Registration Dossier
Registration Dossier
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EC number: 908-820-9 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Reaction mass of (E)-1-chlorobut-2-ene and 3-chlorobut-1-ene
- EC Number:
- 908-820-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of (E)-1-chlorobut-2-ene and 3-chlorobut-1-ene
Constituent 1
Method
- Target gene:
- hprt locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability:no data
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Arochlor 1254- induced rat liver
- Test concentrations with justification for top dose:
- 7.81, 15.63, 31.25, 62.5, 125 µg/mL (first experiment)
15.63, 31.25, 62.5, 125, 250 µg/mL (second experiment) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: appropraite sovent for the test
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethyl methanesulfonate without S9 mix and 9,10-Dimethyl-1,2-benzanthracene with S9-mix, respectively
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24h
- Exposure duration: 24h without S9-mix, 4 hours with S9-mix
- Expression time (cells in growth medium): 8 days
- Selection time (if incubation with a selection agent): 8 days (plating efficiency), 12 days (6-Thioguanine)
SELECTION AGENT (mutation assays): 6-thioguanine (10 µg/mL, 5 replicate plates)
NUMBER OF REPLICATIONS: 3 for Expression time, 5 for selection time
NUMBER OF CELLS EVALUATED: n.a.
DETERMINATION OF CYTOTOXICITY
cloning efficiency
- Evaluation criteria:
- Test item is negative in the test system, if
- in both independent experiments solvent and positive controls show results within the norm
- test item does not increase the mutation frequency 2fold above the mean of the solvent controls under any condition
- the mutation frequency is always lower than 20 x 10^-6 cells and
- at least 1 x 10^6 cells per conditions have been evaluated
test item is regarded to be positive in the test in case of
- a dose dependent increase of the mutation frequency in both independent exeriments (similar concentrations) to at least 2-fold solvent control
- at least 20x10^-6 both in presence/absence of S9 mix
Solvent control: historical background mutation frequency in the system is reported to be 1-44 mutants per 10^6 survivors (without metabolic activation) and 6-46 mutants per 10^6 survivors (with metabolic activation)
Positive controls: 10fold greater mutation frequency than the solvent control
Mean mutation frequency of the control background data: 14.5 x 10^-6 cells, 20 x 10^-6 cells is taken as cut off - Statistics:
- no satisfactory mathematical methods are available
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 125 and 250 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Conc (µg/mL) |
First experiment - S9 |
Second experiment –S9 |
1stexperiment +S9 |
2ndexperiment + S9 |
||||
|
PE |
MF |
PE |
MF |
PE |
MF |
PE |
MF |
Control (DMSO) |
0.95 |
2.53 |
0.86 |
3.37 |
0.81 |
1.45 |
0.92 |
9.47 |
7.81 |
0.92 |
2.37 |
-- |
-- |
0.83 |
1.71 |
-- |
-- |
15.63 |
0.92 |
2.39 |
0.8 |
3.41 |
0.74 |
4.06 |
0.81 |
3.64 |
31.25 |
0.82 |
7.22 |
0.77 |
7.67 |
0.69 |
7.74 |
0.79 |
5.39 |
62.5 |
0.69 |
17.61 |
0.72 |
8.51 |
0.57 |
4.07 |
0.79 |
6.02 |
125 |
0.65 |
10.49 |
0.50 |
17.6 |
0.41 |
4.55 |
0.57 |
12.38 |
250 |
-- |
-- |
0.075 |
16.92 |
-- |
-- |
0.30 |
17.67 |
EMS600 |
0.5 |
126.67 |
0.33 |
607.45 |
-- |
-- |
-- |
-- |
EMS700 |
0.25 |
208.39 |
0.37 |
482.91 |
-- |
-- |
-- |
-- |
DMBA 20 |
-- |
-- |
-- |
-- |
0.24 |
229.47 |
0.23 |
869.41 |
DMBA 30 |
-- |
-- |
-- |
-- |
0.22 |
129.66 |
0.19 |
620.00 |
Applicant's summary and conclusion
- Conclusions:
- negative
Under tested conditions, test substance showed no mutagenic effects in V79 cells up to cytotoxic concentrations. All mutations frequencies were below the cut-off value of 20x10^-6. Dose response was not observable in all experiments.
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