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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:
From 2019-07-29 to 2019-08-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed to current OECD guidelines with no significant deviations and run in OECD GLP certified lab.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch No.: A03-18-0081
Purity: ≥99.9%
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Age at study initiation: less than 24 hours old and they should not the first brood progeny.
- Source: Introduced from college of applied chemistry of China agricultural university and propagated in the facility.

ACCLIMATION
- Acclimation conditions (same as test or not): The stock animals were maintained in culture conditions (light, temperature, and medium) similar to those was used in the test.
- Light condition: 16 hours light, 8 hours darkness
- Temperature: 20 ± 2 °C
- Type and amount of food: A concentrated algal suspension
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
170 mg/L (as CaCO3)
Test temperature:
20.1 - 20.3 °C
pH:
7.96 - 8.08
Dissolved oxygen:
8.35 - 8.48 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: 24.2 mg/L (overall mean determined concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Aeration: During the test, there was no aerating to vessels
- No. of organisms per replicate: 5 daphnias
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground water treated with aquapro pure water system.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily, 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Each test vessel was checked for immobilized daphnias at 24 and 48 hours after the beginning of the test. In addition to immobility, any abnormal behavior or appearance were recorded. Those animals that were not able to swim within 15 seconds, after gentle agitation of the test vessel were considered to be immobilised (even if they can still move their antennae).
- The hardness of water was measured before the test.
- Dissolved oxygen and pH of test media were measured in each replicate vessel for both control and test solutions at the beginning of the test and the end of the test.
- Temperature (for water bath): it was monitored continuously by automatic temperature monitoring system.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L (nominal concentration)
- Results used to determine the conditions for the definitive study: No visible symptoms
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 24.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
During the 48-hour exposure period, no immobilisation and visible toxic sign was observed in the blank control groups and the test group.
The results showed that for the nominal test item concentration of 100 mg/L, the mean determined concentration in 0-hour and 48-hour media were 25.5 mg/L and 22.8 mg/L. The overall mean determined concentration was 24.2 mg/L.
Results with reference substance (positive control):
The 24-hour EC50 of Potassium dichromate was 1.39 mg/L (95% confidence limits: 1.14 mg/L - 1.69 mg/L).

Validity of the test

Determined dissolved oxygen concentrations were between 8.35 - 8.48 mg/L at the beginning and the end of test, which met the criteria of ≥ 3 mg/L during the test period;

The pH values were in the range of 7.96 - 8.08, the difference was 0.12, which met the criteria of not vary by more than 1.5 units;

At the end of the test, the animal number of immobility in the control was 0, which met the criteria of < 10%;

With above points, this test was valid.

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 of test item to Daphnia magna was greater than 24.2 mg/L (the overall mean determined concentration).
Executive summary:

An acute immobilisation study of the test item was conducted with Daphnia magna over a 48-hour exposure period according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).

According to the preliminary test results, the definitive test was conducted with the test item concentration of 100 mg/L. A concurrent blank control was performed in parallel. 4 replicates were used with 5 daphnias for each replicate. The test was performed with a static system. Dissolved oxygen and pH values of the test media were measured at the beginning and the end of the test. Temperature was monitored continuously by automatic temperature monitoring system. The hardness of water was 170 mg/L (as CaCO3), which was measured before the test.

 

During the 48-hour exposure period, no immobilisation and visible toxic sign was observed in the blank control groups and the test group.

The concentrations of test item were determined in samples of test media by GC method. The results showed that for the nominal test item concentration of 100 mg/L, the mean determined concentration in 0-hour and 48-hour media were 25.5 mg/L and 22.8 mg/L. The overall mean determined concentration was 24.2 mg/L.

 

According to the results, the 48-hour EC50 of test item to Daphnia magna was greater than 24.2 mg/L.

Description of key information

The 48-hour EC50 of test item to Daphnia magna was greater than 24.2 mg/L (the overall mean determined concentration).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
24.2 mg/L

Additional information

An acute immobilisation study of the test item was conducted with Daphnia magna over a 48-hour exposure period according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).

According to the preliminary test results, the definitive test was conducted with the test item concentration of 100 mg/L. A concurrent blank control was performed in parallel. 4 replicates were used with 5 daphnias for each replicate. The test was performed with a static system. Dissolved oxygen and pH values of the test media were measured at the beginning and the end of the test. Temperature was monitored continuously by automatic temperature monitoring system. The hardness of water was 170 mg/L (as CaCO3), which was measured before the test.

 

During the 48-hour exposure period, no immobilisation and visible toxic sign was observed in the blank control groups and the test group.

The concentrations of test item were determined in samples of test media by GC method. The results showed that for the nominal test item concentration of 100 mg/L, the mean determined concentration in 0-hour and 48-hour media were 25.5 mg/L and 22.8 mg/L. The overall mean determined concentration was 24.2 mg/L.

 

According to the results, the 48-hour EC50 of test item to Daphnia magna was greater than 24.2 mg/L.