Registration Dossier
Registration Dossier
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EC number: 307-546-1 | CAS number: 97660-35-0
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:
- key study
- Study period:
- 16. March - 25. March 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Calcium, carbonate hydroxy aluminum complexes
- EC Number:
- 307-546-1
- EC Name:
- Calcium, carbonate hydroxy aluminum complexes
- Cas Number:
- 97660-35-0
- Molecular formula:
- Ca4Al2(OH)12CO3*5H20
- IUPAC Name:
- dialuminium(3+) tetracalcium dodecahydroxide carbonate
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- other: S. typhimurium TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Plate incorporation method:
Per strain and dose, four plates with and four plates without S9 mix were used.
Concentrations tested:
5057 / 1509 / 506 / 151 / 51 µg/palte
Pre-incubation method:
Per strain and dose, four plates with and four plates without S9 mix were used.
Concentrations tested:
5015 / 2501 / 1254 / 626 / 317 µg/plate
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Remarks:
- Positive Controls: Without metabolic activation: 4-Nitro-1,2-penylene diamine (NPD) in DMAO, 20 µg/plate
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive Controls: Without metabolic activation: Sodium azide (Na-anzide) in deionised water 1 µg/plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Remarks:
- Positive Controls: With metabolic activation: 2-Amino anthracene (2-AA) in DMSO, 1 µg/plate
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Positive Controls: With metabolic activation: Benzo-a-pyrene (BaP) in DMSO, 20 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 1535
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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