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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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.