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EC number: 915-748-1 | CAS number: -
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:
- 1999-11-18 to 2000-01-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 56706-10-6, 56706-11-7 and 60764-86-5
- IUPAC Name:
- 56706-10-6, 56706-11-7 and 60764-86-5
- Reference substance name:
- Reaction mass of 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane, 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane
- IUPAC Name:
- Reaction mass of 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane, 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane
- Reference substance name:
- 260-350-7 and 260-351-2
- IUPAC Name:
- 260-350-7 and 260-351-2
- Reference substance name:
- S1/S2/S3
- IUPAC Name:
- S1/S2/S3
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 75-5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Sponsor's request and compatibility with target cells.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All Salmonella Strains, WP2 uvrA (with activation)
- 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)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 (without activation)
- 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)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA (without activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar, preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 to 72 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 12 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn monitoring - Evaluation criteria:
- For the test article to be positive, it must cause a dose-related increase in mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations per test article.
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 WP2 uvrA, and 3-fold of the solvent control for TA 1535 and TA 1537.
Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or a sparse background lawn.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
Any other information on results incl. tables
Table 2: Experiment 1 Preliminary toxicity assay, Number of revertants per plate
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
NC*** |
30 |
No |
128 |
172 |
No |
15 |
8 |
No |
6.7 |
14 |
29 |
No |
145 |
124 |
No |
19 |
14 |
No |
10 |
18 |
22 |
No |
150 |
171 |
No |
19 |
11 |
No |
33 |
12 |
19 |
No |
142 |
177 |
No |
12 |
13 |
No |
67 |
21 |
28 |
No |
170 |
193 |
No |
16 |
10 |
No |
100 |
9 |
19 |
No |
136 |
189 |
No |
19 |
13 |
No |
333 |
17 |
24 |
No |
138 |
181 |
No |
23 |
23 |
No |
667 |
23 |
23 |
No |
147 |
162 |
No |
15 |
15 |
No |
1000 |
14** |
24** |
No |
132** |
169** |
No |
19** |
25** |
No |
3333 |
15** |
17** |
No |
167** |
184** |
No |
24** |
16** |
No |
5000 |
21** |
26** |
No |
139** |
199** |
No |
23** |
15** |
No |
*solvent control with DMSO
**Non-Interfering Precipitate
***No count due to procedural error in which plate did not receive an aliquot of tester strain
Table 2: Experiment 1 Preliminary toxicity assay, Number of revertants per plate
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
56 |
45 |
No |
14 |
16 |
No |
6.7 |
49 |
42 |
No |
19 |
15 |
No |
10 |
37 |
41 |
No |
12 |
19 |
No |
33 |
49 |
43 |
No |
12 |
17 |
No |
67 |
47 |
40 |
No |
10 |
10 |
No |
100 |
47 |
46 |
No |
13 |
17 |
No |
333 |
37 |
48 |
No |
9 |
12 |
No |
667 |
48 |
39 |
No |
10 |
16 |
No |
1000 |
37** |
67** |
No |
11** |
12** |
No |
3333 |
45** |
52** |
No |
8** |
18** |
No |
5000 |
44** |
55** |
No |
15** |
14** |
No |
*solvent control with DMSO
**Non-Interfering Precipitate
***No count due to procedural error in which plate did not receive an aliquot of tester strain
Table 3: Experiment 2 Preincubation mutagenicity assay, Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
16 |
21 |
No |
174 |
203 |
No |
13 |
15 |
No |
75 |
9 |
25 |
No |
161 |
217 |
No |
13 |
16 |
No |
200 |
14 |
24 |
No |
166 |
213 |
No |
17 |
16 |
No |
600 |
10 |
18 |
No |
159 |
212 |
No |
17 |
18 |
No |
1800 |
13 |
17 |
No |
169 |
232 |
No |
14 |
16 |
No |
5000 |
9 |
17 |
No |
140 |
209 |
No |
16 |
18 |
No |
Positive control |
981 |
1350 |
No |
626 |
1197 |
No |
370 |
140 |
No |
*solvent control with DMSO
Table 3: Experiment 2 Preincubation mutagenicity assay, Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
8 |
9 |
No |
12 |
14 |
No |
75 |
4 |
6 |
No |
9 |
12 |
No |
200 |
5 |
5 |
No |
8 |
13 |
No |
600 |
4 |
9 |
No |
9 |
11 |
No |
1800 |
4 |
5 |
No |
9 |
15 |
No |
5000 |
5 |
8 |
No |
9 |
6 |
No |
Positive control |
827 |
149 |
No |
495 |
462 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Preincubation (Repeat) mutagenicity assay,Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
17 |
16 |
No |
152 |
160 |
No |
11 |
10 |
No |
75 |
14 |
14 |
No |
145 |
171 |
No |
7 |
13 |
No |
200 |
15 |
19 |
No |
135 |
189 |
No |
7 |
15 |
No |
600 |
14 |
10 |
No |
137 |
159 |
No |
10 |
9 |
No |
1800 |
16 |
14 |
No |
143 |
156 |
No |
9 |
12 |
No |
5000 |
15 |
12 |
No |
115 |
173 |
No |
8 |
7 |
No |
Positive control |
409 |
785 |
No |
677 |
759 |
No |
207 |
68 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Preincubation (Repeat) mutagenicity assay, Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
5 |
6 |
No |
10 |
10 |
No |
75 |
4 |
4 |
No |
12 |
6 |
No |
200 |
4 |
6 |
No |
9 |
8 |
No |
600 |
5 |
5 |
No |
12 |
10 |
No |
1800 |
2 |
7 |
No |
9 |
12 |
No |
5000 |
4 |
5 |
No |
11 |
8 |
No |
Positive control |
719 |
71 |
No |
317 |
75 |
No |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- In a reliable test conducted in compliance with OECD 471, under GLP, the test substance (8.3% Bis(triethoxysilylpropyl) (S1), 65.4% Bis(triethoxysilylpropyl) (S2), 16.6% Bis(triethoxysilylpropyl) (S3)) did not cause a positive response in any of the tester strains with or without metabolic activation in either of the tests. The test substance is non mutagenic in E. coli and Salmonella strains under the conditions of the test.
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