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

Endpoint summary

Additional information

Short-term toxicity to fish

Key study:

The acute toxicity of the test item to fish (zebrafish), was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2013-01-21 to 2013-01-29 with the definitive exposure phase from 2013-01-21 to 2013-01-25, at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany.
A semi-static limit test with daily renewal of the test media was conducted with the nominal test item concentration of 1.30 mg/L. The nominal loading of 1.30 mg/L corresponds to the maximum solubility level of the main component 2-(Perfluorooctyl)ethyl acrylate (water solubility: 0.7 mg/L, nominal content: 54.0 %). The test was carried out without headspace. Duration of the test was 96 hours. 7 test organisms were exposed to the limit test concentration and the solvent control (without test item) containing the same solvent concentration as the test replicate. Water quality parameters temperature, pH-value and O₂-saturation measured at 0, 24, 48, 72 and 96 hours were within the acceptable limits.
The determination of the concentration of2-(Perfluorooctyl)ethyl acrylate (main component of thethe test itemFluowet AC 812 solid) was carried out via GC-MSfrom freshly prepared media after 0 and 72 h, and from the corresponding 24 h old test media after 24 and 96 h.
The measured concentrations ofFluowet AC 812 solid(determined via content of 2-(Perfluorooctyl)ethyl acrylate) in freshly prepared media were 102 % of the nominal value and 83 – 90 % in 24 h aged test media. All effect levels are given based on the nominal concentrations of the test itemFluowet AC 812 solid.

LC-Valueswith 95 % Confidence Intervals (0 – 96 hours)

                  Based on nominal test item concentrations [mg/L]

Test duration [h]	LC50	p = 95 %
24	> 1.30	n.a.
48	> 1.30	n.a.
72	> 1.30	n.a.
96	> 1.30	n.a.
LC100=	> 1.30
Lowest test item concentration
with 100 % mortality after 96 h
LC0=	1.30
Highest test item concentration
with 0 % mortality after 96 h

A static limit test (FAZ84111) was conducted with a saturated solution. The test vessel was coated with the test item for 14 days before the test started. Duration of the test was 96 hours. Thirty test organisms were exposed to the saturated solution and the control. For the preparation of the saturated solution a suspension with a nominal loading of 100 mg/L was shaken for 96 hours and centrifuged. The clear supernatant was used for the test.

All effect levels are based on the initially measured concentration of the test item (0.18 mg/L). At the end of the test the concentration of the test item was 0.0063 mg/L. Sorption to the glass of the test vessels is unlikely as the walls were already pre-coated for 14 days before the test started.

The 96-hour NOEC and LC0 was 0.18 mg/L. The 96-hour LC50 and LC100 was > 0.18 mg/L.

Supporting studies:

A static limit test (FAZ84112) was conducted with the water accomodated fraction. The test vessel was coated with the test item for 14 days before the test started. Duration of the test was 96 hours. Thirty test organisms were exposed to the water accomodated fraction and the control. For the preparation of the water accomodated fraction, a suspension with a nominal loading of 100 mg/L was shaken for 96 hours. After phase separation, the clear liquid phase was used for the test.

All effect levels are based on the initially measured concentration of the test item (0.14 mg/L). At the end of the test the concentration of the test item was below the detection limit of 0.009 mg/L. Sorption to the glass of the test vessels is unlikely as the walls were already pre-coated for 14 days before the test started.

The 96-hour NOEC and LC0 was 0.14 mg/L. The 96-hour LC50 and LC100 was > 0.14 mg/L.

Long-term toxicity to fish

Waiving according to "column 2" in Annex IX of REGULATION (EC) No 1907/2006 (CSA does not indicate need for further investigations). No toxic effects was found in the short-term toxicity test up the water solubility. Also the degradation product showed no toxic effect in a long-term toxicity test to daphnia.

Short-term toxicity to aquatic invertebrates

Key study:

In the acute immobilization test withDaphnia magna(STRAUS) the effects of the dispersion with the nominal concentration of 1.30 mg/L of the test item, using methanol as solvent, were determined according to OECD 202 (2004). The limit test was conducted in sealed glass flasks without headspace under semi-static conditions over a period of 48 h from 2013-01-22 to 2013-01-26, with the definitive exposure phase from 2013-01-23 to 2013-01-25, at Dr.U.Noack-Laboratorien,Käthe-Paulus-Str. 1,31157 Sarstedt, Germany .

The concentration of 1.30 mg/L represents the maximum solubility level of the main component 2-(Perfluorooctyl)ethyl acrylate (water solubility: 0.7 mg/L, nominal content: 54.0 %). A solvent control containing dilution water spiked with 0.1 mL methanol/L was tested additionally. Twenty daphnids were exposed to the limit concentration, the solvent control and the control. The test item Fluowet AC 812 solidwas analytically verified by GC-MS at the start of the exposure intervals (0 and 24 h) and at the end of the exposure intervals (24 and 48 h) in samples of the limit concentration of 1.30 mg/L and the control. The solvent control was analytically verified at test start (0 h) and test end (48 h).

The measured concentrations of the test item at the start of the exposure were 1.10 mg/L (at 0 hours) and 1.12 mg/L (at 24 hours). The measured concentrations at the end of the exposure intervals were 0.760 mg/L corresponding to a recovery rate of 58 % (after 24 hours) and 0.405 mg/L corresponding to a recovery rate of 31 % (after 48 hours) of the nominal value. The geometric mean measured concentration of the test item was calculated to be 0.785 mg/L.
All effect values are based on the geometric mean measured concentration of 0.785 mg/L of the test item Fluowet AC 812 solid.

Water quality parameters (i.e. pH-values and dissolved oxygen concentrations), measured at the start (0 and 24 h) and at the end of each exposure interval (24 and 48 h), were within the acceptable limits. The validity criteria of the test guideline were fulfilled.

EC-Values, NOEC and LOEC

(based on the geometric mean measured concentration)

Fluowet AC 812 solid
	Test Duration [h]	Geometric Mean Measured Test Item Concentration [mg/L]	Confidence Interval p = 95% [mg/L]
EC10/ EC50/ EC100	24	> 0.785	not applicable
	48	> 0.785	not applicable
NOEC	48	0.785	---
LOEC	48	> 0.785	---

At the limit concentration of 1.30 mg/L of the test itemFluowet AC 812 solid,
which corresponds to the geometric mean measured concentration of 0.785 mg/L,

no effects were observed onDaphnia magna.

A static limit test (DAI84111) was conducted with the water accomodated fraction. The test vessel was coated with the test item for 14 days before the test started. Duration of the test was 96 hours. Thirty test organisms were exposed to the water accomodated fraction and the control. For the preparation of the water accomodated fraction, a suspension with a nominal loading of 100 mg/L was shaken for 96 hours. After phase separation, the clear liquid phase was used for the test.

All effect levels are based on the initially measured concentration of the test item (0.14 mg/L). At the end of the test the concentration of the test item was below the detection limit of 0.009 mg/L. Sorption to the glass of the test vessels is unlikely as the walls were already pre-coated for 14 days before the test started.

The 96-hour NOEC and LC0 was 0.14 mg/L. The 96-hour LC50 and LC100 was > 0.14 mg/L.

Supporting studies:

A limit test (DAi84113) with the water accomodated fraction was conducted on test item. A coating period of 14 days was carried out prior to study start. The study was conducted under static conditions for a period of 48 hours. Twenty test organisms were exposed to the water accomodated fraction and control. The water accomodated fraction was analytically verified by GC analysis. The mean

measured concentration of the water accomodated fraction was 0.70 mg/L.

At the water accomodated fraction concentration of 0.70 mg/L, no biologically significant effect was determined. No immobilization was observed in either the control or the saturated solution at 24 or 48-hours. The 48-hour NOEC and EC0 values were 0.70 mg/L. The 48-hour EC50 value was > 0.70 mg/L.

Water quality parameters of pH and dissolved oxygen concentration measured at 0 and 48 hours were determined to be within acceptable limits. The validity criteria of the test guideline were fulfilled.

Long-term toxicity to aquatic invertebrates

One study evaluating the long-term toxicity of 8:2 FTOH (CAS No. 678-39-7) to Daphnia magna is available (Noack, 2003). The limit-test was conducted according to OECD Guideline 211, under GLP conditions. After 21 days of exposure in a semi-static water regime, which was chosen based on preliminary investigations due to the high volatility of the test substance, the test resulted in a NOEC (geometric mean measured concentration) of 45.3 µg/L.

Toxicity to aquatic algae

Key study:

The toxicity of the test itemto the unicellular freshwater green algaDesmodesmus subspicatuswas determined according to the principles of OECD 201atDr.U.Noack-Laboratorienin 31157 Sarstedt, Germanyfrom 2013-01-22 to 2013-02-16, with the definite exposure phase from2013-02-12 to 2013-02-15.The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours in a limit test.

The study was conducted under static conditions with an initial cell density of 4332 cells/mL.Based on the results of a preliminary range finding test the limit concentration of 1.30 mg/L was tested, using methanol as solvent. Therefore, a solvent control containing dilution water spiked with 0.100 mL Methanol/L was tested additionally. The nominal loading of 1.30 mg/L corresponds to the maximum solubility level of the main component C8-Perfluoroalkyl-ethylacrylate (water solubility: 0.7 mg/L, nominal content: 54.0 %). Six replicates were tested for the limit concentration, the solvent control and the control, respectively.With regard to the volatility of the test item, glass flasks without headspace were used to reduce the losses of the test item via the surface. Environmental conditionswere within the acceptable limits.

The limit concentration, the solvent control and the control were analysed by GC-MS after 0 hours (fresh media) and 72 hours (old media). The measured concentration of the main component C8-Perfluoroalkylethylacrylate of FluowetAC 812 solid(content 54.0 %) at test startwas 100 %of the nominal value. At the end of the testthe main componentgave measured concentration of 87 % of the nominal value. For details of the analytical results. All effect values are given based on the nominal concentration of the test item.

NOEC, LOEC, EC - Values of FluowetAC 812 solid(0 - 72 hours)

 based on nominal test item concentration [mg/L]

	Growth Rate Inhibition
NOEC	1.30
LOEC	1.30
ErC10	1.30
ErC20	> 1.30
ErC50	> 1.30
	Inhibition of Yield
NOEC	1.30
LOEC	1.30
EyC10	1.30
EyC20	1.30
EyC50	> 1.30

The study (SSO84111) was conducted under static conditions over a duration of 72 hours with an initial cell density of 10⁴cells/mL and a saturated solution as limit concentration, containing 0.20 mg/L. For the preparation of the saturated solution a suspension with a nominal loading of 100 mg/L was shaken for 96 hours and centrifuged. The clear supernatant was used for the test.

The test vessels were coated with the test item for 14 days before the test started. Three replicates were tested for the limit concentration and six replicates for the control. The test item was clearly dissolved throughout the test. Microscopic evaluation of the cells at study start and end of the incubation period revealed no morphological abnormalities. Water quality parameters of pH-value, measured at 0 and 72 hours, and room temperature, measured continuously, were deemed to be within acceptable limits.

The initial measured concentration of the saturated solution was 0.20 mg/L. At the end of the test the concentration of the test item was below the detection limit of 0.009 mg/L. Sorption to the glass walls of the test vessels was unlikely as the walls were already pre-coated for 14 days prior to study start.

The 72-h EbC50 (inhibition of biomass growth) > 0.20 mg/L.

The 72-h ErC50 (rate related inhibition) > 0.20 mg/L.

The 72-h NOEC for both endpoints = 0.20 mg/L.

The 72-h LOEC for both endpoints was > 0.20 mg/L.

Supporting studies:

The study (SSO84112) was conducted under static conditions over a duration of 72 hours with an initial cell density of 10⁴cells/mL and a water accomodated fraction as limit concentration, containing 0.47 mg/L. For the preparation of the water accomodated fraction a suspension with a nominal loading of 100 mg/L was shaken for 96 hours.

The test vessels were coated with the test item for 14 days before the test started. Three replicates were tested for the limit concentration and six replicates for the control. The test item was clearly dissolved throughout the test. Microscopic evaluation of the cells at study start and end of the incubation period revealed no morphological abnormalities. Water quality parameters of pH-value, measured at 0 and 72 hours, and room temperature, measured continuously, were deemed to be within acceptable limits.

The initial measured concentration of the saturated solution was 0.47 mg/L. At the end of the test the concentration of the test item was below the detection limit of 0.009 mg/L. Sorption to the glass walls of the test vessels was unlikely as the walls were already pre-coated for 14 days prior to study start.

The 72-h EbC50 (inhibition of biomass growth) > 0.47 mg/L.

The 72-h ErC50 (rate related inhibition) > 0.47 mg/L.

The 72-h LOEC for both endpoints was > 0.47 mg/L.

The 72-h NOEC for both endpoints = 0.47 mg/L.

The study (SSO84112) was conducted under static conditions over a duration of 72 hours with an initial cell density of 10⁴cells/mL and a water accomodated fraction as limit concentration, containing 0.47 mg/L. For the preparation of the water accomodated fraction a suspension with a nominal loading of 100 mg/L was shaken for 96 hours.

The test vessels were coated with the test item for 14 days before the test started. Three replicates were tested for the limit concentration and six replicates for the control. The test item was clearly dissolved throughout the test. Microscopic evaluation of the cells at study start and end of the incubation period revealed no morphological abnormalities. Water quality parameters of pH-value, measured at 0 and 72 hours, and room temperature, measured continuously, were deemed to be within acceptable limits.

The initial measured concentration of the saturated solution was 0.47 mg/L. At the end of the test the concentration of the test item was below the detection limit of 0.009 mg/L. Sorption to the glass walls of the test vessels was unlikely as the walls were already pre-coated for 14 days prior to study start.

The 72-h EbC50 (inhibition of biomass growth) > 0.47 mg/L.

The 72-h ErC50 (rate related inhibition) > 0.47 mg/L.

The 72-h LOEC for both endpoints was > 0.47 mg/L.

The 72-h NOEC for both endpoints = 0.47 mg/L.

Toxixity to microorganisms

Key study:

A Respiration Inhibition Test with activated sludge according to OECD Guideline No. 209 was carried out with the test item from 2013-01-07 to 2013-01-08, with the definitive experimental phase on 2013-01-08 at theDr.U.Noack-Laboratorien, 31157Sarstedt, Germany.Test system was activated sludge of the municipal treatment plant of 31137 Hildesheim, Germany. The test was carried out under static conditions with the substance concentrations of 500 and 1000 mg/L. The respiration rates of the control, reference and test item replicates were measured after a contact time of three hours, and the inhibitory effects of the test and reference item were determined in comparison to the control respiration rates. The mean inhibition of respiration for the test item replicates were -6 % and 3 %.

In order to check the activity of the test system and the test conditions a reference test was carried out with copper (II) sulphate pentahydrate as reference item and the reference toxicity was determined. The EC₅₀-value for the reference item was 97.9 mg/L.

NOEC and EC-Values of Fluowet AC 812 solid

		EC-values [mg/L]
NOEC*		1000
EC20		> 1000
EC50		> 1000
EC80		> 1000

                        *) No statistically significant effect (p 0.05), ANOVA

The NOEC of the test itemFluowet AC 812 solid is1000mg/L, the EC50of the test item is > 1000 mg/L. The test item is not toxic up to the concentration of1000mg/L to activated sludge of a municipal sewage treatment plant.

Supporting study:

A Respiration lnhibition Test with activated sludge according to OECD Guideline No. 209 and GLP principles was performed for 3 hrs with the test substance. The test system was activated sludge of the municipal treatment plant. The test method was static. Nominal concentrations of the test item were as follows:100, 180, 320, 580, and 1000 mg/L. The respiration rates of control, reference and test item were measured after a contact time of three hours, and the inhibitory effects of the test and reference concentrations were determined in comparison to the control respiration rates. The inhibition ranged from 2 to 9 %. The EC20, EC50 and EC80 values could not be calculated in the tested concentration range. In order to check the activity of the test system and the test conditions a reference test is carried out once every 7 days with copper-(II)-sulphate-pentahydrate as reference item and the reference toxicity is determined. The EC50 value for the reference item was 104 mg/L.

Validity criteria of the test guideline were fulfilled.

The test substance is not toxic in concentrations < 1000 mg/L to activated sludge of a municipal sewage treatment plant.