Registration Dossier
Registration Dossier
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EC number: 463-070-5 | CAS number: 106966-25-0
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
- Study period:
- 21.01.2008. - 12.02.2008.
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - 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:
- -
- EC Number:
- 463-070-5
- EC Name:
- -
- Cas Number:
- 106966-25-0
- Molecular formula:
- C7H17N2O2Br
- IUPAC Name:
- 2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide
Constituent 1
Method
- Target gene:
- Human peripheral blood lymphocyte
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions of rats + cofactors
- Test concentrations with justification for top dose:
- 50, 500 and 5000 micrograms/ml.
- Vehicle / solvent:
- Water for injections
- Details on test system and experimental conditions:
- Human lymphocytes obtained by cell culture of whole blood from peripheral blood of healthy volunteers.
METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 24 h
- Fixation time (start of exposure up to fixation or harvest of cells): 44 h
STAINING (for cytogenetic assays): Specimens were stained with working solution of Giemsa dye. Staining lasted 30 minutes and the specimens were next throughly rinsed in distilled water.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Remarks:
- >5000 microgram/ml
- Cytotoxicity / choice of top concentrations:
- not determined
- Species / strain:
- lymphocytes:
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- >5000 microgram/ml
- Cytotoxicity / choice of top concentrations:
- not determined
- 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 with metabolic activation
negative without metabolic activation
Test substance did not show any genotoxic effect in all experiments with or without metabolic activation. Negative effect in In vitro chromosome
aberration test indicates that the test substance did not induce chromosome aberrations in the cultures of human somatic cells.
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