Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. That´s why the reliability is estimated to be at level 2.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Reverse mutation assay (Ames test + E. Coli). OECD Guideline No 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:
- C24 H30 O6
- 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 (with 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:
- 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)
- Additional information on results:
- Observations: /
- 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
negative with metabolic and without metabolic activation
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