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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:
05.02.2018 - 10.04.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Analytical monitoring:
yes
Details on sampling:
Analysis of test concentration and stability of the test substance was made at the start (0 hour) on day 0 and at end of test (48 hours) from all test concentration during range finding and main study. 15 mL of samples were collected in duplicates from each group during range finding and main study.
Vehicle:
no
Details on test solutions:
Stock solution was freshly prepared prior to exposure, by weighing required quantity of test item in a beaker, a small volume of reconstituted water was added and mixed well using a glass rod. After complete soluble of the test item, test formulation was transferred into a measuring cylinder and the beaker was rinsed with reconstituted water and transferred again to the measuring cylinder, rinsing process was repeated until the complete transfer of test contents. Stock solution prepared kept on magnetic stirrer to maintain homogeneity. Test medium of chosen concentration was prepared by dilution of stock solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Waterflea
- Strain: Straus
- Source: Environmental and Molecular Toxicology Division, Department of Zoology, Karnataka University, Karnataka, India
- Feeding during test: no

ACCLIMATION
- Acclimation period: 48h
- Acclimation conditions: same as test conditions
- Type and amount of food: live algal cells (Pseudokirchneriella subcapitata) of 2 mL per liter
- Health during acclimation: no mortality
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
220 mg CaCO3/L
Test temperature:
20.7 - 20.9°C
pH:
7.47 - 7.61
Dissolved oxygen:
7.27 - 7.34 mg/L
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Measured concentration: 108.6 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass jars
- Material, fill volume: glass, 100 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1

TEST MEDIUM PARAMETERS
- Preparation of dilution water: reconstituted water according to OECD 202 (with Calcium chloride, Potassium chloride, Magnesium sulfate and Sodium bicarbonate)

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

EFFECT PARAMETERS MEASURED:
Each test vessel was observed for immobilized Daphnids at 24 and 48 hours after the beginning of the test.
Total hardness of the diluent water (reconstituted water) prior to its use for exposure was analyzed. Temperature, pH and dissolved oxygen were recorded at the beginning and at end of the test in control and in all the tested concentrations.

RANGE-FINDING STUDY
- Test concentrations: 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L
- Results used to determine the conditions for the definitive study: During range finding study no immobility was observed.
Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
The 48 hours EC50 of Potassium dichromate on Daphnia magna was measure to be 0.56 mg/L. This 48 hour EC50 of Potassium dichromate lies within the validity criteria acceptance range (0.50 to 2.12 mg/L) towards test system response and test procedure followed. Hence this test with reference standard establishes the acceptability of test system response and test procedure followed.
Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 of the test item on Daphnia magna was determined to be >100 mg/L.
Executive summary:

The test item was evaluated for acute toxicity on Daphnia as per the OECD Guideline No. 202, “Daphina sp., Acute Immobilisation Test”. The acute toxicity study of the test item on Daphnia was performed to determine the 48 hours Effective Concentration (EC50) and to determine Lowest Observed Effect Concentration (LOEC) and No Observed Effect Concentration (NOEC). Daphnids were exposed to the test item by aqueous exposure under static condition. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. Based on the results of the range finding study, a limit test was conducted as main study at the test concentration of 100.0 mg/L in the test medium along with a control. No clinical signs of toxicity were observed in control and in the tested concentration of 100 mg/L during the 48 hour observation period. During the main study, a sample from the test concentration was collected at the start and the end of the test and analyzed. Results showed that the test concentrations were within the acceptable range of ± 20% to the nominal concentrations. Based on the results of the experiment it can be concluded that after 48 hours the EC50 of the test item on Daphnia is >100 mg/L. Therefore the results are based on the nominal concentration. The No Observed Effect Concentration (NOEC) over the 48 hour exposure period is 100 mg/L, the and Lowest Observed Effect Concentration (LOEC) is >100 mg/L.

Description of key information

The 48-hour EC50 of the test item on Daphnia magna was determined to be >100 mg/L.

Key value for chemical safety assessment

Additional information

The test item was evaluated for acute toxicity on Daphnia as per the OECD Guideline No. 202, “Daphina sp., Acute Immobilisation Test”. The acute toxicity study of the test item on Daphnia was performed to determine the 48 hours Effective Concentration (EC50) and to determine Lowest Observed Effect Concentration (LOEC) and No Observed Effect Concentration (NOEC). Daphnids were exposed to the test item by aqueous exposure under static condition. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. Based on the results of the range finding study, a limit test was conducted as main study at the test concentration of 100.0 mg/L in the test medium along with a control. No clinical signs of toxicity were observed in control and in the tested concentration of 100 mg/L during the 48 hour observation period. During the main study, a sample from the test concentration was collected at the start and the end of the test and analyzed. Results showed that the test concentrations were within the acceptable range of ± 20% to the nominal concentrations. Based on the results of the experiment it can be concluded that after 48 hours the EC50 of the test item on Daphnia is >100 mg/L. Therefore the results are based on the nominal concentration. The No Observed Effect Concentration (NOEC) over the 48 hour exposure period is 100 mg/L, the and Lowest Observed Effect Concentration (LOEC) is >100 mg/L.