Sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 18, 2012 - Dec 20, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 202.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

EC Number:

700-540-3

Molecular formula:

C27H28F21NaO12S

IUPAC Name:

sodium 1,1,1,2,2,3,3,19,19,20,20,21,21,21-tetradecafluoro-11-({[1-(2,2,3,3,4,4,4-heptafluorobutoxy)propan-2-yl]oxy}carbonyl)-7,15-dimethyl-9,13-dioxo-5,8,14,17-tetraoxahenicosane-10-sulfonate

Test material form:

liquid: viscous

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 100 mg/L
- Sampling method: pooled samples were taken at the start and at the end of the experimental part
- Sample storage conditions before analysis: storage and transfer to the external analytical laboratory on dry ice

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test medium (reconstituted water and test material) was prepared freshly. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia
- Strain: Daphnia magna Straus
- Source: IBACON GmbH (Rossdorf, Germany)
- Age at study initiation: younger than 24 h

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/mL

Test temperature:

20.4 - 21.4 °C

pH:

7.9 +/- 0.3

Dissolved oxygen:

about 8 mg/mL

Nominal and measured concentrations:

nominal 100 mg/mL = measured 0.36 mg/mL (start) 0.32 mg/L (end)

Details on test conditions:

TEST SYSTEM
- Test vessel: 4 control, 4 test material
- Type (delete if not applicable): open
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per vehicle control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: standard medium accordng to Elendt

Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Trace elements (mg/L):
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003

Macro nutrients (mg/L):
Na2EDTA x 2H20 2.50

Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75


After preparation, the reconstituded water was aerated for 24 hours.

- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after an aeration for 24 hours.



References:

ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990

Reference substance (positive control):

yes

Remarks:

data taken from another GLP study performed at the same test facility in 2013

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 0.36 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.36 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

no mortality, no other remarkable observations

Results with reference substance (positive control):

24 h EC50 1.018 (0.887 - 1.195) mg/L
48 h ECso 0.769 (0.672- 0.883) mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study, an aqueous solution of 100 mg/L of the test material revealed no aquatic toxicity in the test system.
The 48h EC50 was > 0.36 mg/L (> 100 mg/L, nominal) and could thus not be determined in this study.

Executive summary:

Study Design

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 202.

The objective of this study was to evaluate the influence of the test material on the immobilization of Daphnia magna.

For this purpose, juvenile daphnids were exposed to  an aqueous test  material solution over 48 hours, under defined conditions. The daphnids were observed for immobilization 24 and 48 hours after placing in the test medium. The study comprised of four test vessels in the test material group containing five daphnids each, i.e. 20 daphnids per concentration. Additionally, one control group (20 daphnids) was used.

Daphnids were exposed to a nominal test material concentration of 100 mg/L (limit test). A stability test with a similar test material at a nominal concentration of  100 mg/L in reconstituted water in open vessels revealed a recovery rate of 89.9% after 48 hours. Therefore, the test was performed as a static test in open vessels.

Analytical controls of the test material preparation were performed at the start of the study and after 48 hours.

Results

The analytically determined test  material concentration immediately after  preparation of the medium was 28% and 48 hours thereafter 25% of the nominal concentration.

Nominal and corresponding analytical concentrations and the recovery rate are given in the following table:

Nominal test material concentration in [mg/L]	Analytical concentration after 0 hours		Analytical concentration after 48 hours		Recovery rate of the initial concentration after 48 hours
	in [%]	in [mg/L]	in [%]	in [mg/L]	in [%]
0	< LOQ	< LOQ	< LOQ	< LOQ	-
100	0.4	0.36	0.3	0.32	89

LOQ = limit of quantification of the analytical system (10 µg/L)
During the experimental phase of the study, the test item concentration could be maintained within ± 20% of the initial analytical concentration. Therefore, the EC 50 values were calculated with the initial analytical concentration.

The daphnids were not affected after exposure to an aqueous preparation of a nominal concentration of 100 mg/L.

The motility is given in the following table:

Nominal test material concentration in [mg/L]	Measured test material concentration in [mg/L]	Number of daphnids immobilized / exposed		% of daphnids immobilized / exposed
		24 h	48 h	24 h	48 h
0	< LOQ	0 / 20	0 / 20	0 %	0 %
100	0.36	0 / 20	0 / 20	0 %	0 %

During the experimental phase of the study, the test material concentration could be maintained at levels of >80% of the initial concentration. Therefore, the EC 50 values were calculated with the measured initial concentration.

For the test material, the following nominal EC50 values for daphnids were determined:

24h EC50 > 0.36 mg/L (> 100 mg/L, nominal)

48h EC50 > 0.36 mg/L (> 100 mg/L, nominal)

Conclusion

Under the conditions of the present study, an aqueous solution of 100 mg/L of the test material revealed no aquatic toxicity in the test system.

The 48h EC50 was > 0.36 mg/L (> 100 mg/L, nominal) and could thus not be determined in this study.