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Toxicological information

Genetic toxicity: in vitro

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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:
2011
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

Constituent 1
Chemical structure
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 %

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.