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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
EC Number:
940-803-1
Molecular formula:
This is a multi-constituent susbstance there is no molecular formula or molecular weight range available
IUPAC Name:
Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate
Test material form:
liquid
Specific details on test material used for the study:
Lot #: W17033003

Method

Target gene:
Point mutations which involve substitution, addition or deletion of one or a few DNA base pairs are detected in amino acid-requiring strains of Salmonella typhimurium (S. typhimurium, ST) and Escherichia coli (E. coli, EC) by their ability to functionally reverse mutations.
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (cofactor supplemented post-mitochondrial fraction) was included to simulate mammalian metabolism since some test substances only become mutagenic following metabolic activation.
Test concentrations with justification for top dose:
commercial grade 28% material at levels of 5.643, 17.857, 56.43, 178.57, 564.3, 1785.7, 5643, and 17,857 μg/plate, with the high level being the standard limit for this test and corresponding to ca 5000 ug/plate actives
Vehicle / solvent:
Sterile water was used as the vehicle control
Controls
Untreated negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
methylmethanesulfonate
other: ICR 191 Acridine; Daunomycin; 2-Aminoanthracene

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
No signs of precipitation or contamination were noted in any of the strains. Signs of toxicity were observed for TA 1535, TA 1537 and TA 98 at doses ≥ 5643 μg/plate in the plate incorporation and/or pre-incubation methods with and without of S9 with evidence of decrease revertant counts and or incomplete lawn. For all bacterial strains at least six dose levels without toxicity were evaluated, therefore bacterial mutagenicity was adequately assessed.
There was no concentration-related or substantial test substance related increases in the number of revertant colonies observed with strains TA1535, TA1537, TA98 , TA100 or E. Coli WP2 uvrA in both the absence and presence of S9 using either the plate incorporation or the pre-incubation method.
In conclusion, based on these findings and on the evaluation system used, Thetawet FS-8250 did not elicit evidence of bacterial mutagenicity in the Ames assay