Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
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: A study summary was made available by ECHA under Article 25, Para 3, of EC Regulation 1907/2006.
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: Method of B.N.Ames with and without metabolic activation.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- EC Number:
- 402-950-5
- EC Name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- Cas Number:
- 87826-41-3
- Molecular formula:
- C22H26O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-methylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- aroclor 1254 induced rat liver microsomal S9 mix.
- Test concentrations with justification for top dose:
- Main test with metabolic activation: 0-500 microgrammes/plate
Main test without metabolic activation: 0-500 microgrammes/plate - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO)
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 1500 microgrammes/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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