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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was perfomed only with the strains TA98 and TA100

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar 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-chloro-6-fluorotoluene
EC Number:
207-141-9
EC Name:
2-chloro-6-fluorotoluene
Cas Number:
443-83-4
Molecular formula:
C7H6ClF
IUPAC Name:
1-chloro-3-fluoro-2-methylbenzene

Method

Target gene:
histidine
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

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
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:
cytotoxicity
Remarks:
slight toxic effects with S9 mix at 5000 ug/plate
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

A moderate but dose dependent increase in revertant colony numbers was observed following treatment with 2 -chloro-6 -fluorotoluene in strain TA98 from 1000 up to 5000 ug/plate without S9 mix and at 5000 ug/plate with S9 mix. In strain TA98 the factor exceeded the threshold of 2.0 at concentrations of 1000 ug/plate and above in the absence and at 5000 ug/plate in the presence of metabolic activation. No increase in revertant colony numbers was observed in strain TA100.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

It can be stated that during that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by frameshifts in the genome of the strain TA98.