Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
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: Result is taken from an official NONS dossier and cites an official EC testing regime so is therefore considered reliable, however the original test report was not available.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Guideline 84/449/EEC B.14 (Ames)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- EC Number:
- 406-176-9
- EC Name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- Cas Number:
- 79072-96-1
- Molecular formula:
- Hill formula: C24 H30 O6
- IUPAC Name:
- 1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Main test, with and without metabolic activation: 5 mg NC-4 / mL DMSO; plates treated with 0.5, 0.15, 0.05, 0.015, 0.005, and 0.1 mL.
(2.5, 0.75, 0.25, 0.075, 0.025, 0.5 mg/plate) - Vehicle / solvent:
- DMSO
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No indication was observed of the mutagenic potential of NC-4 either with or withour metabolic activation in this bacterial reverse mutation assay.
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