Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate

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:

2018-04-27 to 2018-07-18

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 13. April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: At the start of the exposure (0 hours), two aliquots as samples of the fresh media (control and limit concentration) were taken after preparation of the limit concentration and analyzed. At the end of the exposure (48 hours), two aliquots as samples of the old media (control and limit concentration) were taken directly from the test vessels.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A limit concentration (100 mg/L of the test item were weighed out) was freshly prepared with dilution water prior to the start of the exposure (at 0 hours). The limit concentration was mixed thoroughly by manual agitation.
- Controls: Dilution water without test item incubated under the same conditions as the test group.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: Daphnia magna (Straus), clone 5
- Age at study initiation: 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.
- Method of breeding: The daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with a cell density of > 1E6 cells/mL. The algae were cultured at the test facility.
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
- Feeding during test: No

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:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Hardness:

216 mg CaCO3/L

Test temperature:

18 – 22 °C, constant within ± 1 °C

pH:

8.19 (control group)
8.23 (100 mg/L group)

Dissolved oxygen:

8.95 mg/L

Salinity:

not applicable

Conductivity:

620 µS/cm

Nominal and measured concentrations:

Nominal conc.: 100 mg/L
Measured conc.: between 102 and 107 % of the nominal value of the limit concentration

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers, 50 mL capacity
- Type: closed (loosely covered with watch glasses)
- Volume of solution: 20 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 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 Lux

EFFECT PARAMETERS MEASURED: the number of immobile daphnids were determined by visual observation and recorded after 24 and 48 hours.

RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

In the limit concentration of 100 mg/L of the test item, no effects on Daphnia magna were observed.
The limit concentration of 100 mg test item/L was colourless and visually clear throughout the exposure.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Limit test: no
- Dose-response test: yes
- EC50: 2.07 mg/L (95 % CI: 1.00 – 4.00 mg/L)

Validity Criteria

The study was performed according to OECD Guideline 202 (2004). 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 behaviour such as trapping on the surface of the water, during the 48 hour test period (required: not more than 10 % of the daphnids in the control).

- The dissolved oxygen concentration in the old media at the end of the exposure was a 8.04 mg/L (required: > 3 mg/L at the end of the exposure) in the limit concentration and in the control.

 

Measured Exposure Concentrations during the Definitive Test

The measured concentration of the test item in fresh media at the start of the exposure (0 hours) was 102 % of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 107 % of the nominal value of the limit concentration. Since the measured concentration of the test item remained stable within ± 20 % of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation.

Validity criteria fulfilled:

yes

Conclusions:

Based on the nominal concentrations of the test item, the 48 hours-EC10, EC50 and EC100 for Daphnia magna was >100 mg/L.

Executive summary:

The effect of the test item on the mobility of Daphnia magna was determined in a 48 h “Acute Immobilization Test” according to OECD TG 202 and under GLP conditions. For this purpose, young daphnids were exposed in a static test for 48 h to the nominal concentration of 100 mg/L under defined conditions. The recorded effects were the mobility after 24 and 48 hours. The limit test was performed in compliance with guidelines in order to demonstrate that the test item has no toxic effects on the daphnids up to this concentration. In parallel with the test item treatments Potassium dichromate was used as reference control. The concentrations of the test item were analytically verified via LC-MS/MS in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in the limit concentration and in the control. The measured concentration of the test item in fresh media at the start of the exposure (0 hours) was 102 % of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 107 % of the nominal value of the limit concentration. Since the measured concentration of the test item remained stable within ± 20 % of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation. The validity criteria of the test guideline were fulfilled. No effects were found at the limit concentration of 100 mg/L of the test item. Based on the nominal concentrations of the test item, the 48 hours EC10, EC50 and EC100 for Daphnia magna were >100 mg/L.

Description of key information

Based on the nominal concentrations of the test item, the 48 hours EC10, EC50 and EC100 for Daphnia magna were determined to be >100 mg/L (reference 6.1.3-1).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

The effect of the test item on the mobility of Daphnia magna was determined in a 48 h “Acute Immobilization Test” according to OECD TG 202 and under GLP conditions. For this purpose, young daphnids were exposed in a static test for 48 h to the nominal concentration of 100 mg/L under defined conditions. The recorded effects were the mobility after 24 and 48 hours. The limit test was performed in compliance with guidelines in order to demonstrate that the test item has no toxic effects on the daphnids up to this concentration. In parallel with the test item treatments Potassium dichromate was used as reference control. The concentrations of the test item were analytically verified via LC-MS/MS in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in the limit concentration and in the control. The measured concentration of the test item in fresh media at the start of the exposure (0 hours) was 102 % of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 107 % of the nominal value of the limit concentration. Since the measured concentration of the test item remained stable within ± 20 % of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation. The validity criteria of the test guideline were fulfilled. No effects were found at the limit concentration of 100 mg/L of the test item. Based on the nominal concentrations of the test item, the 48 hours EC10, EC50 and EC100 for Daphnia magna were determined to be >100 mg/L.