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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1999

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: UKEMS guidelines
Qualifier:
according to guideline
Guideline:
other: ICH Harmonised tripartite guideline
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-bromo-2-methylpropionyl bromide
EC Number:
244-017-3
EC Name:
2-bromo-2-methylpropionyl bromide
Cas Number:
20769-85-1
Molecular formula:
C4H6Br2O
IUPAC Name:
2-bromo-2-methylpropanoyl bromide

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:
8, 40, 200, 1000 and 5000 µg/plate or doses extending into (or approching) the toxic range.
Vehicle / solvent:
Dimethyl Formamide (DMF)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMF
True negative controls:
yes
Positive controls:
yes
Remarks:
5 positive controls : see substances below
Positive control substance:
other: 2-nitrofluorene, sodium azide, 9-aminoacridine, glutaraldheyde, 2-aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA 100, TA 1535
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

It was concluded that 2-bromoisobutyryl bromide induced mutation in Salmonella typhimurium strain TA 100 both in the absence or in the presence of a rat liver metabolic activation system (S-9) and Salmonella typhimurium strain TA 1535 in the absence of S-9, when tested under the conditions employed for this study, which included treatments at concentrations up to 5000 µg/plate.