3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate

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

Study period:

from 12th January 2007 to 14th February 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with international guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate

EC Number:

241-527-8

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate

Cas Number:

17527-29-6

Molecular formula:

C11H7F13O2

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl prop-2-enoate

Test material form:

other: liquid

Details on test material:

Name of the substance: 3,3,4,4,5,5,6,6,7,7,8,8,8 tridecafluorooctylacrylate
Other Name: 13F-SFA
CAS No.: 17527-29-6
Lot No. 6X002
Molecular formula: C11H7F13O2
Purity: 99.7%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver microsomes (S9)

Test concentrations with justification for top dose:

The main test was examined, a total of 5 doses, 5,000 µg/plate as the highest dose and 4 lower doses of 2,500, 1,250, 625, and 313 µg/plate diluted with a geometric progression of 2, were employed in all test condition.

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

the solvent used in the test was employed as a negative control

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

0.5 µg/plate with S9 mix and TA 1535

Controls 2

Untreated negative controls:

yes

Remarks:

the solvent used in the test was employed as a negative control

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Remarks:

at 0.01 µg/plate with S9 mix and TA 100, at 0.01 µg/plate with S9 mix and WP2uvrA and at 0.1 µg/plate with S9 mix and TA98

Controls 3

Untreated negative controls:

yes

Remarks:

the solvent used in the test was employed as a negative control

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-methoxy-6-chloro-9-(3-(2-chloroethyl)-aminopropylamino)acridinex2HCl

Remarks:

at 0.5 µg/plate with S9 mix and TA1537

Controls 4

Untreated negative controls:

yes

Remarks:

the solvent used in the test was employed as a negative control

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

at 1 µg/plate without S9 mix and TA100, at 2 µg/plate without S9 mix and 1535, at 10 µg/plate without S9 mix and WP2uvrA, at 0.5 µg/plate without S9 mix and TA 98, at 2 µg/plate without S9 mix and TA1537

Details on test system and experimental conditions:

This study was performed by the pre-incubation method with and without S9 mix. Triplicate plates were used for the negative control group and duplicate plates per dose for the test substance treatment groups and the positive control groups. The test code number, name of test strain, presence or absence of S9 mix and dose level were noted on each plate.
Procedures:
After 0.1 mL of the test substance solution, solvent or the positive control solution, 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) or S9 mix and 0.1 mL of the bacterial culture were added to a test tube, the mixture was shaken at 37 ±0.5 °C for 20 minutes. Two milliliters of the soft agar were then added to each tube and the mixture was poured onto a minimal glucose agar plate. The number of revertant colonies was counted after incubation at 37 ±0.5 °C for 48 hours.

Evaluation criteria:

The test substance was judged to be positive when the number of revertant colonies increased to twice or more that in the negative control in a concentration-dependent manner and also the reproducibility of the test results was obtained. In all other cases, it was judged to be negative.

Statistics:

Any statistical methods were used.

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:

not specified

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:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative with metabolic activation
negative without metabolic activation

The test substance was judged to be negative because the number of the revertant colonies in the test substance treatment groups in all test strains was less than twice that in the negative control regardless of the presence or absence of S9 mix.
The numbers of the revertant colonies in the positive controls were above two times that in the negative controls. The test results showed that the numbers of revertant colonies in the negative control and the positive controls were within the range of the historical data in the testing facility. It was also confirmed that the test system was free from bacterial contamination, which indicates the test results to be valid.
From the above results, it was concluded that the substance had no ability to induce mutations under the present test conditions.

Executive summary:

The ability of 3,3,4,4,5,5,6,6,7,7,8,8,8 tridecafluorooctylacrylate to induce mutations was investigated using Salmonella typhimurium strains TA100, TA 1535, TA 98 and TA1537 and Escherichia coil strain WP2uvrA with a pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). As a result, the mutagenicity of the test substance was judged to be negative because the numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all test strains with and without S9 mix. Therefore, it is concluded that the substance has no ability to induce mutations under the present test conditions.