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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: ECHA inquiry result
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
mammalian cell line, other: Chinese hamster ovary cells
Metabolic activation system:
Arolor-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 313 ... 5000 μg/ml
Concentration range in the main test (without metabolic activation): 313 ... 5000 μg/ml
Vehicle / solvent:
Dimethyl sulfoxide, the test substance is soluble at 500mg
Details on test system and experimental conditions:
Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours
Fixation time:20 hours

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 ug/ml
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000 ug/ml
Additional information on results:
Observations:
No toxicity was observed in CHO cells when heated for 4
hours in the absence or presence of S9-action regardless of
dose level.The percentage of cells with structural and
numerical aberrations in the test article-treated group was
not significantly increased above that of the solvent
control.
The positive and solvent controls fulfilled the requirements
for a valid test.
The positive controls, cyclophosphamide and mytomycin C,
induced a significant increase in the frequency of
aberrations. Negative control values were within the normal
range
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 without metabolic activation
negative with metabolic activation