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EC number: 700-051-5 | CAS number: 35077-00-0
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:
- September 3 2002 - September 30 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- diethyl(triethoxysilyl)amine
- EC Number:
- 700-051-5
- Cas Number:
- 35077-00-0
- Molecular formula:
- C10H25NO3Si
- IUPAC Name:
- diethyl(triethoxysilyl)amine
Constituent 1
Method
- Target gene:
- Histadine for Salmonella
Tryptophan for E. coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9, post-mitochondrial supernatant of rat-liver homogenate. 5,6-Benzoflavone and phenobarbital were used as an inducer of drug-metabolizing enzyme system.
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500 and 5000 micro gramper plate.
The mutagenicity was assayed from a maximum level of 5000 micro gram test substance/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Anhydrous DMSO
- Justification for choice of solvent/vehicle: Not recorded
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitoro-2-furyl)acrylamide (AF-2)
- Remarks:
- 99.0 wt% Purity
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 99.9 wt% Purity
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 97.0 wt% Purity
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2-AA)
- Remarks:
- 96.7 wt% Purity
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation)
DURATION
- Preincubation period:
20 minutes at 37 deg C
- Exposure duration:
48 hours
- Expression time:
48 hours and 20 minutes
- Selection time (if incubation with a selection agent):
48 hours and 20 minutes preincubation.
- Fixation time (start of exposure up to fixation or harvest of cells):
Not applicable
NUMBER OF REPLICATIONS:
2 x 2 experiments
NUMBER OF CELLS EVALUATED:
Not recorded. - Evaluation criteria:
- A compound is regarded as mutagenetic when it induced the revertant colonies dose-dependently and the number of revertants is more than twice the control.
- Statistics:
- None recorded
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Diethylaminotriethoxysilane did not increase revertant colonies up to 5000 micro gram/plate with or withpout metabolic activation.
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Diethylaminotriethoxysilane did not increase revertant colonies up to 5000 micro gram/plate with or withpout metabolic activation.
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not recorded
- Effects of osmolality: Not recorded
- Evaporation from medium: Not recorded
- Water solubility: The substance decomposed with water. This did not affect the study data.
- Precipitation: Not recorded
- Other confounding effects: None recorded.
RANGE-FINDING/SCREENING STUDIES:
Please see Attachment 1.
COMPARISON WITH HISTORICAL CONTROL DATA:
None recorded.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Please see attachment 2 for full table of results.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Diethylaminotriethoxysilane did not increase revertant colonies up to 5000 micro gram/plate with or withpout metabolic activation.
The test material was considered to be non-mutagenic under the conditions of this test. - Executive summary:
In a reverse gene mutation assay in bacteria TA1535, TA1537, TA98 and TA100 strains of S. typhimurium and WP2 uvr A strain of E. coli were exposed to Diethylaminotriethoxysilane at concentrations of 156, 313, 625, 1250, 2500 and 5000 micro g/plate in the presence and absence of rat liver homogenate metabolising system (0.1 ml liver S9 in 1ml S9 with standard co-factors).
Diethylaminotriethoxysilane was tested up to the maximum recommended dose level of 5000 micro g/plate.
The positive controls induced the appropriate responses in the corresponding strains. There was no recorded evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline: : Guidelines for Screening Mutagenicity Testing Of Chemicals for in vitromutagenicity (bacterial reverse gene mutation) data.
Diethylaminotriethoxysilane was considered to be non-mutagenic under the conditions of this test.
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