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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
adopted in 1997
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carbonyl fluoride
EC Number:
811-684-2
Cas Number:
1255735-07-9
Molecular formula:
C6 H4 F4 N2 O
IUPAC Name:
3-(difluoromethyl)-5-fluoro-1-methyl-1H-pyrazole-4-carbonyl fluoride

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
Test concentrations with justification for top dose:
3.16, 10.0, 31.6, 100, 316 and 1000 μg/plate with and without metabolic activation
The top dose was chosen based on a preliminary cyctotoxicity test in TA100 were cytotoxicity was observed at and above 1000 µg/plate with and without metabolic activation.
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
mitomycin C
other: 2-aminoanthracene: +S9, 2 µg/plate for TA100 and TA1535

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA102, TA100 and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 1000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In this mutagenicity test in bacteria, the test substance was not mutagenic in any of the five Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA102) tested with and without metabolic activation up to 1000 µg/plate in the plate incorporation test as well as in the pre-incubation test. Cytotoxicity was noted at the top concentration of 1000 μg/plate in all test strains for both incubation methods (plate incorporation and pre-incubation), each carried out without and with metabolic activation.