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EC number: 908-820-9 | CAS number: -
- Life Cycle description
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- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2E)-1-chlorobut-2-ene; 3-chlorobut-1-ene
- EC Number:
- 908-820-9
- IUPAC Name:
- (2E)-1-chlorobut-2-ene; 3-chlorobut-1-ene
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA102
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Phenobarbital (i.p.) and beta-Naphthoflavone (oral) induced rat liver
- Test concentrations with justification for top dose:
- TA98: 50, 160, 500, 750, 1000 µg/plate
TA100, TA102, TA1535, TA1537: 50, 160, 500, 1600, 5000 µg/plate - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98
Migrated to IUCLID6: 2.5 µg/plate
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA 1535
Migrated to IUCLID6: 5 µg/plate (TA100), 2.5 µg/plate TA1535
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA102
Migrated to IUCLID6: 2.5 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537
Migrated to IUCLID6: 40 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 100 µg/plate 2-Aminofluorene and 2.5 µg/plate 2-Aminoanthracene
- Remarks:
- all tester strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 72h
-Titers of overnight cultures: > 10^8
- Selection time (if incubation with a selection agent): 72h
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS:triplicates, two assays
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth with strains TA98 and TA100
- Evaluation criteria:
- - negative control in the laboratory historical range for each tester strain
- positive control chemicals produces responses in all tester strains within laboratory historical range
- Mean plate count should be at least two times the concurrent vehicle control group mean in both assays and in a dose dependent response
- selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate
- To ensure that appropriate numbers of bacteria are plated, overnight culture titers must be in excess of 10^8 bacteria/ml - Statistics:
- not applicable
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA1535, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- with and without metabolic activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 98, TA 1537, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
COMPARISON WITH HISTORICAL CONTROL DATA: some values were insignificantly above historical control data, but they are regarded as acceptable
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the pretest with the TA98 tester strain, toxicity and/or reduced background lawn was observed at 1600 and 5000 µg/plate - Remarks on result:
- other: strain/cell type: TA 1535
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Assay 1:
Conc (µg/plate) |
TA1535 |
TA1537 |
TA 100 |
TA102 |
||||
|
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Control (water) |
0.9 |
1.1 |
1.2 |
0.9 |
1.0 |
1.0 |
1.0 |
1.0 |
50 |
1.6 |
2.4 |
0.7 |
0.8 |
0.9 |
1.0 |
1.2 |
1.1 |
160 |
2.0 |
2.7 |
0.8 |
0.9 |
1.0 |
1.1 |
1.2 |
1.2 |
500 |
2.8 |
3.1 |
0.8 |
0.7 |
1.1 |
1.4 |
1.3 |
1.5 |
1600 |
3.9 |
6.3 |
0.8 |
0.7 |
1.6 |
1.6 |
1.4 |
1.9 |
5000 |
2.0# |
5.0# |
0.5* |
0.8 |
1.6# |
1.3# |
0.7# |
1.1# |
Positive control |
30.7 |
|
7.2 |
|
3.9 |
|
4.1 |
|
2-Aminofluorene |
|
2.2 |
|
3.3 |
|
9.2 |
|
2.2 |
2- Aminoanthracene |
|
7.2 |
|
5.6 |
|
7.5 |
|
1.5 |
Assay 2
Conc (µg/plate) |
TA1535 |
TA1537 |
TA 100 |
TA102 |
||||
|
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Control (water) |
0.8 |
1.5 |
1.2 |
1.1 |
1.0 |
1.1 |
1.1 |
1.0 |
25 |
1.2 |
1.5 |
1.1 |
1.0 |
1.0 |
1.1 |
1.0 |
1.1 |
160 |
1.4 |
2.2 |
1.1 |
1.0 |
1.2 |
1.0 |
1.0 |
1.4 |
250 |
1.6 |
2.3 |
0.9 |
1.0 |
1.4 |
1.2 |
1.0 |
1.4 |
1600 |
2.9 |
5.2 |
0.9 |
0.9 |
2.6 |
1.7 |
1.2 |
1.6 |
2500 |
4.5 |
6.4 |
0.6#* |
0.8 |
2.9 |
2.2 |
0.2 |
1.4 |
Positive control |
32.6 |
|
6.3 |
|
5.5 |
|
3.4 |
|
2-Aminofluorene |
|
3.5 |
|
3.2 |
|
10.9 |
|
2.6 |
2- Aminoanthracene |
|
10.6 |
|
4.8 |
|
7.7 |
|
1.8 |
TA98
Conc (µg/plate) |
Assay 1 |
Assay2 |
|
|
|
|
- S9 |
+ S9 |
Control (water) |
+ S9 |
- S9 |
Control (water) |
1.4 |
1.2 |
50 |
1.2 |
0.9 |
50 |
1.0 |
0.9 |
160 |
1.1 |
0.9 |
160 |
1.0 |
1.1 |
250 |
1.0 |
0.8 |
500 |
1.3 |
1.2 |
500 |
1.0 |
0.8 |
750 |
1.2 |
1.1 |
750 |
0.7# |
0.7 |
1000 |
1.1 |
0.8 |
2-nitrofluorene |
0.9# |
0.9 |
2-nitrofluorene |
5.8 |
|
2-Aminofluorene |
4.5 |
|
2-Aminofluorene |
|
56.6 |
2- Aminoanthracene |
|
41.0 |
2- Aminoanthracene |
|
20.8 |
Control (water) |
|
21.7 |
#: reduced background lawn
*: no background lawn, toxicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Test substance induce a mutagenic effect in S. typhimurium TA 100 and TA1535 with and without metabolic activation. It is therefore considered to be a bacterial mutagen.
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