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Diss Factsheets
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EC number: 700-334-3 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 03 June 2008 and 05 June 2008.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: SkinEthic HCE model
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Principles of method if other than guideline:
- The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic HCE model and are sufficiently cytotoxic to cause cell death in the underlying cell layers.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate
- EC Number:
- 700-334-3
- Molecular formula:
- C17H38O6Si3
- IUPAC Name:
- 10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- Sponsor's identification: SiMAA2
Description: clear colourless liquid
Lot number: 003068
Date received: 25 March 2008
Storage conditions: approximately 4°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: SkinEthic Reconstituted Human Corneal model
- Strain:
- other: Reconstituted HCE model
- Details on test animals or tissues and environmental conditions:
- Tissue: Consists of the transformed human kerotinocytes of the cell line HCE that formed a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye.
- Source: HCE, SkinEthic Laboratories, Nice, France
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature
- Storage: wells containing 1ml of maintenance medium
-Incubation: Incubated over night at 37 deg C, 5% CO2 in air
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl
- Concentration (if solution): NA
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- None, at the end of the expsoure period, each skinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.
- Number of animals or in vitro replicates:
- Not applicable as tissues were used. Triplicate SkinEthic tissues were used.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the relevant exposure period, each tissue insert was removed from the well using forceps and rinsed using a wash bottle containing DPBS.
- Time after start of exposure: 10 minutes
SCORING SYSTEM: After exposure of tissues to the test material, the tissues are removed and rinsed. The rinsed tissues are taken for MTT loading, were the reduced MTT is extracted from the tissues. After extraction, the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured (OD50). Data is presnted in the form of % viability (MTT conversion relative to negative controls).
TOOL USED TO ASSESS SCORE: The test material was classified according to the following criteria:
* If the % relative viability was greater than or equal to 60% the test material was considered to not likely to be a severe ocular irritant.
* If the % relative viability was less than 60% the test material was considered to be irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Relative mean viability (%)
- Run / experiment:
- 10 minute exposure
- Value:
- 104.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Not likely to be a severe ocular irritant
Any other information on results incl. tables
Assessment of Direct test Material Reduction of MTT
The test material was not able to directly reduce MTT.
Assessment of Eye Irritation Potential:
The mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 104.8%.
It was considered unnecessary to proceed with tissue histopathology.
Table1:
Material |
Mean OD540 |
% Viability |
Negative Control |
0.888 |
100* |
Positive Control |
0.566 |
63.7 |
Positive Control |
0.376 |
42.3 |
Test Material |
0.931 |
104.8 |
* = The mean viability of the negative tissues is set at 100%
Quantitative Evaluation of Tissue Viability (MTT Uptake Visaul Assessment)
The quantitative evaluation of tissue viability is presented in table 2.
The negative control and test material treated tissues appeared blue. This was considered to be indicative of viable tissue. The positive control material at each concentration appeared blue/white and was considered to be indicative of semi‑viable tissue.
Table 2:
Material |
Score |
|
Tissue 1 |
Tissue 2 |
|
Negative Control |
- |
- |
Positive Control |
+ |
+ |
Positive Control |
+ |
+ |
Test Material |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- According to the protocol followed the test material was considered not likely to be a severe ocular irritant (NI).
- Executive summary:
Introduction. The purpose of this study was to determine the eye irritation potential of the test materials using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, , ) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
Methods. The experimental design of the study consists of a test for Direct Reduction of MTT by the test materials, followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with 30 ml of the test material for 10 minutes. Triplicate tissues treated with 30 µl of Solution A served as the negative control and triplicate tissues treated with 30 µl of Sodium Dodecyl Sulphate at concentrations of 1% w/v and 0.5% w/v served as the positive control.
At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.
After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured (OD540). Data is presented in the form of % viability (MTT conversion relative to negative controls).
The test material was classified according to the following criteria:
i) If the % relative viability was ≥ 60% the test material was considered to not likely to be a severe ocular irritant.
ii) If the % relative viability was 60% the test material was considered to be irritant.
Results. The relative mean viability of the test material treated tissues after a 10 minute exposure was 104.8%.
It was considered unnecessary to proceed with tissue histopathology.
Quality criteria. The quality criteria required for acceptance of results in the test were satisfied.
Conclusion. According to the protocol followed the test material was considered not likely to be a severe ocular irritant (NI).
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