Registration Dossier
Registration Dossier
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EC number: 604-384-6 | CAS number: 14384-34-0
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,3,4,9-tetrahydro-1H-carbazol-3-ol
- EC Number:
- 604-384-6
- Cas Number:
- 14384-34-0
- Molecular formula:
- C12H13NO
- IUPAC Name:
- 2,3,4,9-tetrahydro-1H-carbazol-3-ol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 98, TA 100, TA 1535, TA 1537, Escherichia coli, CM891
- Metabolic activation:
- with and without
- Metabolic activation system:
- Acroclor 1254 rat liver S9-Mix
- Test concentrations with justification for top dose:
- Concentration range Main test with metabolic activation : 5 - 5000 µg/plate
Concentration range Main test without metabolic activation : 5 - 5000 µg/plate
Preliminary test with metabolic activation causing bacteria toxicity: 1500 µg/plate
Preliminary test without metabolic activation causing bacteria toxicity: 5000 µg/plate
Main test with metabolic activation causing bacteria toxicity: 1500 µg/plate
Main test without metabolic activation causing bacteria toxicity: 5000 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- mitomycin C
- other: Ampicillin, 2-Aminofluorene, N-Ethyl-N'-Nitrosoguanidine (ENNG)
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
The TS exhibited mutagenic activity in this study, inducing primarily frameshift mutations following metabolic activation.
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