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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
201-08-14 to 2018-10-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Remarks:
HPLC-DAD
Details on sampling:
- Concentrations: 200 mg/L (nominal) and 0 mg/L
- Sampling method: At the start of the exposure and at renewal (0 and 24 h), samples of the fresh media were taken after preparation of the limit concentration and analyzed. At renewal and at the end of the exposure (24 and 48 hours), samples of the 24-hours old media were taken directly from the test vessels and analyzed.
- Sample storage conditions before analysis: If necessary, all original samples were stored at room temperature before preparation. Prepared samples were stored in an autosampler at room temperature until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A limit concentration of 200 mg/L of the test item was prepared with dilution water prior to the start of the exposure (at day 0) and prior to the renewal of the test solution (at day 1). The test item solution was treated with ultrasound for 5 min at room temperature and stirred thereafter for 1 h with a magnetic stirrer at approximately 1100 rpm at room temperature. As a Tyndall effect was still visible, the stirring period was prolonged to 2 h. Since the Tyndall effect was still present, the solution was treated with ultrasound at room temperature for another 10 min. After that, only a slight Tyndall effect was visible.
- Controls: Dilution water without test item incubated under the same conditions as the test groups.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS
- Age of parental stock (mean and range, SD): Less than 24 hours old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.

ACCLIMATION
- Acclimation period: Acclimatization of the daphnids was not necessary, because the composition of the dilution water was equivalent to the culture medium.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
259-263 mg CaCO3/L
Test temperature:
20.0 °C ± 1°C
pH:
7.38-7.48
Dissolved oxygen:
7.68-8.33 mg/L
Nominal and measured concentrations:
200 mg/L and 0 mg/L nominal
148 mg/L and < LOQ measured
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers
- Type (delete if not applicable): loosely covered with glasses
- Material, size, headspace, fill volume: 50 mL capacity, glass, fill volume 20 mL
- Renewal rate of test solution (frequency/flow rate): renewal at 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Culture Medium Elendt M4 according to OECD 202
pH: 8.2 ± 0.8
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: Diffuse light, light intensity of max. 1500 lx

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0, 1.0, 10.0, 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilisation was found at the concentrations tested.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
148 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 148 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 148 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 148 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: a slight Tyndal effect was observed at the concentration tested.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels:
- ECx: EC50: 2.03 mg/L CI (1.17-3.57 mg/L), validity range: 0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000); clone 5 0.6 - 2.1 mg/L, acc. to OECD 202 (2004); clone A

- Other:
Reported statistics and error estimates:
The effects of the limit concentration were deduced directly from the observed immobilization rates. The effect levels (EC10 / 50 / 100) are given based on the analytically confirmed nominal concentrations. An EC50-value and confidence intervals were calculated for the reference item by linear dose-response regression with the software GraphPad Prism.

The validity criteria were fulfilled:

In the control group, no daphnids were immobilized or showed any signs of disease or stress, e.g. discoloration or unusual behavior such as trapping on the surface of the water, during the 48-hour test period (required: not more than 10% of the daphnids immobilized in the control). The dissolved O2concentration in the 24-hours old media was ≥ 7.68 mg/L (required: ≥ 3 mg/L in the 24-hours old media) in the limit concentration and in the control.

Table 1: Measured Concentrations and Percent of Nominal Concentration of the Test Item 2-Phthalimidoethanesulfonamide (TA-3) during the Definitive Test

Sampling date

0 hours

Fresh medium

24 hours

Old medium

24 hours

Fresh medium

48 hours

Old medium

Geometric mean meas. conc.
[mg/L]

Nominal concentration of the

2‑Phthalimidoethanesulfonamide(TA-3)

test item

[mg/L]

Meas. conc.

[mg/L]

%

Meas. conc.

[mg/L]

%

Meas. conc.

[mg/L]

%

Meas. conc.

[mg/L]

%

200

181

91

118

59

181

90

124

62

148

Control

< LOQ

< LOQ

< LOQ

< LOQ

 

Validity criteria fulfilled:
yes
Conclusions:
In the limit concentration of 148 mg/L (based on geometric mean measured concentrations corresponding to a nominal concentration of 200 mg/L) of the test item 2-Phthalimidoethanesulfonamide (TA-3), no effects on Daphnia magna were observed.

Description of key information

In  the  acute  immobilization  test  with  Daphnia  magna  (STRAUS),  the  effects  of 2-Phthalimidoethanesulfonamide (TA-3) were determined according to OECD 202 (2004). The validity criteria of the test guidelines were fulfilled. In the limit concentration of 148 mg/L (based on geometric mean measured concentrations corresponding to a nominal concentration of 200 mg/L) of the test item 2-Phthalimidoethanesulfonamide (TA-3), no effects on Daphnia magna were observed.

Key value for chemical safety assessment

Additional information