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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
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: guidance test and GLP

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: Ames, B.N. 1973, 1975 et.al
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation system:
Rat liver microsomal fraction (89 mix)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 ... 5120 μg/plate
Concentration range in the main test (without metabolic activation): 20 ... 5120 μg/plate
Vehicle:
Solvent: Acetone
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 4000 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
(> 1280 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
(> 1280 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:
In experiments with 5-9 activation with strain TA 100 at the concentration 312 microgram/plate a slight increase of back-mutants was observed.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation