1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1997

Deviations:

no

Remarks:

No deviations occurred that impacted the integrity of the study.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Novec 7300

IUPAC Name:

Novec 7300

Details on test material:

- Name of test material (as cited in study report): Novec 7300
- Physical state: Colorless, clear liquid
- Analytical purity: 99.85%

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
3M Company, Batch 41-2601-2240-7
- Expiration date of the lot/batch:
30 November, 2005
- Purity test date:
10 June, 2005

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test article was dissolved in ethanol.

Method

Target gene:

Histidine operon, tryptophan operon.

Species / strain

Species / strain / cell type:

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

Remarks:

E. Coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 mix

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 10, 33, 100, 333, 1000, 3330, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 10, 33, 100, 333, 1000, 3330, 5000 µg/plate

Vehicle / solvent:

Solvent: Ethanol

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

Ethanol

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

sodium azide

methylmethanesulfonate

other: Daunomycin, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 10^9 cells/mL

DURATION
- Preincubation period: None
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
- Selection time (if incubation with a selection agent): 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours

SELECTION AGENT (mutation assays): histidine and tryptophan-minimal agar.

DETERMINATION OF CYTOTOXICITY
- Method: bacterial lawn health

Rationale for test conditions:

Per OECD 471.

Evaluation criteria:

A test substance is considered negative (not mutagenic) in the test if:
a) The total numbe rof revertants in any tester strain at any concentration is not greater than
two times the solvent control value,with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated
experiment.
A test substance is considered positive (mutagenic in the test) if:
a) It induces at least a 2-fold, dose related increase in the number of revertants with respect to
the number induced by the solvent control in any of the tester strains, either with or without
metabolic activation. However, any mean plate count of less than 20 is considered to be not
significant.
b) The positive response should be reproducible in at least one independently repeated
experiment.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Based on the results of the study, the test article is negative in the bacterial reverse mutation assay (Ames assay).

Executive summary:

The mutagenic activity of the test article was evaluated in the Salmonella typhimurium reverse mutation assay (strains: TA1535, TA1537, TA98 and TA100, histidine-requiring) and the Escherichia coli reverse mutation assay (strain: WP2uvrA, tryptophan-requiring) in the presence and absence of a metabolic activation system (S9-mix: rat liver S9-mix induced by a combination of phenobarbital and ß naphthoflavone). The study was conducted in compliance with OECD GLP regulations (1997). The test method was based on OECD 471 (1997). The test material was dissolved in ethanol (vehicle). A combined rangefinding test/first mutation assay was conducted in all strains with concentrations up to 5,000 ug/plate in the presence and absence of S-9 mix. The test article precipitated on the plates at the 5,000 ug/plate dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. In the second mutation assay the test article was tested up to concentrations of 5,000 ug/plate in the presence and absence of S-9 mix. The test article precipitated at the highest dose level. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertant colonies was observed. The test article did not induce a dose-related increase in the number of revertant colonies in any of the tester strains in the presence or absence of metabolic activation. Based on the results of the study, the test article is negative in the bacterial reverse mutation assay (Ames assay).