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EC number: 242-262-0 | CAS number: 18379-25-4
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-11-02 to 2001-02-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. It is considered that read-across to the registered substance is scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Triethoxy(2,4,4-trimethylpentyl)silane
- EC Number:
- 252-558-1
- EC Name:
- Triethoxy(2,4,4-trimethylpentyl)silane
- Cas Number:
- 35435-21-3
- IUPAC Name:
- triethoxy(2,4,4-trimethylpentyl)silane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Beta-Napthoflavone and Phenobarbital induced rat liver S9
- Test concentrations with justification for top dose:
- 500, 2000, 5000 µg/ml (expt 1 -S9), 50, 200, 5000 µg/ml (expt 1 +S9); 50, 200, 500 µg/ml (expt 2, -S9)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Cell culture medium. The test substance was prepared and diluted in cell culture mediu, Freshly prepared solutions (applied within 1 h after preparation) were used.
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:
- cyclophosphamide
- Remarks:
- with activation
- Details on test system and experimental conditions:
- ACTIVATION: S9 mix contained0.75 mg/ml protein and NADP as cofactor. 50 µl were added to test organisms, test or control substance and medium in each chamber of Quadriperm dishes.
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours with and without S9 (exp 1); 20 hours without S9 (exp 2)
- Expression time (cells in growth medium): 16 hours (exp 1); 20 hours (exp 2)
- Selection time (if incubation with a selection agent): 2 days
- Fixation time (start of exposure up to fixation or harvest of cells): 17.5 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemide
STAIN (for cytogenetic assays): giesma
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: At least 200 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; relative total growth
OTHER EXAMINATIONS:
- Determination of polyploidy: determined in 100 cells per culture of each test group - Evaluation criteria:
- A positive result is determined by a dose related increase in the number of cells with aberration, and a biologically relevant positive response for at least one of the test points.
The number of aberrations found in the negative control should be between 0 % and 4.5 %. The positive control should produce biologically relevant increases in the number of cells with structural chromosome aberrations.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 μg/ml (exp 2, 20h treatment without activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: noted in experiment 2 at 5000 μg/ml, so 500 μg/ml selected as top concentration.
COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data - Remarks on result:
- other: strain/cell type: Chinese hamster lung fibroblasts (V79)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2: Results of chromosome analysis Experiment 1, 4h treatment without activation (total count from 2 cultures)
|
Solvent* Control |
Positive Control |
Low dose 500 μg/ml |
Medium dose 2000 μg/ml |
High dose 5000 μg/ml |
|
Cytotoxicity |
No |
No |
No |
No |
No |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
3 |
4 |
0 |
1 |
2 |
deletions |
0 |
1 |
1 |
0 |
1 |
|
interchanges |
0 |
21 |
0 |
1 |
2 |
|
Chromosome |
gaps |
- |
- |
- |
- |
- |
deletions |
0 |
0 |
0 |
0 |
0 |
|
interchanges |
0 |
4 |
0 |
0 |
0 |
|
Mitotic index |
100 % |
103 % |
140 % |
116 % |
86 % |
|
Polyploidy |
6 |
7 |
1.5 |
1 |
4 |
|
Endo reduplication |
ND |
ND |
ND |
ND |
ND |
*Solvent control with culture medium
ND not determined
Table 3: Results of chromosome analysis Experiment 1, 4h treatment with activation (total count from 2 cultures)
|
Solvent* Control |
Positive Control |
Low dose 250 μg/ml |
Medium dose 2000 μg/ml |
High dose 5000 μg/ml |
|
Cytotoxicity |
No |
No |
No |
No |
No |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
2 |
4 |
4 |
2 |
0 |
deletions |
0 |
1 |
0 |
0 |
0 |
|
interchanges |
2 |
17 |
1 |
1 |
1 |
|
Chromosome |
gaps |
- |
- |
- |
- |
- |
deletions |
0 |
0 |
0 |
0 |
0 |
|
interchanges |
0 |
0 |
0 |
0 |
0 |
|
Mitotic index |
100 % |
126 % |
93 % |
95 % |
83 % |
|
Polyploidy |
3.5 |
5 |
3.5 |
3.5 |
2 |
|
Endo reduplication |
ND |
ND |
ND |
ND |
ND |
*Solvent control with culture medium
ND not determined
Table 4: Results of chromosome analysis Experiment 2, 20h treatment without activation (total count from 2 cultures)
|
Solvent* Control |
Positive Control |
Low dose 50 μg/ml |
Medium dose 200 μg/ml |
High dose 500 μg/ml |
|
Cytotoxicity |
No |
Yes |
No |
No |
Yes |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
1 |
11 |
3 |
1 |
0 |
deletions |
0 |
2 |
1 |
0 |
0 |
|
interchanges |
0 |
35 |
0 |
0 |
0 |
|
Chromosome |
gaps |
- |
- |
- |
- |
- |
deletions |
0 |
0 |
0 |
0 |
0 |
|
interchanges |
0 |
2 |
0 |
0 |
0 |
|
Mitotic index |
100 % |
51 % |
91 % |
85 % |
29 % |
|
Polyploidy |
3.5 |
2.5 |
4.5 |
1.5 |
3 |
|
Endo reduplication |
ND |
ND |
ND |
ND |
ND |
*Solvent control with culture medium
ND not determined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Triethoxy(2,4,4-trimethylpentyl)silane has been tested in a valid and reliable test performed according to OECD 473, under GLP. The test substance did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line. It si concluded that the test substance is negative for the induction of chromosome aberrations under the conditions of the test.
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