Sodium 1,2-diisobutoxycarbonylethanesulphonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

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)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all
- Sampling method and Sample storage conditions before analysis: Specimens were diluted with methanol (1:1) and were stored deep frozen (≤ -18°C) until they were analysed. Concentrations of the test item in test solutions were analysed at test start (0 hours) and at the test end (48 hours).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:

A stock solution was prepared by adding the test item to test medium.
The stock solution was stirred for 10 minutes on a magnetic stirrer.
Stock solution and test vessels were prepared in the following way:

-A stock solution was prepared by weighing of 2310.0 mg test item (0 hours) into a graduated flask and filling up to 1000 mL using test medium
(= stock solution A, corresponding to a concentration of 2310.0 mg/L test item).

The test solutions of the chosen concentrations were prepared directly in the test vessels by the dilution of the stock solution A with the test medium immediately before the transfer of the Daphnia into the test vessels.


- Controls: blank control

- Test concentration separation factor: about 1.5

- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
- Other relevant information:

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone origin: RWTH Aachen University, Institute for Environmental Research (Biology V)
Worringerweg 1
52074 Aachen
Germany

- Age at study initiation (mean and range, SD): < 24 h

- Method of breeding: breeding was performed in glass beakers (50 mL) under the same conditions as in the test; test animals were separated from the adults by means of a pipette. Parental daphnids were maintained in 100 % test medium (AAP test medium according to OECD 201) at the test temperature for at least 48 hours prior test start

- Source: held and bred in the test facility under standardised laboratory conditions, test animals derived from a healthy stock, not first brood progeny

- Feeding during test : no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

140 - 250 mg/L (CaCO3)

Test temperature:

20.4 – 20.5 °C (recorded continuously)

pH:

pH value (test medium) before test start: 7.75

Dissolved oxygen:

Oxygen concentration before test start: 8.89 mg/L O2

Nominal and measured concentrations:

Control, 434.3, 649.1, 974.8, 1462, 2192 mg/L test item; Control, 178.1, 266.1, 399.7, 599.5, 898.8 mg/L active matter

Concentrations of the test item were analytically verified in the test solutions. As a result, the measured concentrations of the test item remained within a range of 102 – 104% of nominal concentrations in the freshly prepared test solutions at the start of the test. The test item concentrations in the spent test solutions were determined at 111 – 120% of nominal concentrations at the end of the test (48 hours).

The calculated endpoints are based on the nominal concentrations for the test item since the measured concentrations were within 80 to 120% of nominal.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker (25 mL)
- Material, size, headspace, fill volume: 10 mL
- Volume of solution: 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 + 3 additional vessels (1 for measuring of water parameters, 1 for analysis, 1 retain specimen)
- No. of vessels per control (replicates): 4 + 3 additional vessels (1 for measuring of water parameters, 1 for analysis, 1 retain specimen)
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 2 mL test solution per Daphnia

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: AAP test medium (according to OECD guideline 201)
- Culture medium different from test medium: AAP test medium (according to OECD guideline 201) was used for culturing (48 hours in advance) and in the test, prepared 5 days in advance;

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 light/dark phases
- Light intensity: on average 20 µE *m-2*s-1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50

VEHICLE CONTROL PERFORMED: no

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 898.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: immobilization

Details on results:

- Behavioural abnormalities: No abnormal behaviour or appearance was observed (e.g. trapping at surface of water or discoloration).
- Mortality of control: none
- Other adverse effects control: none
- Immobilisation of control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Limit test: no
- Dose-response test: yes
- ECx: EC50 1.76 mg/L

Reported statistics and error estimates:

no statistics needed: no immobilization in any of the test groups

Validity criteria fulfilled:

yes

Conclusions:

48h-EC50 > 898.8 mg a.i./L

Executive summary:

In the Klimisch 1 GLP study from Warning (2021) the acute toxicity of the registered substance to Daphnia magna was determined in a static test according to OECD 202. The test was started with a control and a nominal concentrations of 178, 266, 399, 600 and 899 mg a.i./L. The concentrations were analyzed by LC-MS analyses. The measured concentrations were witjhin 102 to 120 % of the nominal concentrations. Since all values were > 80 % the results were based on nominal concentrations. For each test concentration and the control, 4 replicates with 5 daphinds each were set up. After 48 hours of exposure no immobilization was observed in the control and any test solution. The corresponding 48 h EC50 value is > 898.8 mg a.i./L.

 

The results of the test are considered relevant and reliable for the risk assessment.

Description of key information

48 h EC50 > 898.8 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 898.8 mg/L

Additional information

In the Klimisch 1 GLP study from Warning (2021) the acute toxicity of the registered substance to Daphnia magna was determined in a static test according to OECD 202. The test was started with a control and a nominal concentrations of 178, 266, 399, 600 and 899 mg a.i./L. The concentrations were analyzed by LC-MS analyses. The measured concentrations were witjhin 102 to 120 % of the nominal concentrations. Since all values were > 80 % the results were based on nominal concentrations. For each test concentration and the control, 4 replicates with 5 daphinds each were set up. After 48 hours of exposure no immobilization was observed in the control and any test solution. The corresponding 48 h EC50 value is > 898.8 mg a.i./L.

 

The results of the test are considered relevant and reliable for the risk assessment.