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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
January, 1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

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:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptadecafluorooctanesulphonyl fluoride
EC Number:
206-200-6
EC Name:
Heptadecafluorooctanesulphonyl fluoride
Cas Number:
307-35-7
Molecular formula:
C8F18O2S
IUPAC Name:
heptadecafluorooctane-1-sulfonyl fluoride
Details on test material:
Name: RM90
Aggregate State at RT: liquid
Colour: colourless
Analysis: GLC
Purity: 97.4
Stability pure: stable under storage conditions
Stability in solvent: 48 hours in polyethylene glycol, CMC, acetone
Storage: ventilated and dry area, container well closed

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
Test concentrations with justification for top dose:
33.3; 100; 333.3; 1000; 2500; 5000 ug/plate
Controls
Untreated negative controls:
yes
Positive controls:
yes

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No substantial incrreases in revertant colony numbers of any of the two tester strains were observed following treatment with RM90 at any concentration level, either in the presence or absence of metabolic activation (S9 mix), There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biologica relevance.

Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies. 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the descrive mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, RM 90 is considered to be non mutagenic in this Salmonella typhimurium reverse mutation assay.