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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:
from 12th January 2007 to 14th February 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with international guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
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 the substance: 3,3,4,4,5,5,6,6,7,7,8,8,8 tridecafluorooctylacrylate
Other Name: 13F-SFA
CAS No.: 17527-29-6
Lot No. 6X002
Molecular formula: C11H7F13O2
Purity: 99.7%

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver microsomes (S9)
Species / strain:
E. coli WP2 uvr A
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver microsomes (S9)
Test concentrations with justification for top dose:
Therefore, the main test was examined, a total of 5 doses, 5,000 µg/plate as the highest dose and 4 lower doses of 2,500, 1,250, 625, and 313 µg/plate diluted with a geometric progression of 2, were employed in all test condition.
Vehicle:
DMSO
Controlsopen allclose all
Negative controls:
yes
Remarks:
the solvent used in the test was employed as a negative control
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
0.5 µg/plate with S9 mix and TA 1535
Negative controls:
yes
Remarks:
the solvent used in the test was employed as a negative control
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
at 0.01 µg/plate with S9 mix and TA 100, at 0.01 µg/plate with S9 mix and WP2uvrA and at 0.1 µg/plate with S9 mix and TA98
Negative controls:
yes
Remarks:
the solvent used in the test was employed as a negative control
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-methoxy-6-chloro-9-(3-(2-chloroethyl)-aminopropylamino)acridinex2HCl
Remarks:
at 0.5 µg/plate with S9 mix and TA1537
Negative controls:
yes
Remarks:
the solvent used in the test was employed as a negative control
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
at 1 µg/plate without S9 mix and TA100, at 2 µg/plate without S9 mix and 1535, at 10 µg/plate without S9 mix and WP2uvrA, at 0.5 µg/plate without S9 mix and TA 98, at 2 µg/plate without S9 mix and TA1537
Details on test system and conditions:
This study was performed by the pre-incubation method with and without S9 mix. Triplicate plates were used for the negative control group and duplicate plates per dose for the test substance treatment groups and the positive control groups. The test code number, name of test strain, presence or absence of S9 mix and dose level were noted on each plate.
Procedures:
After 0.1 mL of the test substance solution, solvent or the positive control solution, 0.5 mL of 0.1 M sodium phosphate buffer (pH 7.4) or S9 mix and 0.1 mL of the bacterial culture were added to a test tube, the mixture was shaken at 37±0.5°C for 20 minutes. Two milliliters of the soft agar were then added to each tube and the mixture was poured onto a minimal glucose agar plate. The number of revertant colonies was counted after incubation at 37±0.5°C for 48 hours.
Evaluation criteria:
The test substance was judged to be 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 was obtained. In all other cases, it was judged to be negative.
Statistics:
Any statistical methods were used.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test substance was judged to be negative because the number of the revertant colonies in the test substance treatment groups in all test strains was less than twice that in the negative control regardless of the presence or absence of S9 mix.
The numbers of the revertant colonies in the positive controls were above two times that in the negative controls. The test results showed that the numbers of revertant colonies in the negative control and the positive controls were within the range of the historical data in the testing facility. It was also confirmed that the test system was free from bacterial contamination, which indicates the test results to be valid.
From the above results, it was concluded that the substance had no ability to induce mutations under the present test conditions.
Executive summary:

The ability of 3,3,4,4,5,5,6,6,7,7,8,8,8 tridecafluorooctylacrylate to induce mutations was investigated using Salmonella typhirnurium strains TA100, TA 1535, TA 98 and TA1537 and Escherichia coil strain WP2uvrA with a pre-incubation method in the presence and absence of a metabolic activation system (S9 mix). As a result, the mutagenicity of the test substance was judged to be negative because the numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all test strains with and without S9 mix. Therefore, it is concluded that the substance has no ability to induce mutations under the present test conditions.