Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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
Study period:
2003

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
The S9 mix prepared from a liver microsomal fraction (S9 fractions) of rats induced with Aroclor 1254
Test concentrations with justification for top dose:
312.5 microg / plate to 5000 microg / plate
Vehicle / solvent:
DMSO
Details on test system and experimental conditions:
- vehicle as negative controls
- adequate positive controls for each strain
Evaluation criteria:
number of revertant vs. negative controls; dose-relationship; historical data
Statistics:
yes (vs. negative controls)

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 98 , TA 100 and TA102
Metabolic activation:
with and without
Genotoxicity:
other: minimal increase in revertant on strain TA102 only, with metabolic activation only, at high concentrations (> 3600 µg/plate)
Cytotoxicity / choice of top concentrations:
other: thinning of bacterial lawn from 1250 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Metabolic activation: with and without (arochlor induced rat S9).
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):
other: positive with metabolic activation, in only one strain and at very high concentrations (from 3600 µg/plate)
negative without metabolic activation

Categories Display