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EC number: 288-003-5 | CAS number: 85631-54-5
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-05-11 to 2001-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Perfluoroalkylethyl Acrylate Esters
- IUPAC Name:
- Perfluoroalkylethyl Acrylate Esters
- Reference substance name:
- 2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters
- EC Number:
- 288-003-5
- EC Name:
- 2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters
- Cas Number:
- 85631-54-5
- Molecular formula:
- C11H7F13O2 - C17H7F25O2
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,12-henicosafluorododecyl prop-2-enoate; 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,11,11,12,12,13,13,14,14,14-pentacosafluorotetradecyl prop-2-enoate
- Test material form:
- other: Yellow to amber solid
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- 5000, 3333, 1000, 333, and 100 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Acetone was selected as the solvent of choice based on compatibility with the target cells and solubility of the test article.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- E. coli WP2uvrA
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA1537
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA100, TA1535
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA98
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Positive control substance:
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls as follows (inclusive): S. typhimurium TA 98, 10-50; TA 100, 80-240; TA 1535, 5-45; TA 1537, 3-21 and E. coli WP2uvrA, 10-60. To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10e9 cells/mL. The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels are required to evaluate test data. A dose level is considered toxic if one or both of the following criteria are met: 1) A >50% reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose dependent drop in the revertant count. 2) A reduction in the background lawn.
- Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test article to be evaluated positive, it must cause a doe related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of the test article. Data sets for tester strain TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times in the mean vehicle control value. Data sets for tester strains TA98, TA 100 and WP2uvrA were judged positive if the increase in mean rever tan ts at the peak of dose response is equal to or greater than two times the mean vehicle control value.
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
- Remarks:
- In Experiment B1 (initial mutagenicity test),no positve response were observed with any of the tester strains +/- S9 activation. In Experiment B2 (independent repeat test),no positve response were observed with any of the tester strains +/- S9 activation.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- The maximum dose tested was 5000µg per plate, neiter preciptate nor appreciable toxicity was observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1:Mutagenic and Cytotoxic Effects of the test item H-24889
Strain |
S9 |
Tested Concentration Range [µg/plate] |
Lowest Mutagenic Concentration [µg/plate] |
Lowest Cytotoxic Concentration [µg/plate] |
TA1535, TA1537, TA100, TA98, WP2uvrA |
— |
6.7– 5000 |
none |
6.7 |
+ |
6.7– 5000 |
none |
6.7 |
Table 2:Summary of mean number of revertants (mean of 3 plates) in Salmonella typhimurium strains following treatment with H-24889 with and without metabolic activation
Experiment B1 |
||||||||||
Concentration |
TA1535 |
TA1537 |
TA100 |
TA98 |
WP2uvrA |
|||||
[µg/plate] |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Vehicle |
11 |
9 |
9 |
6 |
177 |
167 |
14 |
17 |
12 |
13 |
100 |
9 |
10 |
4 |
6 |
157 |
177 |
9 |
13 |
12 |
12 |
333 |
16 |
9 |
6 |
8 |
176 |
137 |
11 |
12 |
11 |
11 |
1000 |
12 |
10 |
7 |
11 |
150 |
170 |
12 |
18 |
10 |
10 |
3333 |
14 |
14 |
3 |
8 |
174 |
111 |
12 |
21 |
13 |
13 |
5000 |
13 |
11 |
6 |
8 |
169 |
161 |
9 |
17 |
14 |
9 |
positive |
170 |
112 |
927 |
189 |
575 |
1763 |
120 |
1111 |
63 |
164 |
Experiment B2 |
||||||||||
|
TA1535 |
TA1537 |
TA100 |
TA98 |
WP2uvrA |
|||||
[µg/plate] |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
Vehicle |
15 |
10 |
3 |
9 |
148 |
169 |
14 |
13 |
15 |
17 |
100 |
10 |
6 |
5 |
6 |
153 |
153 |
6 |
10 |
11 |
11 |
333 |
10 |
10 |
6 |
6 |
159 |
146 |
11 |
11 |
14 |
10 |
1000 |
11 |
7 |
4 |
6 |
162 |
177 |
8 |
12 |
15 |
10 |
3333 |
14 |
8 |
6 |
4 |
164 |
158 |
10 |
13 |
8 |
10 |
5000 |
11 |
9 |
5 |
5 |
145 |
185 |
5 |
9 |
12 |
7 |
positive |
375 |
215 |
1164 |
234 |
670 |
1453 |
221 |
1043 |
90 |
601 |
Applicant's summary and conclusion
- Conclusions:
- The results of the H-24889: Bacterial Reverse Mutation Test with an Independent Repeat Assay indicate that, under the conditions of this study, H-24889 did not cause a positive response in the presence and absence of Aroclor-induced rat liver S9.
- Executive summary:
The mutagenic effects of the test item were determined in a reverse mutation assay with Salmonella typhimurium. Test systems were the strains TA98, TA100, TA1535, TA1537 and E. coli WP2uvrA with (+) and without (-) the metabolic activation system S9 (from Aroclor induced SD-rats rats). Concentrations tested were 100, 333, 1000, 3333 and 5000 µg/plate. Three replicates per concentration level and control were performed. Based on the results of this study the test item was found to have no mutagenic effects on Salmonella typhimuriumstrains TA98, TA100, TA1535, TA1537 and E. coli WP2uvrA with (+) and without (-) the metabolic activation system S9 at concentrations up to 5000µg/plate.
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