Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.14 (Ames-Test)
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 system:
Aroclor-induced rat-liver S9
Test concentrations with justification for top dose:
Concentration range In the main test (with metabolic activation): 20 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 20 ,.. 5000 μg/plate
Vehicle:
Solvent: Aceton

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
(> 5000 μg/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 μg/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