2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters

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:

2001

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

Test material information

Constituent 1

Reference substance name:

Perfluoroalkylethyl Acrylate Esters

IUPAC Name:

Perfluoroalkylethyl Acrylate Esters

Constituent 2

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

Method

Species / strain

Species / strain 1

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 2

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.

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

E. coli WP2uvrA

Positive control substance:

methylmethanesulfonate

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA1537

Positive control substance:

9-aminoacridine

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA100, TA1535

Positive control substance:

sodium azide

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

TA98

Positive control substance:

2-nitrofluorene

Controls 5

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.