Registration Dossier
Registration Dossier
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EC number: 456-160-0 | CAS number: 73942-87-7
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP. Guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 456-160-0
- EC Name:
- -
- Cas Number:
- 73942-87-7
- Molecular formula:
- C12H13NO3
- IUPAC Name:
- 7,8-dimethoxy-2,3-dihydro-1H-3-benzazepin-2-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S9 mix consists of induce enzymatic systems contained in rat liver post-mitochondrial fraction and tehe cofactors necessary for their function.
- Test concentrations with justification for top dose:
- Range: 312,5 - 5000 µg/plate
Results and discussion
Any other information on results incl. tables
No toxicity was noted towards all the strains used, with and without S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions, Veralactama did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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