Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

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:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
For determination of the test item concentrations, samples (5 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test. From the treatment group five replicate samples were taken at the start and four at the end of the test. From the control two replicate samples were taken at both analytical occasions.
Vehicle:
no
Details on test solutions:
The test solution was prepared by mechanical dispersion. An amount of 0.03 g test item was dissolved in 300 mL test medium (ISO medium) resulting a nominal concentration of 100 mg/L. The test solution was freshly prepared in the test laboratory just before introduction of the test animals (start of the experiment).
Test organisms (species):
Daphnia magna
Details on test organisms:
Species and strain: Daphnia magna (Straus)
Origin: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
Breeding: The Daphnia are bred in the Laboratory of TOXI-COOP ZRT.
Number of animals: Twenty animals in both groups (concentration and untreated control), divided into 4 concurrent batches (5 animals per batch).
Age of animals: Less than 24 h old at the beginning of the test.
Sex: Female
Animal health: Apparently healthy animals were used in this test with a known history
Acclimatization: Test animals were bred under similar (or the same) conditions as that used during the exposure period (holding water, temperature, background colour etc.), therefore additional acclimatisation before the test was not necessary. Brood daphnids were maintained in dilution water at the test temperature for at least 48 hours prior to the start of the test.
Food and Feeding: The Daphnia were fed with concentrated algal suspension of Raphidocelis subcapitata during the holding. Test animals were not fed during the exposure.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
According to Guidelines.
Post exposure observation period:
No.
Hardness:
The reconstituted water (ISO medium) had an approximate theoretical total hardness of 249 mg/L (as CaCO3).
Test temperature:
The test temperature was in the range of 20.3 – 20.6°C measured in the test vessels during the test. The additionally measured ambient temperature within the climate chamber was between 20.1 – 21.0°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 7.38 – 7.93 during the test.
Dissolved oxygen:
The dissolved oxygen concentration was in the range of 7.93 – 8.66 mg/L during the test.
Salinity:
No.
Conductivity:
Not reported.
Nominal and measured concentrations:
0 - 100 mg/L.
Details on test conditions:
Reconstituted water (ISO medium, according to OECD 202) was used as dilution water in the experiment.
The test vessels were kept during the test in a climate chamber under controlled conditions. The dissolved oxygen concentration and pH were measured in the test item treated and the control group at the start (before test solutions had been distributed into the test vessels) and in each test vessel at the end of the test. The water temperature was measured in each test vessel at the start and at the end of the test. Additionally, the ambient temperature was measured continuously using a min/max thermometer in the climate chamber.
Light-Dark Cycle: The light-dark cycle during the test was 16 hours light (artificial illumination) and 8 hours darkness.
In order to select appropriate test concentrations for use in the definitive test, a non-GLP preliminary range-finding test was conducted to determine the approximate toxicity of the test item.
No toxic effects were observed during the preliminary test therefore, a single concentration of 100 mg/L (limit concentration) and a concurrent control were included in the main test.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate.
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
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:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
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.
Results with reference substance (positive control):
The date of the last study (Study Code: 392-202-1922) with reference item Potassium dichromate was: 20 – 21 September 2016.
The 24-h EC50: 1.57 mg/L, (95 % confidence limits: 1.31 – 1.79 mg/L).

Validity of the Study

• Immobilisation or any sub-lethal effects were not detected either in the control or in the test item treated group.

• The dissolved oxygen concentration in was greater 3 mg/L in each test vessel at the end of the test.

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

The concentration of the test item was analytically determined at the start and at the end of the test. In the untreated control group the test item was not detected. The measured mean concentration of the test item was 116 mg/L at the start and 117 mg/L at the end of the test.

The analytically measured test item concentration remained within ± 20 % of the nominal concentration during the test period of 48 hours therefore biological results are based on the nominal concentration.

Validity criteria fulfilled:
yes
Conclusions:
The test item had no toxic effect at 100 mg/L concentration (i.e. limit test concentration) on Daphnia magna; the EC10, EC20, EC50 results and the LOEC are higher than 100 mg/L.
Executive summary:

The test item had no toxic effect at 100 mg/L concentration (i.e. limit test concentration) on Daphnia magna; the EC10, EC20, EC50 results and the LOEC are higher than 100 mg/L.

Description of key information

The test item had no toxic effect at 100 mg/L concentration (i.e. limit test concentration) on Daphnia magna; the EC10, EC20, EC50 results and the LOEC are higher than 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

The EC50 is not 100 mg/L, as one is forced to enter in the field above, but the EC50 is >100 mg/kg.