Benzyldimethylamine

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline test and GLP

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1989

Reference 3

Reference Type:

publication

Title:

Mutagenitätsprüfungen von Arbeitsstoffen mit wesentlicher Bedeutung und Verbreitung

Author:

Heimann K.-G- et al.

Year:

1998

Bibliographic source:

GUM 4/89

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

- preincubation method

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

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:

N,N-dimethylbenzylamin, purity: 99.34 %

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimuriun TA98. TA100. TA1535, TA1537, TA1538

Additional strain / cell type characteristics:

other: Salmonella typhimuriun TA98. TA10,. TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix of male Wistar rat liver after induction with Aroclor 1254

Test concentrations with justification for top dose:

0 - 1.58 - 5 - 15.8 - 50 - 158 -500 -1580 - 5000 µg/plate

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: Methyl methansulfonatem 9-Aminoacridine, 2-Nitrofluorene, N-ethyl-Nnitro-N.nitrosoguanidine, 2-Aminoanthracene, Benzo(a)pyrene

Details on test system and experimental conditions:

IUCLID4 Type: Ames test, according to the respective guieline: preincubation procedere

Evaluation criteria:

A material is identified as a mutagen in this test system if ther was a reproducible demonstration of a dose-effect relation with a 2-fold increase in the number of revertants compared with the concurrent negative control in at least 1 strain. With the strain TA100 a 1.5-fold increase was the criterion for a positive result.

Statistics:

no data

Results and discussion

Test results

Species / strain:

other: Salmonella typhimuriun TA98. TA100. TA1535, TA1537, TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

+/- S9-mix: at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

negative

Executive summary:

N,N-Dimethylbenzylamine diluted in DMSO was tested for point mutations in the Ames-test according to OECD TG 471 and GLP using Salmonella typhimuriun TA98, TA100, TA1535, TA1537, TA1538 in the presence and in the absence of a metabolic activation system and concentrations ranging between 1.58 and 5000 µg/plate. Cytotoxicity was observed at the highest test concentration. Under the conditions of this test N,N-dimethylbenzylamine did not induce point mutations (BG Chemie 1986).