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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:
key 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:
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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Remarks:
HPLC method with UV detection
Details on sampling:
- Sampling method: Four parallel samples were taken from the 100 mg/L concentration level and from the control sample. The samples were prepared immediately after sampling.
Vehicle:
no
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:
yes
Total exposure duration:
48 h
Post exposure observation period:
no
Hardness:
249 mg/L (as CaCO3)
Test temperature:
20 °C
pH:
7 - 8
Dissolved oxygen:
8 mg/L
Nominal and measured concentrations:
Nominal concentration: 100 mg/L (limit concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, approximately 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
- Volume/Organism: 2 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water proportionally.
Stock solution 1: CaCl2 x 2 H2O 11.76 g/L
Stock solution 2: MgSO4 x 7H2O 4.93 g/L
Stock solution 3: NaHCO3 2.59 g/L
Stock solution 4: KCl 0.23 g/L

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
- Results used to determine the conditions for the definitive study: A preliminary test was performed at the nominal concentation of 100 mg/L in order to check the toxicity of the test item on the daphnids up to at least this concentration. In the preliminary test no immobility or any sub-lethal effect was detected in the treated 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
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: results not yet available
Conclusions:
The short-term toxicity of Daphnia magna will be determined.
Executive summary:

A study will be performed in accordance with OECD TG 202 in order to determine the short-term toxicity to Daphnia magna. The study was initiated in January 2020 but was not completed by the CRO in due time to complete the registration dossier. The study record will be updated as soon as the results will become available.

Description of key information

The short-term toxicity 48-h LC50 value for Daphnia was determined to 1345.975 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
1 346.975 mg/L

Additional information

Using ECOSAR v1.11 the short-term toxicity 48-h LC50 value for Daphnia was determined to be 1345.975 mg/L. This value does not exceed the estimated water solubility of 454000 mg/L. The substance is within the applicability domain of the model.

A study will be performed in accordance with OECD TG 202 in order to determine the short-term toxicity to Daphnia magna. The study record will be updated as soon as the results will become available.