N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate

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

Study period:

22.09.2022 to 23.11.2022

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:

Adopted 13th April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 6.25, 12.50, 25.00, 50.00 and 100.00 mg/L including control group.
- Sampling method: Analysis of the test substance was performed in each replicate at the beginning(0 h) and 48 h after exposure

Vehicle:

no

Details on test solutions:

The required amount of the test substance 0.1002 g was weighted using a balance(Ohaus, U.S.A.)
into 1 L volumetric flask and the test water(M4 medium) was added until the 1 L for preparing of
100.00 mg/L. This solution was sealed and mixed using a magnetic stirrer(Misung Scientific. Co.,
Ltd., Korea) for 24 h and was filtered through a 0.45 µm PVDF membrane filter(Cuota Lab, Korea).
Two same 100.00 mg/L was prepared according to the above preparation method. 62.5, 125.0, 250.0
and 500.0 mL of the stock solution was added into each 1 L volumetric flask to prepare test
solution(6.25, 12.50, 25.00 and 50.00 mg/L) and final volume was adjusted to 1 L using the test water.
The remaining stock solution was used as the test solution(100.00 mg/L).

Test organisms (species):

Daphnia magna

Details on test organisms:

< 24 h old, third generation neonates.

Test type:

static

Water media type:

freshwater

Remarks:

Elendt M4 Medium

Limit test:

no

Total exposure duration:

48 h

Hardness:

Hardness(Test water) : 160 mg CaCO3/L
Alkalinity(Test water) : 30 mg CaCO3/L

Test temperature:

20.3°C (20.1~20.5°C)

pH:

7.62(7.11~7.90)

Dissolved oxygen:

8.31 mg/L(7.83~8.51 mg/L)

Nominal and measured concentrations:

Nominal: 6.25, 12.50, 25.00, 50.00 and 100.00 mg/L
Geometric mean measured: 5.885, 11.527, 23.097, 45.329 and 94.094
mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: separation test dish(Φ80×45 H (mm)) in the water bath(20±2 ˚C)
- Volume of solution: 100 mL
- Aeration: none


- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Feeding: None

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 Medium

- Intervals of water quality measurement: 0 and 48 h

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 24 h continuous darkness
- Light intensity: not mentioned

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations every 24 h

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.00, 10.00, 100.00 mg/L and a control group(0 mg/L)
- Results used to determine the conditions for the definitive study: 5 Daphnia magna per group were used at treatment group and control group during an exposure period of 48 h under the semi static condition. results not mentioned.

On the basis of the result of the range finding test, the treatment group of the definitive test was composed
to be 6.25, 12.50, 25.00, 50.00 and 100.00 mg/L including the control group.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

24.77 mg/L

95% CI:

20.348 - < 30.309

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

% Immobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

12.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

% Immobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

6.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

% Immobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

36.234 mg/L

95% CI:

28.912 - < 45.228

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

% Immobility

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of this study the result of EC50 24.8 mg/L means that the test substance is classified as Aquatic Chronic 3 H412.

Executive summary:

This study evaluated acute immobilisation caused by the test substance, in the Daphnia magna. In accordance with the guidelines for range finding test, the treatment group received 6.25, 12.50, 25.00, 50.00 and 100.00 mg/L of the test substance. The treatment and a control group remained under a static condition for 48 h, and then the median effective concentration(EC50) was calculated. The solubility test, stability test, range finding test and definitive test were conducted under thedarkness conditions based on the storage conditions(darkness) of the test substance.
Solubility test was conducted with a test solution of 100.00 mg/L. The method that stirring for 24 h resulted in the highest solubility in the test water. So, this method applied to this study. The stability test was conducted with a test solution of 100.00 mg/L. The result was stable to
102.4 %(0~48 h) in the 100.00 mg/L test solution. This result was 80~120 % of the initial measured concentration. So, this study was conducted under the static condition. On the basis of the result of the range finding test, this test was conducted of the definitive test, the
treatment group was composed to 6.25, 12.50, 25.00, 50.00 and 100.00 mg/L including control group. As a result of the definitive test, the geometric mean measured concentration at the treatment group(6.25, 12.50, 25.00, 50.00 and 100.00 mg/L) was 5.885, 11.527, 23.097, 45.329 and 94.094 mg/L. These results were 94.2, 92.2, 92.4, 90.7 and 94.1 % of the nominal concentration. This result was 80~120 % of the nominal concentration. Therefore, the test results were determined based on the nominal concentration.
1) The result is as follows.
Observation Time (h)
EC50a (mg/L)
95 % Confidence limits (mg/L)
The highest concentration causing no immobility or mortality (mg/L) The lowest concentration producing 100 % immobility or mortality (mg/L)
24 36.234 28.912~45.228 12.50 - b 48 24.777 20.348~30.309 6.25 100.00
a: Median effective concentration, based on nominal concentration
b: Not applicable
2) Result measurement of test solution(minimum~maximum)
Average, range of temperature : 20.3 C (20.1~20.5 C)
Average, range of Dissolved : 8.31 mg/L(7.83~8.51 mg/L)
Oxygen(D.O.) 91.5 %(85.9~94.1 %)
Average, range of pH : 7.62(7.11~7.90)

Hardness(Test water) : 160 mg CaCO3/L
Alkalinity(Test water) : 30 mg CaCO3/L

Description of key information

Under the conditions of this study the result of EC50 24.8 mg/L means that the test substance is classified as Aquatic Chronic 3 H412.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

24.777 mg/L