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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:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Cytogenetics)
GLP compliance:
yes
Type of assay:
other: in vitro mammalian cytogenicity (810)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: cultured human lymphocytes
Metabolic activation system:
Aroclor-induced rat liver S9
Test concentrations with justification for top dose:
concentration range in the main test (with metabolic activation)" 10...333ug/ml
concentration range in the main test(without metabolic activation): 10...100ug/ml
Vehicle / solvent:
dimethylsulfoxide
Details on test system and experimental conditions:
Fixation time: 23 hours

Results and discussion

Test resultsopen allclose all
Species / strain:
mammalian cell line, other: Cultured human lymphocytes
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
1000 ug/ml
Species / strain:
mammalian cell line, other: Cultured human lymphocytes
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
333 ug/ml
Additional information on results:
Observations: Mitotic index reduced to 35% to 67% of control without S9; 52% to 82% with S9.Positive controls gave the expected responces.
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