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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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. certificate)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
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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