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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:
from 2018-12-11 to 2018-12-13
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:
13th April 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
October 2016
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: Lab NP_20171034-003
- Expiration date of the lot/batch: 2022-07-24

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

OTHER SPECIFICS:
white solid
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:
18.4 – 21.5°C
pH:
7.69 – 7.82
Dissolved oxygen:
7.19 – 7.64 mg/L
Nominal and measured concentrations:
nominal concentration: 100 mg/L
The exposure concentration of the saturated test solution was analytically determined to be 5.84 mg/L (calculated as the geometric mean of start and end concentrations).
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: 780 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
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 5.84 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
5.84 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: No
Validity criteria fulfilled:
yes
Conclusions:
In this 48-hour static acute toxicity test with Daphnia magna the test item had no toxic effect on Daphnia at aquatic saturation (measured value: 5.84 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 48-h EC50 value was determined to be > 5.84 mg/L (equivalent to 100 mg/L nominal concentration). The 48-h NOEC was determined to be 5.84 mg/L (equivalent to 100 mg/L nominal concentration).
Executive summary:

The purpose of this study was to evaluate the influence of the test item on the mobility respectively survival of Daphnia magna. A limit test was performed in which young Daphnia were exposed to aqueous test media containing the test item for 48 hours at the limit of its solubility in the test medium (i.e. saturation) plus a control in order to demonstrate that the test item has no influence on the mobility of Daphnia up to at least the saturation concentration.Limit test; using a single concentration at saturation (corresponding to 100 mg/L nominal concentration); concurrent control ran.The exposure concentration of the saturated test solution was analytically determined to be 5.84 mg/L (calculated as the geometric mean of start and end concentrations).The test item and the control were tested using 20 Daphnia, divided into four groups (glass beaker; test medium app. 40 mL) of five animals each were exposed to the test item concentration or run as control for 48 hours under static conditions. The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure.Concentrations of the test item were determined at the start (0 hour) and the end of exposure (48 hours) using ICP-OES method.Statistical analysis was not necessary; endpoints were determined directly from the raw data. All validity criteria were met and therefore the study is considered as valid. The mean measured concentration of the test item was 6.22 mg/L at the start and 5.49 mg/L at the end of the test. There was no immobilisation observed in twenty daphnids exposed to each test item treated and control group. Further no abnormal behaviour or appearance of test animals was noted. In this 48-hour static acute toxicity test with Daphnia magna the test item had no toxic effect on Daphnia at aquatic saturation (measured value: 5.84 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 48-h EC50 value was determined to be > 5.84 mg/L (equivalent to 100 mg/L nominal concentration). The 48-h NOEC was determined to be 5.84 mg/L (equivalent to 100 mg/L nominal concentration).

Description of key information

In a 48-hour static acute toxicity test with Daphnia magna the test item had no toxic effect on Daphnia at aquatic saturation (measured value: 5.84 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 48-h EC50 value was determined to be > 5.84 mg/L (equivalent to 100 mg/L nominal concentration). The 48-h NOEC was determined to be 5.84 mg/L (equivalent to 100 mg/L nominal concentration).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
5.84 mg/L

Additional information

A study according OECD TG 202 was conducted to evaluate the influence of the test item on the mobility respectively survival of Daphnia magna. A limit test was performed in which young Daphnia were exposed to aqueous test media containing the test item for 48 hours at the limit of its solubility in the test medium (i.e. saturation) plus a control in order to demonstrate that the test item has no influence on the mobility of Daphnia up to at least the saturation concentration. Limit test; using a single concentration at saturation (corresponding to 100 mg/L nominal concentration); concurrent control ran. The exposure concentration of the saturated test solution was analytically determined to be 5.84 mg/L (calculated as the geometric mean of start and end concentrations). In this 48-hour static acute toxicity test with Daphnia magna the test item had no toxic effect on Daphnia at aquatic saturation (measured value: 5.84 mg/L; equivalent to 100 mg/L nominal concentration). Accordingly, the 48-h EC50 value was determined to be > 5.84 mg/L (equivalent to 100 mg/L nominal concentration). The 48-h NOEC was determined to be 5.84 mg/L (equivalent to 100 mg/L nominal concentration).