3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)-hexane

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:

July 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according 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:

T-7145

IUPAC Name:

T-7145

Details on test material:

- Name of test material (as cited in study report) T-7145
- Physical state: liquid 99.89%
- Impurities (identity and concentrations): impurity identites not reported. 0.11%
- Stability under test conditions: Stable

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 AND WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

5, 20, 78, 313, 1250, 5000 micrograms/plate

Vehicle / solvent:

Acetone was be approved solvent in which the test material was soluble.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9-aminoacridine N-ethyl-N'-nitro-N-nitrosoguanidine, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION:
Preincubation;

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours

Evaluation criteria:

2X+ control background

Statistics:

NA

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and WP2 uvrA

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:

TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: N.A.
- Effects of osmolality: N.A.
- Evaporation from medium: N.A.
- Water solubility: very low water solubility
- Other confounding effects: None

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

T-7145 is negative in all strains tested

Executive summary:

In the main test, the numbers of revertants induced by the test substance were not increased more than double of the solvent control value with and without S9 mix. The reproducibility of this negative result was confirmed.

In the contamination test, others bacteria was not observed.

Mircrobial growth inhibition was not observed. Precipitated test substance was not observed on the agar plate.

In the positive control tests using specific mutagens with and without S9 mix, they induced significant revertants exceeding those of the solvent control. For solvent control and positive control, the numbers of revertants of all the tester strains were within the normal range of our laboratory's background data respectively. These results assured that the tests were performed correctly.

These results led to the conclusion that T-7145 is not mutagenic under the test conditions employed.