Registration Dossier
Registration Dossier
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EC number: 244-955-3 | CAS number: 22397-58-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the Analogue Approach Justification document provided in Section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : no E.coli strain tested
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
- EC Number:
- 287-809-4
- EC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, sodium salts
- Cas Number:
- 85586-07-8
- Molecular formula:
- C12-14H25-29SO4Na
- IUPAC Name:
- Sulfuric acid, C12-14-alkyl (even numbered) esters, sodium salts
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 1. test:
-S9: 5, 15, 50, 150, 500, and 1500 µg/plate
+S9: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
2. test:
with and without S9: 5, 15, 50, 150, 500, and 1500 µg/plate - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N-nitro-N-nitrosoguanidine, 9-aminoacridine, 4-nitro-o-phenylenediamine, 4-nitroquinoline-N-oxide
- Statistics:
- No.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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