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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-fluorotoluene
EC Number:
202-428-5
EC Name:
2-fluorotoluene
Cas Number:
95-52-3
Molecular formula:
C7H7F
IUPAC Name:
2-fluorotoluene

Method

Target gene:
hystidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
s9 mix
Test concentrations with justification for top dose:
3.3, 10.0, 33.3, 100.0, 333.3, 1000.0, 2500.0, 5000.0 ug/plate
Controls
Positive controls:
yes
Remarks:
sodium azide for TA100 without S9; 4-NOPD for TA98 without S9; 2-aminoanthracene for TA98 and TA100 with S9

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Additional information on results:
No relevant toxic effects, evident as a reduction in the number of revertants, occurred with and without S9 min in all strain used.
The plates incubated with the test article showed normal background growth up to the highest concentration with and without S9 mix.
No substantial increase in revertant colony numbers of any of the two tester strains was observed following treatment with 2-fluorotoluene at any concentration level, neither with or without S9 mix. There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
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

It can be concluded that the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.