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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cell gene mutation (B17)
- 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 - 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'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
