1,1,1-triethoxy-N,N-diethylsilanamine

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:

2002

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

Test material information

Constituent 1

Reference substance name:

diethyl(triethoxysilyl)amine

EC Number:

700-051-5

Cas Number:

35077-00-0

Molecular formula:

C10H25NO3Si

IUPAC Name:

diethyl(triethoxysilyl)amine

Method

Target gene:

Histadine for Salmonella
Tryptophan for E. coli

Species / strain

Species / strain 1

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 2

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

Controls

Controls 1

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

Controls 2

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

99.9 wt% Purity

Controls 3

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

97.0 wt% Purity

Controls 4

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 results

Test results 1

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

Test results 2

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.