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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (In Vitro Mammalian Cell Gene Mutation)
GLP compliance:
yes
Type of assay:
other: In vitro Mammalian Cell Gene Mutation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: Chinese hamster ovary
Metabolic activation system:
Aroclor 1254 induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 125 µg/ml
Concentration range in the main test (without metabolic activation): 5 ... 60 µg/ml
Vehicle / solvent:
Dimethyl sulfoxide
Details on test system and experimental conditions:
Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours

Expression time:
7 days

Selection time:
7 Days

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 125 µg/ml)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 60 µg/ml)
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 90 µg/ml)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 40 µg/ml)
Additional information on results:
Observations:
No significant or dose-related increases in mutant frequency

were seen in either the first or second experiment.

Negative control values were within the normal range. Ethyl

methane sulphonate and 20-Methylcholanthrene were used as

positive controls for non-activation and activation assays,

respectively. These controls induced significant increases

in mutant frequency.
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