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Registration Dossier
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EC number: 603-009-3 | CAS number: 124729-02-8
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
- Study period:
- 07.11.2000 - 14.03.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-Ethoxy-2,3-difluoro-4-(trans-4-pentylcyclohexyl)-benzene
- EC Number:
- 603-009-3
- Cas Number:
- 124729-02-8
- Molecular formula:
- C₁₉H₂₈F₂O
- IUPAC Name:
- 1-Ethoxy-2,3-difluoro-4-(trans-4-pentylcyclohexyl)-benzene
- Test material form:
- other: solid
Constituent 1
Method
- Target gene:
- HIS operon (S. thyphimurium)TRY operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- his G 46, uvrB, rfa
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- his C 3076, uvrB, rfa
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- his D 3052, uvrB, rfa + R-factor
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- his G 46, uvrB, rfa + R-factor
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- his G 428, rfa + R-factor
- Additional strain / cell type characteristics:
- other: mutations in the histidine operon
- Species / strain / cell type:
- E. coli WP2
- Details on mammalian cell type (if applicable):
- his C 3076, uvrB, rfa
- Additional strain / cell type characteristics:
- other: mutations in the tryptophan operon
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate (S9 mix) with standard co-factors with metabolic activation (Aroclor)
- Test concentrations with justification for top dose:
- The test material concentrations were used selected according to the EC and OECD guidelines for this test system and the requirements of the Labor Ministry of Japan: 1. Series: 5, 33, 100, 333, 1000, 2500, 5000 µg/plate2. Series: 5, 33, 100, 333, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- DMSO (> 99 %)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Acceptability of the AssayThe Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:- regular background growth in the negative and solvent control- the spontaneous reversion rates in the negative and solvent control are in the range of our historical data- the positive control substances should produce a significant increase in mutant colony frequenciesEvaluation of ResultsA test substance is considered positive if either a dose related and reproducible, biologically relevant increase in the number of revertants or a biologically relevant and reproducible increase for at least one test concentration is induced.A test substance producing neither a dose related and reproducible, biologically relevant increase in the number of revertants, nor a biologically relevant and reproducibly increase at any one of the test points is considered non-mutagenic in this system.A biologically relevant, test substance-related increase occurs if in the strains TA 98, TA 100, TA 102 and WP2 uvrA the number of reversions is at least twice as high and in the strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate Method:This study was performed to investigate the potential the test material to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II).
- Evaluation criteria:
- cf. details in results
- Statistics:
- n.a.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test substance on the minimal agar plates was observed at 1000 µg/plate and above with activation and at 5000 µg/without metabolic activation in experiment I, and at 2500 µg/plate with metabolic activation in experiment II.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative with and without metabolic activationWith and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.
- Executive summary:
Purpose
The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the genotoxic potential of the test item in man.
Study Design
This study was performed to investigate the potential the test material to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA
100, and TA 102 and the Escherichia coli strain WP2 uvrA.
The assay was performed with and without liver microsomal activation (S9 mix). Each concentration, including the controls, was tested in triplicate. The test substance was tested at the following concentrations:
33; 100; 333; 1000; 2500; and 5000 µg/plate
Results
No toxic effects, evident as a reduction in the number of revertants, were observed in experiment with and without metabolic activation in both experiments. Furthermore, the plates incubated with the test substance showed normal background growth up to
5000 µg/plate with and without metabolic activation in both independent experiments.
Precipitation of the test substance on the minimal agar plates was observed at 1000
IJg/plate and above with activation and at 5000 µg/without metabolic activation in experiment I, and at 2500 µg/plate with metabolic activation in experiment II.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test material at any dose level, neither in the presence nor absence of S9 mix.
Appropriate reference mutagens were used as positive controls which showed distinct increases of induced revertant colonies.
Conclusion
With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.
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