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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α,α-trifluoro-o-toluidine
EC Number:
201-806-7
EC Name:
α,α,α-trifluoro-o-toluidine
Cas Number:
88-17-5
Molecular formula:
C7H6F3N
IUPAC Name:
2-(trifluoromethyl)aniline

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:
Aroclor 1254(R) induced rat liver S9-mix
Test concentrations with justification for top dose:
Experiment I: 0, 4, 20, 100, 500, 2 500, 5 000 µg/plate
Experiment II: 0, 4, 20, 100, 500, 1000, 2 500, 5 000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- the test substance was dissolved in 100 µL respectively
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, N-methyl-N-nitro-N-nitrosoguanidine, sodium azide, 2-nitrofluorene, 2-aminoanthracene, benzo[a]pyrene
Remarks:
without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION:
in agar (plate incorporation)

DURATION
- Exposure duration: incubation for at least 48 to 72 hours

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls, two independent experiments

Evaluation criteria:
negative result: no significant and no dose dependant increase in the number of revertant colonies
Statistics:
Arithmetic means of the counted colonies were calculated.

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:
2 500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
2 500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
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:
5 000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test item did not exert mutagenic activity in the Salmonella typhimurium and Escherichia coli reverse mutation assay (plate incorporation test) with and without metabolic activation.
Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98, 100 and 1538 as well as Escherichia coli WP2 uvrA with and without metabolic activation (induced rat liver S9-mix) at concentrations of 0, 4, 20, 100, 500, 1000, 2500 and 5 000 µg/plate. Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed.

The test substance proved to be toxic at doses 2 500 µg/plate (for S. typhimurium strains) and 5 000 µg/plate (for E. coli strain)

Therefore the test item is not considered mutagenic under the conditions in this bacterial reverse mutation assay.