Octane, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-

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:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

EC Number:

700-684-7

Cas Number:

80793-17-5

Molecular formula:

C8H5F13

IUPAC Name:

1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane

Details on test material:

- Name of test material (as cited in study report): 1,1,1,2,2,3,3,4,4,5,5,6,6-Tridecafluorooctane
- Physical state: colourless transparent liquid
- Batch number: #060616
- Purity: 99.9%
- Storage condition of test material: at room temperature
- Stability under storage conditions: stable

Method

Target gene:

His, Trp

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:

phenobarbital/benzoflavone induced rat liver S-9 mix

Test concentrations with justification for top dose:

4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate (dose range finding test)
313, 625, 1250, 2500 and 5000 µg/plate (main test)

The dose finding test showed that the number of revertant colonies in all test strains at all dose levels with or without S9 was less than twice the solvent control. Bacterial growth inhibition and precipitation were not observed in any treatment group. Therefore, 5,000 μg/plate was used as the top dose.

Vehicle / solvent:

acetone

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

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

Remarks:

strains TA 100, TA 98 and WP2uvrA, without S-9 mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

strain TA 1535, without S-9 mix

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 6-chloro-9-[[3-[(2-chloroethyl)amino]propyl]amino]-2-methoxyacridine dihydrochloride

Remarks:

strain TA 1537, without S-9 mix

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

all strains, with S-9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes at 37 °C
- Expression time (cells in growth medium): 48 hours at 37 °C

The test was performed in triplicate. A confirmatory test was also performed in triplicate.

Precipitation of the substance was observed macroscopically and bacterial growth inhibition was observed using a stereomicroscope.

Evaluation criteria:

The substance was judged 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 were obtained. In all other cases, it was judged negative.

Statistics:

Any statistical methods were not used.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

In both the dose range finding test and the main test, the number of revertant colonies in the substance treatment groups in all test strains with and without S-9 mix was less than twice that in the solvent control. Bacterial growth inhibition was not observed at any doses in the groups of treatment in all test strains with and without S-9 mix. Precipitation of the test substance was not observed at any doses in the groups of treatment in all test strains with and without S-9 mix.

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

The number of revertant colonies in all of the test substance treatment groups with or without metabolic activation was less than twice that in the negative controls. The test results were deemed valid, because the number of revertant colonies in positive controls was more than twice the negative controls and the test system was free from bacterial contamination. It was concluded that AC-6000 had no ability to induce mutations under these test conditions.

Executive summary:

The mutagenic activity of AC-6000 was examined in the reverse mutation test by using bacterial strains Salmonella typhimurium TA100, TA1535, TA98 and 1537 and Escherichia coli WP2uvrA. The GLP-compliant study was performed comparable to OECD guideline 471. The reverse mutation test was composed of a dose range finding and a main test. The pre-incubation method was used for all bacterial strains in both the presence and the absence of metabolic activation using the following concentrations: 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate (dose range finding test) and 313, 625, 1250, 2500 and 5000 µg/plate (main test). In both the dose range finding test and the main test, the number of revertant colonies in the substance treatment groups in all test strains with and without S-9 mix was less than twice that in the solvent control. Bacterial growth inhibition and precipitation of the substance were not observed at any doses in the groups of treatment in all test strains with and without S-9 mix. Therefore it is concluded that the mutagenic activity of AC-6000 is considered negative under the test conditions employed.