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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

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:
from 2018-01-19 to 2018-04-17
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
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, section 3.1.2 Media preparation methods, Direct addition. OECD Series on Testing and Assessment No. 23, Paris September 2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch No.: 08/2016_R_JM
Purity: 96.8 %
Analytical monitoring:
yes
Details on sampling:
Four parallel samples were taken from the 100 mg/L concentration level and from the control at the start and end of the experiment.
Vehicle:
no
Details on test solutions:
The test solution used in the test was prepared by mechanical dispersion. 0.0700 g of test item were dissolved in 700 mL dilution water (ISO Medium) in order to obtain the concentration of 100 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Waterflea
- Strain/clone: Straus
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Age at test start: Less than 24 hours old
- Feeding during test: no

ACCLIMATION
- Acclimation period: no, breeding conditions same as test conditions
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
249 mg/L (as CaCO3)
Test temperature:
20.6 – 20.8 °C
pH:
6.59 – 8.24
Dissolved oxygen:
7.95 – 8.51 mg/L
Nominal and measured concentrations:
nominal concentration: 100 mg/L
measured concentration: 97 - 98 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers
- Material, fill volume: glass, 40 mL medium
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: ISO medium, according to OECD 202

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness
- Light intensity: 609 lux

EFFECT PARAMETERS MEASURED
after 24 and 48 hours of exposure visual observation (immobility)

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L nominal concentration
- Results used to determine the conditions for the definitive study: No immobility or any sub-lethal effect was detected in the test concentration and in the control group during the 48-h exposure period.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2Cr2O7)
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
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Biological results are based on the nominal test item concentrations.
- No immobilisation or any abnormal behaviour of test animals was observed in the control group and no immobilization was observed at the test concentration of 100 mg/L after 48 hours of exposure.
Results with reference substance (positive control):
- Results with reference substance valid - yes
- Relevant effect levels: 24h EC50: 1.53 mg/L, (95 % confidence limits: 1.30 – 1.78 mg/L)

Validity of the Study

Control: The immobilisation rate of the introduced Daphnia did not exceed 10 %. Immobility was not observed in the untreated control and no Daphnia were trapped at the water surface or showed any sign of disease or stress.

Dissolved Oxygen Concentration: The dissolved oxygen concentration at the end of the test was more than 3 mg/L in control and test vessels. The dissolved oxygen concentration was in the range of 7.95 – 8.51 mg/L during the test.

All validity criteria were within acceptable limits and therefore, the study was considered as valid.

Analytical results

The measured concentration of the test item in the test solution was 98 % of the nominal value at the start and 97 % of the nominal value at the end of the test. There is evidence that the concentration of the tested substance was maintained within ± 20 % of the nominal concentration throughout the test. Therefore the analysis of the results was based on the nominal concentration values.

Validity criteria fulfilled:
yes
Conclusions:
The 48-h EC50 on Daphnia magna was determined to be >100 mg/L and the NOEC to be 100 mg/L, respectively.
Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the test item were determined according to OECD 202, Regulation (EC) No. 440/2008 Method C.2 and EPA OPPTS 850.1010. The study was conducted in a static system over a period of 48 hours with a limit concentration of 100 mg/L. 20 daphnids per test concentration and control were tested. The test item concentration was determined at the start and at the end of the test with HPLC-UV and it was in the range of 94 - 97 % of the nominal concentration. Therefore, the biological endpoints were based on the nominal concentration. The validity criteria of the test guideline were fulfilled. There was no immobilisation observed in the twenty daphnids exposed to the test item and control group. Furthermore, no abnormal behaviour or appearance of the test animals was noted. The estimated EC50 value (48 hours) of the test item based on the nominal concentration is >100 mg/L. The NOEC was determined to be 100 mg/L. The test item had no significant toxic effects on the mobility of the daphnids.

Description of key information

The 48-h EC50 on Daphnia magna was determined to be >100 mg/L and the NOEC to be 100 mg/L, respectively.

Key value for chemical safety assessment

Additional information

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the test item were determined according to OECD 202, Regulation (EC) No. 440/2008 Method C.2 and EPA OPPTS 850.1010. The study was conducted in a static system over a period of 48 hours with a limit concentration of 100 mg/L. 20 daphnids per test concentration and control were tested. The test item concentration was determined at the start and at the end of the test with HPLC-UV and it was in the range of 94 - 97 % of the nominal concentration. Therefore, the biological endpoints were based on the nominal concentration. The validity criteria of the test guideline were fulfilled. There was no immobilisation observed in the twenty daphnids exposed to the test item and control group. Furthermore, no abnormal behaviour or appearance of the test animals was noted. The estimated EC50 value (48 hours) of the test item based on the nominal concentration is >100 mg/L. The NOEC was determined to be 100 mg/L. The test item had no significant toxic effects on the mobility of the daphnids.