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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 Nov - 4 Dec 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)

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: 2 mL
- Sampling method: During the limit test single 2 mL samples were taken from the center of the test vessels from the test solution and control vessels. Samples were taken at the start of the test and after 96 hours from the freshly prepared solutions.
- Sample storage conditions before analysis: Samples were stored in a freezer and defrosted at room temperature on the day of analysis

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. In the range-finding test an overnight period of magnetic stirring was sufficient to completely dissolve the test substance. In the final test additional treatment with ultrasonic waves and a 48-hour period of magnetic stirring were needed to obtain a clear and colourless solution. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions were all clear and colourless.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material: No visible undissolved test substance was observed at the test initiation.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra-fish
- Source: Wageningen University and Research Centre, The Netherlands
- Length at study initiation: range-finder, 2.8 ± 0.1 cm; limit test, 3.1 ± 0.2 cm
- Weight at study initiation: range-finder, 0.30 ± 0.04 g; limit test, 0.52 ± 0.18 g
- Feeding during test: No

ACCLIMATION
- Acclimation period: At least 12 days after receipt by laboratory delivery.
- Acclimation conditions (same as test or not): unknown
- Type and amount of food: Pelleted fish food (Cyprico Crumble Excellent (300-500 um), Coppens
International bv, Helmond, The Netherlands)
- Feeding frequency: Daily until 24 hours prior to the start of the test.
- Health during acclimation (any mortality observed): less than 5% mortality in the seven days prior to
the test

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

180 mg/L as CaCO3

Test temperature:

21.3 - 22.7 °C

pH:

7.5 - 7.9

Dissolved oxygen:

5.2 - 9.2 mg/L

Nominal and measured concentrations:

Nominal: 10, 18, 32, 56 (45 mgL measured) and 100 (91 mg/L measured) mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L, all-glass container. Fill volume was 9.8 L.
- Aeration: Introduced after 48 hours of exposure
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.37 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium prepared using reverse-osmosis purified water
(GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Culture medium different from test medium: No
- Intervals of water quality measurement: Daily in all vessels with surviving fish, beginning at the start of the test (day 0)

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours light; 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and/or severely distressed fish at 2.75, 24, 48, 72, and 96 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: Yes
- Test concentrations: 10, 18, 32, 56 and 100 mg/L

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

95 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: based on 0% mortality at 56 mg/L and 57% mortality at 100 mg/L

Details on results:

- Mortality results are shown in Table 1.
- Behavioural abnormalities: all observations for 100 mg/L nominal: discoloured (7/7 at 2.75 h), loss of equilibrium (3/7 at 2.75 h), discoloured (3/3 at 24-96 h), swimming at the bottom of the vessel (3/3 at 48-96 h)
- Mortality of control: None
- Other adverse effects control: None

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: yes
- LC50: 0.25 mg/L
- Other: Result falls in the normal range of historical controls (0.10 mg/L and 0.46 mg/L). Reference substance test was conducted 53 days before the final toxicity test.

Reported statistics and error estimates:

The LC50 was estimated using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition).

Sublethal observations / clinical signs:

Table 1. Incidence of mortality and total mortality during the final test.

.	.	Cumulative mortality					.
Nominal concentration MTDID 23321 (mg/L)	Initial number of fish	2.75 h	24 h	48 h	72 h	96 h	Total mortality (%)
control	7	0	0	0	0	0	0
10	7	0	0	0	0	0	0
18	7	0	0	0	0	0	0
32	7	0	0	0	0	0	0
56	7	0	0	0	0	0	0
100	7	0	4	4	4	4	57

Validity criteria fulfilled:

yes

Remarks:

No control mortality, DOC > 60% of saturation

Conclusions:

The 96-hour LC50 of FBSEE diol to zebra-fish (Brachydanio rerio) was 95 mg/L (nominal; OECD 203).

Executive summary:

The toxicity of FBSEE diol to zebra-fish (Brachydanio rerio) was assessed in a 96 -hour toxicity test conducted according to the OECD 203 method. The 96 -hour LC50 of FBSEE diol was 95 mg/L based on 0% mortality at 56 mg/L and 57% mortality at 100 mg/L. The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

9 - 13 May 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: JA9215
- Expiration date of the lot/batch: 2017.08.21
- Purity: 99.94%
- Purity test date: 2015.09.02

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (15-25 °C)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 60.0, 68.2, 77.5, 88.0, and 100 mg/L
- Sampling method: Samples were taken before and after medium replacement. For pre-replacement medium, samples were taken directly from the freshly prepared solutions at times 0 and 72 hours. Spent medium was taken from test vessels at times 24 hours and 96 hours. 10 mL was taken from each of the test solutions; 5 mL was diluted with 50% v/v methanol TW solution then filtered through a micro membrane filter.
- Sample storage conditions before analysis: stored at 2-8 °C

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Nominal amounts of the test items (0.600 g, 0.682 g, 0.775 g, 0.880 g, and 1.00 g) were weighed and dissolved with test water to make 10 L of the test solutions. The solutions were mixed with magnetic stirrers for 23-24 hours before exposure.
- Controls: Test water
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no information available

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

TEST ORGANISM
- Common name: Rare minnow
- Source: Shanghai Academy of Public Measurement
- Length at study initiation: 3.2 - 3.8 cm
- Weight at study initiation: 0.4707 - 0.8219 g
- Feeding during testing: No

ACCLIMATION
- Acclimation period:
- Acclimation conditions: 12 hours light: 12 hours darkness; temp: 23 ± 2 °C; oxygen concentration: not less than 80% of air saturation value
- Type and amount of food during acclimation: Brine shrimp twice on weekdays and once on weekends, discontinued approximately 24 hours prior to the start of the test
- Health during acclimation (any mortality observed): no sign of disease or mortalities in fish maintained in-house since August 26, 2015

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Daily renewal of test solutions

Hardness:

140 mg CaCO3/L

Test temperature:

21.70 - 23.73 °C

pH:

7.47 - 8.39

Dissolved oxygen:

63.9 - 96.7% of air saturation value

Nominal and measured concentrations:

Nominal: 60.0, 68.2, 77.5, 88.0 and 100 mg/L
Measured: 63.9, 77.0, 82.9, 95.3, and 105 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L rectangular glass tank (30 cm x 20cm x 30 cm)
- Aeration: No
- Renewal rate of test solution: once every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground water treated with Aquapro pure water system
- Culture medium different from test medium: No
- Intervals of water quality measurement: Daily in both control and test solutions

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 12 hours light: 12 hours darkness

EFFECT PARAMETERS MEASURED: Mortality, visible abnormalities

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 5, 10, 50, 60, 70, 85, 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

98.36 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CI: 95.33-101.48 mg/L

Details on results:

- Behavioural abnormalities: Erratic swimming and discoloration were observed at 68.2 mg/L, 77.5 mg/L and 88.0 mg/L concentrations.
- Mortality: One death (of 7) occurred in the 88.0 mg/L concentration and 7 deaths (of 7) in 100 mg/L concentration.
- Mortality of control: None

Results with reference substance (positive control):

- Results with reference substance valid? not specified
- Mortality: yes
- LC50: 464.31 mg/L (95% CI: 407.28-529.32 mg/L) at 24 hours

Reported statistics and error estimates:

Trimmed Spearman-Karber method was used to evaluate the data.

Validity criteria fulfilled:

yes

Remarks:

No control mortality, DOC > 60% of saturation

Conclusions:

The 96-hour LC50 of FBSEE diol to rare minnow (Gobiocypris rarus) was 98.36 mg/L (95% CI: 95.33-101.48 mg/L) (OECD 203).

Executive summary:

The toxicity of FBSEE diol to rare minnow (Gobiocypris rarus) was assessed in a 96-hour toxicity test conducted according to the OECD 203 method. The 96-hour LC50 of FBSEE diol was 98.36 mg/L (95% CI: 95.33-101.48 mg/L). The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

24-28 May 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity 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 (400.5 mg test substance diluted to 4.0 L dilution water). The solution was stirred on a magnetic stir plate for 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):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Source: Aquatic Biosystems, Fort Collins, CO, USA
- Age at study initiation: juvenile
- Length at study termination (mean): 1.1 cm
- Weight at study termination (mean): 8.0 mg

ACCLIMATION
- Acclimation period: Held for 14 days before testing under static renewal conditions using test dilution water
- Feeding frequency during acclimation: Daily

FEEDING DURING TEST
- Did not feed during the test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

252 - 260 CaCO3 mg/L

Test temperature:

19.6 - 20.7 °C

pH:

7.39 - 8.16

Dissolved oxygen:

8.0 - 8.7 mg/L

Conductivity:

675 - 708 μmhos/cm

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: not evaluated

Details on test conditions:

TEST SYSTEM
- Test vessel: 1.0 liter borosilcate glass beakers
- Type: open (kept covered except when experimental observations were made)
- Material, size, headspace, fill volume: 900 mL of dilution water or test solution per chamber
- Aeration: No
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

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
- All test chambers were identical. Test organisms were impartially assigned to test chambers. Treatments were randomly assigned to individual test chamber locations. Any two test chambers did not have more than 2 °C measured temperature difference.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 24, 48, 72, and 96 hours

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No

Reported statistics and error estimates:

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

Validity criteria fulfilled:

yes

Remarks:

No control mortality, DOC > 60% of saturation, the concentration of the test substance was satisfactorily maintained

Conclusions:

96-hour LC50 of FBSEE diacid to fathead minnow (Pimephales promelas) > 100 mg/L in a limit test per OECD 203.

Executive summary:

FBSEE diacid is a degradation product of FBSEE diol. The 96-hour LC50 of FBSEE diacid to fathead minnow (Pimephales promelas) was examined in a static, limit test according to OECD 203. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. No mortality 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 96-hour LC50 of FBSEE diol to zebra-fish (Brachydanio rerio) was 95 mg/L (nominal; OECD 203).

Additional information

In the key study, the toxicity of FBSEE diol to zebra-fish (Brachydanio rerio) was assessed in a 96-hour toxicity test conducted according to the OECD 203 method. The 96-hour LC50 of FBSEE diol was 95 mg/L based on 0% mortality at 56 mg/L and 57% mortality at 100 mg/L. The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis. The supporting study was designated as such due to slightly less clear documentation and a less conservative result. In this study, the toxicity of FBSEE diol to rare minnow (Gobiocypris rarus) was assessed in a 96-hour toxicity test conducted according to the OECD 203 method. The 96-hour LC50 of FBSEE diol was 98.36 mg/L (95% CI: 95.33-101.48 mg/L). The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, this study is reliable without restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis. FBSEE diol will be rapidly converted to FBSEE diacid (see section 5.2.1). In a separate study, the 96-hour LC50 of FBSEE diacid to fathead minnow (Pimephales promelas) was examined in a static, limit test according to OECD 203. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. No mortality was observed at the 100 mg/L loading rate or in controls. The study followed an international standard method but was not GLP compliant. Therefore the study is deemed reliable with restrictions.