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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 688-124-7 | CAS number: 152261-43-3
- 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:
- key study
- Study period:
- 2018-04-09 to 2018-05-08
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, No. 442E: “In vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT)” adopted 29 July 2016
- Qualifier:
- according to guideline
- Guideline:
- other: Human Cell Line Activation Test (h-CLAT) for Skin Sensitisation, DB-ALM Protocol n°158, July 1st, 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of study:
- activation of dendritic cells
- Justification for non-LLNA method:
- In vitro testing strategy
Test material
- Reference substance name:
- Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine
- EC Number:
- 813-152-5
- Cas Number:
- 152261-44-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine
- Test material form:
- liquid
Constituent 1
In vitro test system
- 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.
Results and discussion
- Positive control results:
- The positive control (DNCB) led to an upregulation of the expression of CD54 and CD86 in both experiments. The threshold of 150% for CD86 (252% experiment 1; 303% experiment 2) and 200% for CD54 (201% experiment 1; 226% experiment 2) were clearly exceeded.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 116
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 11979.17 µg/mL
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 122
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration:14375.00 µg/mL
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD86 [%]
- Value:
- 119
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 17250.00 µg/mL
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: relative fluorescence intensity CD54 [%]
- Value:
- 113
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Concentration: 17250.00µg/mL
- Other effects / acceptance of results:
- 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%.
The test met the acceptance criteria.
Any other information on results incl. tables
In all experiments no precipitation or turbidity of the test item was observed for all concentration steps 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.
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 79.4% (CD86), 79.4% (CD54) and 79.5% (isotype IgG1 control) in the first experiment and to 87.5% (CD86), 86.1% (CD54) and 86.8% (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 cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments. Therefore, the test item is considered to be no skin sensitiser.
The controls confirmed the validity of the study for all experiments.
Results of the Cell Batch Activation Test (Batch 19)
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 |
81.1 |
347 |
>150 |
79.7 |
269 |
>200 |
yes |
pass |
NiSO4 |
100 µg/mL |
82.1 |
347 |
>150 |
82.5 |
391 |
>200 |
yes |
pass |
LA |
1000 µg/mL |
96.7 |
89 |
≤150 |
96.4 |
109 |
≤200 |
no |
pass |
Results of the Cell Batch Activation Test (Batch 20)
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 |
89.2 |
266 |
>150 |
88.4 |
206 |
>200 |
yes |
pass |
NiSO4 |
100 µg/mL |
82.3 |
220 |
>150 |
80.6 |
283 |
>200 |
yes |
pass |
LA |
1000 µg/mL |
96.2 |
79 |
≤150 |
96.9 |
101 |
≤200 |
no |
pass |
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 |
-- |
-- |
93.10 |
-- |
95.70 |
Solvent Control |
NaCl |
-- |
92.60 |
-- |
94.70 |
Ethanol, 2,2’[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine |
C8 |
26.95 |
95.10 |
134.77 |
94.90 |
C7 |
53.91 |
95.40 |
269.53 |
95.40 |
|
C6 |
107.81 |
95.40 |
539.06 |
94.80 |
|
C5 |
215.63 |
95.30 |
1078.13 |
95.00 |
|
C4 |
431.25 |
95.00 |
2156.25 |
95.40 |
|
C3 |
862.50 |
95.00 |
4312.50 |
94.60 |
|
C2 |
1725.00 |
95.00 |
8625.00 |
92.20 |
|
C1 |
3450.00 |
93.30 |
17250.00 |
84.90 |
|
Calculated CV75 [µg/mL] |
No CV75 |
No CV75 |
|||
Mean CV75 [µg/mL] |
No CV75 |
||||
SD CV 75 [µg/mL] |
No SD |
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 |
- |
93.6 |
93.2 |
94.0 |
5539 |
1543 |
723 |
4816 |
820 |
100 |
100 |
766 |
213 |
Solvent Control |
0.20% |
92.7 |
92.2 |
92.8 |
5225 |
1464 |
712 |
4513 |
752 |
94 |
92 |
734 |
206 |
DNCB |
4.00 |
83.8 |
84.4 |
84.5 |
12159 |
2295 |
786 |
11373 |
1509 |
252 |
201 |
1547 |
292 |
Ethanol, 2,2’[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine |
17250 |
79.4 |
79.4 |
79.5 |
6232 |
1753 |
820 |
5412 |
933 |
112 |
114 |
760 |
214 |
14375.00 |
82.0 |
81.4 |
81.7 |
6213 |
1893 |
896 |
5317 |
997 |
110 |
122 |
693 |
211 |
|
11979.17 |
84.6 |
84.6 |
84.1 |
6359 |
1619 |
787 |
5572 |
832 |
116 |
101 |
808 |
206 |
|
9982.64 |
87.5 |
88.3 |
87.9 |
5801 |
1697 |
779 |
5022 |
918 |
104 |
112 |
745 |
218 |
|
8318.87 |
89.6 |
90.3 |
89.3 |
5688 |
1620 |
767 |
4921 |
853 |
102 |
104 |
742 |
211 |
|
6932.39 |
91.5 |
91.7 |
92.0 |
5302 |
1523 |
781 |
4521 |
742 |
94 |
90 |
679 |
195 |
|
5776.99 |
91.5 |
91.1 |
90.9 |
5600 |
1518 |
788 |
4812 |
730 |
100 |
89 |
711 |
193 |
|
4814.16 |
91.3 |
92.2 |
91.7 |
5326 |
1491 |
779 |
4547 |
712 |
94 |
87 |
684 |
191 |
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 |
CD86 |
CD54 |
||
Medium Control |
- |
94.6 |
94.3 |
94.1 |
5423 |
1785 |
731 |
4692 |
1054 |
100 |
100 |
742 |
244 |
Solvent Control |
0.20% |
94.7 |
95.1 |
94.5 |
5772 |
1783 |
704 |
5068 |
1079 |
108 |
102 |
820 |
253 |
DNCB |
4.0 |
81.4 |
82.1 |
82.3 |
16087 |
3161 |
726 |
15361 |
2435 |
303 |
226 |
2216 |
435 |
Ethanol, 2,2’[1,2-ethanediylbis(oxy)] bis-, reaction products with 3-(triethoxysilyl)-1-propanamine |
17250.00 |
87.5 |
86.1 |
86.8 |
6383 |
1991 |
801 |
5582 |
1190 |
119 |
113 |
797 |
249 |
14375.00 |
87.2 |
88.3 |
88.4 |
5982 |
1863 |
999 |
4983 |
864 |
106 |
82 |
599 |
186 |
|
11979.17 |
89.6 |
89.6 |
89.8 |
5988 |
1944 |
970 |
5018 |
974 |
107 |
92 |
617 |
200 |
|
9982.64 |
91.0 |
90.9 |
90.9 |
6024 |
1830 |
813 |
5211 |
1017 |
111 |
96 |
741 |
225 |
|
8318.87 |
92.5 |
92.2 |
92.4 |
5436 |
1761 |
819 |
4617 |
942 |
98 |
89 |
664 |
215 |
|
6932.39 |
92.7 |
92.3 |
92.8 |
5946 |
1769 |
807 |
5139 |
962 |
110 |
91 |
737 |
219 |
|
5776.99 |
93.9 |
93.4 |
93.9 |
5103 |
1761 |
799 |
4304 |
962 |
92 |
91 |
639 |
220 |
|
4814.16 |
93.5 |
93.6 |
94.1 |
5217 |
1671 |
825 |
4392 |
846 |
94 |
80 |
632 |
203 |
Acceptance Criteria
Acceptance Criterion |
Range |
Experiment 1 |
pass/fail |
Experiment 2 |
pass/fail |
||||
cell viability solvent controls [%] |
>90 |
92.2 |
- |
94.0 |
pass |
94.1 |
- |
95.1 |
pass |
number of test dosed with viability >50% CD86 |
≥4 |
8 |
pass |
8 |
pass |
||||
number of test dosed with viability >50% CD54 |
≥4 |
8 |
pass |
8 |
pass |
||||
number of test dosed with viability >50% IgG1 |
≥4 |
8 |
pass |
8 |
pass |
||||
RFI of positive control of CD86 |
≥150 |
252 |
pass |
303 |
pass |
||||
RFI of positive control of CD54 |
≥200 |
201 |
pass |
226 |
pass |
||||
RFI of solvent control of CD86 |
<150 |
94 |
pass |
108 |
pass |
||||
RFI of solvent control of CD54 |
<200 |
92 |
pass |
102 |
pass |
||||
MFI ratio IgG1/CD86 for medium control [%] |
>105 |
766 |
pass |
742 |
pass |
||||
MFI ratio IgG1/CD86 for DMSO control [%] |
>105 |
734 |
pass |
820 |
pass |
||||
MFI ratio IgG1/CD54 for medium control [%] |
>105 |
213 |
pass |
244 |
pass |
||||
MFI ratio IgG1/CD54 for DMSO control [%] |
>105 |
206 |
pass |
253 |
pass |
||||
Historical Data
Criterion |
mean |
SD |
N |
cell viability solvent controls [%] |
97.0 |
1.3 |
672 |
number of test doses with viability >50% |
- |
- |
1786 |
RFI of positive control of CD86 |
401.0 |
146.8 |
112 |
RFI of positive control of CD54 |
576.6 |
312.0 |
112 |
RFI of solvent control of CD86 |
115.0 |
15.1 |
112 |
RFI of solvent control of CD54 |
118.8 |
25.5 |
112 |
MFI ratio IgG1/CD86 for medium control [%] |
202.4 |
50.0 |
112 |
MFI ratio IgG1/CD86 for DMSO control [%] |
221.6 |
58.5 |
112 |
MFI ratio IgG1/CD54 for medium control [%] |
141.0 |
24.7 |
112 |
MFI ratio IgG1/CD54 for DMSO control [%] |
147.7 |
25.6 |
112 |
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 item might be considered as non-sensitiser.
- Executive summary:
In the present study the test item was dissolved in 0.9% NaCl. Due to a lack of cytotoxicity, no CV75 could be derived. Therefore the main experiment was performed covering the following concentration steps:
5000.00, 4166.67, 3472.22, 2893.52, 2411.27, 2009.39, 1674.49, 1395.41µg/mL
This corresponds to the following weights, since a correction factor of 3.45 was applied to correct for the active component of the test item: 17250, 14375, 11979.17, 9982.64, 8318.87, 6932.39, 5776.99, 4814.16 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 79.4% (CD86), 79.4% (CD54) and 79.5% (isotype IgG1 control) in the first experiment and to 87.5% (CD86), 86.1% (CD54) and 86.8% (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 cell surface marker CD54 was not upregulated above the threshold of 200% in any of the experiments.
Therefore, the test item is considered to be no skin sensitiser.
The positive control (DNCB) led to an upregulation of CD54 and CD86 in both experiments. The threshold of 150% for CD86 (252% experiment 1; 303% experiment 2) and 200% for CD54 (201% experiment 1; 226% experiment 2) were clearly exceeded.
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.