Registration Dossier
Registration Dossier
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EC number: 201-660-4 | CAS number: 86-28-2
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable scientific journal, sufficient description of performed studies
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of substituted carbazoles in Salmonella typhimurium
- Author:
- LaVoie E., Briggs G., Bedenko V., Hoffmann D.
- Year:
- 1 982
- Bibliographic source:
- Mutation Research, 101 (1982), p. 141-150
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 9-ethylcarbazole
- EC Number:
- 201-660-4
- EC Name:
- 9-ethylcarbazole
- Cas Number:
- 86-28-2
- Molecular formula:
- C14H13N
- IUPAC Name:
- 9-ethyl-9H-carbazole
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254(R) induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 0, 5, 10, 25, 50, 100, 250 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine, N-Methyl-N-nitro-N-nitrosoguanidine, quinoline, chrysene, 2-aminoanthracene, picrolonic acid
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls - Evaluation criteria:
- Compound was considered mutagenic when the average number of revertants obtained at any dose level was at least twice that of the solvent control.
- Statistics:
- The average number of revertant colonies is calculated for each dose.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
The test item is mutagenic in S. typhimurium strain TA 100 in the presence of exogenous metabolic activation. - Executive summary:
Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA1538 with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 5, 10, 25, 50, 100, 250 µg/plate. Under the conditions tested the test compound caused an increase in the number of revertant colonies in S. typhimurium TA 100 in the presence of metabolic activation.
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