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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
from 2000-10-17 to 2000-11-16
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:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Analytical controls were carried out with 10, 31.6, and 100 mg/L.
- Sampling method: For the analytical measurement a sample from the freshly prepared test medium from the concentrations was taken at the start of the study. For the determination of the maintenance of the test material concentration during the exposure period a sample was taken from the medium at the end of the exposure period
- Sample storage conditions before analysis: at room temperature
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test material was solved in reconstituted water. The stock preparation was diluted with reconstituted water to the different test medium concentrations by mechanical dispersion.
- Controls:
Untreated control performed with reconstituted water without the test substance
Positive control performed with the reference substance potassium dichromate
- Evidence of undissolved material: no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Source: Institute of Toxicology, Merck KGaA, Darmstadt, Germany
- Age at study initiation (mean and range, SD): not older than 24 hours
- Feeding during test no

ACCLIMATION
- Acclimation conditions: same as the test
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg/L
Test temperature:
20 - 21 °C
pH:
7.9 ± 0.3
Dissolved oxygen:
> 95 %
Nominal and measured concentrations:
- Nominal concentrations: 10, 17.8, 31.6, 56.2 and 100 mg/L have been used in the test.
- Measured concentrations:
freshly prepared: 9.4, 31.1 and 10.58 mg/L corresponding to 94, 98 and 106 % of the nominal concentrations respectively
after 48 hours: 10.1, 31.9 and 107.5 mg/L corresponding to 101, 101 and 108 % respectively.

Details on test conditions:
TEST SYSTEM
- Test vessel: 25 mL all-glass
- Volume: 10 mL reconstitued water
- Type: open
- Aeration: yes
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to OECD 202 (1992)
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH-values and dissolved oxygen concentration (O2) were measured in the control and all test material concentrations at the beginning and at the end of the experimental part. During the experimental part, the temperature was registered in a control vessel with an electronic thermometer continuously.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light - 8 hours dark regime

EFFECT PARAMETERS MEASURED: Adverse effects of the test substance on thee normal mobility behaviour and the loss of locomotory actions of the waterfleas neonates, observed at 24 and 48 hours.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: A. range-finding test was carried out with concentrations of 100, 50, 10, and 1 mg/L test material.
- Results used to determine the conditions for the definitive study: Only the Daphnia magna of the highest test material concentration showed immobilization.
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
Details on results:
- Behavioural abnormalities: not observed
- Observations on body length and weight: not observed
- Other biological observations: not observed
- Mortality of control: no
- Other adverse effects control: not observed
- Immobilisation of control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L and the NOEC was determined to be 17.8 mg/L according to OECD 202 (1992) under GLP conditions.
Results with reference substance (positive control):
The sensitivity of the test system was demonstrated periodically with the reference substance potassium dichromate. The validity criteria was met.
Reported statistics and error estimates:
The EC50 was calculated as a logit analysis according the procedure of Unkelbach and Wolf (1985) using the PC-program 511.
Validity criteria fulfilled:
yes
Conclusions:
The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L according to OECD 202 (1992) under GLP conditions.
Executive summary:

The objective of this study was to determine the acute toxicity of the test substance to Daphnia magna. For this purpose, young Daphnia magna were exposed to aqueous test material concentrations under defined conditions. The study comprised of four vessels per concentration containing five Daphnia magna, i.e. 20 Daphnia per concentration (test medium group). The Daphnia were observed for immobilization up to 48 hours. The study comprised the exposure of Daphnia to test material concentrations of nominally 10, 17.8, 31.6, 56.2 and 100 mg/L in an open static system. Analytical controls were carried out with 10, 31.6, and 100 mg/L. The measured concentration were determined to be 9.4, 31.1 and 105.8 mg/L (freshly prepared) corresponding to 94, 98 and 106 % of the nominal concentrations and 10.1, 31.9 and 107.5 mg/L (after 48 hours) corresponding to 101, 101 and 108 % of the nominal concentration. The analytically determined test material concentrations at the end of the experimental part could be maintained at > 80 % of the initial concentrations and the exposure in an open static test system was valid. The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L.

Description of key information

The EC50 (48 h) of the source substance to Daphnia magna was determined to be > 100 mg/L according to OECD 202 (1992) under GLP conditions. Therefore, the EC50 (48 h) to Daphnia magna is considered to be > 100 mg/L for the target substance.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
> 100 mg/L

Additional information

No experimental data on short-term toxicity to aquatic invertebrates with test item was available. Read-across to a structural analogous substance was done instead.


The objective of the study with the read-across source substance was to determine the acute toxicity of the test substance to Daphnia magna. For this purpose, young Daphnia magna were exposed to aqueous test material concentrations under defined conditions. The study comprised of four vessels per concentration containing five Daphnia magna, i.e. 20 Daphnia per concentration (test medium group). The Daphnia were observed for immobilization up to 48 hours. The study comprised the exposure of Daphnia to test material concentrations of nominally 10, 17.8, 31.6, 56.2 and 100 mg/L in an open static system. Analytical controls were carried out with 10, 31.6, and 100 mg/L. The measured concentration were determined to be 9.4, 31.1 and 105.8 mg/L (freshly prepared) corresponding to 94, 98 and 106 % of the nominal concentrations and 10.1, 31.9 and 107.5 mg/L (after 48 hours) corresponding to 101, 101 and 108 % of the nominal concentration. The analytically determined test material concentrations at the end of the experimental part could be maintained at > 80 % of the initial concentrations and the exposure in an open static test system was valid. The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L.


Based on the data from the read-across source substance, the target substance is determined to have an EC50 (48 h) value > 100 mg/L for Daphnia magna.