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Diss Factsheets

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 2017-08-21 to 2017-09-13
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)
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
GLP compliance:
yes (incl. QA statement)
Remarks:
TOXI-COOP ZRT., 8230 Balatonfüred, Arácsi út 97., Hungary
Analytical monitoring:
yes
Details on sampling:
- Sampling method: 4 replicate samples of 5 mL were taken from the test solution (100 mg/L) and the control at the start and the end of the test. Formulation samples were diluted with Ultrapure Water and analysed after derivatization by an HPLC method with UV detection.
- Sample storage conditions before analysis: Samples were tested immediately after sampling.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent. An amount of 0.03 g test item was dissolved in 300 mL dilution water (ISO Medium) to obtain the nominal concentration of 100 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Straus
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3., Hungary
- Feeding during test: no

ACCLIMATION
- Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
249 mg/L CaCO3
Test temperature:
19.6 - 20.2 °C
pH:
6.18 - 8.11
Dissolved oxygen:
7.49 - 8.21 mg/L
Salinity:
NA
Nominal and measured concentrations:
Nominal concentrations: 0 and 100 mg/L
Measured concentration: in the range of 100 - 105 % of the nominal concentration
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Fill volume: approximately 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
- Source/preparation of dilution water: ISO Medium, prepared according to OECD 202
- Culture medium different from test medium: Reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light, 8-hour dark cycle
- Light intensity: 638 lux

RANGE-FINDING STUDY
- Test concentrations: 0 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobility or any sub-lethal effects were detected.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC10
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.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There was no immobilisation observed in twenty daphnids exposed to either test item treated or control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected. Accordingly, the 48-h NOEC was determined to be 100 mg/L. The 48-h EC50 and LOEC were determined to be higher than 100 mg/L.
Results with reference substance (positive control):
The date of the last study with reference item Potassium dichromate was: 07 – 08 March 2017.
The 24h EC50: 1.41 mg/L, (95 % confidence limits: 1.19 – 1.68 mg/L)

Analytical Results

The measured concentration of O-Phospho-L-serine was 105 % of the nominal at the start and 100 % at the end of the test. The measured test item concentration remained within ± 20 % of the nominal during the test period of 48 hours, therefore, the biological results are based on the nominal concentration.

Table 1. Test item measured concentrations

Sampling date

Nominal
concentration
(
mg Test Item/L)

Mean of the measured concentrations
(mg Test Item/L)

Measured concentration in percentage of the nominal

Relative Standard Deviation % (n=4)

22 August 2017

100

105.4

105

1

24 August 2017

100

100.4

100

2

Table 2. Summary of biological endpoints

Endpoints

Concentration [mg/L]
(endpoints are based on nominal concentration)

48 h-EC10

> 100

48 h-EC20

> 100

48 h-EC50

> 100

48 h-NOEC

100

48 h-LOEC

> 100

Validity criteria fulfilled:
yes
Conclusions:
In a short-term toxicity test with Daphnia magna, the test item showed no immobilisation or any other toxic effects up to the limit test concentration. Accordingly, the 48-h EC50 was determined to be >100 mg/L.
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 100 - 105 % 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 twenty daphnids exposed to each test item treated and control group. Further no abnormal behaviour or appearance of test animals was noted. The estimated EC50 value (48 hours) of the test item based on the nominal concentration is >100 mg/L.

Description of key information

In a short-term toxicity test with Daphnia magna, the test item showed no immobilisation or any other toxic effects up to the limit test concentration. Accordingly, the 48-h EC50 was determined to be >100 mg/L.

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 (reference 6.1.3-1). 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 100 - 105 % 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 twenty daphnids exposed to each test item treated and control group. Further no abnormal behaviour or appearance of test animals was noted. The estimated EC50 value (48 hours) of the test item based on the nominal concentration is >100 mg/L.