Registration Dossier
Registration Dossier
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EC number: 812-024-6 | CAS number: 1638534-24-3
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:
- 1 998
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:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
- EC Number:
- 812-024-6
- Cas Number:
- 1638534-24-3
- Molecular formula:
- C20H23ClN2
- IUPAC Name:
- (3R)-N-[(1S)-phenylethyl]-2,3,4,9-tetrahydro-1H-carbazol-3-amine hydrochloride
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 100, TA 1537, TA 98, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor rat liver S9-Mix
- Test concentrations with justification for top dose:
- Preliminary test with metabolic activation >= 320 µg/plate
Preliminary test without metabolic activation >= 160 µg/plate
Main test with metabolic activation: >= 320 µg/plate
Main test without metabolic activation: >= 320 µg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- cumene hydroperoxide
- other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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 metabolic activation
negative without metabolic activation
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