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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:
2010-05-12 to 2010-10-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples were taken from all concentrations at the beginning of the study and after 72 hours. After preparation of the test media the analytical values were determined.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. The formulation was then passed through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus
- Age at study initiation: not older than 24 hours
- Source: Merck KGaA, Darmstadt, Institute of Toxicology

ACCLIMATION
- Acclimation period: no
- Breeding conditions: same as test
- Type and amount of food: suspension of fresh water algae
- Health during acclimation: no mortality was observed
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
14 ° dH (about 250 mg/L CaCO3)
Test temperature:
21 – 22°C
pH:
7.7 ± 0.1
Dissolved oxygen:
7.8 - 8.2 mg /L
Nominal and measured concentrations:
100.0 mg/L nominal = 4.34 mg/L measured
Details on test conditions:
for details see executive summary
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Corresponding to > 4.34 mg/L (measured)
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
Remarks on result:
other: Corresponding to > 4.34 mg/L (measured)
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Immobilisation of control: no
- Abnormal responses: no

No remarkable observations were made concerning the appearance of the solution of the test material preparation. The test medium was a clear preparation and stayed unchanged throughout the study.

Table 1: Number of immobilized Daphnids

 

Nominal concentration (mg/L)

No. of daphnids immobilized / exposed

24 hours

48 hours

0

0/20

0/20

100

0/20

0/20

The EC50 values based on the analytical concentrations are given below.

24 h EC50 > 4.34 mg/L (nominal > 100 mg/L)

48 h EC50 > 4.34 mg/L (nominal > 100 mg/L)

Validity criteria fulfilled:
yes
Conclusions:
An aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hours EC50 was > 4.34 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this test.
Executive summary:

The objective of this study was to evaluate the influence of the test item on the immobilization of Daphnia magna according to OECD TG 202 and EU Method C.2. For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) in an open static system for 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five daphnids each, i.e. 20 daphnids for the test medium group and the control group. Analytical controls of the test item preparation were performed at the start of the study and after 48 hours. The limit of quantification of the analytical method was 1.0 mg/L. Due to the low water solubility of the test item, the analytically determined test item concentrations were 4.3 % immediately after preparation of the medium and 48 hours thereafter. During the experimental phase of the study, the test material concentration could be maintained at > 80 % of the initial concentration. The test was performed as a static test in open vessels. The EC50 values were calculated with the mean analytical concentrations due to the low solubility of the test item. Daphnids exposed to an aqueous preparation of a nominal concentration of 100 mg/L were not affected. The 48 h EC50 was determined to be > 4.34 mg/L (nominal > 100 mg/L) and the 24 h EC50 was determined to be > 4.34 mg/L (nominal > 100 mg/L). Thus, could not be determined in this test.

Description of key information

An aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hours EC50 was > 4.34 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this test (reference 6.1.3-1).

Key value for chemical safety assessment

Additional information

The objective of this study was to evaluate the influence of the test item on the immobilization of Daphnia magna according to OECD TG 202 and EU Method C.2. For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) in an open static system for 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five daphnids each, i.e. 20 daphnids for the test medium group and the control group. Analytical controls of the test item preparation were performed at the start of the study and after 48 hours. The limit of quantification of the analytical method was 1.0 mg/L. Due to the low water solubility of the test item, the analytically determined test item concentrations were 4.3 % immediately after preparation of the medium and 48 hours thereafter. During the experimental phase of the study, the test material concentration could be maintained at > 80 % of the initial concentration. The test was performed as a static test in open vessels. The EC50 values were calculated with the mean analytical concentrations due to the low solubility of the test item. Daphnids exposed to an aqueous preparation of a nominal concentration of 100 mg/L were not affected. The 48 h EC50 was determined to be > 4.34 mg/L (nominal > 100 mg/L) and the 24 h EC50 was determined to be > 4.34 mg/L (nominal > 100 mg/L). Thus, could not be determined in this test.