Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2012-03-30 to 2013-03-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study, OECD 211 compliant

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

All test solutions were taken from all test solutions at the beginning (0 d), immediately prior to the first renewal of the test solution (3 d) and weekly thereafter (9, 21 d). 10 ml collected water samples passing through the 0.22 µm membrane were analysed by UPLC-MS/MS.

Vehicle:

no

Details on test solutions:

A stock solution was firstly prepared and the test solutions at different concentrations were diluted by the stock solution.
The stock solution of 10000 mg/L was prepared by adding 1.00 g test substance into 100mL test water. Then the solution was diluted by 100mL Elendt M7 medium to give a concentration of 100 mg/L. The test solutions were prepared by diluting the stock solution with Elendt M7 medium. Details of the solutions prepared were showed as follows:
Concentration of test substance Volume of stock solution Total medium volume
(mg/L) (at 100 mg/L) added (µL) (mL)
Blank control - -
0.63 313 50
1.25 625 50
2.50 1250 50
5.00 2500 50
10.0 5000 50

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: own laboratory breeding
- Age of parental stock (mean and range, SD): not being the first brood progeny, was the test species which were 6 to 24 hours old at the start of the test
- Feeding during test: yes
- Food type: Chlorella vulgaris Beij.
- Amount: 0.2 - 0.4 mg C/Daphnia each time.
- Frequency: once every two days

ACCLIMATION: none, culture conditions during breeding

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

221 to 232 mg/L as CaCO3

Test temperature:

20 ± 1°C

pH:

7.4 - 7.7

Dissolved oxygen:

92% to 101% of the air saturation at the test temperature

Nominal and measured concentrations:

Nominal: 0, 0.63, 1.25, 2.5, 5 and 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-mL glass beakers. (100-mL, Tianbo Glass Instruments Factory)
- Type (delete if not applicable): open
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 0
- No. of vessels per control (replicates): 0


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M7 was used
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

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) :
- Observations: the number of living offspring was counted for each vessel daily. The offspring produced by each parent animal were preferably removed and counted daily from the appearance of the first brood to prevent them consuming food intended for the adult.
- Concentration: all test concentrations were analyzed at the beginning (0 d), immediately prior to the first renewal of the test solution (3 d) and weekly thereafter (9, 21 d). In all cases, determination of test substance concentrations prior to renewal was performed on one seperate vessel at each test concentration.
- Other parameters: including time to production of first brood; number of broods per animal.
Besides, oxygen concentration, temperature, hardness and pH values were measured once a week, in the control(s) and the highest test substance concentration.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK

Basis for effect:

reproduction

Details on results:

Analysis of Test Substance in Test Solutions:
The analytical results showed that the analysed concentrations of TFAK and TFSK are consistent in the test medium throughout the test period (deviation within 20% of the initial concentration). Thus a semi-static method of 72 h-renewal test procedure was reasonable.

Test Conditions:
During the whole test period, the pH values of the control mediums and Test Media were between 7.4 and 7.7, and the Dissolved Oxygen (DO) values varied from 92% to 101% of the air saturation at the test temperature, the hardness values varied from 221 to 232 mg (CaCO3)/L, and the temperature of the Test Media was maintained in the range of 20°C to 21°C.

Reproduction and Mortality:
During the test, all animals in the control were alive and the mean number of live offspring produced per parent animal surviving at the end of the test was > 60. The coefficient of variation around the mean number of living offspring produced per parent animal in the control(s) was<25%.
At the end of the test period, one adult died in 2.50 mg/L, 5.00 mg/L and 10.0 mg/L respectively. The adult died during the 4th day and 7th day. No dead adults were observed in the control.
The effects on mortality of the adult, the time to production of first brood, the number of broods per animal alive were observed daily. Compared with the reproduction of the controls, no significant differences were found in treatments and the control. As a result, the LOEC is greater than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK) and the NOEC is not less than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK ).

Reproduction Inhibition Effects

Nominal Conc.(mg/L)	Initial No.of Adults	21d
		Mean Fecundity  (No. live offspring per adult)	Inhibition rate
0	10	64	—
0.63	10	61	4.38%
1.25	10	61	5.16%
2.50	10	62	3.13%
5.00	10	59	7.29%
10.0	10	60	5.56%
LOEC (by One-Way ANOVA)		> 10.0 mg/L (nominal concentration)
NOEC (by One-Way ANOVA)		≥10.0 mg/L (nominal concentration)

Validity criteria fulfilled:

yes

Remarks:

All animals in the control were alive and the mean number of live offspring was > 60. The coefficient of variation around the mean number of living offspring in the control(s) was ≤ 25%.

Conclusions:

No statistical significative effect on the reproduction of organisms was observed compared to the control. The results showed that under valid semi-static test conditions (72 h-renewal), the LOEC is greater than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK) and the NOEC is not less than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK).

Executive summary:

Under semi-static conditions of 72 h-renewal, the effect on the reproductive output of Daphnia magna exposed to the test substance (Reaction mass of potassium trifluoromethanesulphinate and potassium trifluoroacetate) for 21 days was conducted according to the OECD Testing Guideline 211.

During the whole test period, the pH values of the control mediums and Test Media were between 7.4 and 7.7, and the Dissolved Oxygen (DO) values varied from 92% to 101% of the air saturation at the test temperature, the hardness values varied from 221 to 232 mg(CaCO₃)/L, and the temperature of the Test Media was maintained in the range of 20°C to 21°C.

All animals in the control were alive and the mean number of live offspring produced per parent animal surviving at the end of the test was > 60. The coefficient of variation around the mean number of living offspring produced per parent animal in the control(s) was < 25%. So the study met the acceptability criteria. 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 during the study. The analysed concentration of the test item was therefore expressed by the active matter of TFAK and TFSK. The analytical results showed that the analysed concentrations of TFAK and TFSK are consistent in the test medium throughout the test period (deviation within 20% of the initial concentration)

 

At the end of the test period, one adult died in 2.50 mg/L, 5.00 mg/L and 10.0 mg/L respectively. The adult died during the 4th day and 7th day. The effects on mortality of the adult, the time to production of first brood, the number of broods per animal alive were observed daily. Compared with the reproduction of the controls, no significant differences were found in treatments and the control. As a result, the LOEC is greater than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK) and the NOEC is not less than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK ).

Description of key information

In a long term toxicity study to Daphnia, no statistical significant effect on the reproduction of organisms was observed compared to the control. The NOEC is ≥ 3.21 mg/L of reaction mass (1.45 mg/L TFAK and 1.76 mg/L TFSK).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

3.21 mg/L

Additional information

A long-term toxicity study to Daphnia is available for the reaction mass potassium trifluoroacetate and potassium trifluoromethanesulphinate and is selected as key study. In this study, the effect on the reproductive output of Daphnia magna exposed to the test substance for 21 days was conducted according to the OECD Testing Guideline 211 under semi-static conditions of 72 h-renewal.

The test item was an aqueous solution of the reaction mass of TFSK and TFAK because it is the form under which the substance is manufactured and used. The results were expressed in both test item and active matter (i.e. both dried constituents of the reaction mass). The ecotoxicity profile of the substance has been determined based on the results expressed as active matter and therefore are applicable to the substance described in the section 1.2 of the iuclid.

During the whole test period, the pH values of the control medium and Test Media were between 7.4 and 7.7, and the Dissolved Oxygen (DO) values varied from 92% to 101% of the air saturation at the test temperature, the hardness values varied from 221 to 232 mg(CaCO3)/L, and the temperature of the Test Media was maintained in the range of 20°C to 21°C.

All animals in the control were alive and the mean number of live offspring produced per parent animal surviving at the end of the test was > 60. The coefficient of variation around the mean number of living offspring produced per parent animal in the control(s) was < 25%. So the study met the acceptability criteria. 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 during the study. The analysed concentration of the test item was therefore expressed by the active matter of TFAK and TFSK. The analytical results showed that the analysed concentrations of TFAK and TFSK are consistent in the test medium throughout the test period (deviation within 20% of the initial concentration)

At the end of the test period, one adult died in 2.50 mg/L, 5.00 mg/L and 10.0 mg/L respectively. The adult died during the 4th day and 7th day. The effects on mortality of the adult, the time to production of first brood, the number of broods per animal alive were observed daily. Compared with the reproduction of the controls, no significant differences were found in treatments and the control. As a result, the LOEC is greater than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK) and the NOEC is not less than 10.0 mg/L (nominal concentration, analysed concentration: 1.45 mg/L TFAK and 1.76 mg/L TFSK ).