Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD method, GLP compliance
Data source
Reference
- Reference Type:
- other: inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Reverse mutation assay (Ames test + E. Coli). OECD Guideline n° 471 (1983) EEC Directive 84/449 (1984) - Annex V - Method B14
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 413-110-2
- EC Name:
- -
- Cas Number:
- 135861-56-2
- Molecular formula:
- C24H30O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella Typhimurium TA98 - TA100 - TA1535 - TA1537 -TA1538 Escherichia coli tryptophan auxotroph WP2uvrA
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (wifh metabolic activation): 100 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 μg/plate - Vehicle / solvent:
- Solvent: Dimethylsulfoxide (DMSO)
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- 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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