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EC number: 280-084-5 | CAS number: 82985-35-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 2005 to 26 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- (no data on test material purity given, slightly modified data evaluation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2000)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BAYERISCHES LANDESAMT FÜR ARBEITSSCHUTZ, ARBEITSMEDIZIN UND SICHERHEITSTECHNIK, Munich, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(trimethoxysilylpropyl)amine
- EC Number:
- 280-084-5
- EC Name:
- Bis(trimethoxysilylpropyl)amine
- Cas Number:
- 82985-35-1
- Molecular formula:
- C12H31NO6Si2
- IUPAC Name:
- 3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane
- Details on test material:
- - Name of test material (as cited in study report): Bis(trimethoxysilylpropyl)amine, Silquest A-1170 silane
- Physical state: clear, pale liquid
- Expiration date of the lot/batch: 499931
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- with aqua destillata
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Remarks:
- with aqua destillata
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD: 10 µg/plate for TA 98 and 40 µg/plate for TA 1537 TA 98, TA 1537 (without metabolic activation)
- Untreated negative controls:
- yes
- Remarks:
- with aqua destillata
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- yes
- Remarks:
- with aqua destillata
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA (2.5 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min at 37 °C
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 independent experiments with 3 plates each strain and dose level
DETERMINATION OF CYTOTOXICITY
- Method: reduced background lawn (25% and above) or a reduction in the number of revertants down to a mutation factor of approx. up to 0.5 in relation to solvent control - Evaluation criteria:
- A test item was considered mutagenic if:
- a clear and dose related increase in the number of revertants over at least two increasing concentrations occurs without concomitant cytotoxicity in at least one of these dose groups, and/or
- a biologically relevant positive response for at least one of the non cytotoxic dose groups in at least one tester strain with or without metabolic activation.
Cytotoxicity is measured by clearing 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. - Statistics:
- The mutation factor was calculated by dividing the mean number of revertants in the test item by the mean number of revertants in the solvent control.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2500 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- none stated in the study report
COMPARISON WITH HISTORICAL CONTROL DATA
The results were within range of the historical control data. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Tabl.1: Experiment 1 Plate incorporation Number of revertants per plate(mean out of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
Negative control** |
44±5.5 |
41±2.3 |
No |
122±9.9 |
127±21.9 |
No |
18±4 .9 |
9±3.2 |
No |
solvent control* |
34±10.1 |
42±10 |
No |
114±8.5 |
139±24.8 |
No |
20±5.3 |
8±2.6 |
No |
31.6 |
34±9.6 |
46±57 |
No |
133±14.0 |
126±28.2 |
No |
20±2.6 |
10±1.5 |
No |
100 |
29±3.2 |
37±3.8 |
No |
120±8.1 |
122±8.1 |
No |
21±5.0 |
10±4.9 |
No |
316 |
28±1.5 |
37±8.1 |
No |
120±10.1 |
109±5.7 |
No |
25±8.9 |
13±6.1 |
No |
1000 |
28±1.5 |
48±1.7 |
No |
116±5.8 |
97±11.0 |
No |
18±5.3 |
11±2.5 |
No |
2500 |
26±2.6 |
43±4.9 |
No |
102±7.6 |
105±13.5 |
No |
11±3.0 |
8±2.5 |
No |
5000 |
24±1.7 |
49±3.1 |
No |
118±11.4 |
87±11.6 |
Yes |
12±2.3 |
8±3.5 |
Yes |
Positive control |
1234±173.1 |
2636±123.7 |
No |
1116±28.9 |
2327±94.9 |
No |
1138±27.7 |
108±7.6 |
No |
*solvent control with DMSO
**negative control with water
Tab. 1: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates) (ctd.)
|
TA1537 |
E. coli WP2 uvrA |
||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
Negative control** |
17±1.7 |
20±1.0 |
No |
52±5.0 |
43±9.2 |
No |
solvent control* |
15±5.0 |
22±0.5 |
No |
40±9.5 |
38±8.6 |
No |
31.6 |
18±2.1 |
20±5.1 |
No |
47±7.1 |
45±8.0 |
No |
100 |
16±2.5 |
18±0.0 |
No |
45±2.1 |
48±6.6 |
No |
316 |
17±1.5 |
28±3.0 |
No |
42±5.6 |
53±10.0 |
No |
1000 |
12±0.8 |
17±5.1 |
No |
44±0.6 |
57±9.3 |
No |
2500 |
7±3.6 |
18±3.1 |
Yes |
48±4 .9 |
50±14.5 |
No |
5000 |
5±1.0 |
6±1.5 |
Yes |
32±7.5 |
55±8.8 |
No |
Positive control |
165±12.6 |
343±44.0 |
No |
573±107.7 |
194±25.6 |
No |
*solvent control with DMSO
**negative control with water
Tab. 2: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
Negative control** |
29±5.6 |
45±3.1 |
No |
130±10.2 |
132±10.6 |
No |
20±2.6 |
11±2.6 |
No |
solvent control* |
34±3.6 |
40±8.1 |
No |
126±12.0 |
115±8.3 |
No |
25±7.2 |
12±3.5 |
No |
31.6 |
31±3.6 |
44±1.7 |
No |
128±6.4 |
117±10.8 |
No |
21±5.3 |
13±4.0 |
No |
100 |
33±2.1 |
45±8.4 |
No |
137±16.9 |
131±20.4 |
No |
20±6.1 |
11±2.6 |
No |
316 |
28±3.5 |
46±7.6 |
No |
114±2.0 |
114±4.6 |
No |
20±1.5 |
12±1.2 |
No |
1000 |
27±6.1 |
43±4.5 |
No |
98±6.7 |
123±10.0 |
No |
19±2.9 |
15±5.0 |
No |
2500 |
23±2.6 |
29±6.1 |
No |
89±8.3 |
117±8.3 |
No |
12±1.2 |
5±2.3 |
Yes |
5000 |
19±2.3 |
15±3.2 |
Yes |
78±25.5 |
57±6.7 |
Yes |
0±0 |
4±1.5 |
Yes |
Positive control |
1768±191.4 |
1277±102.8 |
No |
1278±35.9 |
1583±71.1 |
No |
1353±27.6 |
68±13.7 |
No |
*solvent control with DMSO
**negative control with water
Tab. 2: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates) (ctd.)
|
TA1537 |
E. coli WP2 uvrA |
||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
Negative control** |
8±1.2 |
9±1.2 |
No |
49±3.6 |
61±4.5 |
No |
solvent control* |
13±3.5 |
8±1.5 |
No |
38±5.5 |
61±6.1 |
No |
31.6 |
12±4.6 |
8±3.5 |
No |
48±2.9 |
47±5.7 |
No |
100 |
19±1.2 |
7±1.7 |
No |
35±11.2 |
48±9.9 |
No |
316 |
9±1.5 |
9±2.3 |
No |
38±5.0 |
59±9.0 |
No |
1000 |
5±2.5 |
9±1.7 |
Yes |
41±12.3 |
57±16.5 |
No |
2500 |
5±1.2 |
3±2.5 |
Yes |
24±11.8 |
41±4.9 |
Yes |
5000 |
6±1.0 |
2±0.0 |
Yes |
22±8.1 |
24±5.0 |
Yes |
Positive control |
266±46.6 |
131±24.6 |
No |
654±22.3 |
139±6.1 |
No |
*solvent control with DMSO
**negative control with water
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test item was investigated for mutagenicicty to bacteria according to the OECD TG 471, and in compliance with GLP. In two independent experiments (plate incorporation and preincubation) the test material was tested in S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and in E. coli WP2 uvrA up to precipitation and cytotoxic concentrations with and without a metabolic activation system. No significant increase in the number of revertants was observered in any of the tester strain with and without metabolic activation. Appropriate negative, solvent, and positive controls were included into the test and gave the expected results. Hence, the test item was considered to be not mutagenic to bacteria under the conditions of the test.
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