Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
Reliability:
1 (reliable without restriction)

Data source

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

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:
Isopropyl 2-bromo-2-methylpropionate
EC Number:
257-158-0
EC Name:
Isopropyl 2-bromo-2-methylpropionate
Cas Number:
51368-55-9
Molecular formula:
C7H13BrO2
IUPAC Name:
isopropyl 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 results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
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, TA 102, TA 1537
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.