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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 471/ 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 / cell type:
bacteria, other: sat TA98,100,1535,1537
Metabolic activation system:
Aroclor-induced rat liver S9 mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 ... 5000µg/plate
Concentration range in the main test (without metabolic activation): 20 ... 5000µg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Any other information on results incl. tables

Comments:

For the bacterial toxic concentration

b) imHaupt-TestohnemetablischeAktivierungnurmitTA98 imPrinkuloationstestbei5000myg/Platte

KonzentrationderTestsubstanz, beiderAusfllungauftritt :GallstndigeLslichkeit

Applicant's summary and conclusion

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