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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS harmonised guidelines
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 2-bromo-2-methylpropionate
EC Number:
209-980-6
EC Name:
Ethyl 2-bromo-2-methylpropionate
Cas Number:
600-00-0
Molecular formula:
C6H11BrO2
IUPAC Name:
ethyl 2-bromo-2-methylpropionate

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:
S-9
Test concentrations with justification for top dose:
5 doses beetween 50 to 5000 µg/plate
Controls
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulphoxide
Positive controls:
yes
Positive control substance:
other: standard control chemicals

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
from 500 µg/plate
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
5000 µg/plate
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA 100
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
The test material was considered to be mutagenic under the conditions of this test.