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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)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DBMC, purity: 97-98%

Method

Target gene:
hprt locus
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix, S9 from phenobarbital/beta-naphthoflavone induced male Wistar rat livers
Test concentrations with justification for top dose:
pre-tests (2nd, 3rd): -S9 short-term treatment: 0.001 to 3.0 µg/ml, -S9: long-term treatment: 0.16 to 30.0 µg/ml, +S9 short-term treatment: 0.5 to 30 µg/ml; concentrations used for mutation rate analysis: -S9 short-term treatment: 0.094 to 1.5 µg/ml, -S9 long-term treatment: 1.0 to 8.0 µg/ml, +S9 short-term treatment: 12.5 to 22.5 µg/ml
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9: ethylmethanesulphonate, +S9: 7,12-dimethylbenzanthracene

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: Chinese hamster lung fibroblasts (V79)
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No substantial and reproducible dose dependent increase of the mutation frequency was observed in both main experiments.

The author stated that the test substance did not induce gene mutations at the HPRT locus in V79 cells under the experimental conditions used.

Applicant's summary and conclusion