Registration Dossier
Registration Dossier
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EC number: 917-473-2 | CAS number: 188416-34-4
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: Study run to a method comparable with current guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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:
- other: in vitro mammalian cytogenicity (B10)
Test material
- Reference substance name:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- EC Number:
- 917-473-2
- Cas Number:
- 188416-34-4
- Molecular formula:
- C16H14F3N5O . C10H16O4S
- IUPAC Name:
- 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4-triazol-1-yl)butan-2-yl [(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonate
- Reference substance name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- IUPAC Name:
- (2RS,3SR)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol (1R)-10- camphorsulphonate
- Details on test material:
- - Batch No.: 5ABK-003
- Purity: 96.5%
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Human lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced at liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 312.5 ... 2500 µg/ml
Concentration range in the main test (without metabolic activation): 156.3 ... 750 µg/ml - Vehicle / solvent:
- dimethyl sulphoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 21 hours
Fixation time:
First test, without S-9 mix, 21 hour harvest
First test, with S-9 mix, 21 hour harvest
Second test, without S-9 mix, 21 and 45 hour harvest
Second test, with S-9 mix, 21 and 45 hour harvest
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mammalian cell line, other: Human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 2500 µg/ml
- Species / strain:
- mammalian cell line, other: Human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 750 µg/ml
- Remarks on result:
- other: other: main 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
Under conditions of this study, the substance was found to be nonmutagenic (negative) in both with metabolic activation and without metabolic activation.
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