Registration Dossier
Registration Dossier
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EC number: 401-100-0 | CAS number: 109037-78-7 TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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: Information from migrated NONS file, as per inquiry number 06-2120053135-66-0000, permission to refer granted by ECHA
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cell gene mutation (B17)
Test material
- Reference substance name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- EC Number:
- 401-100-0
- EC Name:
- Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate
- Cas Number:
- 109037-78-7
- Molecular formula:
- not applicable
- IUPAC Name:
- dititanium(4+) triethanolate bis(propan-1-olate) dibutyl phosphate butyl phosphate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Mouse Lymphoma L5178Y (TK locus)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 500 μg/ml
Concentration range in the main test (without metabolic activation): 50 ... 500 μg/ml - Vehicle / solvent:
- Ethanol
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 3 hours
Expression time: 48 h
Selection time: 12 days
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- mammalian cell line, other: Mouse Lymphoma L5178Y (TK locus)
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 500 μg/ml)
- Key result
- Species / strain:
- mammalian cell line, other: Mouse Lymphoma L5178Y (TK locus)
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 0 μg/ml)
- Species / strain:
- mammalian cell line, other: Mouse Lymphoma L5178Y (TK locus)
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 500 μg/ml)
- Species / strain:
- mammalian cell line, other: Mouse Lymphoma L5178Y (TK locus)
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ( 500 μg/ml)
- Additional information on results:
- Observations:
The test substance produced no significant increases in mutation frequency under any of the test conditions used. - 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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