Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 908-820-9 | CAS number: -
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
