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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC B.13 OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-830-5
EC Name:
-
Cas Number:
2557-13-3
Molecular formula:
Hill formula: C9 H7 F3 O2
IUPAC Name:
Methyl, 3-Trifluoromethylbenzoate

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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:
Concentration range in the main test (with metabolic activation): 20 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 20 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene with S9 mix; N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and 4-nitroquinoline-N-oxide without S9 mix.
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 0 µg/plate

Metabolic activation system: The S-9 mix is prepared freshly prior to each experiment
(1,2). For this purpose, a sufficient amount


of S-9 fraction is thawed at room temperature and 1 volume
of S-9 fraction is mixed with 9 volumes of

S-9 supplement (cofactors). This preparation, the so-called
S-9 mix, is kept on ice until used. The

concentrations of the cofactors in the S-9 mix are:

MgCl2 8 mM

KCl 33 mM

Glucose-6-phosphate 5 mM

NADP 4 mM

Phosphate buffer (pH 7.4) 15 mM

The phosphate buffer (6) is prepared by mixing an Na2HPO4
solution with an NaH2PO4 solution in a ratio of about 4 : 1.

To demonstrate the efficacy of the S-9 mix in this assay,
the S-9 batch was characterized with benzo(a)pyrene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>=1000 µg/plate)
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>=1000 µg/plate)
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 1000 µg/plate)
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 1000 µg/plate)
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 with metabolic activation
negative without metabolic activation

The substance did not show any evidence of mutagenic activity in the Salmonella typhimurium/Escherichia coli bacterial system.