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EC number: 229-713-7 | CAS number: 6674-22-2
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- and OECD Guideline 472 (Gene Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (only 2-aminoanthracene as positive control with metabolic activation)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,8-diazabicyclo[5.4.0]undec-7-ene
- EC Number:
- 229-713-7
- EC Name:
- 1,8-diazabicyclo[5.4.0]undec-7-ene
- Cas Number:
- 6674-22-2
- Molecular formula:
- C9H16N2
- IUPAC Name:
- 2,3,4,6,7,8,9,10-octahydropyrimido[1,2-a]azepine
- Details on test material:
- - Name of test substance (as cited in study report): 1, 8-Diazabicyclo (5, 4, 0) undecen-7
- Analytical purity: 97.7%
- Physical state: liquid
- Batch number: 13-0948
- Test substance number: 96/661
- Storage: room temperature
- Stability: The stability of the test substance throughout the study period has been verified by reanalysis.
Constituent 1
Method
- Target gene:
- His- and Trp-Operon
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-mix
- Test concentrations with justification for top dose:
- - Standard plate test: 20, 100, 500, 2,500 and 5,000 µg/plate
- Preincubation test: 4, 20, 100, 500 and 2,000 µg/plate - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9: 2-aminoanthracene (all tester strains); without S9: N-methyl-N'-nitro-N-nitrosoguanidine (TA 1535, TA 100), 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine (TA 1537), N-ethyl-N'-nitro-N-nitrosoguanidine (E. coli WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION (standard plate test): Experiment 1
DURATION
- Exposure duration: 48 - 72 h, 37 °C
METHOD OF APPLICATION (preincubation test): Experiment 2
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 h, 37 °C
NUMBER OF REPLICATIONS: 3 per dose per expermiment
DETERMINATION OF CYTOTOXICITY
- Method: 1) reduction of the number of revertants compared to negative control; 2) clearing of background lawn; 3) reduction of titer - Evaluation criteria:
- The test subtance is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9-mix or after adding a metabolizing system.
Generally, the experiment is to be considered valid if the following criteria are met :
• The number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control articles both with and without S-9 mix induced a significant increase in the number of revertant colonies within the range of the historical control data.
• The titer of viable bacteria was >= 10^9/ml . - Statistics:
- Not generally required for this assay
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 5000 µg/plate in all tester strains (in TA 100 and TA 2537 at 2500 µg/plate) in the standard plate test and at 2000 µg/plate in the preincubation test (all tester strains).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at 5000 µg/plate in the standard plate test and at 2000 µg/plate in the preincubation test (only without S9-mix).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Because of contamination the preincubation test was repeated for the E. coli strain in a third experiment.
- Precipitation: no precipitation occurred - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Standard plate test:
Dose (µg/plate) |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
20±4 |
19±1 |
117±15 |
137±6 |
12±2 |
12±1 |
29±3 |
37±4 |
31±3 |
36±5 |
20 |
17±2 |
17±1 |
123±13 |
132±5 |
9±1 |
12±1 |
25±1 |
33±2 |
33±3 |
32±4 |
100 |
17±1 |
18±4 |
114±7 |
107±7 |
9±1 |
11±2 |
26±2 |
33±3 |
24±3 |
32±3 |
500 |
14±2 |
12±2 |
141±12 |
120±11 |
9±2 |
8±2 |
22±1 |
26±1 |
28±7 |
19±6 |
2500 |
15±2 |
11±1 |
110±9x |
116±4x |
7±1x |
5±2x |
19±3x |
21±1x |
18±2 |
20±4 |
5000 |
5±3x |
7±1x |
0x |
67±6x |
0x |
4±2x |
1±1x |
7±2x |
10±2x |
12±2x |
2 -AA |
- |
141±8 |
- |
1423± 216 |
- |
154±22 |
- |
1006± 25 |
- |
271± 11 |
MNNG |
1022± 86 |
- |
1085± 11 |
- |
- |
- |
- |
- |
- |
- |
AAC |
- |
- |
- |
- |
654±51 |
- |
- |
- |
- |
- |
NOPD |
- |
- |
- |
- |
- |
- |
940± 9 |
- |
- |
- |
ENNG |
- |
- |
- |
- |
- |
- |
- |
- |
974± 46 |
- |
Mean ± SD
Preincubation-test:
Dose (µg/plate) |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
0 |
19±1 |
19±1 |
111±14 |
111±4 |
10±1 |
11±1 |
25±2 |
39±3 |
32±4 |
38±7 |
4 |
18±1 |
18±1 |
106±8 |
117±16 |
10±1 |
9±1 |
23±2 |
37±2 |
25±3 |
34±4 |
20 |
17±2 |
15±2 |
100±6 |
120±26 |
11±1 |
9±1 |
24±3 |
31±3 |
30±3 |
31±4 |
100 |
17±2 |
15±3 |
98±3 |
109±5 |
8±1 |
9±1 |
24±5 |
30±2 |
27±5 |
33±5 |
500 |
18±2 |
12±3 |
105±12 |
94±3 |
9±1 |
8±3 |
17±6 |
35±3 |
29±5 |
34±4 |
2000 |
1±2x |
12±1x |
0x |
96±9x |
0x |
4±2x |
0x |
19±3x |
8±1x |
24±5 |
2-AA |
- |
203±5 |
- |
829± 64 |
- |
127±22 |
- |
797± 36 |
- |
188±3 |
MNNG |
1060± 43 |
- |
913±90 |
- |
- |
- |
- |
- |
- |
- |
AAC |
- |
- |
- |
- |
436±10 |
- |
- |
- |
- |
- |
NOPD |
- |
- |
- |
- |
- |
- |
901±43 |
- |
- |
- |
ENNG |
- |
- |
- |
- |
- |
- |
- |
- |
753±56 |
- |
Mean ± SD
X: reduced background growth
2-AA: 2-aminoanthracene
MNNG; N-methyl-N-nitro-N-nitrosoguanidine
ENNG; N-ethyl-N-nitro-N-nitrosoguanidine
NOPD: 4-nitro-o-phenylendiamine
AAC: 9-aminoacridine chloride monohydrate
According to the results of the study, the test substance is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the experimental conditions chosen here. The positive controls gave the expected results.
Applicant's summary and conclusion
- Conclusions:
- No evidence of any induction of reverse mutation was seen under the conditions of this assay.
- Executive summary:
DBU was investigated for the ability to induce reverse mutation in Salmonella typhimurium strains TA98, TA100, TA 1535 and TA 1535 and in Eschericia coli strain WP2uvrA. Strains were exposed to concentrations up to the limit concentration of 5000 ug/plate in the absence and presence of an exogenous metabolic activation system (Aroclor 1254 -induce rat liver S9 fraction) in an initial plate-incorporation assay and at concentrations of up to 2000 ug/plate in a confirmatory pre-incubation assay. Cytotoxicity was apparent at the highest concentrations used. No evidence of any induction of reverse mutation was seen under the conditions of this assay; the sensitivity of the assay was confirmed by appropriate responses to positive control compounds.
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