Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate

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:

From 2017-04-06 to 2017-12-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from 25 September 2017

Analytical monitoring:

yes

Remarks:

Ionic Chromatography (IC)

Details on sampling:

- Concentrations: Sampling in the control vessel and the vessel exposed to the limit concentration (120 mg/L test substance nominal).
- Sampling method: 15 mL of test solution were taken from each test vessel at the beginning and at the end of the test.
- Sample storage conditions before analysis: The samples were analyzed directly without storage.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: 1.0005 g test substance was dissolved in 1L test water to prepare the test solution with a nominal concentration of 1 g/L. The test solution was prepared by dilution of the stock solution with test water.
- Controls: Yes, test medium without test substance.

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

TEST ORGANISM
- Common name: Chinese Rare Minnow.
- Source: Bred in Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement.
- Length at study termination: 2.3 ± 0.1 cm (mean ± SD).
- Weight at study termination: 0.21 ± 0.04 g (mean ± SD).

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions: Same as test:
* Water: Tap water dechlorinated by activated carbon and sterilized by UV lamp.
* Temperature: 21-25°C and constant within a range of 2°C.
* pH: 6.0 - 8.5;
* Dissolved oxygen concentration: > 80% of air saturation value (ASV).
* Photoperiod: Light / Dark = 12 hours / 12 hours.
- Type of food during acclimation: Fish were fed with brine shrimp flake (O.S.I®, USA).
- Feeding frequency during acclimation: Daily until 24 hours before the test was started.
- Health during acclimation: No diseases were observed during the acclimation period. No mortality was observed within the 7 days before the start of the test.

FEEDING DURING TEST
No feeding during the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.0 - 23.0°C

pH:

7.70 - 8.15

Dissolved oxygen:

79.0 % - 92.1 % ASV

Nominal and measured concentrations:

- Nominal concentration: 120 mg/L
- Geometric mean measured concentration: 122 mg/L. During the test, the measured concentrations of the test substance analyzed by IC varied less than 20% over the 96-hour exposure (i.e. concentration decreased by 0% from the start to the end of the test). The geometric mean measured concentration of test substance was 122 mg/L which did not deviate by more than 20% from the nominal concentration of 120 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessels: 5L glass tanks were used containing 4L test solution
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: ca. 0.5 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water dechlorinated by activated carbon and sterilized by UV lamp. The water was aerated continuously over 24h.
- Intervals of water quality measurement: pH, dissolved oxygen and temperature were measured at 0, 24, 48, 72 and 96 hours after test initiation.

OTHER TEST CONDITIONS
- Photoperiod: Light / Dark = 12 hours / 12 hours.

EFFECT PARAMETERS MEASURED
Fish mortality and abnormalities at 0, 3, 24, 48, 72 and 96 hours after test initiation.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test.
- Range finding study:
* Duration: 96 hours.
* Test concentrations: 10, 50 and 100 mg/L (nominal). An aliquot of 1.0007 g test substance was dissolved in 1L test to prepare the stock solution with a nominal concentration of 1 g/L. The test solutions were prepared by
dilution of the stock solution with test water. A blank control (test water without test substance) was also tested in parallel.
* Results used to determine the conditions for the definitive study: Neither mortality, nor abnormalities in the fish of the control and the test substance groups.

Reference substance (positive control):

yes

Remarks:

No reference substance was directly tested in the context of the present study. However, potassium dichromate is routinely tested once a year in the laboratory to demonstrate satisfactory test conditions.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 122 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were neither mortality, nor abnormalities in the fish of the control and the test substance groups during the test.

Results with reference substance (positive control):

- Results with reference substance (potassium dichromate) valid? Yes, 96h-LC50 within the ± 2 SD range of the QC chart of the testing laboratory (81.6 - 307 mg/L).
- Relevant effect levels: After 96 hours, no mortality was observed at the nominal potassium dichromate concentrations of 60, 90 and 135 mg/L reference substance. Mortality of 29 %, 71 % and 100 % were observed at nominal potassium chromate concentrations of 200, 300 and 400 mg/L, respectively.
- Dose-response test: Yes with the following nominal test concentrations: 0, 60, 90, 135, 200, 300 and 400 mg/L potassium dichromate.
- 96h-LC50 (Gobiocypris rarus): 243 mg/L (95 % confidence limits: 194 - 297 mg/L).
- Other: The test was performed from 01 to 05 August 2016.

Reported statistics and error estimates:

No statistics was needed for the test substance in the absence of any effects: the 96h-LC50 was thus set as higher than the limit test concentration of 122 mg/L (geometric mean measured concentration).

Sublethal observations / clinical signs:

Mortality and abnormalities during the range-finding test: (5 fish in each control and treatment group)

Group		Duration (h)	Mortality	Cumulative Mortality	Abnormalities
Blank Control		0	0	0	none
		24	0	0	none
		48	0	0	none
		72	0	0	none
		96	0	0	none
Treatment Groups (Nominal Concentration, mg/L)	10	0	0	0	none
		24	0	0	none
		48	0	0	none
		72	0	0	none
		96	0	0	none
	50	0	0	0	none
		24	0	0	none
		48	0	0	none
		72	0	0	none
		96	0	0	none
	100	0	0	0	none
		24	0	0	none
		48	0	0	none
		72	0	0	none
		96	0	0	none

Mortality and abnormalities during the limit test: (10 fish in each concentration)

Group	Duration (h)	Mortality	Cumulative Mortality	Abnormalities
Blank Control	0	0	0	none
	3	0	0	none
	24	0	0	none
	48	0	0	none
	72	0	0	none
	96	0	0	none
Treatment Group (Geometric mean measured concentration of 122 mg/L)	0	0	0	none
	3	0	0	none
	24	0	0	none
	48	0	0	none
	72	0	0	none
	96	0	0	none

Measured concentrations of the test substance during the limit test:

Group	Nominal concentration (mg/L)	Measure concentration (mg/L)
		0 h	96h	Geometric mean	Variation over the 96h exposure (%)
Blank control	0	<LOQ2	<LOQ2	-	-
Treatment group	120	122	122	122	0

< LOQ2 = 5.30 mg/L

“-”, not determined.

Dissolved oxygen, temperature and pH during the limit test

Group Parameter		Blank Control	Treatment Group (Geometric mean measured concentration of 122 mg/L)
0h	Oxygen (%ASV)	92.1	91.7
	Temperature (°C)	22.3	22.4
	pH	7.80	7.70
24h	Oxygen (%ASV)	82.9	82.8
	Temperature (°C)	23.0	22.9
	pH	8.00	7.92
48h	Oxygen (%ASV)	84.8	79.0
	Temperature (°C)	22.2	22.0
	pH	7.98	7.89
72h	Oxygen (%ASV)	85.5	83.7
	Temperature (°C)	22.1	22.3
	pH	8.05	7.95
96h	Oxygen (%ASV)	85.9	85.2
	Temperature (°C)	22.4	22.3
	pH	8.15	7.98

 

Validity criteria fulfilled:

yes

Remarks:

See in the field "Overall remarks".

Conclusions:

The 96h-LC50 for Gobiocypris rarus exposed to Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate was higher than 122 mg/L under the tested conditions.

Executive summary:

The acute toxicity of Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate (Reaction mass of TFAK and TFSK) to fish was investigated in a GLP compliant OECD guideline 203 study.

A preliminary range-finding test revealed no adverse effect on fish exposed for 96 hours to nominal concentrations of 10, 50 and 100 mg/L test substance. In the definitive test, groups of ten Chinese rare minnow (Gobiocypris rarus) were exposed for 96 hours under static conditions to a control treatment and to a treatment with a limit concentrations of 120 mg/L test substance (nominal concentration). Mortality and abnormalities were observed after 3, 24, 48, 72 and 96 hours.

 

To study exposure to the test substance, samples of test solution were taken and analysed with ionic chromatography (IC) at the beginning (on day 0) and at the end of the test (on day 4). During the test, the measured concentrations of the test substance varied less than 20% over the 96-hour exposure (i.e.concentration decreased by 0% from the start to the end of the test). The geometric mean measured concentration of test substance was 122 mg/L which did not deviate by more than 20% from the nominal concentration of 120 mg/L. No mortality occurred in the control during the test and the dissolved oxygen concentration was greater than 60% of the air saturation value throughout the test duration. Hence the test was considered to be valid.

 

Because neither mortality, nor abnormalities were observed in the fish exposed to the concentration of 122 mg/L (geometric mean measured concentration), the 96h-LC50 was set as higher than this concentration. It can be thus concluded that

the Reaction mass of TFAK and TFSK did not cause any adverse acute effect on Gobiocypris rarus under the present experimental conditions.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2012-05-30 to 2013-03-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples were taken from all test solutions at the beginning (0 d), immediately prior to the first renewal of the test solution (3 d) and at the termination of the test (14 d).
10.0 mL collected water samples were diluted to 100 mL by 60% acetonitrile (acetonitrile:water(0.1% ammonia) (v:v)=60:40), then 10.0 ml diluted solution was draw and diluted to a total volume of 100 mL with 60% acetonitrile (acetonitrile:water(0.1% ammonia) (v:v)=60:40), and filtrated by 0.22 μm millipore membrane, then the filtrates were analysed by UPLC-MS/MS.
As the test substance is a reaction mass containing two constituents in water, the concentration of each constituent, i.e. potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK), was determined in test medium.

Vehicle:

no

Details on test solutions:

The test solution of mixed Reaction Mass of TFAK and TFSK was prepared by directly adding appropriate amount of the test item into test water. Ultrasonication for 30 min was used to facilitate the dispersion of the test substance .
According to the purity of test substance (16.7% (TFAK), 18.7% (TFSK)), provided by sponsor, the test substance was converted to 100% active ingredient into dilution water.
- A nominal concentration of 283 mg/L corresponds to 100 mg (TFAK + TFSK)/L
- A nominal concentration of 600 mg/L corresponds to 212 mg/L (TFAK + TFSK)/L

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Danio rerio
- Source: obtained as fry from a commercial fish supplier of Guangzhou Hongfa Aquatic Animals Culture Company in China.
- Age at study initiation (mean and range, SD): fry
- Method of breeding: A population of a single stock was used in the test.
Feeding fry were held for 30 days in holding tanks supplied with a continuous flow of aerated water before being used for testing. During the pre-culture, the following conditions were maintained:
-Light: 16 hours photoperiod daily (light intensity: 1000 to 1500 lux);
-Temperature: 22 ℃ to 23 ℃ for Zebrafish;
-Oxygen concentration: 60% of the air saturation;
The fish were fed daily during the holding period on proprietary fish food. Food was withheld from the stock population for 24 h prior to the start of the test. The ingredients of the fish food are given as follows:
Crude Protein >36.0%
Crude Fat > 2.0%
Crude Fibre < 3.0%
Crude Ash < 12.0%
Moisture < 10.0%

- Feeding during test: yes
- Food type: same as above.
- Amount: the quantity of food being kept constant 2% dry weight related to the initial fish weight
- Frequency: daily

ENVIRONMENTAL CONDITIONS
Temperature: 23 ± 2℃ for zebra fish.
Oxygen concentration: Not less than 60 per cent of the maximum air saturation value throughout the test; aeration forbidden.
Light: 16-hour light and 8-hour dark cycle daily (light intensity: 1000 to 1500 lux).

ACCLIMATION
Using a general anaesthetic (an aqueous solution of 100 mg/L tricaine methane sulphonate (MS 222) neutralized by the addition of two parts of sodium bicarbonate per part of MS 222), a subsample of 10 fishes before the test were weighed and measured individually as wet weights (blotted dry). Handling of the fish was done with the utmost care to avoid stressing and injuring test animals.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

14 d

Hardness:

122.2 mg/L CaCO3

Test temperature:

23 to 23.3℃

pH:

7.71 - 7.80

Dissolved oxygen:

78% to 92% of the air saturation at the test temperature

Nominal and measured concentrations:

As the test substance is a reaction mass containing two constituents in water, the concentration of each constituent, i.e. potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK), has been considered for the selection of the test concentrations. According to the test results of the range finding study, test fish in nominal concentration of 600 mg/L (i.e: 212 mg/L Reaction Mass TFAK/TFSK) behave normal and no death were observed.
The nominal concentrations of 283 mg/L (corresponding to 100 mg/L Reaction Mass TFAK/TFSK) and 600 mg/L (corresponding to 212 mg/L Reaction Mass TFAK/TFSK) were tested. Additionally, a control was tested in parallel (dilution medium without test substance).

Details on test conditions:

TEST SYSTEM
- Test vessel: Tanks: Made of chemically inert material, with a sealable inert lid, and with a capacity of approximately 3 L.
- Type (delete if not applicable): open
- Aeration: no
- No. of organisms per vessel: 10 for each treatment and control.
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 0.8 to 1.0 g of fish/L.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Good quality tap water which had been dechlorinated for at least 24 h was used. The total hardness of the test water was 122.2 mg (CaCO3)/L, oxygen concentration was about 98% of the air saturation value and pH was 7.55 at room temperature. Characteristics of the dilution water are measured at least twice a year by Jiangsu Provincial Center for Disease Prevention and Control.
- Total organic carbon: 1.91 mg/L
Characteristics of the Dilution Water:
Items Analyzed value Acceptable value
As < 0.001 mg /L ≤0.001 mg /L
Cd < 0.0001 mg /L ≤0.0001 mg /L
Pb < 0.001 mg /L ≤0.001 mg /L
Hg < 0.0002 mg /L ≤0.0005 mg /L
Co < 0.001 mg /L ≤0.001 mg /L
Ni 0.001 mg /L ≤0.001 mg /L
Cu 0.002 mg /L ≤ 0.01 mg /L
Cr6+ < 0.004 mg /L ≤0.05 mg /L
Fe < 0.03 mg /L ≤0.3 mg /L
Al 0.01 mg /L ≤0.2 mg /L
Zn 0.25 mg /L ≤0.1 mg /L
Mn < 0.001 mg /L ≤0.1 mg /L
Ag < 0.001 mg /L ≤0.1 mg /L
pH 7.55 6.0~8.5
The total hardness 122.2 mg /L 10~250 mg (CaCO3)/L
Visible substance None None
Methyl parathion < 0.001 mg /L ≤0.02 mg /L
Malathion < 0.0005 mg /L ≤0.005 mg /L
Parathion < 0.001 mg /L ≤0.003 mg /L
Total organic carbon 1.91 mg /L ≤2 mg /L

- Culture medium different from test medium: no
- Intervals of water quality measurement: twice a year

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark cycle daily
- Light intensity: 1000 to 1500 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Representative samples of 10 individuals in the tank population (blotted dry) were weighed before the test started. At the start of the test, the total wet-weights (blotted dry) of fishes in each concentration were also recorded. At the end of the test all surviving fish were weighed as wet weights (blotted dry) by individual.
All test concentrations were analyzed at the beginning (0 d), immediately prior to the first renewal of the test solution (3 d) and at the termination of the test (14 d).
Measurements of pH, dissolved oxygen and temperature were carried out twice each week.


TEST CONCENTRATIONS
- Spacing factor for test concentrations: < 3.2
- Range finding study
- Test concentrations: 100 mg/L, 212 mg/L (TFAK/TFSK)

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.1

- Range finding study
- Test concentrations: 0, 100 and 212 mg/L (TFAK/TFSK)
- Results used to determine the conditions for the definitive study: no mortality observed, the same doses are kept for the definitive test.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 212 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L)

Basis for effect:

mortality (fish)

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 212 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L)

Basis for effect:

mortality (fish)

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 212 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L)

Basis for effect:

other: behaviour, weights and length

Details on results:

EC50 (96h) > 212 mg/L
14 d-LOLC > 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);
14 d-LOEC (behaviours) > 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L);
14 d-LOEC (weights & length) > 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);

Table 1 shows mortality and visible abnormalities observed in the range finding study and Table 2 shows mortality and visible abnormalities observedin the main study. Table 3 and Table 4 show the individual and mean fish weights and individual and mean fish lengths on Day 0 respectively.
During the test, no fish died in all concentration (100 mg/L, 212 mg/L) and control treatments. Thus the LOLC (the lowest observed lethal concentration) is greater than 600 mg/L, while the NOLC (the No observed lethal concentration) is equal or greater than 212 mg/L.
According to the effects of behaviours, abnormal behaviour was not observed in the control and all concentration treatments (100 mg/L, 212 mg/L). Thus the LOEC for behaviours is greater than 212 mg/L, while the NOEC for behaviours is equal or greater than 212 mg/L.
At the start of the test, fishes weighed about 0.262 g (± 7.09%) and measured about 2.84 cm (± 6.12%) in average length. Fish were chosen and randomly put into different test solutions after the temperature has been adjusted to the required value. At the end of the test, the mean weight and the length of fish in the controls increased.
Based on analysis of variance (ANOVA, STATA 10.0), the pseudo specific growth rates and the length changing rates for each concentration were then compared with the control values using an multiple comparison method of Dunnett’s tests. The results showed that there was no significant difference for pseudo specific growth rates and the length changing rates among all test concentrations and the control (p>0.05). Therefore according to the effects of weights and lengths, the LOEC is greater than 212 mg/L, while the NOEC is equal or greater than 212 mg/L.

Reported statistics and error estimates:

Dunnett’s tests

Sublethal observations / clinical signs:

Table 1: The Mortality and Visual Observations during the Range-finding Test

Nominal Concentration (mg/L)*	Initial number of fish	The number of the dead fish
		24 h	48 h	72 h	96 h
0	5	0	0	0	0
283	5	0	0	0	0
600	5	0	0	0	0
Nominal Concentration (mg/L)*	Initial number of fish	Visual observations
		24 h	48 h	72 h	96 h
0	5	NB	NB	NB	NB
283	5	NB	NB	NB	NB
600	5	NB	NB	NB	NB

*Corresponding to 100 and 212 mg/L (Reaction Mass TFAK + TFSK)

Table 2: Mortality and Visible Abnormalities Observed in the Test Fish

Nominal Concentration(mg/L)	Initial Number of Fish		Total of the dead	Mortality/Observation
				Day 1	Day 2	Day 7	Day 8	Day 9	Day 13	Day 14
Blank Control	10		0	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB
283	10		0	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB
600	10		0	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB	0/NB
LOEC（behaviours）	600 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L)
NOEC（behaviours）	600 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L)
LOLC	600 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L)
NOLC	600 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L)

Note: Abbreviations of symptoms of intoxication described in the table NB: Normal Behaviou

Table 3: Individual and Mean Fish Weights on Day 0

	No. of the Subsample Fish
	1	2	3	4	5	6	7	8	9	10
Weight (g)	0.267	0.284	0.272	0.222	0.265	0.271	0.259	0.270	0.238	0.272
Min.	0.222 g
Max.	0.284 g
Mean	0.262 g
RSD.	7.09%
	Nominal concentration (mg/L)
	Blank Control			283			600
1	0.280			0.261			0.260
2	0.302			0.246			0.274
3	0.288			0.282			0.268
4	0.266			0.246			0.262
5	0.271			0.241			0.263
6	0.277			0.239			0.278
7	0.268			0.252			0.274
8	0.257			0.247			0.265
9	0.246			0.258			0.288
10	0.262			0.245			0.289
Mean weight (g)	0.272			0.252			0.272
Mean Logarithms	-1.30			-1.38			-1.30

 

Table 4: Individual and Mean Fish Lengths on Day 0

	No. of the Subsample Fish
	1	2	3	4	5	6	7	8	9	10
Lengths (cm)	2.89	3.02	2.78	2.77	2.86	2.87	2.67	2.65	2.68	3.21
Min.	2.65 cm
Max.	3.21 cm
Mean	2.84 cm
RSD	6.12%
Lengths (cm)	Nominal Concentration (mg/L)
	Blank Control			283			600
	2.66			2.78			2.98
	2.42			2.34			2.71
	2.36			2.55			2.42
	2.51			2.6			2.39
	2.57			2.73			2.75
	2.69			2.57			2.67
	2.84			2.86			2.48
	2.92			2.66			2.34
	2.88			2.73			2.25
	2.75			2.94			2.67
	2.66			2.68			2.57
	0.976			0.982			0.939

 

Validity criteria fulfilled:

yes

Remarks:

All fishes in the control group were normal. So the study met the acceptability criteria (dissolved oxygen concentration: no less than 60% of the air saturation value; mortality in the control group must not exceed 10% at the end of the test)

Conclusions:

There was no mortality observed during the test.
EC50 (96h) >212 mg/L
14 d-LOLC >212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);
14 d-LOEC (behaviours, weights and length) >212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration110 mg/L);

Executive summary:

Under semi-static conditions of 72 h-renewal, the threshold levels of lethal and other observed effects in fish (Brachydanio rerio) exposed to the test substance for 14 days was conducted according to the OECD Testing Guideline 204.

During the whole test period, the pH values of the control and Test Media were between 7.71 and 7.80, and the Dissolved Oxygen (DO) values varied from 78% to 92% of the air saturation at the test temperature, and the temperature of the Test Media was maintained in the range of 23 to 23.3°C. All fish in the control group were normal. The test substance concentrations were maintained constant during the study. So the study met the acceptability criteria (dissolved oxygen concentration: no less than 60% of the air saturation value;mortality in the control group must not exceed 10% at the end of the test; concentration of the substance being tested has been satisfactorily maintained over the test period). Therefore the test was considered valid.

As the test substance is a reaction mass containing two constituents in water, the concentration of each constituent, i.e.potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK), was determined in test medium by UPLC-MS/MS.

No mortality and effects on appearance, size and behaviour was observed at the tested concentrations. Therefore, under valid semi-static test conditions (72 h-renewal), the EC50 and the NOEC (the lowest No observed effect concentration) of the test substance were concluded as follows:

96 h-EC50 >212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);

14 d-NOEC (behaviours) >= 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);

14 d-NOEC (weights and length) >= 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L).

Description of key information

The 96h-LC50 for Gobiocypris rarus exposed to Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate was higher than 122 mg/L under the tested conditions.

Additional information

Two reliable short-term toxicity studies in fish are available for the reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate.

A GLP-compliant OECD 203 guideline study with fish was conducted with the reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate as part of a new chemical substance notification in China. In this static limit test, groups of ten Chinese rare minnow (Gobiocypris rarus) were exposed for 96 hours to a control treatment and to a treatment with a nominal concentration of 120 mg/L, which geometric mean measured concentration was 122 mg/L.

There were no mortalities and abnormalities observed in the treatment group during the test period. No mortality occurred in the control during the test and the dissolved oxygen concentration was greater than 60% of the air saturation value throughout the test. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance analyzed by Ion Chromatography varied by less than 20% (i.e. 0%). The 96h LC50 for the test substance to Gobiocypris rarus was higher than 122 mg/L under the tested conditions

The second study is a GLP-compliant prolonged 14-day toxicity test in fish according to OECD 204 that was conducted with the reaction mass of potassium trifluoromethanesulphinate and potassium trifluoroacetate as part of a new chemical substance notification in China. The 14-day prolonged fish test is not considered as a chronic test because the sensitive life-stages (juveniles, eggs, larvae) are not exposed. Therefore the results will be considered as part of the dataset for short-term toxicity to fish. Based on the results of a preliminary test, groups of 10 zebrafish (Brachydanio rerio) were exposed for 14 days under semi-static conditions of 72-h renewal to a control treatment and to treatment groups with nominal concentrations of 100 and 212 mg/L.

As the test substance is a reaction mass containing two constituents in water, the concentration of each constituent, i.e. potassium trifluoroacetate (TFAK) and potassium trifluoromethanesulphinate (TFSK), was determined in test medium by UPLC-MS/MS. The test substance concentrations were maintained constant during the study. No mortality was observed in the control group and the dissolved oxygen concentration was greater than 60% of the air saturation value throughout the test. Therefore the test was considered valid.

No mortality and effects on appearance, size and behaviour was observed at the tested concentrations. Therefore, the results of the main test confirm the 96LC50 determined in the range-finding study and the results are the following:

96 h-L(E)C50 > 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);

14 d-NOEC (behaviour, weight and length) >= 212 mg/L (TFAK measured concentration 91.5 mg/L; TFSK measured concentration 110 mg/L);

  

Based on the above information, the reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate is not harmful to fish.