Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 81541-12-0 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: Guideline study without detailed documentation. Study accepted by competent national authorities (ELINCS substance) from EU member states. Reference see section 13 Assessment Reports, ECHA derogation statement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (67/548/EWG)
- 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:
- 81541-12-0
- Molecular formula:
- C22H26O6
- IUPAC Name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arcolor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 0....5000 μg/plate
Concentration range in the main test (without metabolic activation): <.000001....5000 μg/plate - Vehicle / solvent:
- solvent: acetone
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 μg/plate
- Species / strain:
- other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >5000 μg/plate
- Remarks on result:
- other: other: main test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Observations: there were no significant increases in the numbers of revertants, with or without S-9
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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