reaction mass of mixed (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphates, ammonium salt

Genetic toxicity: in vitro

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)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Details on test material:

- Purity: not reported as such

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

50, 150, 500, 1500 and 5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: Based on the solubility of the test substance and compatibility with the target cells.

Controls

Untreated negative controls:

yes

Remarks:

Sterile distilled water

Negative solvent / vehicle controls:

yes

Remarks:

Sterile distilled water

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene(WP2uvrA +S9), 2-nitrofluorene (TA98 -S9), sodium azide (TA100 and TA1535 -S9), 9-aminoacridine (TA1537 –S9), methyl methane sulfonate (WP2urvA -S9)

Remarks:

All positive controls were diluted with dimethyl sulfoxide (DMSO) except sodium azide, which was diluted with water.

Details on test system and experimental conditions:

METHOD OF APPLICATION: The plate incorporation method was applied. Treatment without activation was conducted by adding 0.1 mL of overnight culture containing 1x10e9 bacteria to top agar supplemented with L-histidine, D-biotin and L-tryptophan. The components were mixed and poured onto a plate containing Vogel-Bonner minimal agar. Treatments with activation were conducted as those without activation except that S9 mix was added to the bacteria/top agar mixture before it was poured onto a Vogel-Bonner minimal agar plate. The plates were incubated at approximately 37°C for approximately 48 to 72 hours.

DURATION
- Exposure duration: 48 to 72 hours

NUMBER OF REPLICATIONS: 2 trials with 3 treatments per concentration

Evaluation criteria:

A test substance was classified as positive when (1) there is a positive dose-related increase in the mean revertants per plate of at least one test strain AND (2) the average number of revertants in any strain at any test substance concentration studied is at least 2 times (TA98, TA100 and WP2 uvrA) or 3 times (TA1535 and TA1537) greater than the average number of revertants in the negative control. An equivocal response is a biologically relevant increase in revertant count that partially meets the criteria for evaluation as positive. A test substance is classified as negative, it if is nether positive nor equivocal.

Statistics:

Trials were evaluated independently. For each selected tester strain, the average number of revertants and the standard deviation at each concentration with and without S9 activation were calculated.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and 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

Test results 2

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:

Negative when tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2 uvr A in the absence and presence of S9 activation.

Executive summary:

The test substance was evaluated for mutagenicity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2 uvr A with and without an exogenous metabolic activation system (S9). The maximum concentration tested was 5000 µg/plate. No evidence of mutagenic activity was detected in either of two independent trials. In this study, the test substance was negative.