Registration Dossier
Registration Dossier
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EC number: 231-177-4 | CAS number: 7440-69-9
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited details in literature publication. (Only results, no tables) Non GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity Studies of Heavy Metals: Lead, Bismuth, Indium, Silver and Antimony
- Author:
- Keiko Asakura, Hiroshi Satoh, Momoko Chiba,, Masahide Okamoto, Koji Serizawa, Makiko Nakano, Kazuyuki Omae
- Year:
- 2 009
- Bibliographic source:
- Journal of Occupational Health Vol. 51 (2009) No. 6 P 498-512
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No historical control data available
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bismuth
- EC Number:
- 231-177-4
- EC Name:
- Bismuth
- Cas Number:
- 7440-69-9
- Molecular formula:
- Bi
- IUPAC Name:
- bismuth
- Details on test material:
- purity 99.9%
average particle size 10 micrometer
supplier: Kojyundo Chemical Laboratory, Japan
storage at room temperature in the dark
lot no 67243G
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- 5000 - 2500 - 1250- 635 - 313 microgramms/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- preincubation assay
The dose-range-finding test was seen as first experiment. The main experiment was seen as repeat experiment. - Evaluation criteria:
- A twofold increase in mutant colonies was considered to represent a mutagenic response.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation was observed at all dose levels.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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