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Toxicological information

Genetic toxicity: in vitro

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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)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Principles of method if other than guideline:
Not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Not applicable
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not applicable
Test concentrations with justification for top dose:
Preliminary test: 10, 100, 500, 1000, 2500 and 5000 µg/plate
Main experiment:
- 0.82, 2.47, 7.41, 22.22 and 66.67 µg/plate, for the TA 102 strain in the first experiment
- 2.47, 7.41, 22.22, 66.67 and 200 µg/plate, for the TA 1535 and TA 1537 strains in the first experiment
- 0.27, 0.82, 2.47, 7.41 and 22.22 µg/plate, for the TA 98 and TA 100 strains in both experiments as well as for the TA 1535 and TA 102 strains in the second experiment
- 0.09, 0.27, 0.82, 2.47 and 7.41 µg/plate, for the TA 1537 in the second experiment

Results and discussion

Test resultsopen allclose all
Species / strain:
bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
mainly at dose-levels ≥ 22.22 µg/plate, depending on the tester strains and the experiments.
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
mainly at dose-levels ≥ 7.41 µg/plate, depending on the tester strains and the experiments
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

See file attached

Applicant's summary and conclusion