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EC number: 212-104-5 | CAS number: 762-72-1
- 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:
- 06 to 08 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Allyltrimethylsilane
- EC Number:
- 212-104-5
- EC Name:
- Allyltrimethylsilane
- Cas Number:
- 762-72-1
- Molecular formula:
- C6H14Si
- IUPAC Name:
- trimethyl(prop-2-en-1-yl)silane
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Human donors
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 28686
- Delivery date: 05 March 2019
- Date of initiation of testing: 06 March 2019
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 was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco's Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: yes
- Wavelength: 570 nm
- Filter: Yes
- Filter bandwidth: 10 nm
NUMBER OF REPLICATE TISSUES: The test was performed on a total of 6 tissues for each test item and for the negative and positive controls, with 2 replicates for each treatment period (3 min and 60 min).
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
Three independent experiments were conducted with the following exposure periods: 3 min and 60 min
PREDICTION MODEL / DECISION CRITERIA
A substance was considered corrosive if tissue viabilities were < 50% after 3 min exposure or if tissue viabilities were ≥ 50% after 3 min exposure AND < 15% after 60 min exposure. If a substance was considered corrosive, it was classified as Category 1A if tissue viabilities were < 20% after 3 min exposure. It was classified as Category 1B/1C if tissue viabilities were ≥ 25% after 3 min exposure. A substance was considered non-corrosive if tissue viabilities were ≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure.
The test meets acceptance criteria if:
- The mean OD570 of the two negative control tissues was between ≥ 0.8 and ≤ 2.8 for each exposure time.
- The mean relative tissue viability of the 60-minute positive control is < 15%.
In the range 20 and 100% viability, the Coefficient of Variation between tissue replicates should be ≤ 30%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration: undiluted
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: undiluted
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8.0N Potassium Hydroxide - Duration of treatment / exposure:
- 3 min or 60 min
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- The test was performed on a total of 6 tissues for each test item, negative control, and positive control, 2 replicates for each treatment period (3 min and 60 min).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 87.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 98.4
- 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: The test item showed no visible damage to the test system.
- Direct-MTT reduction: The test item showed no non-specific MMT-reducing potential.
- Colour interference with MTT: The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The test item showed no corrosive effects. All test acceptance criteria were met. Positive and negative controls responded appropriately. The maximum inter-tissue viability difference of replicate tissues fell within the acceptance criteria.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 2.469 for the 3-Minute exposure period and 2.314 for the 60-Minute exposure period. 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 2.5% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-corrosive according to Regulation (EC) No 1272/2008
- Conclusions:
- In an in vitro skin corrosion human skin model test according to OECD guideline 431 and in compliance with GLP, cell viabilities of 98.4% after 60 minutes of exposure, and 87.5% after 3 minutes of exposure were measured when compared to the untreated control. Therefore, the test item should not be classified as corrosive.
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