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Toxicological information

Genetic toxicity: in vitro

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986
Reference Type:
secondary source
Title:
Unnamed
Year:
1989
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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
- preincubation method
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
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).