Registration Dossier
Registration Dossier
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EC number: 283-130-2 | CAS number: 84540-37-4
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:
- 24.10.1984 - 30.09.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
- EC Number:
- 283-130-2
- EC Name:
- trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
- Cas Number:
- 84540-37-4
- Molecular formula:
- C23H30
- IUPAC Name:
- trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
Constituent 1
- Specific details on test material used for the study:
- Batch: E437566
Purity: 99.9 % (HPLC)
Method
- Target gene:
- HIS operon (S. thyphimurium)
TRY operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix from Aroclor 1254-pretreated rats with standard co-factors
- Test concentrations with justification for top dose:
- 1st and 2nd series: 50, 250, 1250, 2500, 5000, and 10000 μg per plate
- Vehicle / solvent:
- Acetone (> 99 %)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine, daunomycin, l-ethyl-2-nitro-3-nitrosoguanidine, methyl methanesulfonate , N-methyl- N-nitro-N-nitrosoguanidine, 2-nitrofluorene, 4-nitro-1,2-phenylene diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 3-5 hours
- Exposure duration: about 2 days
SELECTION AGENT (mutation assays): Histidine, Tryptophane
NUMBER OF REPLICATIONS:
Negative controls 6
Test material 3
Positive controls 3
NUMBER OF CELLS EVALUATED: about 1e9
DETERMINATION OF CYTOTOXICITY
- Method: other: background cytotox - Rationale for test conditions:
- According to guideline
- Evaluation criteria:
- - valid assay (cf. laboratory historical data)
- no or weak increase in revertant colonies = negative
- clear, dose dependent (over at least two concentrations), and reproducible increase in revertant colonies= positve - Statistics:
- No statistical evaluation of the data is required.
Results and discussion
Test results
- Species / strain:
- other: all strains/cell types tested
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no
- Effects of osmolality: no
- Evaporation from medium: no
- Water solubility: ok
- Precipitation:yes ( ≥ 250 µg/plate)
- Other confounding effects: no - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the test substance did not induce gene mutations under the experimental conditions reported. The test material was, thus, non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
- Executive summary:
The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 471. The test substance did not induce gene mutations under the experimental conditions reported. The test material was, thus, non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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