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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
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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
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:
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:
acetone
Controlsopen allclose all
Negative controls:
yes
Solvent 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
Negative controls:
yes
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
strain TA 1535, without S-9 mix
Negative controls:
yes
Solvent 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
Negative controls:
yes
Solvent 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 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:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
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.

Applicant's summary and conclusion