Registration Dossier
Registration Dossier
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EC number: 406-030-4 | CAS number: 105812-81-5
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
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: extracted from ECHA database
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Annex V, B.14 (Ames test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- EC Number:
- 406-030-4
- EC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
- Cas Number:
- 105812-81-5
- Molecular formula:
- C13H18FNO
- IUPAC Name:
- (-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
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 system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Main test
with metabolic activation: 8... 5000 ug/plate
without metabolic activation: 8... 5000 ug/plate - Vehicle / solvent:
- DMSO
Results and discussion
Test results
- Species / strain:
- other: as stated above
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 ug/plate
- Additional information on results:
- The solvent control plates gave counts of revertant colonies within the normal range.
All positive control chemicals gave increases in revertants, either with or without metabolising system as appropriate, within expected ranges.
No significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance either with or without metabolic activation. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance was found to be non-mutagenic under the conditions of the test.
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