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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Important aspects are in line with current OECD guidelines, but study design is restricted due to missing confirmation of negative results by further testing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: company guideline based on the method described by Ames et al (1973) and similar to OECD 471
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2',4'-dimethylacetoacetanilide
EC Number:
202-576-0
EC Name:
2',4'-dimethylacetoacetanilide
Cas Number:
97-36-9
Molecular formula:
C12H15NO2
IUPAC Name:
2',4'-dimethylacetoacetanilide
Details on test material:
- Name of test material (as cited in study report): Acetessig-m-xylidid TRTR

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix
Test concentrations with justification for top dose:
Dosages: 0, 4, 20, 100, 500, 2500, 5000, 10000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, 2-aminoanthracene
Remarks:
TA1537, without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1537, with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: methylhydrazone derivative, 2-aminoanthracene
Remarks:
TA98, TA1538, TA100 without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA98, TA1538, TA100 with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: streptocotocine, 2-aminoanthracene
Remarks:
TA1535, without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1535, with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: ENNG, 2-aminoanthracene
Remarks:
E. coli WP2 uvrA, without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
E. coli WP2 uvrA, with metabolic activation
Evaluation criteria:
A chemical is considered to have a positive response if the number of revertants is more than double the spontaneous mutations

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100, E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: not determined, but signs for toxicity at higher concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In the present study the test item was not mutagenic in either of tested concentrations.
Executive summary:

Acetessig-m-xylidid TRTR was examined in the mutagenicity screening test in bacteria first described by Ames and co-workers, which is similar to OECD 471. Following this method concentrations of 2 - 10000 µg/plate were teste in tester strains S. typhimurium TA 1535, TA 1537, TA1538, TA 98 and TA 100, E. coli WP2 uvr A with and without metabolic activation. Under the conditions of this test the test substance showed no mutagenic activity.