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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:
2013-03-26 to 2013-03-28
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:
31 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13th April 2004
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
April 1996
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
For determination of the test item concentration, samples were taken from the testing concentration and the control at the start and at the end of the water renewal periods. Four replicates samples were taken at the start and at the end of the water renewal periods from the test solution, and two samples were taken from the control samples.
Vehicle:
no
Details on test solutions:
A preliminary test was performed to check that the test item has no toxic effects on the Daphnia up to its solubility limit in the test medium (saturation concentration).
In order to obtain the saturated test solution water-accommodated fractions of the test item (WAF method, according to OECD Series on Testing and Assessment No. 23) were prepared as follows: A supersaturated solution (100 mg/L nominal loading) was prepared by dispersing/dissolving the test item amount into the test medium (ISO medium) one day before the start of the test. This solution was moderately stirred for a period of approx. 24 hours and then left settled for about 1 hour. After settling the non-dissolved test material was separated by 20 min centrifugation at 5000 rpm and 20 °C in order to obtain the saturated test solution. The pH of the obtained test solution was not adjusted and was determined to be 7.86. Ten daphnids (divided into two replicates) at the concentration of the above-mentioned preparation method and control were exposed for 48 hours. No immobility or any sub-lethal effect was detected in the treated group or in the control group during the 48-h exposure period. Significant toxic effects were not observed during the preliminary test, therefore only one test concentration at saturation and one control group were tested in a limit test.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna (Straus)
- Age at test start: Less than 24 hours old
- Sex: Female
- Origin: 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 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.
- Acclimatisation: 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:
249 mg/L (as CaCO3)
Test temperature:
19.6 – 19.9 °C (in the test vessels)
19.3 – 20.1 °C (in the climate chamber)
pH:
7.67 – 8.03
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
No measured concentrations (low LOQ)
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers of approximately 40 mL test medium. Each test unit was uniquely identified with study code, test concentration and replicate number.
- No. of vessels per concentration: Twenty Daphnia per test group and control, divided into four groups of five animals, each group in approx. 40 mL test medium.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Reconstituted 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 by MILLIPORE ELIX 3 water purification system). The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water.

OTHER CONDITIONS
- Light: The light-dark cycle during the test was 16 hours light (artificial illumination) and 8 hours darkness.
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED
Observations: 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.

TEST CONCENTRATIONS
- Concentration (nominal): 100 mg/L
- Range finding study and results used to determine the conditions for the definitive study:
A preliminary test was performed to check that the test item has no toxic effects on the Daphnia up to its solubility limit in the test medium (saturation concentration; nominal concentration of 100 mg/L)
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
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:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Analytical results
- Test Concentration: Concentration of the test item both in the test and control group was below the quantification limit (LOQ = 5 mg/L) considering tenfold concentration of the samples before the analysis. Therefore, nominal concentrations were used.

Biological results
Results after 48 hours:
Accordingly, the 48 h-NOEC was determined as the saturation concentration (i.e. 100% v/v saturated solution, equivalent to 100 mg/L nominal concentration). The EC50 values and the 48 h-LOEC were determined to be higher than saturation.
Results with reference substance (positive control):
The date of the last study with reference item potassium dichromate was: 05 – 06 March 2013.
The 24h EC50: 0.97 mg/L, (95 % confidence limits: 0.81 – 1.14 mg/L)
Reported statistics and error estimates:
Statistical analysis:
A limit test was performed and toxic effects were not observed, therefore statistical analysis was not performed. The NOEC, LOEC, EC50 and EC100 values of the test item were determined directly from the raw data.

Validity of the study:

- Control: The immobilisation rate of the introduced Daphnia did not exceed 10 %. Immobility was not observed in the untreated control and no Daphnia were trapped at the water surface or showed any sign of 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.

All validity criteria were within acceptable limits and therefore the study was considered as valid.

Validity criteria fulfilled:
yes
Conclusions:
In this 48-hour immobilisation test with Daphnia magna the EC50 and NOEC were determined to be > 100 mg/L and 100 mg/L, respectively.

Executive summary:

This 48 -hour immobilisation test with Daphnia magna was performed in accordance with OECD no. 202 guideline, EU method C.2 and OPPTS 850.1010 guideline. The obtained results showed that the test item ditetradecyl peroxydicarbonate had no toxic effect at aquatic saturation (i.e. 100% v/v saturated solution, equivalent to 100 mg/L nominal concentration) on the animals.

Accordingly, the EC50, EC100 and the LOEC values were determined to be higher than the solubility level of the test item in the test medium which corresponds to a nominal value of > 100 mg/L. The NOEC was determined to be 100 mg/L (nominal concentration).

Description of key information

In this 48-hour immobilisation test with Daphnia magna the EC50 and NOEC were determined to be > 100 mg/L and 100 mg/L, respectively.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

This 48 -hour immobilisation test with Daphnia magna was performed in accordance with OECD no. 202 guideline, EU method C.2 and OPPTS 850.1010 guideline. The obtained results showed that the test item ditetradecyl peroxydicarbonate had no toxic effect at aquatic saturation (i.e. 100% v/v saturated solution, equivalent to 100 mg/L nominal concentration) on the animals. Accordingly, the EC50, EC100 and the LOEC values were determined to be higher than the solubility level of the test item in the test medium which corresponds to a nominal value of > 100 mg/L. The NOEC was determined to be 100 mg/L (nominal concentration).