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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
2020-02-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Please refer to attached QMRF and QPRF Documents
Qualifier:
according to guideline
Guideline:
other: REACH guidance on QSARS R.6
Principles of method if other than guideline:
Calculation of Short-Term toxicity in Daphnia. Software used: ECOSAR 1.11 (EPISUITE) for chemical class "Vinyl/Allyl Ethers"
GLP compliance:
no
Specific details on test material used for the study:
SMILES : O(CCO)CC=C
Analytical monitoring:
not required
Test organisms (species):
Daphnia sp.
Water media type:
freshwater
Remarks on exposure duration:
acute exposure (duration not specified)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
1 345.975 mg/L
Remarks on result:
other: QSAR predicted value: The substance is within the applicability domain of the model.

Values used to Generate ECOSAR Profile:

Log Kow: -0.061    (EPISuite Kowwin v1.68 Estimate)

Wat Sol: 4.54E+005 (mg/L, EPISuite WSKowwin v1.43 Estimate)

Conclusions:
Using ECOSAR v1.11 the short-term toxicity 48-h LC50 value for Daphnia was determined to be >100 mg/L. The substance is within the applicability domain of the model.
Executive summary:

Using ECOSAR v1.11 the short-term toxicity 48-h LC50 value for Daphnia was determined to be > 100 mg/L, as no effects up to the limit dose were observed. The substance is within the applicability domain of the model.

The adequacy of a prediction depends on the following conditions:

a) the (Q)SAR model is scientifically valid: the scientific validity is established according to the OECD principles for (Q)SAR validation;

b) the (Q)SAR model is applicable to the query chemical: a (Q)SAR is applicable if the query chemical falls within the defined applicability domain of the model;

c) the (Q)SAR result is reliable: a valid (Q)SAR that is applied to a chemical falling within its applicability domain provides a reliable result;

d) the (Q)SAR model is relevant for the regulatory purpose.

For assessment and justification of these 4 requirements the QMRF and QPRF files were developed and attached to this study record.

Description of the prediction Model

The prediction model was descripted using the harmonised template for summarising and reporting key information on (Q)SAR models. For more details please refer to the attached QSAR Model Reporting Format (QMRF) file.

Assessment of estimation domain

The assessment of the estimation domain was documented in the QSAR Prediction Reporting Format file (QPRF). Please refer to the attached document for the details of the prediction and the assessment of the estimation domain.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2020-11-10 to 2020-12-16
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:
Adopted 13 April, 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
May 30, 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)
Analytical monitoring:
yes
Details on sampling:
- Sampling method: For the determination of the test item concentrations, samples were taken from the test item treated groups and from the control group (4 x 10 mL from each test group at the start and 4 x 10 mL from each test group at the end of the experiment).
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solutions used in the test were prepared by mechanical dispersion without using of any solubilising agent. A stock solution was first prepared by dissolving 0.0412 g of the test item in 412 mL dilution water (ISO medium). The test solutions of subsequent lower test concentrations were prepared by the appropriate diluting of this stock solution.

- Controls: Dilution water without test item incubated under the same conditions as the test group.

- Test concentration separation factor: spacing factor of 2
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Breeding conditions: Daphnia were bred in the Laboratory of TOXI-COOP ZRT. under similar temperature and light conditions as in the test, and in 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. The test animals were fed with centrifuged green alga suspension.
- Age of parental stock: less than 24 hours old
- Feeding during test: none

ACCLIMATION
- Acclimation period: Test animals were bred under similar conditions as that used during the exposure period, therefore additional acclimatisation before the test was not necessary.
- Health during acclimation: no mortality observed
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
249 mg/L (as CaCO3)
Test temperature:
20.9 - 21.1 °C
pH:
8.00 - 8.33
Dissolved oxygen:
8.48 - 8.84 mg/L
Salinity:
not applicable
Conductivity:
not specified
Nominal and measured concentrations:
Nominal conc.: 6.25, 12.5, 25, 50 and 100 mg/L
Measured conc.: The analytically determined concentrations of the test item were 94 % and 114 % of the nominal value at the start and between 96 % and 115 % of the nominal value at the end of the test.
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Material, size, fill volume: glass, ~ 50 mL, ~ 40 mL test 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 (according to OECD 202)

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

EFFECT PARAMETERS MEASURED:
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
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:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
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 untreated control group and at any of the test concentrations after 48 hours of exposure.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Dose-response test: yes
- EC50: 24h EC50: 0.84 mg/L (95 % conf. limits: 0.53 – 0.95 mg/L)

Validity

Control: The immobilisation rate of the introduced Daphnia did not exceed 10 %. No immobility was 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 8.48 – 8.84 mg/L during the test.

 

Analytical Results

The measured concentrations of the test item in the test solutions were between 94 % and 114 % of the nominal value at the start and between 96 % and 115 % of the nominal value at the end of the test. There is evidence that the concentrations of the test item concentrations were maintained within ± 20 % of the nominal concentrations throughout the test. Therefore, the analysis of the results was based on the nominal concentration values.

 

Biological Results

Table 1: Immobilization of the Test Animals

Nominal concentration
[mg/L]

Number of
Daphnia
tested

Number of immobilised
Daphnia after

% of immobilised
Daphnia after

24 h

48 h

24 h

48 h

Control

20

0

0

0

0

6.25

20

0

0

0

0

12.5

20

0

0

0

0

25

20

0

0

0

0

50

20

0

0

0

0

100

20

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
The 48-h EC10, EC20, EC50 values as well as the 48-h LOEC value based on immobility of the daphnids were determined to be > 100 mg/L. The 48-h NOEC was determined to be 100 mg/L.
Executive summary:

The effect of the test item on the mobility of Daphnia magna was determined in a 48-h “Acute Immobilization Test” according to OECD TG 202, EU Method C.2 under GLP. For this purpose, young Daphnia were exposed in an immobilisation test to aqueous test media containing the test item at a range of concentration for 48 hours. The number of Daphnia being no longer capable of swimming at the end of the test or being dead was recorded. Based on the results of the non-GLP Preliminary Range-Finding Tests, 6.25, 12.5, 25, 50 and 100 mg/L test item concentrations were used in the main test. Untreated control ran parallel and Potassium dichromate served as the reference item. Twenty animals, divided into four replicates of five animals each were exposed to the test concentrations or run as control for 48 hours in a static test. The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. For determination of the test item concentrations, samples were taken from the concentration levels and from the untreated control at the start and at the end of the test. Concentrations were determined using GC-MS method. The mean measured concentrations of the test item in the test solutions were between 94 % and 114 % of the nominal value at the start and between 96 % and 115 % of the nominal value at the end of the test. There is evidence that the concentrations of the test item was maintained within ± 20 % of the nominal concentrations throughout the test. Therefore, the analysis of the results was based on the nominal concentration values. There was no immobilisation observed in the twenty daphnids exposed to each of the test item treated groups and there was no immobilization observed in the twenty daphnids exposed to the control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected. The 48-h EC10, EC20, EC50 values as well as the 48-h LOEC value based on immobility of the daphnids were determined to be > 100 mg/L. The 48-h NOEC was determined to be 100 mg/L.

Description of key information

The 48-h EC10, EC20, EC50 values as well as the 48-h LOEC value based on immobility of the daphnids were determined to be > 100 mg/L. The 48-h NOEC was determined to be 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
> 100 mg/L

Additional information

The effect of the test item on the mobility of Daphnia magna was determined in a 48-h “Acute Immobilization Test” according to OECD TG 202, EU Method C.2 under GLP. For this purpose, young Daphnia were exposed in an immobilisation test to aqueous test media containing the test item at a range of concentration for 48 hours. The number of Daphnia being no longer capable of swimming at the end of the test or being dead was recorded. Based on the results of the non-GLP Preliminary Range-Finding Tests, 6.25, 12.5, 25, 50 and 100 mg/L test item concentrations were used in the main test. Untreated control ran parallel and Potassium dichromate served as the reference item. Twenty animals, divided into four replicates of five animals each were exposed to the test concentrations or run as control for 48 hours in a static test. The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. For determination of the test item concentrations, samples were taken from the concentration levels and from the untreated control at the start and at the end of the test. Concentrations were determined using GC-MS method. The mean measured concentrations of the test item in the test solutions were between 94 % and 114 % of the nominal value at the start and between 96 % and 115 % of the nominal value at the end of the test. There is evidence that the concentrations of the test item was maintained within ± 20 % of the nominal concentrations throughout the test. Therefore, the analysis of the results was based on the nominal concentration values. There was no immobilisation observed in the twenty daphnids exposed to each of the test item treated groups and there was no immobilization observed in the twenty daphnids exposed to the control group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected. The 48-h EC10, EC20, EC50 values as well as the 48-h LOEC value based on immobility of the daphnids were determined to be > 100 mg/L. The 48-h NOEC was determined to be 100 mg/L.


The short-term toxicity on aquatic invertebrates was also estimated using ECOSAR v1.11. The 48h LC50 was determined to be > 100 mg/L.