Registration Dossier
Registration Dossier
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EC number: 425-980-0 | CAS number: 129499-78-1
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)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The First Evaluation and Registration Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfar ed., Commentary on the Guidelines for toxicity studies of drugs, 1990, pp. 30-40. The Yakuji Nippo Co. Ltd. (1990) (se basant sur la Directive 92/69/CEE, B.13/14)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 425-980-0
- EC Name:
- -
- Cas Number:
- 129499-78-1
- Molecular formula:
- C12H18O11
- IUPAC Name:
- (5R)-5-[(1S)-1,2-dihydroxyethyl]-4-hydroxy-3-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-2,5-dihydrofuran-2-one
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 313 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 313 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: eau distillée
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 μg/plate
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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