Registration Dossier
Registration Dossier
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EC number: 203-149-1 | CAS number: 103-83-3
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: Guideline study and GLP
Data source
Reference
- Reference Type:
- other: draft study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- HPRT
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Benzyldimethylamine
- EC Number:
- 203-149-1
- EC Name:
- Benzyldimethylamine
- Cas Number:
- 103-83-3
- Molecular formula:
- C9H13N
- IUPAC Name:
- benzyldimethylamine
- Details on test material:
- purity 99.8 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- other: Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9-mix fron 6-12 week old male Wistar rats induced by phenobarbital/ß-naphthoflavone
- Test concentrations with justification for top dose:
- 85.0, 170.0, 340.0, 680.0, 1360.0 µg/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: EMS (ethylmethane sulfonate), DMBA (7,12-dimethylbenz(a)anthracene
- Details on test system and experimental conditions:
- according to the respective OECD test guideline: 2 seperate experiments: incubation time with and without S9-mix: 4 hours
- Evaluation criteria:
- A test item producing neither a biologically relevant concentration-related increase of the mutant frequecy nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
- Statistics:
- linear regression
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Chinese Hamster lung fibroblasts (V79)
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
N,N-dimethylbenzylamine was tested for genotoxicity in Chinese hamster V79 cells according to OECD TG 376 in the presense and in the absence of a metabolic activation system (S9 -mix from rat liver). Based on the negative result N,N-dimethylbenzylamine was considered to be non-mutagenic in this test system.
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