Registration Dossier
Registration Dossier
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EC number: 272-249-5 | CAS number: 68784-47-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- -
- EC Number:
- 410-660-5
- EC Name:
- -
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster ovary cells
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/ml
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/ml - Vehicle / solvent:
- DMSO (dimethylsulfoxide)
- Details on test system and experimental conditions:
- Fixation time:
24 hours. In one experiment, cells were treated continuously
without S9 for 46 hours and harvested at 48 hours.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/ml
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Observations:
No toxicity was observed, although precipitation above 250
micrograms per plate without S9 made evaluation impossible.
No increase in the frequency of aberrant metaphase was
observed.
Applicant's summary and conclusion
- Conclusions:
- The test substance was negative with and without metabolic activiation. There was no evidence that the substance induced chromosomal aberrations in the presence or absence of S9 mix.
The visible precipitation at higher concentrations may be a result of titanium dioxide forming during abiotic degradation
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