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Toxicological information

Genetic toxicity: in vitro

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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:
1997
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

Constituent 1
Chemical structure
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
Constituent 2
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%

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.