Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Adequacy of study:
supporting study
Data waiving:
other justification
Justification for data waiving:
other:

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC B.14 / OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix from rat liver S9-mix from hamster liver
Test concentrations with justification for top dose:
0 ... 5000 yg/plate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks on result:
other: other: preliminary test and main test
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

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