Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Guideline study reported in Japanese with a summary in English, but no data available concerning the year of performance or reporting.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
N-methylaniline
EC Number:
202-870-9
EC Name:
N-methylaniline
Cas Number:
100-61-8
Molecular formula:
C7H9N
IUPAC Name:
N-methylaniline

Method

Target gene:
the amino acid requirement, UV-sensitive mutant and the membrane (rfa) and ampicillin resistance factor (pKM101)
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 Mix of Rat liver, induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
0, 156.3*, 312.5, 625, 1250, 2500, 5000 ug/plate (* only without S9)
Vehicle / solvent:
Dimethylsulphoxide (DMSO)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: -S9 Mix, AF-2 (TA100, WP2, TA98), sodium azide (TA1535) and 9-aminoacridine (TA1537) +S9 Mix, 2-aminoanthracene (all strains)
Details on test system and experimental conditions:
Using the plate method, S9 Mix was tested under conditions with or wthout additives.
Mixed in a small test tube: test substance preparation 0.1 ml, phosphate buffer 0.5 ml (S9 Mix was added in the test S9 Mix 0.5 ml), test bacterial solution and 0.1 ml 2 ml Toppuaga. After mixing, the synthetic medium plates was allowed to harden on the flow.
The plates were cultured for 48 hours at 37℃.
The number of resulting colonies were calculated. The plates were grossly examined or under a stereoscopic microscope.
Evaluation criteria:
The test for five different strains of the bacteria test of at least 1 S9 Mix without additives or additives in the test, the average number of colonies on plates containing the test substance, twice that of vehicle control increased over and if it showed a dose-dependent increase in reproducibility or the substance has mutagenic in the test system (positive) were judged to be.
Statistics:
Not specified.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 5000 ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 5000 ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative.

The test substance proved not to be genotoxic to various bacterial strains in the reverse mutation assay up to concentrations of 5000 ug/plate, which appeared to be cytotoxic by inhibiting bacterial growth.