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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-12-01 to 2016-06-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: limit test, 100 mg/L
- Sampling method: For determination of the test item concentration, samples were taken from the test concentration and the control at the start, then on Day 1 before and after renewal and at the end of the experiment.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: mechanical dispersion using 10 min ultrasonic dispersion
- Eluate: ISO medium
- Untreated Controls: the dilution water (ISO medium) was used without addition of the test item.
- Toxic Reference Controls: for the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
- Evidence of undissolved material: none
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia
- Strain/clone: Straus
- Sex: Female
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Age of parental stock: Less than 24 hours old
- Feeding during test: none
- Breeding: 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.

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:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
The reconstituted water (ISO medium) has an approximate theoretical total hardness of 249 mg/L (as CaCO3); it was not measured during the study.
Test temperature:
The test temperature was in the range of 19.8 – 20.3 °C measured in the test vessels during the test. The additionally measured ambient temperature within the climate chamber was between 19.2 – 20.8 °C.
pH:
The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was in the range of 7.33 – 7.98 during the test.
Dissolved oxygen:
The dissolved oxygen concentration was in the range of 7.25 – 8.08 mg/L during the test.
Salinity:
not applicable
Conductivity:
not applicable
Nominal and measured concentrations:
- nominal: 100 mg/L
- measured: 87.3 mg/L
Details on test conditions:
The test containers were kept during the test in a climate chamber under controlled conditions. The water temperature, dissolved oxygen concentration and pH were measured in each test group at the start, after the renewal and in each test vessel before the renewal and at the end of the test. Additionally, the ambient temperature was measured continuously using a min/max thermometer in the climate chamber.

TEST SYSTEM
- Test vessel type and size: Glass beakers of approximately 40 mL test medium
- Renewal rate of test solution: once a day
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium (according to OECD 202) was used as dilution water in the experiment.
Separate stock solutions of individual substances were first prepared in deionised water (prepared in TOXI-COOP ZRT. by MILLIPORE ELIX water purification system). The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water.

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: Significant toxic effects were not observed during the non-GLP preliminary range-finding test.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
87.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 87.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 87.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 87.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations that might cause a difference between measured and nominal values: none
Validity criteria fulfilled:
yes
Conclusions:
In this 48-hour acute toxicity test with Daphnia magna the 48 h EC50 value was determined to be higher than 87.3 mg/L, and the 48 h NOEC was determined as 87.3 mg/L. The results are based on the measured, calculated test item concentrations.
Executive summary:

Purpose

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, the test animals were exposed to aqueous test media containing the test item for 48 hours at only one concentration (100 mg/L) plus a control in order to demonstrate that the test item has no influence on the mobility of Daphnia up to at least this test concentration. Considering the information about the possible degradation of the test item, a semi-static test was performed with a renewal of the test medium after 24 hours.

Test concentrations

Significant toxic effect was not observed during the non-GLP preliminary range-finding test, therefore only one test concentration (100 mg/L) and one control group was tested in a limit test. The measured concentrations deviated more than 20 % from the nominal therefore the geometric mean of the measured concentrations was calculated in order to determine exposure concentration. The corresponding calculated geometric mean concentration was 87.3 mg/L.

Results

Analytical results

The quantification of the test item was performed by a previously validated analytical method by the analytical laboratory of TOXI-COOP ZRT. Samples were taken and analysed from the test concentration and the control at the start, before and after the renewal and at the end of the experiment. The measured concentrations of the test item varied between 75 and 102 % of the nominal concentration.

Biological results

There was no immobilisation 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. The measured test item concentrations at 24 hours (before renewal) and at the end of the test differed more than 20% from the nominal 100 mg/L value, therefore geometric mean was calculated. The geometric mean was calculated to be 87.3 mg/L. Accordingly, the 48-h NOEC was determined as 87.3 mg/L. The 48-h EC50 and LOEC were determined to be higher than 87.3 mg/L.

Description of key information

In the 48-hours acute toxicity test with Daphnia magna the 48 h EC50 value was determined to be greater than 87.3 mg/L, and the 48 h NOEC was determined as 87.3 mg/L. The results are based on the measured, calculated test item concentrations.

Key value for chemical safety assessment

Additional information

Test concentrations

Significant toxic effect was not observed during the non-GLP preliminary range-finding test, therefore only one test concentration (100 mg/L) and one control group was tested in a limit test. The measured concentrations deviated more than 20 % from the nominal therefore the geometric mean of the measured concentrations was calculated in order to determine exposure concentration. The corresponding calculated geometric mean concentration was 87.3 mg/L.

Results

Analytical results

The quantification of the test item was performed by a previously validated analytical method by the analytical laboratory of TOXI-COOP ZRT. Samples were taken and analysed from the test concentration and the control at the start, before and after the renewal and at the end of the experiment. The measured concentrations of the test item varied between 75 and 102 % of the nominal concentration.

Biological results

There was no immobilisation 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. The measured test item concentrations at 24 hours (before renewal) and at the end of the test differed more than 20% from the nominal 100 mg/L value, therefore geometric mean was calculated. The geometric mean was calculated to be 87.3 mg/L. Accordingly, the 48-h NOEC was determined as 87.3 mg/L. The 48-h EC50 and LOEC were determined to be higher than 87.3 mg/L.