Registration Dossier
Registration Dossier
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: 701-301-6 | CAS number: -
- 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:
- From 24 February 2016 to 24 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ethyl (2S)-2-{[ethenylbis({[(2S)-1-ethoxy-1-oxopropan-2-yl]oxy})silyl]oxy}propanoate
- EC Number:
- 701-301-6
- Molecular formula:
- C17H30O9Si
- IUPAC Name:
- ethyl (2S)-2-{[ethenylbis({[(2S)-1-ethoxy-1-oxopropan-2-yl]oxy})silyl]oxy}propanoate
- Test material form:
- liquid
- Details on test material:
- - Stabilisation: in water undergoes hydrolysis
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Purity: 92%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature and humidity avoided
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- Wistar
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Centre for Experimental Medicine at the Medical University in Katowice
- Sex: females
- Age at study initiation (in days): 21 days old.
- Housing: plastic cage (58 x 37 x 21 cm) covered with a wire bar lid.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days - Justification for test system used:
- A transcutaneous electrical resistance test (TER) is an important step when trying to predict and evaluate toxic properties of a given test item. It is performed in order to obtain information on risks resulting from skin contact with this test item, whereas the obtained results may be used to classify it. The in vitro skin corrosivity study was performed in order to obtain information on health hazards resulting from skin contact with the test item. Corrosive materials are identified on the basis of their ability to produce a loss of normal stratum corneum integrity and barrier function, which is measured as a reduction in the TER below a threshold level for this method (5 kΩ).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: The animals were euthanized and the dorso-lateral skin of each animal was removed and stripped of excess subcutaneous fat. The skin discs were cut out using a scalpel. Each skin disc was placed over one of the ends of a PTFE (polytetrafluoroethylene) tube. The skin disc were fully submerged in a MgSO4 solution.
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was greater than 10 kΩ
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 21-22°C.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps:1
- Modifications to validated SOP: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: The dye binding procedure was not necessary in this case since all TER values for the test item were higher than 5 kΩ and there were not any visible changes on the skin discs
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 (two animals 3 skin disc per animal)
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean TER value is less than or equal to 5 kΩ and the skin disk is obviously damaged.
- The test substance is considered to be non-corrosive to skin if the mean TER value obtained for the test substance is greater than 5 kΩ, or if the mean TER value is less than or equal to 5 kΩ, and the skin disc is showing no obvious damage. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 150 μL
- Concentration (if solution): undiluted (100%)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 150 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 150 μL
- Concentration (if solution): 10M hydrochloric acid - Duration of treatment / exposure:
- 24 hours
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 1 skin disc 1
- Value:
- 19.01
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 1 skin disk 2
- Value:
- 19.75
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 1 skin disc 3
- Value:
- 19.96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- mean animal 1
- Value:
- 19.57
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 2 skin disc 1
- Value:
- 17.31
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 2 skin disc 2
- Value:
- 17.95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- animal 2 skin disc 3
- Value:
- 18.09
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- mean animal 2
- Value:
- 17.78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative 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
Before the beginning of the experiment, the electrical resistance of two skin discs was measured for each animal skin (animals no. 1 and 2). In each case, the skin discs gave the resistance values greater than 10 kΩ; therefore, the remainder of the skin discs of the animals could have been used in the experiment.
Results of the control transcutaneous electrical resistance test (TER):
Animal number |
Skin disc number |
TER value (kQ) |
1 |
1 |
11.37 |
2 |
13.95 |
|
2 |
1 |
12.36 |
2 |
14.07 |
Experiment: results of the transcutaneous electrical resistance test (TER):
Animal number |
Tested substance |
Skin disc number |
TER value (kQ) |
Mean TER value土SD (kO) |
1 |
Positive control - 10M HCl |
1 |
0.92 |
0.92 ± 0.01 |
2 |
0.91 |
|||
3 |
0.92 |
|||
Negative control - distilled water |
1 |
16.21 |
16.77±0.49 |
|
2 |
17.13 |
|||
3 |
16.98 |
|||
Test item |
1 |
19.01 |
19.57±0.50 |
|
2 |
19.75 |
|||
3 |
19.96 |
|||
2 |
Positive control - 10M HCl |
1 |
0.93 |
0.92 ± 0.01 |
2 |
0.92 |
|||
3 |
0.92 |
|||
Negative control - distilled water |
1 |
16.75 |
16.77±0.25 |
|
2 |
17.03 |
|||
3 |
16.54 |
|||
Test item |
1 |
17.31 |
17.78±0.42 |
|
2 |
17.95 |
|||
3 |
18.09 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not skin corrosive when it is tested in skin discs of Wistar rats.
- Executive summary:
The skin corrosion potential of the test substance was determined in accordance with the OECD nº 430 with GLP. A transcutaneous electrical resistance test (TER) was performed on skin discs of Wistar female rats in order to obtain information on health hazards resulting from skin contact with the test item. At the beginning of the experiment, the animals were 21 days old. In order to control the procedure quality, the electrical resistance of two skin discs obtained from each test animal was measured before the start of the experiment. In each case, the skin disc resistance values were greater than 10 kΩ; therefore, the remainder of the animals’ skin discs could have been used in the experiment. The undiluted test item was uniformly applied to the epidermal surface of the skin disc placed inside a tube. Concurrent positive (10M hydrochloric acid) and negative (distilled water) controls were used. Three skin discs obtained from each animal were used for the test item and three for each control item. The test item and the control items were evenly applied to the discs for 24 hours and kept at 21-22°C. Then, they were removed by washing with a jet of tap water. LCR 6401 low-voltage, alternating current databridge was used to measure the electrical resistance of the skin in kΩby placing the databridge electrodes on either side of the skin disc. After the transcutaneous electrical resistance test (TER), the skin discs were subjected to a gross examination in order to reveal possible damage. The dye binding procedure was not necessary in this case since all TER values for the test item were higher than 5 kΩand there were not any visible changes on the skin discs. The mean TER results for the skin discs treated with the test item were equal to 19.57 kΩ (animal no. 1) and 17.78 kΩ (animal no. 2). They can be accepted because the concurrent positive and negative control values fell within the acceptable ranges for the method. Gross examinations of the skin discs treated with the test item did not reveal any pathological changes. On the grounds of the study, it may be stated that the test substance does not lead skin corrosion/severe irritation.
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.
