4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid

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:

from 2012-08-07 to 2014-02-03

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:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: Three replicate samples were taken from the treatment and the control groups at the start and at the end of the test.
- Sample storage conditions before analysis: at room temperature

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution used in the test was prepared by mechanical dispersion. An amount of 0.5 g test item was dissolved in 5000 mL dilution water (ISO medium) in order to give the concentration of 100 mg/L.
- Evidence of undissolved material: no
- Control: The dilution water (ISO medium) without addition of test item was used as control solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Fish Laboratory of TOXI-COOP ZRT. (8237 Tihany, Klebelsberg K. u. 3., Hungary)
- Age at study initiation: juveniles
- Length at study initiation: 2.0 ± 1 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: not required as bred in laboratory
- Acclimation conditions: same
- Type and amount of food: appropriate, commercial food
- Health during acclimation (any mortality observed): no mortality occurred in seven days before the start of experiment.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

approximate theoretical total hardness of 249 mg/L (as CaCO3)

Test temperature:

23.3 – 23.8 °C

pH:

7.52 – 7.92 (without adjustment)

Dissolved oxygen:

84.6 – 97.5 %

Nominal and measured concentrations:

- Nominal concentration: 100 mg/L
- Measured concentrations: three replicates at the start and at the end of the test.
- 98.8, 99.1 and 99.5 mg/L (99 - 100 % of nominal concentration) at start of the test
- 102.5, 102.5 and 102.7 mg/L (103 % of nominal concentration) at the end of the test

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Type: closed
- Volume: 5 L
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <= 1.0 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (ISO medium, prepared according to Annex 2 of the OECD guideline 203)
- Culture medium different from test medium:
- Intervals of water quality measurement: The water temperature, pH value and dissolved oxygen concentration were determined at the start of the test and on the subsequent days (once daily) in the test concentration and the control.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light and 8 h dark

EFFECT PARAMETERS MEASURED
Observations at approximately 3, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.
The body length of each fish were measured at the end of the test in order to check their compliance with the size range recommended for the species by the test guideline (OECD No. 203). The measured values were within the range of 2.10 - 2.40 cm.

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality observed in a pre-experiment with 100 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: not observed
- Observations on body length and weight: Observed, but normal development
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no effects observed.
The 96h-LC50 was determined to be > 100 mg/L and the NOEC was determined to be >= 100 mg/L.

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

not applicable as no effects observed

Sublethal observations / clinical signs:

Table 1: Cumulative mortality data in the definitive test

Test Group	Cumulative mortality (initial population = 10 fish / test group)
	3h	6h	24h	48h	72h	96h
Control	0	0	0	0	0	0
100 mg/L	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test substance to Zebrafish (Brachydanio rerio) was determined according to OECD 203 (1992) under GLP conditions. The 96h-LC50 was determined to be > 100 mg/L.

Executive summary:

The acute toxicity of the test substance to Zebrafish (Brachydanio rerio) was determined according to OECD 203 (1992) under GLP conditions. Young fish were exposed to aqueous test media containing the test item for 96 hours. Based on results obtained in a preliminary experiment fish were exposed to a single concentration of 100 mg/L (limit test). A concurrent control group was run. A static test was performed as the test item was previously shown to be stable in the test medium over the test period. The measured concentration were determined between 99 - 103 % of the nominal concentration. The analytically measured test item concentration remained within ± 20 % of the nominal during the test period of 96 hours; therefore the biological results are based on the nominal concentration. The fish were observed at approximately 3, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen and temperature were carried out daily. All validity criteria were met. Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. The 96h-LC50 was determined to be > 100 mg/L.

Description of key information

The acute toxicity of the test substance to Zebrafish (Brachydanio rerio) was determined according to OECD 203 (1992) under GLP conditions. The 96h-LC50 was determined to be > 100 mg/L (reference 6.1.1-1).

Additional information

The acute toxicity of the test substance to Zebrafish (Brachydanio rerio) was determined according to OECD 203 (1992) under GLP conditions. Young fish were exposed to aqueous test media containing the test item for 96 hours. Based on results obtained in a preliminary experiment fish were exposed to a single concentration of 100 mg/L (limit test). A concurrent control group was run. A static test was performed as the test item was previously shown to be stable in the test medium over the test period. The measured concentration were determined between 99 - 103 % of the nominal concentration. The analytically measured test item concentration remained within ± 20 % of the nominal during the test period of 96 hours; therefore the biological results are based on the nominal concentration. The fish were observed at approximately 3, 6, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen and temperature were carried out daily. All validity criteria were met. Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. The 96h-LC50 was determined to be > 100 mg/L.