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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no characterisation of S9 mix by mutagen requiring metabolic activation (other than 2-aminoanthracene), missing TA102 or E.coli strain, no data on the purity of the test substance given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
adopted in 1997
Deviations:
yes
Remarks:
no characterisation of S9 mix by mutagen requiring metabolic activation (other than 2-aminoanthracene), missing TA102 or E.coli strain, no data on the purity of the test substance given
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

1
Chemical structure
Reference substance name:
2,4-difluoroaniline
EC Number:
206-687-5
EC Name:
2,4-difluoroaniline
Cas Number:
367-25-9
Molecular formula:
C6H5F2N
IUPAC Name:
2,4-difluoroaniline

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Metabolic activation system:
cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with Aroclor 1254
Test concentrations with justification for top dose:
Preliminary test: 1, 5, 10, 50, 100, 500, 1000, 2500 and 5000 µg/plate in TA 100 without metabolic activation
Main test: 62.5, 125, 250, 500 and 1000 µg/plate with and without metabolic activation
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: dimethylsulfoxide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-anthramine: +S9, 2 µg/plate for all tester strains

Results and discussion

Test results
Key result
Species / strain:
other: TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks:
in preliminary test: at and above 1000 µg/plate for TA100 without metabolic activation
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The potential of the test substance to induce gene mutations was examined in 4 Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 using the plate incorporation method, which was carried out without and with metabolic activation. In a preliminary cytotoxicity test in TA100 concentrations from 1 to 5000 µg/plate were tested without metabolic activation. Cytotoxicty was observed at and above 1000 µg/plate, therefore, in the main experiment concentrations of 62.5, 125, 250, 500 and 1000 µg/plate were tested. The test substance did not cause an increase in the frequency of revertants with and without metabolic activation. Thus, the test material was considered to be non-mutagenic in bacteria.