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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-06-20 until 2018-06-25
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EPISKIN Reconstructed Human Epidermis Model Kit
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin from EpiSkin Laboratories, Lyon, France
- Tissue batch number: 18-EKIN-025
- Maintenance Medium lot number: 18-MAIN3-030
- Assay Medium lot number: 18-ESSC-026
- Delivery date: 19 June 2018
- Date of initiation of testing: 20 June 2018
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: rinsing by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item; transferation to maintenance medium afterwards
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL, diluted in assay medium
- Incubation time: in the dark at 37 °C, 5% CO2 in air for 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Tissues Satisfactory: Yes
- Temperature Indicator Color Satisfactory: Yes
- Agar Medium Color Satisfactory: Yes
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
The prediction model is made according to OECD guideline 439 and shown in table 1. - Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 10 μL test item (26.3 μL/cm2) was applied
NEGATIVE CONTROL
- Amount applied: 10 µL DPBS
POSITIVE CONTROL
- Amount applied: 10 µL SDS
- Concentration: 5% (w/v) - Duration of treatment / exposure:
- 15 minutes at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 hours (37 °C, 5% CO2 in air)
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- relative mean viability
- Run / experiment:
- mean value after 15 min exposure period and 42 h post-exposure incubation period
- Value:
- 8.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - Direct-MTT reduction:
The MTT solution containing the test item did not turn blue or purple which indicated that the test item did not directly reduce MTT.
- Colour interference with MTT:
The solution containing the test item was colorless. It was therefore unnecessary to run color correction tissues.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The mean OD570 for the negative control treated tissues was 1.114 and the standard deviation value of the viability was 4.2%.
The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control:
The relative mean tissue viability for the positive control treated tissues was 3.0% relative to the negative control treated tissues and the standard deviation value of the viability was 0.6%.
The positive control acceptance criteria were therefore satisfied.
- Acceptance criteria met for variability between replicate measurements:
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 2.0%.
The test item acceptance criterion was therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline:
Any other information on results incl. tables
Table 2: Results of the individual and mean OD570 values are given for the test item, negative control item and positive control item.
Item |
OD570 of tissues |
Mean OD570 of triplicate tissues |
± SD of OD570 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
1.064 |
1.114 |
0.047 |
95.5 |
100* |
4.2 |
1.158 |
103.9 |
|||||
1.119 |
100.4 |
|||||
Positive Control Item |
0.032 |
0.033 |
0.006 |
2.9 |
3.0 |
0.6 |
0.039 |
3.5 |
|||||
0.027 |
2.4 |
|||||
Test Item |
0.117 |
0.093 |
0.022 |
10.5 |
8.3 |
2.0 |
0.087 |
7.8 |
|||||
0.075 |
6.7 |
OD = Optical Density
SD = Standard deviation
∗= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item was classified as irritant Cat. 2, (EC) No. 1272/2008 based on the combined knowledge with the findings in the skin corrosion testing.
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