |
80.0 |
97.4 |
88.7 ± 12.3 |
|
7.81 |
90.1 |
97.9 |
94.0 ± 5.5 |
|
15.63 |
87.7 |
95.5 |
91.6 ± 5.5 |
|
31.25 |
91.7 |
97.6 |
94.6 ± 4.2 |
|
62.50 |
94.2 |
97.9 |
96.1 ± 2.6 |
|
125.00 |
102.3 |
95.4 |
98.9 ± 4.9 |
|
250.00 |
109.3 |
98.9 |
104.1 ± 7.4 |
|
500.00 |
113.0 |
102.5 |
107.8 ± 7.4 |
|
1000.00 |
115.2 |
110.0 |
112.6 ± 3.6 |
|
2000.00 |
146.0 |
114.2 |
130.1 ± 22.4 |
Table 3: Overall induction of luciferase activity
|
Concentration [μM] |
Fold induction |
|||||||
Exp. 1 |
Exp. 2 |
||||||||
1 |
2 |
3 |
Mean ± SD |
1 |
2 |
3 |
Mean ± SD |
||
Vehicle control |
- |
1.00 |
1.00 |
1.00 |
1.00 ± 0.1 |
1.00 |
1.00 |
1.00 |
1.00 ± 0.0 |
Positive control |
4.00 |
1.12 |
1.18 |
1.22 |
1.17 ± 0.05 |
1.05 |
1.18 |
1.10 |
1.11 ± 0.06 |
8.00 |
1.31 |
1.29 |
1.18 |
1.26 ± 0.07 |
1.26 |
1.31 |
1.41 |
1.33 ± 0.08 |
|
16.00 |
1.47 |
1.55 |
1.47 |
1.50 ± 0.04 |
1.43 |
1.45 |
1.49 |
1.46 ± 0.03 |
|
32.00 |
2.12 |
1.98 |
2.17 |
2.09 ± 0.10 * |
1.88 |
2.04 |
2.18 |
2.03 ± 0.15 * |
|
64.00 |
3.92 |
3.82 |
4.10 |
3.95 ± 0.14 * |
3.14 |
3.12 |
3.47 |
3.24 ± 0.19 * |
|
Test substance |
0.98 |
0.92 |
0.93 |
0.90 |
0.92 ± 0.02 |
1.04 |
1.01 |
0.98 |
1.01 ± 0.03 |
1.95 |
0.98 |
0.87 |
0.94 |
0.93 ± 0.05 |
1.04 |
1.04 |
1.01 |
1.03 ± 0.02 |
|
3.91 |
1.02 |
1.02 |
0.94 |
1.00 ± 0.05 |
1.03 |
1.08 |
1.09 |
1.07 ± 0.04 |
|
7.81 |
1.12 |
0.97 |
0.98 |
1.02 ± 0.09 |
0.99 |
1.01 |
1.24 |
1.08 ± 0.14 |
|
15.63 |
1.04 |
1.00 |
0.95 |
1.00 ± 0.05 |
1.06 |
1.04 |
1.06 |
1.05 ± 0.01 |
|
31.25 |
1.06 |
1.12 |
0.99 |
1.05 ± 0.07 |
1.03 |
1.04 |
1.07 |
1.05 ± 0.02 |
|
62.50 |
1.07 |
1.06 |
1.04 |
1.06 ± 0.02 |
0.98 |
1.05 |
1.06 |
1.03 ± 0.04 |
|
125.00 |
1.10 |
1.06 |
1.05 |
1.07 ± 0.03 |
1.11 |
1.06 |
1.12 |
1.10 ± 0.03 |
|
250.00 |
1.04 |
1.03 |
0.99 |
1.02 ± 0.03 |
1.13 |
1.10 |
1.15 |
1.13 ± 0.03 |
|
500.00 |
1.25 |
1.08 |
1.06 |
1.13 ± 0.11 |
1.05 |
1.21 |
1.12 |
1.13 ± 0.08 |
|
1000.00 |
1.02 |
1.03 |
0.96 |
1.00 ± 0.04 |
1.14 |
1.25 |
1.19 |
1.20 ± 0.05 |
|
2000.00 |
1.56 |
1.36 |
1.14 |
1.35 ± 0.21 |
1.23 |
1.23 |
1.18 |
1.21 ± 0.03 |
*: significant induction according to Student’s T-test, p<0.05
Applicant's summary and conclusion
- Interpretation of results:
- other: no skin sensitising potential based on the key event “inflammatory response in keratinocytes”
- Conclusions:
- Under the conditions of the test, the test substance did not have a keratinocyte activating potential. The result does not allow for the non-classification or classification as skin sensitiser of the test substance and therefore further evaluation and/or data generation is required.
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.