Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2017-03-27 to 2018-12-28
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)
Version / remarks:
2004
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 one control vessel and in one vessel exposed to the limit concentration (121 mg/L test substance nominal).
- Sampling method: 10 mL of test solution were taken from one vessel of the control and the treatment group 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: 120.9 mg test substance were dissolved in 1L reconstituted water to prepare a stock solution with a nominal concentration of 121 mg/L. The pH of the stock solution was 8.05 and was therefore not adjusted.
- Controls: Yes, test medium without test substance.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea.
- Age at study initiation: Young daphnids used for the test were aged less than 24 hours and were not first brood progeny at the start of the test.
- Method of breeding: Cultures of adult Daphnia magna are fed with a concentrated freshwater suspensions of unicellular green algae Desmodesmus Subspicatus and Pseudokirchneriella subcapitata at a rate equivalent to 0.1~0.2mg of organic carbon per adult per day.
- Source: The winter eggs of the daphnids were originally supplied by MicroBioTests Inc. and each subsequent generation was bred in Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement in the reconstituted water.
- Feeding during test: No.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
160 mg/L (as CaCO3)
Test temperature:
20.7 - 21.5°C
pH:
8.05 - 8.22
Dissolved oxygen:
8.49 - 8.60 mg/L
Nominal and measured concentrations:
- Nominal concentration: 121 mg/L.
- Geometric mean measured concentration: 128 mg/L. During the test, the measured concentrations of the test substance varied by less than 20% (i.e. 2.36%) over the 48-hour exposure. Therefore the substance concentration has been satisfactorily maintained during the test.
Details on test conditions:
TEST SYSTEM
- Test vessel: 75 mL glass containers containing 60 mL test solution.
- Aeration: Not during the test (before the test, test medium was aerated until oxygen saturation was reached).
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 12mL of the test solution per animal.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water. Analytical grade salts were dissolved in deionised water to obtain this medium:
CaSO4·2H2O: 120.0 mg/L
MgSO4: 120.0 mg/L
NaHCO3: 192.0 mg/L
KCl: 8.0 mg/L
Na2SeO3: 2.0 µg/L
Vitamine B12: 1.0 µg/L
- Culture medium different from test medium: No.
- Intervals of water quality measurement: pH, dissolved oxygen and temperature were measured at the beginning and at the end of the test.

OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: Light/Dark: 16 hours/8 hours.

EFFECT PARAMETERS MEASURED
Immobilisation of daphnids at 24 and 48 hours after test initiation.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test.
- Range finding study: Three nominal concentrations of 12.1, 60.5 and 121 mg/L were used in the range-finding test. A blank control of reconstituted water was used. Five daphnids were introduced into each group of treatment and control without replicate. A static test was performed and the test duration was 48 hours. No immobilisation was observed in the control and treatment group during the range-finding test.
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 in the laboratory for each batch of Daphnia magna.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 128 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural and morphological abnormalities: No particular behavioural and morphological changes were observed in the control group and in the group exposed to the limit test concentration.
- Immobilisation of control: No immobilisation in control daphnids (nor in daphnids exposed to the limit test concentration).
Results with reference substance (positive control):
- Results with reference substance (potassium dichromate) valid? Yes, the 24h-EC50 was within the accepted limits of ISO 6341 which was cited as a reference in OECD 202 guideline (i.e. the 24h-EC50 for potassium dichromate should be between 0.6 and 2.1 mg/L).
- Relevant effect levels: After 24 hours, no immobilisation was observed at nominal potassium dichromate concentrations of 0.32 and 0.56 mg/L. Immobilisation of 5 %, 60 % and 90 % were observed at nominal potassium chromate concentrations of 1, 1.8 and 3.2 mg/L, respectively.
- Dose-response test: Yes with the following nominal test concentrations: 0, 0.32, 0.56, 1, 1.8 and 3.2 mg/L potassium dichromate.
- 24h-EC50 (Daphnia magna): 1.76 mg/L (95 % confidence limits: 1.49 - 2.10 mg/L).
- Other: The test was performed from 13 to 14 March 2017.
Reported statistics and error estimates:
No statistics was needed for the test substance in the absence of any effects: the 48h-EC50 was thus set as higher than the limit test concentration of 128 mg/L (geometric mean measured concentration).

Immobilisation of Daphnia magna during the range-finding test

Parameter

Blank Control

Treatment Groups

(Nominal Concentration, mg/L)*

12.1

60.5

121

Duration (h)

24

48

24

48

24

48

24

48

Number of Exposed Daphnids

5

5

5

5

5

5

5

5

Number of Immobilized Daphnids

0

0

0

0

0

0

0

0

Effect (%)

0

0

0

0

0

0

0

0

*No particular behavioural or morphological changes were observed.

 

Immobilisation of Daphnia magna during the limit test

Parameter

Blank Control

Treatment Group (Geometric mean measured concentration, 128mg/L)*

Duration (h)

24

48

24

48

Number of Exposed Daphnids

20

20

20

20

Number of Immobilized Daphnids

Replicate A

0

0

0

0

Replicate B

0

0

0

0

Replicate C

0

0

0

0

Replicate D

0

0

0

0

Total Number of Immobilized Daphnids

0

0

0

0

Effect (%)

0

0

0

0

*No particular behaviouralor morphological changes were observed.

Measured concentrations of the test substance during the limit test

Group

Nominal concentration (mg/L)

Measured concentration (mg/L)

0h

48h

Geometric mean

48h vs 0h (%)

Blank control

0

< LOQ2

< LOQ2

-

-

Treatment group

121

127

130

128

2.36

< LOQ2 = 5.30 mg/L

“-”, not determined.

 

Dissolved oxygen concentrations, pH values and temperature during the limit test  

Parameter

Blank control

Treatment Group

(Geometric mean measured

concentration, 128 mg/L)

0h

pH

8.21

8.05

Temperature (°C)

20.7

20.9

Dissolved oxygen (mg/L)

8.60

8.57

24h

pH

8.22

8.07

Temperature (°C)

21.5

21.5

Dissolved oxygen (mg/L)

8.52

8.56

48h

pH

8.17

8.02

Temperature (°C)

21.5

21.4

Dissolved oxygen (mg/L)

8.49

8.57

Validity criteria fulfilled:
yes
Remarks:
See in the field "Overall remarks".
Conclusions:
The 48h-EC50 for Daphnia magna exposed to Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate was higher than 128 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 daphnids was investigated in a GLP compliant OECD guideline 202 study.

Based on the results of a range-finding test, a limit test was performed under static conditions at a nominal concentration of 121 mg/L. Four replicates of 5 daphnids each were performed in the test and control groups. The test duration was 48 h.

At the end of the test the percentage of dahpnids that were immobilised was 0% for both control and treatment groups. The dissolved oxygen concentrations were higher than 3 mg/L in controls and treatments and therefore the test was considered valid. The test substance concentrations were analysed with ionic chromatography (IC) at the beginning (on day 0) and at the end of the test (on day 2). During the test, the measured concentrations of the test substance varied less than 20% (i.e. 2.36%) of the initial concentration. The geometric mean measured concentration of test substance was 128 mg/L which did not deviate by more than 20% from the nominal concentration of 121 mg/L.

 

Because no adverse effects were observed in the daphnids exposed to the concentration of 128 mg/L (geometric mean measured concentration), the 48h-EC50 was set as higher than this concentration. It can be thus concluded that

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

Description of key information

The 48h-EC50 for Daphnia magna exposed to Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate was higher than 128 mg/L under the tested conditions.

Key value for chemical safety assessment

Additional information

The acute toxicity of Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate (Reaction mass of TFAK and TFSK) to daphnids was investigated in a GLP compliant OECD guideline 202 study.

Based on the results of a range-finding test, a limit test was performed under static conditions at a nominal concentration of 121 mg/L. Four replicates of 5 daphnids each were performed in the test and control groups. The test duration was 48 h.

At the end of the test the percentage of dahpnids that were immobilised was 0% for both control and treatment groups. The dissolved oxygen concentrations were higher than 3 mg/L in controls and treatments and therefore the test was considered valid. The test substance concentrations were analysed with ionic chromatography (IC) at the beginning (on day 0) and at the end of the test (on day 2). During the test, the measured concentrations of the test substance varied less than 20% (i.e. 2.36%) of the initial concentration. The geometric mean measured concentration of test substance was 128 mg/L which did not deviate by more than 20% from the nominal concentration of 121 mg/L.

Because no adverse effects were observed in the daphnids exposed to the concentration of 128 mg/L (geometric mean measured concentration), the 48h-EC50 was set as higher than this concentration.

Based on the above information, it is concluded that the reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate is not harmful to daphnia.