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EC number: 240-212-2 | CAS number: 16068-37-4
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-04-15 to 2002-09-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC 92/69/EEC L383 A: part B Determination of Toxicity-Mutagenicity
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2B: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- EC Number:
- 240-212-2
- EC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- Cas Number:
- 16068-37-4
- Molecular formula:
- C14H34O6Si2
- IUPAC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
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:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 100, 316, 1000, 3160, 5000 µg/plate: all strains, with and without metabolic activation, plate incorporation test and preincubation test
10, 31.5 µg/plate: preincubation test, strains TA1535, TA1537, without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Abs. ethanol
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Abs. ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without activation), 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation), 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without activation), 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 (without activation), 1300 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- TA 98, TA 102, TA 1537 (with activation), 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100, TA 1535 (with activation), 1500 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: AROCLOR 1254-induced rat liver S9
S9 mix components (per 100 mL):
- 5.0 mL rat liver S9
- 2.0 mL 0.4 M MgCl2 + 1.65 M KCl-salt solution (sterile stock solution)
- 141.0 mg glucose-6-phosphate
- 306.5 mg NADP
- 50.0 mL 0.2 M phosphate buffer, pH 7.4 (sterile stock solution)
- sterile aqua ad injectabilia ad 100 mL
DURATION:
- Plate incorporation: 48 hours at 37°C
- Preincubation period: 60 minutes at 37°C
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT: histidine deficient agar
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
A reduction in the number of colonies by more than 50% compared with the solvent control and/or a scarce background lawn - Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments. In addition, a significant concentration related effect in observed.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000-5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 3160 and 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316-5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 316-5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (TA 100)
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic (Y/N) |
solvent control |
124 |
164 |
N |
0.316 |
149 |
155 |
N |
1 |
145 |
173 |
N |
3.16 |
171 |
189 |
N |
10 |
158 |
164 |
N |
31.6 |
161 |
166 |
N |
100 |
148 |
134 |
N |
316 |
155 |
159 |
N |
1000 |
185 |
154 |
N |
3160 |
179 |
159 |
N |
5000 |
185 |
165 |
N |
Plate incorporation: number of revertants per plate (mean of 3 plates)
Conc (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Solvent control |
36.7 |
47.0 |
123.0 |
140.3 |
264.7 |
296.0 |
19.0 |
18.7 |
7.0 |
9.3 |
100 |
40.7 |
42.7 |
122.3 |
130.3 |
260.7 |
244.0 |
15.3 |
14.0 |
7.3 |
11.3 |
316 |
36.3 |
43.0 |
123.3 |
134.3 |
256.7 |
261.0 |
19.3 |
17.3 |
11.0 |
10.7 |
1000 |
33.0 |
37.3 |
124.0 |
142.3 |
249.7 |
271.7 |
16.7 |
13.0 |
5.3 |
8.7 |
3160 |
39.0 |
36.0 |
125.3 |
131.3 |
253.3 |
261.0 |
16.3 |
15.7 |
6.3 |
7.3 |
5000 |
40.7 |
44.0* |
127.7 |
136.0* |
265.0 |
244.0 |
17.3 |
18.3* |
9.3 |
6.0* |
Positive control |
271.0 |
258.0 |
1177.0 |
1198.0 |
121.0 |
1209.3 |
420.0 |
1001.7 |
1123.3 |
1135.0 |
*cytotoxicity seen
Preincubation test: number of revertants per plate (mean of 3 plates)
Conc (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
Solvent control |
29.0 |
27.3 |
130.7 |
147.7 |
287.3 |
287.7 |
11.0 |
15.0 |
4.0 |
4.0 |
10 |
- |
- |
- |
- |
- |
- |
11.0 |
- |
2.3 |
- |
31.5 |
- |
- |
- |
- |
- |
- |
10.0 |
- |
4.0 |
- |
100 |
27.0 |
28.0 |
139.0 |
154.7 |
386.0 |
316.0 |
14.0 |
13.0 |
6.7 |
5.7 |
316 |
24.7 |
25.7 |
142.0 |
165.0 |
300.7 |
287.3 |
0.0* |
14.7 |
0.0* |
7.0 |
1000 |
0.0* |
24.3 |
158.3 |
141.0 |
291.0 |
284.3 |
0.0* |
13.7 |
0.0* |
4.0 |
3160 |
0.0* |
23.0 |
0.0* |
148.0 |
280.7 |
281.7 |
0.0* |
14.3 |
0.0* |
6.7 |
5000 |
0.0* |
29.0 |
0.0* |
154.3 |
289.7 |
289.0 |
0.0* |
16.7 |
0.0* |
6.0 |
Positive control |
591.0 |
311.3 |
1233.7 |
1237.0 |
988.3 |
1305.7 |
525.0 |
936.7 |
422.0 |
594.3 |
*cytotoxicity seen
Applicant's summary and conclusion
- Conclusions:
- 4,4,7,7-Tetraethoxy-3,8-dioxa-4,7-disiladecane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, EC 92/69/EEC L383 A, ICH S2A and ICH S2B, compliant 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 102, TA 1535 or TA 1537 in the initial or the repeat experiments up to cytotoxic concentrations. Appropriate positive and solvent 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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