Registration Dossier
Registration Dossier
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EC number: 232-164-6 | CAS number: 7789-41-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium bromide
- EC Number:
- 231-599-9
- EC Name:
- Sodium bromide
- Cas Number:
- 7647-15-6
- IUPAC Name:
- sodium bromide
- Details on test material:
- 98 % Sodium bromide White granular powder
Sample number 1402
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 5000, 1500, 500, 150 and 50 µg/plate
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene, 2-nitrofluorene, 9-aminoacridine or N-ethyl-N’-nitro-N-nitrosoguanidine
Results and discussion
Test results
- 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:
- other: 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, TA 1538
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Bacterial mutagenicity assay: EPA FIFRA 84-2 equivalent to OECD 471.
No substantial increases in revertant colony numbers of any of the five tester strains were observed following treatment with sodium bromide at any dose level, either in the presence or absence of metabolic activation.
No evidence of mutagenic potential was apparent from this test at the dose levels used.
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