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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
Study period:
21.01.2008. - 12.02.2008.
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Human peripheral blood lymphocyte
Species / strain
Species / strain / cell type:
lymphocytes:
Metabolic activation:
with and without
Metabolic activation system:
S9 liver fractions of rats + cofactors
Test concentrations with justification for top dose:
50, 500 and 5000 micrograms/ml.
Vehicle / solvent:
Water for injections
Details on test system and experimental conditions:
Human lymphocytes obtained by cell culture of whole blood from peripheral blood of healthy volunteers.

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 24 h
- Fixation time (start of exposure up to fixation or harvest of cells): 44 h


STAINING (for cytogenetic assays): Specimens were stained with working solution of Giemsa dye. Staining lasted 30 minutes and the specimens were next throughly rinsed in distilled water.

Results and discussion

Test resultsopen allclose all
Species / strain:
lymphocytes:
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
>5000 microgram/ml
Cytotoxicity / choice of top concentrations:
not determined
Species / strain:
lymphocytes:
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
>5000 microgram/ml
Cytotoxicity / choice of top concentrations:
not determined
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

Test substance did not show any genotoxic effect in all experiments with or without metabolic activation. Negative effect in In vitro chromosome
aberration test indicates that the test substance did not induce chromosome aberrations in the cultures of human somatic cells.