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EC number: 815-305-1 | CAS number: 138938-64-4
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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:
- 2011-12-20 to 2012-01-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- duplicate plates were used instead of triplicate
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- "Reverse Mutagenicity test on Bacteria" of "Mutagenicity Test" stipulated in the "Testing Methods for New Chemical Substances" (March 31, 2011; No. 0331-7, Pharmaceutical and Food Safety Bureau, the Ministry of Health, Labour and Welfare
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-[(1,1-Dimethylethyl)dimethylsilyl]piperazine
- Cas Number:
- 138938-64-4
- Molecular formula:
- C10H24N2Si
- IUPAC Name:
- 1-[(1,1-Dimethylethyl)dimethylsilyl]piperazine
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: colourless transparent liquid
- Stabilisation: stable is storage conditions
Constituent 1
Method
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 5,6-benzoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 39.1, 78.1, 156, 313, 625, 1250 µg/plate
Bacterial growth inhibition was observed at greater than or equal to 1250 µg/plate, therefore 1250 µg/plate was selected to be the highest dose. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance was soluble and stable in dehydrated DMSO. The test substance solution of 50.0 mg/mL prepared with dehydrated DMSO was considered to be stable, because there were no change in colour, exothermic reaction nor gas generation at room temperature within 2 hours after preparation.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- TA100, TA98 and WP2uvrA without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Remarks:
- TA1537 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA100, TA1535, TA98, TA1537 and WP2uvrA with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding (if applicable): 2.3 x 10⁹ cells/mL S. typhimurium and 3.8x10⁹ cells/mL in E. coli
ACTIVATION SYSTEM: 1mL of S9 mix consisted of 8 µmol MgCl2, 33 µmol KCl, 5 µmol Glucose-6-phosphate, 4 µmol NADPH, 4 µmol NADH, 100 µmol sodium-phosphate buffer (pH 7.4) and 0.1 mL of S9.
DURATION
- Preincubation period: 0.1 ml of test substance solution and 0.5 mL of S9 mix were added to 0.1 ml of the bacterial culture and the mixture was shaken for 20 min at 37 +/- 0.5°C
- Exposure duration: The mixture was incubated for 48 hours at 37 +/- 0.5°C
SELECTION AGENT (mutation assays): histidine and biotin deficient agar for S. typhimurium strains, and tryptophan deficient agar for E.coli.
NUMBER OF REPLICATIONS: duplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: number of revertant colonies - Rationale for test conditions:
- The highest selected concentration for the main experiment was 1250 µg/plate, at which bacterial growth inhibition was observed during the range-finding test.
- Evaluation criteria:
- The test substance was concluded to be positive when the number of relevant colonies increased to twice or more than that in the negative control and when the responses were dose related and/or reproducible. Five lower doses diluted with a geometric progression of 2 were selected.
- Statistics:
- No statistical methods were used.
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: TA1535, TA1537, TA100, TA98 and WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1250 µg/plate for test strains with and without S9 mix
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation was not observed with or without S9 mix
RANGE-FINDING/SCREENING STUDIES:
HISTORICAL CONTROL DATA
- Positive historical control data: the positive control results were within the historical control data
- Negative (solvent/vehicle) historical control data: the negative control results were within the historical control data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: the bacterial growth inhibition was observed by a stereomicroscope
- Other observations when applicable: colony counting was performed manually for plates with bacterial growth inhibition; a colony analyser was used for the rest of the colonies.
Any other information on results incl. tables
Table 1: Mean number of revertants with and without metabolic activation
Concentration μg/plate |
TA100 |
|
TA1535 |
|
WP2uvrA |
|
TA98 |
|
TA1537 |
|
|
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
Negative control |
106 |
94 |
10 |
6 |
34 |
27 |
27 |
16 |
17 |
10 |
39.1 |
115 |
108 |
6 |
9 |
33 |
32 |
39 |
22 |
16 |
12 |
78.1 |
107 |
111 |
9 |
9 |
33 |
36 |
32 |
18 |
16 |
9 |
156 |
109 |
101 |
12 |
8 |
26 |
28 |
28 |
19 |
18 |
9 |
313 |
101 |
99 |
8 |
8 |
31 |
35 |
25 |
17 |
19 |
9 |
625 |
116 |
100 |
11 |
8 |
36 |
29 |
25 |
20 |
20 |
12 |
1250 |
87 |
74 |
11 |
9 |
29 |
19 |
23 |
11 |
12 |
8 |
Positive control substance |
2-AA |
AF-2 |
2-AA |
NaN3 |
2-AA |
AF-2 |
2-AA |
AF-2 |
2-AA |
ICR-191 |
Positive control dose (µg/plate) |
1 |
0.01 |
2 |
0.5 |
10 |
0.01 |
0.5 |
0.1 |
2 |
0.5 |
Number of revertants (positive control) |
875 |
840 |
227 |
396 |
696 |
377 |
363 |
505 |
191 |
1436 |
AF-2: 2 -(2 -Furyl)-3 -(5 -nitro-2 -furyl)acrylamide
NaN3: Sodium azide
2AA: 2 -Aminoantracene
Applicant's summary and conclusion
- Conclusions:
- 1-(Tert-butyldimethylsilyl)piperazine has been tested in a valid Bacterial reverse mutation assay, conducted according to a protocol similar to OECD TG 471, and in compliance with GLP, using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and E.coli WP2uvrA. No increase in the number of revertants was observed in any test strain, with or without metabolic activation when tested up to a limit concentration. Appropriate positive and negative (solvent) controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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