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EC number: 210-535-3 | CAS number: 617-86-7
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.11.1997 to 25.06.1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Tetramethylsilane
- EC Number:
- 200-899-1
- EC Name:
- Tetramethylsilane
- Cas Number:
- 75-76-3
- Molecular formula:
- C4H12Si
- IUPAC Name:
- tetramethylsilane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmnH
- Age at study initiation: 'young'
- Weight at study initiation: <500 g
- Housing: Maximum five animals in conventional Type IV Makrolon cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Preliminary study: from: 18.11.1997 to 21.11.1997. Main study: from: 26.05.1998 to 25.06.1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction and challenge phases: undiluted test substance.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction and challenge phases: undiluted test substance.
- No. of animals per dose:
- 20 test animals, 10 control.
- Details on study design:
- RANGE FINDING TESTS: 0.3cm3 of each of the test substance concentrations 5, 25, 50% (in corn oil) and undiluted test substance were applied to patches of surgical gauze. These were placed on the clipped flanks of each of three animals. The patches were covered with occlusive plaster and left in place for six hours. Each animal received two patches on each flank. After removal of the patch, residual test substance was cleared away using corn oil The dermal reactions were assessed 30 and 54 hours after the start of treatment. In the 4th week of the test, three guinea-pigs, kept under the same conditions, but without treatment, were used to re-determine the maximum non-irritant concentration for the challenge treatment. This additional determination was conducted because it was suspected that the sensitivity of the skin changed as the weight of the animals increased. In this test, the concentration administered and the experimental conditions were the same as those of the preliminary test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Left flank
- Frequency of applications: Weekly
- Duration: 28 days from first induction to challenge exposure
- Concentrations: Undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Right flank
- Concentrations: Undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches. - Challenge controls:
- Corn oil
- Positive control substance(s):
- yes
- Remarks:
- α-cinnamaldehyde. The most recent reliability check was performed in November/December 1997
Results and discussion
- Positive control results:
- No positive control.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: undiluted test substance . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No significant treatment-related observations. .
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No significant treatment-related observations..
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- undiluted corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: undiluted corn oil . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No significant treatment-related observations. .
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- undiluted corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: undiluted corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No significant treatment-related observations..
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- positive control
- Dose level:
- 50% alpha-hexylcinnamaldehyde
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Sensitivity of study checked in a study conducted from 24/11/1997 to 24/12/1997
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- positive control
- Dose level:
- 50% alpha-hexylcinnamaldehyde
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Sensitivity of study checked in a study conducted from 24/11/1997 to 24/12/1997
Any other information on results incl. tables
In the induction phase, no skin irritation was observed in any test or control animal.
In the last sensitivity check, 10/20 test animals showed a skin reaction 30 hours post application. At 57 hours post-application, 9/20 test animals showed a skin reaction. No skin reactions were observed in the 10 control animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a well conducted skin sensitisation study conducted to OECD 406 (Buehler method) and GLP (reliability score 1) tetramethylsilane was not sensitising to the skin of guinea pigs.
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