Registration Dossier

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:
2018-08-14 to 2018-09-28
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: 120 mg/L and 0 mg/L
- Sampling method: At the start of the exposure and at renewal (0 and 24 hours), 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: no storage
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A limit concentration of 120 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 mixed thoroughly by manual agitation.
- Controls: Dilution water without test item incubated under the same conditions as the test groups.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No
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 h old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 h before the start of the exposure and discarded. The juveniles born within the following period of max. 24 h preceding the exposure were used for the test. No first brood progeny was used for the test.
- Feeding during test: None

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:
0h: 259 mg CaCO3/L and 24 h: 263 mg CaCO3/L
Test temperature:
18 - 22 °C, constant within ± 1 °C
pH:
7.48 to 7.75 in fresh media and 7.34 to 7.48 in old media
Dissolved oxygen:
8.77 to 8.90 in fresh media and 7.19 to 8.04 in old media
Conductivity:
0h: 574 µS/cm and 24h: 577 µS/cm
Nominal and measured concentrations:
Nominal: 120 mg/L and 0 mg/L
measured: 0h (fresh medium): 136 mg/L, 24h (old medium): 109 mg/L, 24h (fresh medium): 128 mg/L, 48h (old medium): 116 mg/L, variation was ≤ 20% in each case, thus EC-values are given in nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: Beakers
- Type (delete if not applicable): closed, loosely covered with watch glasses
- Renewal rate of test solution (frequency/flow rate): The test solutions were renewed after 24 hours. For this purpose, a second set of test vessels was filled with the freshly prepared test solutions and the daphnids were transferred by pipette
- 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
- 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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization was determined in all groups after 24 and 48 hours. An animal was considered immobile, if it was not able to swim in the water phase within 15 seconds after gentle agitation of the test vessel. Other adverse effects did not appear.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 1, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: no immobilization occurred
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
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: no
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: EC50 (0-24h): 0.6 - 2.4 mg/L acc. 16 AQS P 9/2 (02/2000); Clone 5 and 0.6 - 2.1 mg/L acc. to OECD 202 (2004), Clone A, measured: 2.03 mg/L (1.17 - 3.57 mg/L)
Reported statistics and error estimates:
Methods of evaluation: 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.

Table 1: Measured Concentrations and Percent of Nominal Concentration of the Test item 2H-lsoindole-2-ethanesulfonic acid, 1,3-dihydro-1,3-dioxo-, potassium salt (1:1) (TA-1) during the Definitive Test

Sampling date

0 h fresh medium

24h old medium

24 h fresh medium

48 h old medium

Nominal concentration of the test item [mg/L]

2H-isoindole-2-ethanesulfonic acid, 1,3-dihydro-1,3-dioxo-, potassium salt (1:1) (TA-1)

Meas. Conc. [mg/L]

%

Meas. Conc. [mg/L]

%

Meas. Conc. [mg/L]

%

Meas. Conc. [mg/L]

%

120

136

113

109

91

128

106

116

97

Control

< LOQ

< LOQ

< LOQ

< LOQ

Validity criteria fulfilled:
yes
Conclusions:
In the limit concentration 120 mg/L of the test item 2H-lsoindole-2-ethanesulfonic acid, 1,3-dihydro~1,3-dioxo-, potassium salt (1:1) (TA-1), no effects on Daphnia magna were observed.

Description of key information

In the acute immobilization test with Daphnia magna (STRAUS), the effects of 2H-lsoindole-2-ethanesulfonic acid, 1,3-dihydro-1,3-dioxo-, potassium salt (1:1) (TA-1) were determined according to OECD 202 (2004). The validity criteria of the test guidelines were fulfilled. In the limit concentration of 120 mg/L of the test item 2H-lsoindole-2 -ethanesulfonic acid, 1,3 -dihydro-1,3 -dioxo-, potassium salt (1 :1) (TA-1 ), no effects on Daphnia magna were observed.

Key value for chemical safety assessment

Additional information