Registration Dossier
Registration Dossier
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EC number: 610-840-5 | CAS number: 52449-76-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- methyl 4-cyano-2-nitrobenzoate
- EC Number:
- 610-840-5
- Cas Number:
- 52449-76-0
- Molecular formula:
- C9H6N2O4
- IUPAC Name:
- methyl 4-cyano-2-nitrobenzoate
Constituent 1
Method
- Target gene:
- V79 cells (Chinese hamster cell line) in vitro
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 29.7 µg/ml - 1900 µg/ml
- Vehicle / solvent:
- Solvent: DMSO
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With metabolic activation
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Concurrent solvent controls (DMSO) were performed
- Remarks:
- Concurrent solvent controls (DMSO) were performed
Results and discussion
Test resultsopen allclose all
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- after treatment with 475.0 μg/mL
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- after 4 hrs treatment with 475 μg/mL (49.3 % of control)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- a dose-dependent increase in chromosomal aberrations was observed
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- In the presence of metabolic activation no cytotoxicity was observed.
- Remarks on result:
- other: other: main test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
In conclusion, it can be stated that under the experimental conditions reported, the test item induced structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro.
Therefore, the test item is considered to be clastogenic in this chromosome aberration test in the absence and presence of S9 mix.
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