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Diss Factsheets
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EC number: 242-285-6 | CAS number: 18406-41-2
- 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:
- 2018-10-09 until 2019-10-11
- 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 guideline
- Qualifier:
- according 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)
- Version / remarks:
- 25 June 2018
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Test material
- Reference substance name:
- 3,3,6,6-tetramethoxy-2,7-dioxa-3,6-disilaoctane
- EC Number:
- 242-285-6
- EC Name:
- 3,3,6,6-tetramethoxy-2,7-dioxa-3,6-disilaoctane
- Cas Number:
- 18406-41-2
- Molecular formula:
- C8H22O6Si2
- IUPAC Name:
- 3,3,6,6-tetramethoxy-2,7-dioxa-3,6-disilaoctane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 611220160318
- Storage stability: 31 December 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under test conditions: guaranteed by the sponsor under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: The test item was used as supplied by the sponsor.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- no prior treatment
Test animals / tissue source
- Species:
- human
- Strain:
- other: normal human derived epidermal keratinocytes
- Details on test animals or tissues and environmental conditions:
- Description of the cell system used: Reconstructed human cornea-like epithelium
- Model used: EpiOcular model (OCL-200)
- Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue lot number: 27073
- Assay medium lot number: 100818ISA
- no further details given
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
- Concentration: undiluted test item was used
BENCHMARK CONTROL, NEGATIVE CONTROL, POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: all controls were applied as supplied by the sponsor - Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- tested in duplicates
- Details on study design:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were immersed and swirled three times in each of three beakers filled with sterile PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL MTT diluent
- Incubation: 3 hours, 37°C, 5% CO2, incubated in the dark
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm, without reference filter
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance can not be predicted based on EU CLP/UN GHS Category 1 and Category 2 if the mean relative tissue viability with a test material is less than 60%.
- The test substance is considered to be non- irritant to the eye if the mean relative tissue viability with a test material is greater than 60%.
- Justification for the selection of the cut-off point is based on OECD TG 492.
ACCEPTANCE CRITERIA
- Negative control: Tissue viability is acceptable if the mean OD570 of the negative control (NC) is ≥ 0.8. The mean OD570 of the NC should not exceed 2.5.
- Positive control: Methyl acetate used as positive control (PC) usually leads to a tissue viability of approx. 25%. A viability of ≤ 50% is acceptable.
- Variability: Two tissues were treated under the same conditions. A variability between the tissues is considered to be acceptable if the difference of the viability is ≤ 20%.
- Benchmark control: The assay establishes the acceptance criteria for an acceptable test if the relative mean tissue viability for the benchmark control treated tissues was ≤60% historicrelative to the negative control treated tissues
HISTORICAL DATA : As dicussed before was the benchmark control used to prove the proviciency. No historical data exist to date.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: relative mean viability
- Run / experiment:
- one run / mean of 2 individual experiments
- Value:
- 87.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- OD570 = 2.787, greater than the upper limit of 2.5 set out in the acceptance criteria; Further description is given below (other effects).
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The results of the test are given in table 1.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
Diethyl toluamide was used as a benchmark control as demonstration of proficiency had not been completed in the laboratory.
Based on an agreement, the benchmark control was tested alongside with the test item and negative and positive controls. Diethyl toluamide was selected based on the OECD 492 due to its expected eye irritancy potential of EU CLP/UN GHS Category 2B.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
At 2.787 the mean optical density (OD570) of the negative control tissues was greater than the upper limit of 2.5 set out in the acceptance criteria.
However, as the results of the controls and test item gave unequivocal conclusions it was considered unnecessary to repeat the test.
Besides, test item tissues were both indicative of a negative response and were not close to the cut-off for irritation.
Therefore, the result of the negative control was considered to have not impacted upon the conclusion of the study and the integrity or validity of the study was not compromised.
- Acceptance criteria met for positive control:
The relative mean tissue viability for the positive control treated tissues was 34.7% relative to the negative control treated tissues. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for benchmark control:
The relative mean tissue viability for the benchmark control treated tissues was 31.4% relative to the negative control treated tissues. The benchmark control acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Table 1: Mean OD570 values and percentage viabilities for the negative control item, positive control item, benchmark control item and test item
Item |
OD570 of tissues |
Mean OD570 of duplicate tissues |
Relative individual tissue viability (%) |
Relative mean viability (%) |
CV of Relative mean viability (%) |
Negative Control Item |
2.873 |
2.787 |
103.1 |
100* |
4.4 |
2.701 |
96.9 |
||||
Positive Control Item |
1.073 |
0.968 |
38.5 |
34.7 |
15.3 |
0.863 |
31.0 |
||||
Test Item |
2.521 |
2.448 |
90.5 |
87.8 |
4.2 |
2.375 |
85.2 |
||||
Benchmark Control |
0.864 |
0.876 |
31.0 |
31.4 |
1.9 |
0.888 |
31.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the conditions of the test, the test item was classified as non-irritant.
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