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Ecotoxicological information

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:
from 2007-02-19 to 2007-05-25
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:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Batch: E05960739
Analytical monitoring:
yes
Details on sampling:
The water solubility of the test material was below 0.01 mg/L using a HPLC method. Due to the low water solubility and the fact that the study was a limit test, no further analysis was initiated.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was given through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.
- Controls: Blank control performed with the test solution witout test material, positive control performed with potassium dichromate.
- Evidence of undissolved material: no. All test media were clear solutions and remained clear throughout the entire test period.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Age at study initiation: not older than 24 hours
- Method of breeding: The strain with the parents generation was bred and mantained in vessels containing a lot of Daphnia magna in differents ages. for the study young Dahnia magna were separated in 100 mL of reconstituted water.
- Source: Institute of Toxicology, Merck KGaA, Darmstadt, Germany
- Age of parental stock: differents ages.
- Feeding during test: no
- Aeration during the test: no

ACCLIMATION
- Acclimation conditions: The Daphnia magna were kept in reconstituted water in glass-vessels. The study was located in an air-conditioned room in the Institute of Toxicology. Lighting was controlled by a timer to provide a 16 hours light - 8 hours dark regime.
- Health during acclimation: No mortality was observed during the test.
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:
7.5 +/- 0.3
Dissolved oxygen:
82.1 - 89.9 %
Nominal and measured concentrations:
- Nominal concentration: A single test material concentration of 100 mg/L was tested in an open static system.
- Measured concentration: No concentrations of the test substance were measured.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass vessels
- Type: open
- Aeration: yes
- 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: Reconstituted water according to OECD 202 (1984)
- 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 containing a maximum and minimum memory display.

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

EFFECT PARAMETERS MEASURED: Immobility of the animals after 24, 48 hours

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Not performed
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: not observed
- Abnormal responses: not observed
- Any observations that might cause a difference between measured and nominal values. no
- Effect concentrations exceeding solubility of substance in test medium: no
A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system.
Results with reference substance (positive control):
The sensitivity of the test system is demonstrated periodically. The positive control was carried out with potassium dichromate.

Table 1: Nominal concentration and number of immobilized / exposed Daphnia magna

Nominal concentration

No. of Daphnia magna
immobilized / exposed

[mg/L]

24 hours

48 hours

0

0 / 20

0 / 20

100

0 / 20

0 / 20

 

Table 2: Nominal concentration, pH and oxygen at the start and at the end of the test.

Nominal concentration

Start of the experimental part
(t = 0 hour)

End of the experimental part
(t = 48 hours)

[mg/L]

pH

O2[%]

pH

O2[%]

0

7.76

87.3

7.82

89.9

100

7.28

82.1

7.76

87.9

 

 

 

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 material to Daphnia magna according to OECD 202 (1984) under GLP conditions. For this purpose, juvenile Daphnia magna were exposed to a test material concentration of nominal 100 mg/L (limit test) in an open static system over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia per concentration (test medium group). In addition, a control group of 20 Daphnia in reconstituted water was used. The water solubility of the test material was below 0.01 mg/L using a HPLC method. Due to the low water solubility and the fact that the study was a limit test, no further analysis was initiated. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. During the test a temperature range of 21 – 22 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. Under the given conditions of the study the 48 h EC50 value for Daphnia was determined to be > 100 mg/L.

Description of key information

The EC50 (48h) of the test item to Daphnia magna was determined to be > 100 mg/L (reference 6.1.3-1) according to OECD 202 (1992) under GLP conditions.

Key value for chemical safety assessment

Additional information

The objective of this study was to determine the acute toxicity of the test material to Daphnia magna according to OECD 202 (1984) under GLP conditions. For this purpose, juvenile Daphnia magna were exposed to a test material concentration of nominal 100 mg/L (limit test) in an open static system over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia per concentration (test medium group). In addition, a control group of 20 Daphnia in reconstituted water was used. The water solubility of the test material was below 0.01 mg/L using a HPLC method. Due to the low water solubility and the fact that the study was a limit test, no further analysis was initiated. Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. During the test a temperature range of 21 – 22 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. Under the given conditions of the study the 48 h EC50 value for Daphnia was determined to be > 100 mg/L.