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EC number: 201-127-6 | CAS number: 78-62-6
- 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:
- 2017-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2017-2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2016
- Deviations:
- yes
- Remarks:
- The prediction model used for evaluating the results was amended by the implementation of "borderline" criteria indicating inconclusive test results. The "borderline" criteria are based on historic BASF data and consider the variance of the test method.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, D-55116 Mainz
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 5222A20170420
- Purity test date: 20 Apr 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was applied undiluted.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was applied undiluted. - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia. Tissue model: EPI-200.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM model
- Tissue batch number(s): 25830
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature or incubator at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C ± 1°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL MTT diluent
- Incubation time: 3 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
- Filter:without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD570 of the NC between 0.8 and 2.8
- Barrier function: Lower acceptance limit: ET50 = 4.0 hours. Upper acceptance limit: ET50 = 8.7 hours.
NUMBER OF REPLICATE TISSUES: 2 per exposure time and test group
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: freeze-killed control tissues
- Procedure used to prepare the killed tissues (if applicable): freezing
- N. of replicates : 2
- Method of calculation used: quotient of the mean OD570 divided by the respective OD570 NC value in percent for each exposure time
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean tissue viability after 3 minutes of exposure is less than 45%, or if the viability after 3 minutes exposure is greater than or equal to 45 % and the viability after 1 hour exposure is less than 10%.
- The test substance is considered to be borderline corrosive (inconclusive) to skin if the mean tissue viability after 3 minutes of exposure is 45-55%, or if the viability after 3 minutes exposure is greater than or equal to 55 % and the viability after 1 hour exposure is 10-20%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 55% and the viability after 1 hour exposure is greater than or equal to 20%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: The “borderline“ evaluation (50 ± 5%, 25 ± 5% and 15 ± 5%) was statistically determined by using historic BASF data and hence considers the variance of the test method. This evaluation is an amendment to the evaluation provided in OECD Guideline 431. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration (if solution): undiluted, purity 99.57%
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 3 minutes at room temperature or 1 hour in the incubator
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1, mean of 2 replicate tissues / 3 min exposure period
- Value:
- 102
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1, mean of 2 replicate tissues / 1 hour exposure time
- Value:
- 52.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
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 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was identified as non corrosive to the skin in the EpiDerm™ in vitro skin corrosion test.
- Executive summary:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The following results were obtained in the EpiDerm™ skin corrosion test:
The test substance is not able to directly reduce MTT.
The mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 102.0% and it was 52.4% after an exposure period of 1 hour.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test material shows no skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.
Table 1:Exposure period 3 min: Individual and mean OD570values, individual and mean viability values, standard deviations and coefficient of variation
Test substance identification | tissue 1 | tissue 2 | mean | SD | CV [%] | |
NC | mean OD570 | 1.637 | 1.613 | 1.625 | ||
viability [% of NC] |
100.8 | 99.2 | 100 | 1.1 | 1.1 | |
test substance |
mean OD570 | 1.589 | 1.727 | 1.658 | ||
viability [% of NC] |
97.8 | 106.3 | 102.0 | 6.0 | 5.9 | |
PC | mean OD570 | 0.136 | 0.159 | 0.147 | ||
viability [% of NC] |
8.3 | 9.8 | 9.0 | 1.0 | 11.1 |
NC: Negative control
PC: Positive control
Table 2:Exposure period 1 h: Individual and mean OD570values, individual and mean viability values, standard deviations and coefficient of variation
Test substance identification | tissue 1 | tissue 2 | mean | SD | CV [%] | |
NC | mean OD570 | 1.661 | 1.743 | 1.702 | ||
viability [% of NC] |
97.6 | 2.4 | 100 | |||
test substance |
mean OD570 | 1.042 | 0.742 | 0.892 | ||
viability [% of NC] |
61.2 | 43.6 | 52.4 | 12.4 | 23.7 | |
PC | mean OD570 | 0.061 | 0.069 | 0.065 | ||
viability [% of NC] |
3.6 | 4 | 3.8 | 0.3 | 8.2 |
NC: Negative control
PC: Positive control
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:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Straße 7, D-55116 Mainz
Test material
- Reference substance name:
- Diethoxy(dimethyl)silane
- EC Number:
- 201-127-6
- EC Name:
- Diethoxy(dimethyl)silane
- Cas Number:
- 78-62-6
- Molecular formula:
- C6H16O2Si
- IUPAC Name:
- diethoxydimethylsilane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 5222A20170420
- Purity test date: 20 Apr 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was applied undiluted.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was applied undiluted.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia. Tissue model: EPI-200.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ 200 kit, EPI-200
- Tissue batch number(s): 25830
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 1 hour
- Temperature of post-treatment incubation (if applicable): 37°C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg / mL MTT diluent
- Incubation time: 24 ± 2 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD570 of the NC between 0.8 and 2.8
- Barrier function: Lower acceptance limit: ET50 = 4.0 hours. Upper acceptance limit: ET50 = 8.7 hours.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: freeze-killed control tissues
- Procedure used to prepare the killed tissues (if applicable): freezing
- N. of replicates : 3
- Method of calculation used: quotient of the mean OD570 divided by the respective OD570 NC value in percent for each exposure time.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the mean tissue viability after exposure is less than 45%.
- The test substance is considered to be borderline irritant (inconclusive) to skin if the mean tissue viability after exposure is 45-55%.
- The test substance is considered to be non-irritant to skin if the viability after exposure is greater than or equal to 55%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: The “borderline“ evaluation (50 ± 5%) was statistically determined by using historic BASF data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 439. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration (if solution): undiluted, purity 99.57%
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 25 minutes at room temperature and for 35 minutes in the incubator at 37°C
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Run 1, mean of 3 replicate tissues
- Value:
- 3.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
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
Table 1: Results of the Skin Irritation Test.Individual and mean OD570values, individual and mean viability values, standard deviations and coefficient of variation.
Test substance identification | tissue 1 | tissue 2 | tissue 3 | mean | SD | CV [%] | |
NC | mean OD570 | 1.806 | 1.678 | 1.523 | 1.669 | ||
viability [% of NC] |
108.2 | 100.5 | 91.2 | 100 | 8.5 | 8.5 | |
test substance |
mean OD570 | 0.054 | 0.050 | 0.051 | 0.051 | ||
viability [% of NC] |
3.2 | 3 | 3.1 | 3.1 | 0.1 | 3.9 | |
PC | mean OD570 | 0.046 | 0.041 | 0.041 | 0.043 | ||
viability [% of NC] |
2.8 | 2.4 | 2.5 | 2.5 | 0.2 | 7.2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test material was identified as irritant to the skin in the EpiDerm™ in vitro skin irritation test.
- Executive summary:
The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30 µL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
The irritation test was performed with three EpiDerm™ tissues which were incubated with the test substance for 1 hour followed by a 42-hour post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The following results were obtained in the EpiDerm™ skin irritation test:
The test substance is not able to directly reduce MTT.
The mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubationwas 3.1%.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test material shows a skin irritation potential in the EpiDerm™ in vitro skin irritation test under the test conditions chosen.
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