1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulphonamide

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Nov - 2 Dec 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 124691-59B
- Physical state: White solid
- Analytical purity: 97.6 %
- Expiration date of the lot/batch: 01 July 2012

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions: Stable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All concentrations monitored
- Sampling method: 2-mL samples were taken from all test concentrations and the control at times zero, and 48h from the approximate center of the test vessel. At the end of the exposure period, the replicates were pooled at each concentration before sampling. Additionally reserve samples of 2 mL were taken for possible further analysis.
- Sample storage conditions before analysis: Stored frozen

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with a concentration of 100 mg/L. Ultrasonication and a 48-hour period of magnetic stirring were required to obtain a clear and colorless solution of the test substance in test medium. The lower concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none, test solutions were clear and colorless throughout the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Cladoceran; Water flea
- Source: Cultures maintained by the test laboratory with known history
- Age at study initiation: < 24 hours, from parental daphnids of more than two weeks old
- Culturing: Daphnids were cultured in M7 media (adjusted ISO media plus trace minerals). Adult daphnids in the cultures were held for at least 14 days prior to collection of the juveniles for testing. The adults showed no signs of disease or stress during the holding period. Daphnids in the cultures were fed daily a suspension of the freshwater algae. The adults were fed prior to test initiation, but neonates were not fed during the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

18.9 - 19.8 °C, from continuous measurement during the test

pH:

7.8 - 8.0

Dissolved oxygen:

8.8 - 9.3 mg/L

Nominal and measured concentrations:

Nominal: 0 mg/L, 4.6 mg/L, 10 mg/L, 22 mg/L, 46 mg/L, 100 mg/L
Measured: see Table 1
Results are based on nominal concentrations since analytically determined concentrations were within 7% of nominal values.

Details on test conditions:

TEST SYSTEM
- Test vessels: 100-mL, glass, 80-mL fill volume
- Aeration: no aeration of test solutions
- No. of organisms per vessel: 5
- No. of vessels per concentration: four
- No. of vessels per control: four
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Defined media prepared using analytical grade salts and tap water purified by a Milli-Q water purification system (Millipore, Bedford, MA, USA)
- Medium: Adjusted ISO medium
- Hardness: 180 mg/L as CaCO3
- Culture medium different from test medium: Yes
- Intervals of water quality measurement: pH and dissolved oxygen measured at beginning and 48 hours, temperature continuously measured in a temperature control vessel
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and immobilization at 24 h, and 48 h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: approximately 2x
- Range finding study: Yes
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

34 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mobility: See Table 2
- Mobility of control: no immobilization of controls

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50: 0.38 mg/L. The historical ranges for 48-hr immobilization EC50 lie between 0.3 and 1.0 mg/L.
- Other: Reference substance toxicity assay conducted 112 days before the test substance assay.

Reported statistics and error estimates:

Calculation of EC50:
The EC50-value was calculated at 24 and 48 hours of exposure from the probits of the percentages of
affected daphnids and the logarithms of the corresponding test substance concentrations using the
maximum likelihood estimation method (Finney, D.J., 1971: Probit analysis, Cambridge University
Press, Cambridge, U.K., 3rd edition).

Table 2, Acute immobilization of daphnids after 24 and 48 hours

Nominal concentration (mg/L)	Number of Daphnia exposed	Response at 24 hours (number)	Response at 24 hours (percentage)	Response at 48 hours (number)	Response at 48 hours (percentage)
Control	20	0	0	0	0
4.6	20	0	0	0	0
10	20	0	0	0	0
22	20	1	5	7	35
46	20	0	0	11	55
100	20	12	60	20	100

Validity criteria fulfilled:

yes

Remarks:

The validity criteria of OECD TG 202 were fulfilled. Control immobilization was < 10% at the end of the test. The dissolved oxygen concentration was ≥ 3 mg/L in the control and test vessels at the end of the test.

Conclusions:

The 48-hour EC50 of FBSEE diol to Daphnia magna was 34.0 mg/L (OECD TG 202).

Executive summary:

The 48-hour EC50 of FBSEE diol to Daphnia magna was examined in a static test conducted according to OECD TG 202. Results are based on nominal concentrations since analytically determined concentrations were within 7% of nominal values. No immobilization was observed for the negative control, and at 4.6 mg/L, and 10 mg/L; 35% cumulative immobilization was observed at 22 mg/L, 55% cumulative immobilization was observed at 46 mg/L, and 100% cumulative immobilization was observed at 100 mg/L. The 48-hour EC50 is 34.0 mg/L. The test was conducted according to internationally accepted test guidelines and was GLP compliant. It is reliable without restriction and suitable for Risk Assessment, Classification and Labeling, and PBT Analysis.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Physical state: white powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: store away from heat

Analytical monitoring:

no

Remarks:

Limit test conducted at 100 mg/L (nominal) loading level

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The 100 mg/L test substance concentration solution was prepared by direct addition of test substance to dilution water (91 mg test substance diluted to 910 mL dilution water). The solution was stirred on a magnetic stir plate for approximately two hours to ensure homogeneity.
- Evidence of undissolved material: Visual observations for the test substance solutions showed the test substance solutions to be transparent in color with no suspended material. A precipitate was not observed.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: Obtained from Era stock cultures maintained in water of test dilution water quality
- Age: <24-hour neonates
- Feeding during test: None

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

142 - 144 (as CaCO3 mg/L)

Test temperature:

20.2 - 20.9 °C

pH:

7.53 - 8.35

Dissolved oxygen:

8.5 - 8.7 mg/L

Conductivity:

524 - 606 µmhos/cm

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: not evaluated

Details on test conditions:

TEST SYSTEM
- Test vessel: 60 mL polystyrene plastic beakers
- Type: open (kept covered except when experimental observations were made)
- Fill volume: 50 mL
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory reconstituted water (LRW) prepared according to the formula contained in USEPA document EPA/821/R/02/012: deionized, carbon-filtered water (0.45 μm membrane filter). Daily testing of dissolved oxygen and temperature.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light; 8 hours dark

EFFECT PARAMETERS MEASURED: immobilization and mortality at 24 and 48 hours

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: No

Reported statistics and error estimates:

LC10 and LC50 calculated with USEPA Statistical Programs; NOEC calculated with TOXSTAT statistical software (v 3.5, West, Inc. and University of Wyoming)

Validity criteria fulfilled:

yes

Remarks:

No mortality or immobilization in control, DOC > 60% of saturation, test duration was 48 hours

Conclusions:

48-hour EC50 (immobilization) of FBSEE diacid to Daphnia magna > 100 mg/L in a limit test per OECD 202.

Executive summary:

FBSEE diacid is a degradation product of FBSEE diol. The 48-hour EC50 (immobilization) of FBSEE diacid to water flea (Daphnia magna) was examined in a static, limit test according to OECD 202. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. No immobilization was observed at the 100 mg/L loading rate or in controls. The study followed an international standard method but was not GLP compliant. The results are for a degradation product rather than the parent material. Therefore the study is deemed reliable with restrictions.

Description of key information

The 48-hour EC50 of FBSEE diol to Daphnia magna was 34.0 mg/L (OECD TG 202, EU Method C.2, and ISO 6341 15).

Additional information

The 48-hour EC50 of FBSEE diol to Daphnia magna was examined in a static test conducted according to OECD TG 202, EU Method C.2, and ISO 6341 15. Results are based on nominal concentrations since analytically determined concentrations were within 7% of nominal values. No immobilization was observed for the negative control, and at 4.6 mg/L, and 10 mg/L; 35% cumulative immobilization was observed at 22 mg/L, 55% cumulative immobilization was observed at 46 mg/L, and 100% cumulative immobilization was observed at 100 mg/L. The 48-hour EC50 is 34.0 mg/L. The test was conducted according to internationally accepted test guidelines and was GLP compliant. It is reliable without restriction and suitable for Risk Assessment, Classification and Labeling, and PBT Analysis. FBSEE diol will be rapidly converted to FBSEE diacid (see section 5.2.1). In a supporting study, the 48-hour EC50 (immobilization) of FBSEE diacid to water flea (Daphnia magna) was examined in a static, limit test according to OECD 202. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. No immobilization was observed at the 100 mg/L loading rate or in controls. The study followed an international standard method but was not GLP compliant. The study is deemed reliable with restrictions.