Propane, 1,1,2,2,3,3-hexafluoro-1-[(1,2,2-trifluoroethenyl)oxy]-3-(trifluoromethoxy)-

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:

09 January 2002 to 17 January 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted in accordance with GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Perfluormethoxypropylvinylether

IUPAC Name:

Perfluormethoxypropylvinylether

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Perfluormethoxypropylvinylether
- Substance type: Clear, colorless liquid
- Physical state: Liquid
- Analytical purity: 98%
- Purity test date: 30 November 2001
- Lot/batch no.: 3
- Storage condition of test material: Darkness at approximately 5 °C in a refrigerator under nitrogen

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

Not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9-mix was prepared using Arclor induced rat liver homogenate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: solubility of the test article

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Without metabolic activation: Sodium-azide for TA 100, and 1535; 9-aminoacridine for TA 1537; 2-nitrofluorene for TA98; Mitomycin C for TA 102 With metabolic acitivation: 2-aminoanthracene for all strains.

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: None
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: The test article did not cause a significant increase in the number of revertant colonies at any dose level in the presence or absence of S9-mix.
NUMBER OF CELLS EVALUATED: All plates were examined for revertant colonies.
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Test article was not toxic to the bacterial strains

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test article did not precipitate on the plates up to the highest investigated dose of 5000 ug/plate.

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

Based on the results of the test, the test article is not mutagenic with or without metabolic activation in the Ames assay.

Executive summary:

The mutagenic potential of the test article was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA102, TA1535, and TA1537 in the presence and absence of a metabolic activation system (Aroclor induced-S9 mix). The study was performed in compliance with OECD GLP (1999). The test method was based on OECD No. 471 (1997), U.S. EPA: OPPTS 870.5100 (1998), and EC Directive 2000/32/EC B.13/B.14. All strains were exposed to dose levels of 50, 160, 500, 1600, or 5000 ug per plate by incorporation of the test article into the agar. Strain specific experiments were performed in the presence and absence of metabolic activation. Plates were incubated for 48 hours at 37 C in the dark. After incubation, revertant colonies were counted. No mutagenic responses were observed in any strain in the presence or absence of metabolic activation. Based on the results of the test, the test article is not mutagenic with or without metabolic activation in the Ames assay.