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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: Test was conducted according to Directive 84/449/EEC, B.14 (Ames Test) and compliant with GLP.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Directive 84/449/EEC,B14 (Ames-Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: sat TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induzierte Rattenleber S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20...5000 ug/plate
Concentration range in the main test (without metabolic activation): 20...5000 ug/plate
Vehicle:
Solvent: Aceton
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 313 ug/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 ug/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(>5000 ug/plate)
Remarks on result:
other:
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