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EC number: 242-419-3 | CAS number: 18547-93-8
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:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-trimethoxysilylpropyl methacrylate
- EC Number:
- 219-785-8
- EC Name:
- 3-trimethoxysilylpropyl methacrylate
- Cas Number:
- 2530-85-0
- Molecular formula:
- C10H20O5Si
- IUPAC Name:
- 3-(Trimethoxysilyl)propyl 2-methylprop-2-enoate
- Test material form:
- other: liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537; Escherichia coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- preliminary toxicity test: 0.13 to 5000 µg/plate; definitive assay:15 to 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: request of sponsor; compatibility with target cells; solubility of test article
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- 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 and 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
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation;
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48-72 hours
- Expression time (cells in growth medium): 48-72 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48-72 hours
NUMBER OF REPLICATIONS: triplicate cultures
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of bacterial lawn
METABOLIC ACTIVATION: S9 was prepared from male Sprague-Dawley rats induced with Aroclor 1264. Each batch was assayed for ability to metabolise 2-aminoanthracene and 7,12-dimethylbenz(a)anthracene to forms mutagenic to S. typhimurium TA100. S9 mix contained 10% S9, 5mM glucose-6-phosphate, 4 mM NADP, 8 mM MgCl2 and 33 mM KCl in 100 mM phosphate buffer pH 7.4. 0.5 ml of S9 mix were added to 2.0 ml top agar, 0.1 ml tester strain and 0.05 ml vehicle or test article, giving a final concentration of approximately 2% S9. - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean no. of revertants per plate relative to solvent control over a minimum of two concentrations; by at least 2-fold in strains TA 98, TA 100 and E coli WP2 uvrA; by at least 3-fold in strains TA 1535 and 1537
- Statistics:
- Means and standard deviations were calculated
Results and discussion
Test results
- Species / strain:
- bacteria, other: Salmonella typhimurium TA98, TA100, TA1535 and TA1537; Escherichia coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 1500 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no information
- Effects of osmolality: no information
- Evaporation from medium: no information
- Water solubility: reacts slowly with water
- Precipitation: no precipitate observed
RANGE-FINDING/SCREENING STUDIES: on all strains
COMPARISON WITH HISTORICAL CONTROL DATA: Control results were within the range of historical data
ADDITIONAL INFORMATION ON CYTOTOXICITY: slightly variable between studies - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1: Dose range-finding study. Number of revertants per plate (1 plate per strain)
Conc. µg/plate |
TA98 |
|
|
TA100 |
|
|
TA1535 |
|
|
|
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
15 |
15 |
no |
84 |
102 |
no |
11 |
14 |
no |
6.7 |
16 |
14 |
no |
88 |
109 |
no |
10 |
14 |
no |
10 |
15 |
17 |
no |
94 |
122 |
no |
10 |
9 |
no |
33 |
15 |
15 |
no |
109 |
110 |
no |
11 |
12 |
no |
67 |
19 |
15 |
no |
93 |
101 |
no |
13 |
13 |
no |
100 |
11 |
18 |
no |
72 |
104 |
no |
17 |
10 |
no |
333 |
17 |
17 |
no |
116 |
117 |
no |
8 |
13 |
no |
667 |
15 |
14 |
no |
86 |
115 |
no |
12 |
8 |
no |
1000 |
11 |
20 |
no |
60 |
80 |
no |
6 |
11 |
no |
3333 |
8 |
15 |
Yes** |
75 |
102** |
Yes |
4*** |
7*** |
Yes |
5000 |
0 |
13** |
Yes**** |
69*** |
48*** |
yes |
0**** |
4*** |
yes |
*solvent control with Ethylene glycol dimethyl ether
** Background lawn slightly reduced
***Background lawn severely reduced
****Background lawn extremely reduced
Table 2: Dose range-finding study. Number of revertants per plate (1 plate per strain)
Concentration (μg/Plate) |
TA100 |
|
|
WP2 uvrA |
|
|
|
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (yes/no) |
Plate 1 - MA |
Plate 2 + MA |
Cytotoxic (yes/no) |
0* |
5 |
5 |
no |
11 |
11 |
no |
6.7 |
7 |
8 |
no |
14 |
13 |
no |
10 |
7 |
6 |
no |
11 |
8 |
no |
33 |
3 |
6 |
no |
12 |
11 |
no |
67 |
7 |
4 |
no |
12 |
11 |
no |
100 |
5 |
6 |
no |
11 |
11 |
no |
333 |
3 |
5 |
no |
10 |
12 |
no |
667 |
4 |
2 |
no |
7 |
12 |
no |
1000 |
5 |
6 |
no |
7 |
13 |
no |
3333 |
5*** |
7** |
Yes |
6 |
7 |
No |
5000 |
1**** |
5*** |
yes |
2** |
13 |
yes |
*solvent control with Ethylene glycol dimethyl ether
** Background lawn slightly reduced
***Background lawn severely reduced
****Background lawn extremely reduced
Table 3: Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 3 plates)
Conc. µg/plate |
TA98 |
|
|
TA100 |
|
|
TA1535 |
|
|
|
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
15 |
19 |
no |
100 |
103 |
no |
12 |
10 |
no |
15 |
17 |
16 |
no |
995 |
91 |
no |
11 |
9 |
no |
50 |
14 |
20 |
no |
102 |
91 |
no |
9 |
13 |
no |
150 |
10 |
18 |
no |
106 |
94 |
no |
11 |
12 |
no |
500 |
9 |
19 |
no |
116 |
113 |
no |
12 |
9 |
no |
1500 |
7 |
16 |
Yes |
6 |
100 |
Yes |
8 |
7 |
no |
5000 |
0 |
3 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
324 |
499 |
- |
451 |
458 |
- |
152 |
74 |
- |
*solvent control with Ethylene glycol dimethyl ether
Table 4: Experiment 1 Mutagenicity Assay. Number of revertants per plate (mean of 3 plates)
Concentration (μg/Plate) |
TA1537 |
|
|
WP2 uvrA |
|
|
|
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
6 |
8 |
no |
11 |
11 |
no |
15 |
6 |
6 |
no |
10 |
12 |
no |
50 |
4 |
6 |
no |
9 |
10 |
no |
150 |
5 |
6 |
no |
10 |
11 |
no |
500 |
3 |
5 |
no |
11 |
10 |
no |
1500 |
4 |
4 |
no |
9 |
11 |
no |
5000 |
0 |
0 |
yes |
4 |
6 |
yes |
Positive control |
20 |
65 |
- |
227 |
76 |
- |
*solvent control with Ethylene glycol dimethyl ether
Table 5: Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 3 plates)
Conc. µg/plate |
TA98 |
|
|
TA100 |
|
|
TA1535 |
|
|
|
-MA |
+MA |
Cytotoxic (yes/no) |
-MA |
+MA |
Cytotoxic (yes/no) |
-MA |
+MA |
Cytotoxic (yes/no) |
0* |
15 |
23 |
no |
116 |
135 |
no |
12 |
9 |
no |
15 |
14 |
30 |
no |
126 |
151 |
no |
13 |
6 |
no |
50 |
18 |
22 |
no |
129 |
147 |
no |
9 |
9 |
no |
150 |
18 |
25 |
no |
111 |
154 |
no |
10 |
9 |
no |
500 |
15 |
17 |
no |
133 |
149 |
no |
10 |
7 |
no |
1500 |
17 |
19 |
no |
133 |
122 |
no |
15 |
6 |
no |
5000 |
7 |
8 |
yes |
77 |
57 |
yes |
8 |
8 |
no |
Positive control |
589 |
951 |
- |
509 |
706 |
- |
228 |
163 |
- |
*solvent control withEthylene glycol dimethyl ether
Table 6: Experiment 2 Mutagenicity Assay. Number of revertants per plate (mean of 3 plates)
Concentration (μg/Plate) |
TA1537 |
|
|
WP2 uvrA |
|
|
|
- MA |
+ MA |
Cytotoxic (yes/no) |
- MA |
+ MA |
Cytotoxic (yes/no) |
0* |
4 |
7 |
no |
14 |
12 |
no |
15 |
4 |
6 |
no |
13 |
8 |
no |
50 |
6 |
5 |
no |
12 |
10 |
no |
150 |
6 |
7 |
no |
12 |
6 |
no |
500 |
8 |
5 |
no |
15 |
11 |
no |
1500 |
6 |
7 |
no |
11 |
7 |
no |
5000 |
7 |
3 |
yes |
9 |
8 |
no |
Positive control |
935 |
317 |
- |
219 |
275 |
- |
Applicant's summary and conclusion
- Conclusions:
- 3-Trimethoxysilylpropyl methacrylate has been tested in a valid bacterial reverse mutation assay according to OECD TG 471 and under GLP, using Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2uvrA. No increase in the number of revertants was observed in any test strain, with or without activation. Appropriate positive and solvent controls were added and gave expected results. It is concluded that the test substance is negative for bacterial mutagenicity under the conditions of the test.
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