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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 813-152-5 | CAS number: 152261-44-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-01-16 to 2018-01-18
- 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:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation 440/2008, Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test”, May 30, 2008
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol for: In Vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm; Version 07/11/2014
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
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
- Test system:
- human skin model
- Remarks:
- EpiDerm
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 h MTT incubation
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min. treatment
- Value:
- 97.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0
- Positive controls validity:
- valid
- Remarks:
- 1.5
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min. treatment
- Value:
- 106.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0
- Positive controls validity:
- valid
- Remarks:
- 5.2
- Other effects / acceptance of results:
- Value Cut off pass/fail
Mean Absolute OD570 nm NK
(3 min Experiment) 1.609 0.8 ≤ NK ≤ 2.8 pass
Mean Absolute OD570 nm NK
(60 min Experiment) 1.670 0.8 ≤ NK ≤ 2.8 pass
Mean Relative Tissue Viability [%] of
PC (60 min experiment) 1.5 < 15% pass
CV [%]
(in the range of 20 – 100% viability) 7.8% - 20.1% ≤ 30% pass
Any other information on results incl. tables
The test item showed non-specific MTT-reducing potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT (NSMTT) and the results were corrected to the true MTT metabolic conversion (TODTT). The test item showed no water-colouring potential.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50% (110.7%, NSMTT-corrected) after 3 min treatment and ≥ 15% (97.6%, NSMTTcorrected) after 60 min treatment.
The controls confirmed the validity of the study. The mean OD570nm of the two negative control tissues was ≥ 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (1.5%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was ≤ 30% (7.8% - 20.1%).
Results of 3 minExperiment
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.818 |
1.381 |
1.687 |
1.694 |
0.130 |
0.122 |
1.854 |
1.399 |
1.702 |
1.704 |
0.129 |
0.125 |
|
1.823 |
1.380 |
1.712 |
1.789 |
0.129 |
0.125 |
|
OD570- |
1.773 |
1.335 |
1.642 |
1.648 |
0.085 |
0.077 |
1.808 |
1.354 |
1.656 |
1.659 |
0.083 |
0.079 |
|
1.777 |
1.334 |
1.666 |
1.744 |
0.084 |
0.079 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.786 |
1.341 |
1.655 |
1.684 |
0.084 |
0.079 |
SD OD570 of 3 Aliquots |
0.019 |
0.011 |
0.012 |
0.052 |
0.001 |
0.001 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.564* |
1.669 |
0.081 |
|||
TODTT |
- |
1.731 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.315 |
0.021 |
0.004 |
|||
Mean Relative Tissue |
100.0 |
106.8 |
5.2 |
|||
Mean Relative Tissue Viability [%] |
- |
110.7 |
- |
|||
Coefficient Of Variation [%]*** |
20.1 |
1.2 |
4.8 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
Results of the NSMTT control of 3 min Experiment
NSMTT |
KU |
KT |
Negative Control |
||||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
|
absolute OD570 -values |
0.576 |
0.495 |
0.449 |
0.501 |
1.818 |
1.381 |
|
0.590 |
0.490 |
0.460 |
0.497 |
1.854 |
1.399 |
||
0.597 |
0.493 |
0.445 |
0.497 |
1.823 |
1.380 |
||
OD570(Blank Corrected) |
0.531 |
0.450 |
0.404 |
0.455 |
1.773 |
1.335 |
|
0.545 |
0.445 |
0.415 |
0.451 |
1.808 |
1.354 |
||
|
0.552 |
0.448 |
0.399 |
0.452 |
1.777 |
1.334 |
|
mean OD570 |
0.538 |
0.448 |
0.409 |
0.453 |
1.791 |
1.344 |
|
total mean OD570 |
0.493 |
0.431 |
1.568* |
||||
SD OD570(of the replicate tissues) |
0.064 |
0.031 |
0.315 |
||||
NSMTT [%] |
-3.92 |
- |
|||||
Relative Tissue Viability [%] |
- |
114.2 |
85.8 |
||||
Mean Relative Tissue Viability [%] |
- |
100.0 |
|||||
SD Tissue Viability [%] |
- |
20.1 |
|||||
CV [% Viabilities] |
- |
20.1 |
Results of 60 min Experiment
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.576 |
1.710 |
1.415 |
1.817 |
0.070 |
0.069 |
1.579 |
1.783 |
1.419 |
1.816 |
0.072 |
0.069 |
|
1.587 |
1.787 |
1.494 |
1.822 |
0.072 |
0.069 |
|
OD570- |
1.531 |
1.665 |
1.370 |
1.771 |
0.025 |
0.024 |
1.533 |
1.738 |
1.374 |
1.771 |
0.027 |
0.024 |
|
1.542 |
1.742 |
1.449 |
1.776 |
0.027 |
0.024 |
|
Mean OD570of 3 Aliquots (Blank Corrected) |
1.535 |
1.715 |
1.397 |
1.773 |
0.026 |
0.024 |
SD OD570 of 3 Aliquots |
0.006 |
0.043 |
0.044 |
0.003 |
0.001 |
0.000 |
Total Mean OD570of 2 Replicate Tissues (Blank Corrected) |
1.625* |
1.585 |
0.025 |
|||
TODTT |
- |
1.586 |
- |
|||
SD OD570 of 2 Replicate Tissues |
0.127 |
0.266 |
0.002 |
|||
Mean Relative Tissue |
100.0 |
97.5 |
1.5** |
|||
Mean Relative Tissue Viability [%] |
- |
97.6 |
- |
|||
Coefficient Of Variation [%]*** |
7.8 |
16.8 |
6.3 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control < 15%.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30%.
Results of the NSMTT control of 60 min Experiment
NSMTT |
KU |
KT |
Negative Control |
||||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
|
absolute OD570 -values |
0.106 |
0.095 |
0.087 |
0.113 |
1.576 |
1.710 |
|
0.107 |
0.095 |
0.088 |
0.112 |
1.579 |
1.783 |
||
0.106 |
0.094 |
0.087 |
0.112 |
1.587 |
1.787 |
||
OD570(Blank Corrected) |
0.061 |
0.049 |
0.041 |
0.068 |
1.531 |
1.665 |
|
0.062 |
0.049 |
0.043 |
0.067 |
1.533 |
1.738 |
||
|
0.061 |
0.049 |
0.042 |
0.066 |
1.542 |
1.742 |
|
mean OD570 |
0.061 |
0.049 |
0.042 |
0.067 |
1.532 |
1.702 |
|
total mean OD570 |
0.055 |
0.055 |
1.617* |
||||
SD OD570(of the replicate tissues) |
0.008 |
0.018 |
0.120 |
||||
NSMTT [%] |
-0.04 |
- |
|||||
Relative Tissue Viability [%] |
- |
97.7 |
108.6 |
||||
Mean Relative Tissue Viability [%] |
- |
103.1 |
|||||
SD Tissue Viability [%] |
- |
7.6 |
|||||
CV [% Viabilities] |
- |
7.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In the present study the skin corrosivity potential of the test item was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed non-specific MTT-reducing potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT (NSMTT) and the results were corrected to the true MTT metabolic conversion (TODTT). The test item showed no water-colouring potential.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 50% (110.7%, NSMTT-corrected) after 3 min treatment and ≥ 15% (97.6%, NSMTT-corrected) after 60 min treatment.
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.