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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:
January 23, 2019 - To be completed after finalization of the study report
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Solid content: 99.70%.
Analytical monitoring:
yes
Details on sampling:
Samples of stock solution, control solutions and test solutions were taken to determine the actual test item concentrations. Solutions were sampled in duplicate at the start and at the end of exposure. The duplicate samples were kept separately as a reserve. The nominal volume per sample was 10 mL. After sampling and before shipment to the analytical test site, the samples were stabilised by adding acetonitrile directly after sampling (acetonitrile volume: 20% of the water sample volume: 10 mL of sample were mixed with 2 mL of acetonitrile). All samples were stored in amber glass bottles in the dark at a temperature of ≤ -18 °C.
Vehicle:
no
Details on test solutions:
A stock solution of the test item was prepared by dissolving 100.3 mg of the test item in 1000 mL of test medium, resulting in a nominal concentration of 100 mg test item/L. This stock solution was stirred for 1 hour at ambient temperature in the dark. The stock solution was visually examined for undissolved/particulate matter. The stock solution was clear; no Tyndall effect was observed. The stock solution was used immediately to prepare the desired test item concentrations.

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna STRAUS.
- Strain/clone: clone M10.
- Source: culture from ECT Oekotoxikologie GmbH (organisms originally supplied by KU Leuven, Belgium, in 2011).
- Age of parental daphnids: less than 35 days.
- Age of the daphnids at the beginning of the test: less than 24 hours.
- Feeding during test : none.

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
254 mmol HCO3/L.
Test temperature:
From 19.8°C to 20.6°C.
pH:
From 7.6 to 7.7.
Dissolved oxygen:
From 8.5 to 9.3 mg/L.
Conductivity:
646 µS/cm.
Nominal and measured concentrations:
Nominal concentrations: control, 6.25, 12.5, 25.0, 50.0 and 100.0 mg test item/L.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers (100 mL) covered with watch glasses.
- Volume of solution: 50-60 mL.
- Aeration: none.
- No. of organisms per vessel: 5.
- No. of vessels per concentration (replicates): 4.
- No. of vessels per control (replicates): 4.

TEST MEDIUM / WATER PARAMETERS
- Medium: Elendt Medium M4.

OTHER TEST CONDITIONS
- Adjustment of pH: none.
- Photoperiod: 16 hours light/8 hours dark.
- Light intensity: 50-1000 lx.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility.

RANGE-FINDING STUDY
- Test concentrations: not reported (non-GLP range-finding test).
Reference substance (positive control):
yes
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
63.73 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% cI = 54.88-74.00 mg/L
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
54.81 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% cI = 47.20-63.64 mg/L
Details on results:
The test item concentrations were stable over the test period. Although the measured concentrations based on measured C12 amphopropionate at 100 mg test item/L (nominal) were slightly below 80% of nominal concentrations, the recoveries at 6.25 and 25.0 mg test item/L were between 86 and 100% of nominal. The overall recovery was 86% of nominal (arithmetic mean of recoveries measured at 0 h and 48 h). The biological endpoints are therefore expressed both on the basis of nominal concentrations and on the basis of mean measured concentrations (using the mean recovery of 86% of nominal concentrations).

Sublethal observations on the mobile daphnids were recorded. Reduced swimming activity was observed at 50.0 and 100 mg/L after 24 h and 48 h. One daphnid showed reduced swimming activity at 12.5 mg/L after 48 h.

All validity criteria were fulfilled as required by the test guideline:
- immobile daphnids in the control: 0%;
- dissolved oxygen concentration in control and test vessels at the end of the test: >= 8.5 mg/L.
Signs of disease or stress, for example, discoloration or unusual behaviour, such as being trapped at the water surface, did not exceed 10 per cent of the daphnids in the controls.
Results with reference substance (positive control):
The most recent reference test with potassium dichromate performed in a separate study resulted in an EC50(24h) of 0.614 mg/L. According to the OECD guideline No. 202 (OECD, April 2004) EC50(24h)-values for potassium dichromate obtained from different laboratories should range between 0.6 mg/L and 2.1 mg/L. The toxicity of the reference item is within this range. Therefore the results of this reference test are acceptable and the test conditions are reliable and the sensitivity of the test system could be demonstrated.
Reported statistics and error estimates:
Mortality as assessed by immobility of the daphnids was evaluated. The Spearman-Kaerber procedure was used to estimate the EC50 value. The statistical software package ToxRat Professional 3.3.0 (ToxRat Solutions GmbH, Naheweg 15, D-52477 Alsdorf) was used for these calculations.

Cumulative number of immobile Daphnia magna after 24 and 48 h.

Nominal concentration 

[mg test item/L]

Total number of introduced daphnids

Total number of immobile daphnids (t = 24h)

Immobile daphnids (% of introduced) (t = 24h)

Total number of immobile daphnids (t = 48h)

Immobile daphnids (% of introduced) (t = 24h)

Control

20

0

0.0

0

0.0

6.25

20

0

0.0

0

0.0

12.5

20

0

0.0

1

5.0

25.0

20

0

0.0

1

5.0

50.0

20

0

0.0

2

10.0

100

20

2

10.0

19

95.0

Validity criteria fulfilled:
yes
Conclusions:
A 48h-EC50 value of 63.7 mg/L (95% cI = 54.9 -74.0 mg/L) was determined for the parameter "immobility of daphnids" based on nominal concentrations. A 48h-EC50 value of 54.8 mg/L (95% cI = 47.2-63.6 mg/L) was determined for the parameter "immobility of daphnids" based on mean measured concentrations in mg test item/L (using the mean recovery of 86% of nominal concentrations).
Executive summary:

The acute toxicity of the test item to water fleas (Daphnia magna) was investigated in a GLP-compliant study performed in accordance with OECD Guideline No. 202. A series of concentrations of the test item in Elendt Medium M4 was prepared and the test organisms were exposed to these treatments, as well as to controls without the test item, for a period of 48 hours under static conditions. A clear concentration-response relationship was observed. A 48h-EC50 value of 63.73 mg/L (95% cI = 54.88 -74.00 mg/L) was determined for the parameter "immobility of daphnids" based on nominal concentrations. A 48h-EC50 value of 54.81 mg/L (95% cI = 47.20-63.64 mg/L) was determined for the parameter "immobility of daphnids" based on mean measured concentrations in mg test item/L (using the mean recovery of 86% of nominal concentrations).

Description of key information

The acute toxicity of the test item to water fleas (Daphnia magna) was investigated in a GLP-compliant study (Egeler & Lang, 2019) performed in accordance with OECD Guideline No. 202. A series of concentrations of the test item in Elendt Medium M4 was prepared and the test organisms were exposed to these treatments, as well as to controls without the test item, for a period of 48 hours under static conditions. A clear concentration-response relationship was observed. A 48h-EC50 value of 63.73 mg/L (95% cI = 54.88 -74.00 mg/L) was determined for the parameter "immobility of daphnids" based on nominal concentrations. A 48h-EC50 value of 54.81 mg/L (95% cI = 47.20-63.64 mg/L) was determined for the parameter "immobility of daphnids" based on mean measured concentrations in mg test item/L (using the mean recovery of 86% of nominal concentrations).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
54.81 mg/L

Additional information

The toxicity of the test item to the freshwater flea Daphnia magna was investigated in one GLP-compliant study (Egeler & Lang, 2019) performed in accordance with standard methods, without deviations. The study is considered as reliable (Klimisch 1) and is selected as a key study for the endpoint.