Registration Dossier
Registration Dossier
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EC number: 810-213-8 | CAS number: 1370461-06-5
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP-conformant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- EC Number:
- 810-213-8
- Cas Number:
- 1370461-06-5
- Molecular formula:
- C4 H3 Al O5
- IUPAC Name:
- sra-[(2E)-2-butenedioato(2-)hydroxy aluminium]
- Details on test material:
- - Name of test material (as cited in study report): Aluminum, [(2E)-2-butenedioato(2-)- O1]hydroxy-
- Physical state: white solid
- Analytical purity: 85.8 g/100 g
- Batch No.: 13-0001-2
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- Salmonella: his
E. coli: trp
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of rat livers treated with phneobarbital and b-naphthoflavone
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 3000 and 6000 µg/plate
- Vehicle / solvent:
- DMSO (due to the insolubility of the test substance in water)
Controls
- Untreated negative controls:
- yes
- Remarks:
- sterility controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 4-nitro-o-phenylenediamine, N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 2-aminoanthracene (with S9 mix)
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:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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