Registration Dossier
Registration Dossier
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EC number: 664-495-0 | CAS number: 740817-98-5
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
- Study period:
- M13-3638
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The bacterial reverse mutation assay was used to evaluate the mutagenic potential of the product at 5 different concentrations : 5.0. 1.0, 0.5, 0.1, and 0.05 mg
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- SugaFax D10
- IUPAC Name:
- SugaFax D10
- Test material form:
- other: liquid
- Details on test material:
- The test systems used for the Bacterial Reverse Mutation Assay were:
Salmonella typhimurium TA97A
Salmonella typhimurium TA98
Salmonella typhimurium TA100
Salmonella typhimurium TA102
Salmonella typhimurium TA1535
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 5.0. 1.0, 0.5, 0.1, and 0.05 mg
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- mitomycin C
- other: Daunomicin , acridine and 2- amioantracene
Results and discussion
Test results
- Species / strain:
- other: all strains (see full report)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
The product was found not genotoxic not cytotoxic.
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