Sodium 1,2-diisobutoxycarbonylethanesulphonate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2022

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:

2019

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control and nominal 900 mg /L active matter
- Sampling method: Specimens were stabilized with 50% methanol immediately after sampling.
- Sample storage conditions before analysis: All specimens were stored deep frozen (≤ -18 °C) until analysis.

Vehicle:

no

Details on test solutions:

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

Stock solution and test vessels were prepared in the following way:
- A stock solution was prepared by weighing of
8.78 g test item at 0 hours = test start
into a graduated flask and filling up to 2000 mL using test medium (= stock solution A, corresponding to 4.39 g/L at test start).

The test solution was prepared directly in the test vessels immediately before the transfer of the fish into the test vessels.
2000 mL stock solution A was mixed with 2 L test medium in the pool to reach the final test concentration of 2195.0 mg/L test item.

The control vessels contained test medium (AAP test medium) only. One day before the start of the test, the test medium was prepared and aerated for 2 hours.
- Method:


- Controls: blank control

- Test concentration separation factor: not relevant since only one treated test group was used

- Evidence of undissolved material (e.g. precipitate, surface film, etc.): none reported

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: purchased from fish supplier „Zierfischcenter Scalar“ Paul-Geißler-Straße 14, 04808 Wurzen, Germany,

- Length at study initiation (length definition, mean, range and SD): 1.76 +/- 0.25 cm
- Weight at study initiation (mean and range, SD): 0.097 +/- 0.02 g
- Maintenance of the brood fish: held in the Test Facility under standardised laboratory conditions

ACCLIMATION
- Acclimation period: 11 days
- Acclimation conditions (same as test or not): yes
- Type and amount of food during acclimation: commercial fish food
- Feeding frequency during acclimation: daily (fish food), until 24 hours before test start, no feeding during the test
- Health during acclimation (any mortality observed): Mortality of fish during the acclimatisation period was 0%.

Test type:

static

Water media type:

freshwater

Remarks:

AAP medium according to OECD 201

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L CaCO3

Test temperature:

22.7 – 23.4 °C (recorded continuously)

pH:

6.89 to 7.85

Dissolved oxygen:

8.43 to 8.70 mg/L

Nominal and measured concentrations:

control and nominal 900 mg/L, recoveries within 80 to 120 % of nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: stainless steel container (approx. 6 L volume)
- Material, size, headspace, fill volume: 4 L
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.17 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: AAP-medium according to OECD 201
- Culture medium different from test medium: no

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, LC0 and LC50

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable since threshold test
- Justification for using less concentrations than requested by guideline: threshold test
- Test concentrations: 900 mg/L a.m.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 900 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: no mortality and no abnormal effects observed

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 883.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: no mortality and no abnormal effects observed

Details on results:

- Other abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no

Reported statistics and error estimates:

not relevant since no mortality observed

Validity criteria fulfilled:

yes

Conclusions:

96-hour LC50 > 900 mg/L

Executive summary:

In the Klimisch 1 GLP study from Warning (2022) the acute toxicity of the registered substance to zebra fish (Danio rerio) was determined in a 96‑hour static test according to the OECD Guideline for Testing of Chemicals No. 203 (2019). The following nominal concentration of the registered substance was tested: 900 mg/L active ingredient (threshold approach). Additionally, a control (test water without test item) was tested in parallel. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations ranged between 96 and 100% of the nominal value. Consequently, the test concentration was stable and the reported biological results are related to the nominal test item concentration.

In the control and at the test concentration no mortality and no sublethal effects were observed throughout the 96-hour test period. Thus, the 96‑hour NOEC, LC₀ and LC₅₀ of the registered substance to zebra fish were determined to be >= 900, >= 900 and > 900 mg/L active matter, respectively.

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

Description of key information

96 h LC50 for freshwater fish (zebra fish) = 900 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 900 mg/L

Additional information

In the Klimisch 1 GLP study from Warning (2022) the acute toxicity of the registered substance to zebra fish (Danio rerio) was determined in a 96‑hour static test according to the OECD Guideline for Testing of Chemicals No. 203 (2019). The following nominal concentration of the registered substance was tested: 900 mg/L active ingredient (threshold approach). Additionally, a control (test water without test item) was tested in parallel. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations ranged between 96 and 100% of the nominal value. Consequently, the test concentration was stable and the reported biological results are related to the nominal test item concentration.

In the control and at the test concentration no mortality and no sublethal effects were observed throughout the 96-hour test period. Thus, the 96‑hour NOEC, LC₀ and LC₅₀ of the registered substance to zebra fish were determined to be >= 900, >= 900 and > 900 mg/L active matter, respectively.

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