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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
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:
Alpha,2-dichloro-6-fluorotoluene
EC Number:
259-487-5
EC Name:
Alpha,2-dichloro-6-fluorotoluene
Cas Number:
55117-15-2
Molecular formula:
C7H5Cl2F
IUPAC Name:
1-chloro-2-(chloromethyl)-3-fluorobenzene

Method

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 and 5000.0 ug/plate
Details on test system and experimental conditions:
Each concentration and the controls were tested in triplicate.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
from 1000 to 5000 ug/plate
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 ug/plate
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
from 1000 to 5000 ug/plate

Any other information on results incl. tables

At the higher concentration the background growth was reduced with and without S9 mix in all strain used.

No substantial increase in revertant colony numbers of any of the two tester strains was observed following treatment with the substance 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.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In can be stated that the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
2-chloro-6-fluoro benzylchloride is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.