Registration Dossier
Registration Dossier
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EC number: 700-713-3 | CAS number: 83161-22-2
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:
- 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- EC Number:
- 700-713-3
- Cas Number:
- 83161-22-2
- Molecular formula:
- C11H22O5
- IUPAC Name:
- (2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
- Details on test material:
- For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.
Constituent 1
Method
- Target gene:
- TA98 : target mutation His D 3052
TA100 : His G 46
TA102 : His G 428
TA1535 : His G46
TA1537 : His C 3076
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- tested concentrations : 1, 3, 10, 30 and 100% of APRC5 30% in water/glycerol
- Vehicle / solvent:
- water/glycerol
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 : 2-nitrofluorene, TA100 and TA1535 : Sodium azide, TA102 : Mitomycin C, TA1537 : 9-Aminoacridine
Results and discussion
Test results
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: non mutagenic and non pro-mutagenic
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The Ames test is negative in presence of APRC5.
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