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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
EC Number:
217-288-0
EC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Cas Number:
1800-91-5
Molecular formula:
C10H6F12
IUPAC Name:
3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene
Test material form:
other: liquid
Details on test material:
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 99.6 %
- Impurities (identity and concentrations): Not known
- Lot/batch No.: 941001
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the closed bottle.

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Preliminary test; 5, 15, 50, 150, 1500, 5000 micro gram/plate
Test; 156.3, 312.5, 625, 1250, 2500, 5000 micro gram/plate
Vehicle / solvent:
DMSO: Dimethylsulfoxide
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
Two plates were used for each of seven different concentrations of the sample in the range-finding study and six different concentrations of the sample in the main test. The liver microsome fraction (S9) was prepared from the liver of Slc:Sprague-Dawley rats prepared with phenobarbital and 5,6-benzoflavone.
Evaluation criteria:
The result was considered positive if the number of colonies found was twice the number of colonies of the control, which was exposured to dimethylsulfoxide, the solvent for test sample, and concentration-related increase over the range tested and reproducible increase at range finding trial and main test were observed.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
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

Applicant's summary and conclusion

Conclusions:
negative with and without metabolic activation
The number of revertant colonies in six concentrations, 156.3, 312.5, 625, 1250, 2500 and 5000 microgram/plate did not increase more than twice compare with the solvent control in five bacteria strains with and without activation.
The growth inhibition of the bacteria was not observed.
Executive summary:

The number of revertant colonies in six concentrations, 156.3, 312.5, 625, 1250, 2500 and 5000 microgram/plate did not increase more than twice compare with the solvent control in five bacteria strains with and without activation.

The growth inhibition of the bacteria was not observed either.