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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006
Species / strain
Species / strain:
other: TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006, TA 98
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix: rat liver preparation after Aroclor-1254 induction and co-factors
Test concentrations with justification for top dose:
1 to 5000 µg/mL
Controls
Negative controls:
yes
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
other: TA 7001, TA 7002, TA 7003, TA 7004, TA 7005, TA 7006, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

BI 10773 TMS-Lacton (intermediate in the BI 10773 XX synthesis) caused neither basepair
substitution nor frameshift mutations in a series of S. typhimurium tester strains
(TA Mix and TA 98) in the absence and presence of a metabolic activation system when
tested up to recommended and/or insoluble concentrations. Therefore, based on these
results the test substance can be classified as "Ames II negative".