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EC number: 213-914-1 | CAS number: 1066-40-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-06-13 to 1978-08-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- no duplicates
- Principles of method if other than guideline:
- Modification of Clive and Spector (Mutation Research, 31 17-29, 1975)
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Hydroxytrimethylsilane
- EC Number:
- 213-914-1
- EC Name:
- Hydroxytrimethylsilane
- Cas Number:
- 1066-40-6
- Molecular formula:
- C3H10OSi
- IUPAC Name:
- hydroxytrimethylsilane
Constituent 1
Method
- Target gene:
- thymidine kinase
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Fischer's medium for Leukemic cells of mice with 10% horse serum and sodium pyruvate
- Metabolic activation:
- with and without
- Metabolic activation system:
- Non induced mouse liver S9
- Test concentrations with justification for top dose:
- 0.16, 0.32, 0.64, 1.25, 2.5 µl/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Dimethylnitrosamine
- Remarks:
- with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with activation
- Evaluation criteria:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): BUdR
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Statistics:
- Cloning efficiency, relative growth and mutant frequency were calculated from cell counts. There was no statistical treatment of results.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1.25 - 2.5 μl/ml
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- See table 1
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1: Results of Mammalian Mutagenicity assay with tester strain L5178Y (mean of 3 plates)
Concentration µl/ml |
Mutant* Frequency |
Mutant* Frequency |
Relative cloning eff. % of control |
Relative cloning eff. % of control |
Cytotoxicity |
- |
— MA |
+ MA |
— MA |
+ MA |
- |
Solvent Control** |
20.4 |
24 |
100 |
100 |
No |
0.16 |
21.8 |
22.3 |
88.3 |
120 |
No |
0.32 |
17.9 |
24.9 |
89.2 |
94 |
No |
0.64 |
22.5 |
30 |
105.5 |
100.9 |
No |
1.25 |
12.1 |
8.9 |
115.3 |
71.9 |
Yes |
2.5 |
10.7 |
4.8 |
99 |
79.6 |
Yes |
Positive Control |
687.1 |
162.6 |
41.3 |
72.8 |
No |
*Per 106surviving cells
**solvent control with ethanol
Applicant's summary and conclusion
- Conclusions:
- Trimethylsilanol has been tested for mutagenicity in mouse lymphoma cells up to cytotoxic concentrations. No increase in mutant frequency was observed in either the absence or presence of exogenous metabolic activation. Appropriate controls were included and gave expected results. It is concluded that the test substance is not mutagenic in mouse lymphoma L5178Y cells under the conditions of the test.
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