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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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, this substance did not elicit evidence of bacterial mutagenicity in the Ames assay.

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Lot #: W17033003

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 / 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

Untreated negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

methylmethanesulfonate

other: ICR 191 Acridine; Daunomycin; 2-Aminoanthracene

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

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)