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EC number: 216-467-0 | CAS number: 1591-02-2
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-12-11 to 2015-01-19
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dibutoxy(dimethyl)silane
- EC Number:
- 216-467-0
- EC Name:
- Dibutoxy(dimethyl)silane
- Cas Number:
- 1591-02-2
- Molecular formula:
- C10H24O2Si
- IUPAC Name:
- dibutoxydimethylsilane
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I
31.6, 100, 316, 1000, 2500 and 5000 µg/plate
(TA 98, TA 100, TA 1535, TA 1537 and TA 102)
Experiment II
31.6, 100, 316, 1000, 2500 and 5000 µg/plate
(TA 98, TA 100 (with metabolic activation), TA 1535, TA 1537 and TA 102)
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
(TA 100 (without metabolic activation)) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: aprotic solvent used at request of sponsor. DMSO produced a two phase solution, so acetone was used.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535; Without metabolic activation; 10 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-NOPD; 4-nitro-o-phenylene-diamine
- Remarks:
- Without metabolic activation; 10 µg/plate for TA 98, 40 µg/plate for TA 1537
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Without metabolic activation; TA 102; 1 µL/plate
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-AA; 2-aminoanthracene
- Remarks:
- With metabolic activation; all strains; 2.5 µg/plate; 10 µg/plate for TA 102
- Details on test system and experimental conditions:
- ACTIVATION: phenobarbital and β-naphthoflavone induced rat liver S9 was prepared; the biological activity was determined using 2-aminoanthracene and benzo[a]pyrene.
S9 mix contained:
- 8 mM MgCl2
- 33 mM KCl
- 5 mM glucose-6-phosphate
- 4 mM NADP
- 100 mM sodium-ortho-phosphate-buffer, pH 7.4
- 5% S9
0.5 ml of S9 mix were added to a total volume of 2.7 ml, giving a final concentration of S9 of approximately 1%.
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min at 37 °C
- Exposure duration: at least 48 h in the dark at 37 °C.
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: 3 plates per dose. A pre-experiment for toxicity was carried out using strains TA98 and TA 100. The initial plate incorporation assay was repeated using the preincubation method.
DETERMINATION OF CYTOTOXICITY
- Method: other: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control. - Evaluation criteria:
- A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control - Statistics:
- Not regarded as necessary
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Pre-experiment for toxicity (mean of 3 plates)
Dose (µg/plate) |
TA98 |
TA100 |
||
-MA |
+MA |
-MA |
+MA |
|
Solvent control |
1.0 |
1.0 |
1.0 |
1.0 |
3.16 |
1.1 |
1.5 |
1.2 |
1.1 |
10.0 |
1.1 |
1.2 |
1.2 |
1.1 |
31.6 |
1.4 |
1.1 |
1.1 |
1.0 |
100 |
1.4 |
1.1 |
0.9 |
0.9 |
316 |
1.2 |
1.1 |
1.1 |
0.8 |
1000 |
1.1 |
1.0 |
1.2 |
0.9 |
2500 |
1.2 |
1.0 |
1.4 |
1.0 |
5000 |
1.0 |
1.0 |
1.1 |
0.9 |
Positive control |
14.8 |
80.7 |
12.5 |
24.3 |
Experiment 1: Plate-incorporation test: revertant colonies per plate (mean of 3 plates)
Dose (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Negative control |
19 |
27 |
78 |
93 |
9 |
11 |
5 |
6 |
419 |
517 |
Solvent control |
19 |
23 |
72 |
99 |
13 |
8 |
5 |
5 |
415 |
512 |
31.6 |
27 |
26 |
83 |
99 |
13 |
9 |
6 |
7 |
363 |
495 |
100 |
28 |
26 |
64 |
85 |
12 |
10 |
5 |
5 |
435 |
492 |
316 |
23 |
26 |
82 |
82 |
12 |
11 |
4 |
7 |
446 |
497 |
1000 |
21 |
24 |
83 |
87 |
12 |
8 |
3 |
6 |
464 |
535 |
2500 |
24 |
24 |
100 |
99 |
10 |
12 |
3 |
5 |
461 |
579 |
5000 |
19 |
23 |
80 |
91 |
16 |
9 |
4 |
6 |
394 |
488 |
Positive control |
286 |
1882 |
906 |
2402 |
776 |
125 |
50 |
177 |
2698 |
1187 |
Experiment 2: Pre-incubation test: revertant colonies per plate (mean of 3 plates)
Dose (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Negative control |
19 |
19 |
114 |
75 |
15 |
7 |
6 |
4 |
223 |
369 |
Solvent control |
16 |
20 |
119 |
78 |
20 |
6 |
8 |
6 |
198 |
399 |
3.16 |
- |
- |
115 |
- |
- |
- |
- |
- |
- |
- |
10.0 |
- |
- |
104 |
- |
- |
- |
- |
- |
- |
- |
31.6 |
13 |
20 |
72 |
79 |
21 |
12 |
7 |
6 |
282 |
328 |
100 |
15 |
17 |
86 |
83 |
20 |
7 |
9 |
6 |
251 |
304 |
316 |
15 |
18 |
77 |
64 |
15 |
7 |
4 |
4 |
258 |
326 |
1000 |
11 |
19 |
77 |
81 |
15 |
5 |
5 |
5 |
233 |
306 |
2500 |
14 |
22 |
66 |
76 |
16 |
5 |
6 |
4 |
208 |
294 |
5000 |
20 |
23 |
86 |
89 |
14 |
4 |
8 |
8 |
255 |
385 |
Positive control |
375 |
503 |
1316 |
941 |
1100 |
65 |
66 |
158 |
1847 |
917 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Dibutoxy(dimethyl)silane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471 and in compliance with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 in the initial plate incorporation assay or the repeat experiment conducted using the preincubation method, up to limit concentrations. Appropriate positive, solvent and negative (water) controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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