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EC number: 224-244-4 | CAS number: 4263-52-9
- 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:
- 03 May 2017 - 06 September 2017
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: KeratinoSens™, EURL ECVAM DB-ALM Protocol No. 155, July 1st, 2015
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- This test method is able to detect chemicals that cause skin sensitisation and allows for hazard identification in accordance with UN GHS "Category 1". 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 an integrated approach such as an IATA, combining them with other complementary information e.g., derived from in chemico or in vitro assays addressing other key events of the AOP.
Test material
- Reference substance name:
- Sodium 2-bromoethanesulphonate
- EC Number:
- 224-244-4
- EC Name:
- Sodium 2-bromoethanesulphonate
- Cas Number:
- 4263-52-9
- Molecular formula:
- C2H5BrO3S.Na
- IUPAC Name:
- sodium 2-bromoethanesulphonate
- Test material form:
- solid
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. The induction of the Keap1-Nrf2-ARE signalling pathway by small electrophilic substances such as skin sensitizers was reported by several studies and represents the second key event of the skin sensitisation process as described by the AOP. Therefore the KeratinoSens™ assay is considered relevant for the assessment of the skin sensitisation potential of chemicals.
Results and discussion
- Positive control results:
- The luciferase activity induced by the positive control at a concentration of 64 µM was between 2 and 8 (3.26 (experiment 1); 3.39 (experiment 2); 5.70 (experiment 3)).
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: luciferase activity
- Value:
- 1.27
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: luciferase activity
- Value:
- 1.22
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: luciferase activity
- Value:
- 1.06
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: EC1.5 [µM]
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: EC1.5 [µM]
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Key result
- Run / experiment:
- other: 3
- Parameter:
- other: EC1.5 [µM]
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
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
Table 1: Results of the Cytotoxicity Measurement
|
Concentration [µM] |
Cell Viability [%] |
||||
Experiment 1 |
Experiment 2 |
Experiment 3 |
Mean |
SD |
||
Solvent Control |
- |
100.0 |
100.0 |
100.0 |
100.0 |
0.0 |
Positive Control |
4.00 |
92.5 |
96.3 |
102.4 |
97.1 |
5.0 |
8.00 |
99.0 |
105.7 |
105.5 |
103.4 |
3.8 |
|
16.00 |
93.9 |
103.9 |
112.2 |
103.3 |
9.2 |
|
32.00 |
91.4 |
99.8 |
106.2 |
99.1 |
7.4 |
|
64.00 |
85.0 |
101.6 |
121.1 |
102.6 |
18.1 |
|
Test Item |
0.98 |
110.9 |
89.0 |
95.0 |
98.3 |
11.3 |
1.95 |
121.2 |
83.4 |
108.1 |
104.2 |
19.2 |
|
3.91 |
116.8 |
70.8 |
111.6 |
99.7 |
25.2 |
|
7.81 |
114.8 |
62.5 |
106.9 |
94.8 |
28.2 |
|
15.63 |
102.6 |
64.0 |
111.1 |
92.6 |
25.1 |
|
31.25 |
84.9 |
63.7 |
104.8 |
84.5 |
20.5 |
|
62.50 |
64.1 |
58.2 |
106.9 |
76.4 |
26.6 |
|
125.00 |
55.4 |
57.9 |
107.3 |
73.5 |
29.3 |
|
250.00 |
50.4 |
62.4 |
106.8 |
73.2 |
29.7 |
|
500.00 |
41.3 |
62.8 |
102.7 |
68.9 |
31.2 |
|
1000.00 |
34.7 |
79.0 |
107.7 |
73.8 |
36.7 |
|
2000.00 |
32.5 |
93.3 |
103.3 |
76.4 |
38.3 |
Table 2: 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 |
1.07 |
1.21 |
1.03 |
1.10 |
0.10 |
|
8.00 |
1.20 |
1.31 |
1.50 |
1.34 |
0.15 |
|
|
16.00 |
1.31 |
1.34 |
1.39 |
1.35 |
0.04 |
|
|
32.00 |
1.43 |
1.98 |
2.32 |
1.91 |
0.45 |
* |
|
64.00 |
2.71 |
4.17 |
2.90 |
3.26 |
0.79 |
* |
|
Test Item |
0.98 |
1.25 |
1.35 |
0.97 |
1.19 |
0.19 |
|
1.95 |
1.15 |
1.01 |
0.90 |
1.02 |
0.12 |
|
|
3.91 |
1.14 |
0.94 |
0.95 |
1.01 |
0.11 |
|
|
7.81 |
0.96 |
0.93 |
0.94 |
0.94 |
0.02 |
|
|
15.63 |
1.11 |
1.04 |
0.79 |
0.98 |
0.17 |
|
|
31.25 |
1.28 |
0.90 |
0.80 |
0.99 |
0.26 |
|
|
62.50 |
1.60 |
0.93 |
1.08 |
1.20 |
0.35 |
|
|
125.00 |
1.22 |
1.07 |
0.82 |
1.04 |
0.20 |
|
|
250.00 |
1.41 |
0.86 |
0.79 |
1.02 |
0.34 |
|
|
500.00 |
1.22 |
1.38 |
0.84 |
1.15 |
0.28 |
|
|
1000.00 |
0.94 |
0.93 |
0.92 |
0.93 |
0.01 |
|
|
2000.00 |
1.26 |
1.13 |
1.43 |
1.27 |
0.15 |
|
* = significant induction according to Student’s t-test, p<0.05
Table 3: 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 |
1.12 |
1.11 |
1.05 |
1.09 |
0.04 |
|
8.00 |
1.18 |
1.16 |
1.02 |
1.12 |
0.09 |
|
|
16.00 |
1.32 |
1.28 |
1.23 |
1.28 |
0.04 |
|
|
32.00 |
1.63 |
1.65 |
1.86 |
1.71 |
0.12 |
* |
|
64.00 |
3.25 |
3.46 |
3.47 |
3.39 |
0.12 |
* |
|
Test Item |
0.98 |
1.00 |
0.83 |
1.06 |
0.96 |
0.12 |
|
1.95 |
1.10 |
1.38 |
1.04 |
1.17 |
0.18 |
|
|
3.91 |
1.08 |
1.18 |
0.91 |
1.06 |
0.14 |
|
|
7.81 |
1.01 |
1.28 |
1.27 |
1.19 |
0.15 |
|
|
15.63 |
0.96 |
1.09 |
0.92 |
0.99 |
0.09 |
|
|
31.25 |
0.97 |
1.20 |
0.95 |
1.04 |
0.14 |
|
|
62.50 |
1.04 |
1.50 |
0.87 |
1.13 |
0.32 |
|
|
125.00 |
0.96 |
1.27 |
0.94 |
1.06 |
0.18 |
|
|
250.00 |
0.92 |
1.16 |
0.95 |
1.01 |
0.13 |
|
|
500.00 |
1.03 |
1.28 |
0.90 |
1.07 |
0.19 |
|
|
1000.00 |
1.09 |
1.63 |
0.94 |
1.22 |
0.36 |
|
|
2000.00 |
1.18 |
1.39 |
1.02 |
1.20 |
0.18 |
|
* = significant induction according to Student’s t-test, p<0.05
Table 4: Induction of Luciferase Activity Experiment 3
Experiment 3 |
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 |
1.17 |
1.33 |
1.21 |
1.24 |
0.08 |
|
8.00 |
1.35 |
1.34 |
1.08 |
1.25 |
0.15 |
|
|
16.00 |
1.46 |
1.55 |
1.27 |
1.43 |
0.14 |
|
|
32.00 |
2.11 |
1.98 |
1.64 |
1.91 |
0.24 |
* |
|
64.00 |
6.96 |
5.89 |
4.26 |
5.70 |
1.36 |
* |
|
Test Item |
0.98 |
1.05 |
0.91 |
1.02 |
0.99 |
0.07 |
|
1.95 |
0.82 |
0.81 |
0.82 |
0.82 |
0.01 |
|
|
3.91 |
0.87 |
0.84 |
0.83 |
0.85 |
0.02 |
|
|
7.81 |
0.88 |
0.89 |
0.83 |
0.87 |
0.03 |
|
|
15.63 |
0.88 |
0.92 |
0.85 |
0.88 |
0.04 |
|
|
31.25 |
0.92 |
0.99 |
0.87 |
0.93 |
0.06 |
|
|
62.50 |
1.11 |
0.98 |
0.83 |
0.97 |
0.14 |
|
|
125.00 |
0.91 |
0.92 |
0.84 |
0.89 |
0.04 |
|
|
250.00 |
0.90 |
1.01 |
0.78 |
0.90 |
0.12 |
|
|
500.00 |
1.05 |
0.98 |
0.88 |
0.97 |
0.09 |
|
|
1000.00 |
1.05 |
1.16 |
0.98 |
1.06 |
0.09 |
|
|
2000.00 |
1.00 |
1.17 |
0.90 |
1.02 |
0.14 |
|
* = significant induction according to Student’s t-test, p<0.05
Table 5: Induction of Luciferase Activity – Overall Induction
|
Concentration [µM] |
Fold Induction |
Significance |
||||
Experiment 1 |
Experiment 2 |
Experiment 3 |
Mean |
SD |
|||
Solvent Control |
- |
1.00 |
1.00 |
1.00 |
1.00 |
0.00 |
|
Positive Control |
4.00 |
1.10 |
1.09 |
1.24 |
1.14 |
0.08 |
|
8.00 |
1.34 |
1.12 |
1.25 |
1.24 |
0.11 |
|
|
16.00 |
1.35 |
1.28 |
1.43 |
1.35 |
0.07 |
|
|
32.00 |
1.91 |
1.71 |
1.91 |
1.84 |
0.11 |
* |
|
64.00 |
3.26 |
3.39 |
5.70 |
4.12 |
1.37 |
* |
|
Test Item |
0.98 |
1.19 |
0.96 |
0.99 |
1.05 |
0.12 |
|
1.95 |
1.02 |
1.17 |
0.82 |
1.00 |
0.18 |
|
|
3.91 |
1.01 |
1.06 |
0.85 |
0.97 |
0.11 |
|
|
7.81 |
0.94 |
1.19 |
0.87 |
1.00 |
0.17 |
|
|
15.63 |
0.98 |
0.99 |
0.88 |
0.95 |
0.06 |
|
|
31.25 |
0.99 |
1.04 |
0.93 |
0.99 |
0.06 |
|
|
62.50 |
1.20 |
1.13 |
0.97 |
1.10 |
0.12 |
|
|
125.00 |
1.04 |
1.06 |
0.89 |
0.99 |
0.09 |
|
|
250.00 |
1.02 |
1.01 |
0.90 |
0.98 |
0.07 |
|
|
500.00 |
1.15 |
1.07 |
0.97 |
1.06 |
0.09 |
|
|
1000.00 |
0.93 |
1.22 |
1.06 |
1.07 |
0.15 |
|
|
2000.00 |
1.27 |
1.20 |
1.02 |
1.16 |
0.13 |
|
* = significant induction according to Student’s t-test, p<0.05
Table 6: Additional Parameters
Parameter |
Experiment 1 |
Experiment 2 |
Experiment 3 |
Mean |
SD |
EC1.5[µM] |
n.a. |
n.a. |
n.a. |
- |
- |
Imax |
1.27 |
1.22 |
1.06 |
1.19 |
0.11 |
IC30[µM] |
53.62 |
n.a. |
n.a. |
53.62 |
- |
IC50[µM] |
261.95 |
n.a. |
n.a. |
261.95 |
- |
n.a. = not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vitro skin sensitisation assay according to OECD Guideline 442D (ARE-Nrf2 Luciferase Test; KeratinoSens™), the test item did not show an induction of Luciferase activity and therefore no skin sensitising properties. 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:
In an in vitro skin sensitisation assay according to OECD Guideline 442D (ARE-Nrf2 Luciferase Test; KeratinoSens™), the skin sensitising potential of the test substance was determined. The test item was dissolved in DMSO. Based on a molecular weight of 211.01 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, no significant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated. Within this first experiment a cytotoxic effect could be observed starting from 62.50 µM onwards. In the second experiment, no significant luciferase induction > 1.5 was found in the tested concentration range. Therefore, no EC1.5 value could be calculated. Furthermore, the data showed a cytotoxic effect for the concentration range from 7.81 µM up to 500 µM. However, this effect showed no dose-effect relationship and could not be observed microscopically. In the third experiment, 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 within the third experiment. No dose response for luciferase activity induction was observed for each individual run as well as for an overall luciferase activity induction. Solvent and positive controls were valid. Under the condition of this study the test item is therefore considered as non sensitiser.
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