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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:
2017-07-10 to 2017-12-08
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:
April 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
EC No 440/2006
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW160573
- Expiration date of the lot/batch: 2018-09-26
- Purity test date: ??
- Purity: 99.39%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
Analytical monitoring:
yes
Details on sampling:
- Sampling method:
* Range-Finding Test: A sample of each test concentration was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test conditions.
* Definitive Test: The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 and 48 hours.
- Sample storage conditions before analysis: All samples were stored frozen prior to analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
* Range-Finding Test: The test concentrations to be used in the definitive test were determined by a preliminary range-finding test.
A nominal amount of test item (50 mg) was dissolved in test water and the volume adjusted to 500 mL to give the 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations of 0.10, 1.0 and 10 mg/L. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
* Definitive Test: Based on the results of the range-finding tests the following test concentrations were assigned to the definitive test: 1.0, 3.2, 10, 32 and 100 mg/L.
A nominal amount of test item (200 mg) was dissolved in test water and the volume adjusted to 2 liters to give the 100 mg/L test concentration from which a series of dilutions was made to give further test concentrations of 1.0, 3.2, 10 and 32 mg/L. Adjustments were made to the pH of the test concentrations using 1M hydrochloric acid and 1M sodium hydroxide to bring the pH in the range quoted in the study plan of between 6 and 9.
Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All solutions were clear and colourless.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Method of breeding: Culture conditions ensured that reproduction was by parthenogenesis.
- Feeding during cultivation: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension, daily
- Feeding during test: no

ACCLIMATION
- Acclimation period: not relevant
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
not reported
Test temperature:
21-22°C
pH:
At t=0h: 7.8-7.9
At t=48h: 7.3-8.2
Dissolved oxygen:
At t=0h: 8.8-8.9
At t=48h: 7.6-8.5
Salinity:
not relevant
Nominal and measured concentrations:
Range finder:
Nominal concentrations: 0.1, 1.0, 10 and 100 mg/L (1.0, 10 and 100 mg/L analysed)
Measured concentrations (mg/L) at t=0h: 0.980, 10.2, 107
Measured concentrations (mg/L) at t=48h: 1.03, 10.8, 112

Final test:
Nominal concentrations: 1, 3.2, 10, 32 and 100 mg/L
Measured concentrations (mg/L) at t=0h: 0.0364, 0.977, 3.19, 9.83, 30.9, 99.0
Measured concentrations (mg/L) at t=48h: 0.00820, 0.955, 3.07, 9.67, 29.3, 99.8
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 150 mL, glass beaker filled with 100 mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L (setup: combined range finder/limit test)
- 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
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- NOEC = 32 mg/L
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: no
- EC50/LC50: 48-h EC50 = 0.75 mg/L.
Reported statistics and error estimates:
An estimate of the EC50 values was given by inspection of the immobilization data. The LOEC and the NOEC at 24 and 48 hours were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction using the ToxRat Professional computer software package (TOXRAT).

Table 2: Cumulative Immobilization Data and Observations in the Definitive Test

Nominal Concentration
(mg/L)

24 Hours

Cumulative Immobilized Daphnia
(Initial Population: 5 Per Replicate)

Observations

Rep1

Rep2

Rep3

Rep4

Total

%

Rep1

Rep2

Rep3

Rep4

Control

0

0

0

0

0

0

4N1T

5 N

5 N

5 N

1.0

0

0

0

0

0

0

5 N

4 N 1 T

4 N 1 T

5 N

3.2

0

0

0

0

0

0

5 N

5 N

5 N

5 N

10

0

2

0

0

2

10

4 N 1 R

3 N

3 N 1 T 1 R

4 N 1 R

32

0

0

0

1

1

5

5 N

3 N 2 R

4 N 1 T

4 N

100

0

1

1

2

4

20

4 N 1 C

4 N

3 N 1 C

3 N

 

Nominal Concentration
(mg/L)

48 Hours

Cumulative Immobilized Daphnia
(Initial Population: 5 Per Replicate)

Observations

Rep1

Rep2

Rep3

Rep4

Total

%

Rep1

Rep2

Rep3

Rep4

Control

0

0

0

0

0

0

5 N

5 N

5 N

5 N

1.0

0

0

0

1

1

5

5 N

5 N

5 N

4 N

3.2

0

0

0

0

0

0

5 N

5 N

5 N

5 N

10

0

2

0

0

2

10

5 N

3 N

5 N

5 N

32

1

0

0

1

2

10

3 N 1 R

5 N

4 N 1 T

4 N

100

3

1

1

2

7

35

2 C

4 R

1 R 3 C

3 C

 

Rep =     Replicate

C =         Covered with debris

N=        Normal

R =         Reduced mobility

T=         Trapped at surface

Validity criteria fulfilled:
yes
Remarks:
Considered to be valid given that none of the control daphnids showed immobilization or other signs of disease or stress, and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels
Conclusions:
The acute toxicity of the test substance to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. Based on nominal concentrations, the 48-h EC50 was > 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The acute toxicity of the test substance to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. Based on nominal concentrations, the 48-h EC50 was > 100 mg/L (Squance, 2018). The results of the test can be considered reliable without restriction. Based on the results it can be concluded that the test substance is not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information