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

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

Reference

Name:

Unnamed

Type:

Constituent

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)

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

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

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

Remarks:

Migrated from field 'Test system'.