Registration Dossier
Registration Dossier
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EC number: 203-607-0 | CAS number: 108-69-0
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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 3,5-xylidine
- EC Number:
- 203-607-0
- EC Name:
- 3,5-xylidine
- Cas Number:
- 108-69-0
- Molecular formula:
- C8H11N
- IUPAC Name:
- 3,5-dimethylaniline
- Details on test material:
- Purity 99.9%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- + S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- - S9 mix
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Test results:
Cytogenetic effects were seen as follows.
At the highest concentration (900 µg/ml) after 6 hr short-term treatment with and without exogenous metabolic activation, 22.5 and 12.0% cells demonstrated structural chromosomal aberrations including gaps.
Genotoxic effects: clastogenicity polyploidy
+ ? - + ? -
Without metabolic activation: [ ] [ ] [ * ] [ ] [ ] [ * ]
With metabolic activation: [ * ] [ ] [ ] [ ] [ ] [ * ]
Applicant's summary and conclusion
- Conclusions:
- weekly positive with metabolic activation
3,5-Dimethylaniline induced structural chromosomal aberrations in CHL/IU cells at highest concentration (900µg/L) after 6 hr short-term treatment with and without exogenous metabolic activation. Polyploidy was not induced under the conditions of the present study. - Executive summary:
3,5-Dimethylaniline induced structural chromosomal aberrations in CHL/IU cells at highest concenttraion (900µg/L) after 6 hr short-term treatment with and without exogenous metabolic activation. Polyploidy was not induced under the conditions of the present study.
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