Registration Dossier
Registration Dossier
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EC number: 944-243-9 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Remarks:
- No E.coli strains tested.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium dodecyl sulphate
- EC Number:
- 205-788-1
- EC Name:
- Sodium dodecyl sulphate
- Cas Number:
- 151-21-3
- Molecular formula:
- C12H26O4S.Na
- IUPAC Name:
- sodium dodecyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): Sulfuric acid, mono dodecyl ester sodium salt- Physical state: Powder- Analytical purity: 97% a.i.- Lot/batch No.: No data - Storage condition of test material: No data
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 1. test: 8, 40, 200, 1000, 5000 µg/plate2 test: 5, 10, 20, 40, 80 µg/plate (-S9 mix); 2.5, 10, 40, 160, 640 µg/plate (+S9 mix)
- Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 4-nitroquinoline-N-oxide, 9-aminoacridine, 2-aminoanthracene
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: all strains tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative
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