Registration Dossier

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:
2016-06-23 to 2017-02-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
MONITORING OF TEST SUBSTANCE CONCENTRATION:
Analytical monitoring at the beginning and the end of test.
Vehicle:
no
Details on test solutions:
STOCK AND TEST SOLUTION AND THEIR PREPARATION
The test medium of the highest test concentration of nominal 100 mg test item/L was prepared by dissolving 84.9 mg test item in 849 mL test water by intense stirring for 15 minutes. Adequate volumes of this test medium were diluted with test water to prepare the test media.
The test media were prepared just before introduction of the daphnids (= start of the test).
Test organisms (species):
Daphnia magna
Details on test organisms:
- Strain: Daphnia magna Straus, clone 5
- Source/supplier: inhouse cultur of IBACON GmbH
- Breeding method: The cultivation of the parental daphnids was performed in Elendt M4 medium. The test organisms were not first brood progeny.
- Feeding: green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.
- Pretreatment: Filtration of adults 24 h prior to testing
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20.9 to 21.0 °C at test start;
20.5 to 20.7 °C at test end
pH:
8.0 to 8.4 at test start;
8.0 at test end; and thus the pH-value did not vary by more than 1.5 units
Dissolved oxygen:
8.8 to 9.0 mg/L at test start;
7.4 to 7.9 mg/L at test end
Nominal and measured concentrations:
100, 45.5, 20.7, 9.4, and 4.3 mg test item/L (nominal)   
89.9, 38.5, 16.3, 7.16 and 3.50 mg test item/L (mean initial conc.)   
Details on test conditions:
DILUTION WATER
- Reconstituted water "Elendt M4" prapared according to OECD 202.

TEST SYSTEM
- Exposure vessel type: glass beakers (100 ml) containing approximately 60 mL of test medium. The test vessels were covered with a lid to reduce the loss of water due to evaporation and to avoid the entry of dust into the solutions.

- Number of replicates/individuals per replicate: 4/5
- Intensity of irradiation: 220-900 Lux
- Photoperiod: 16 h illumination
- aeration: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The mobility of the daphnids was determined by visual observation after 24 and 48 hours.


Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 89.9 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 89.9 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 64.7 - >89.9
Details on results:
After 48 hours of exposure no immobilisation of the daphnids was observed in the control and up to the test item concentration of 16.3 mg test item/L. At the concentration of 38.5 mg test item/L, three animals were immobile and 7 animals were immobile at the concentration of 89.9 mg test item/L
Results with reference substance (positive control):
In the most recent test with the reference item potassium dichromate performed in January 2016 (study code 88295220) the EC50 after 24 hours was determined to be 1.58 mg test item/L, indicating that the sensitivity of the daphnids was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).
Reported statistics and error estimates:
The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis. The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 value was calculated to be > 89.9 mg test item/L (nominal conc. of 100 mg/L).
Executive summary:

In the acute immobilization test to Daphnia magna (STRAUS) the effects of the the test item were determined according to OECD 202 (2004) and Council Regulation (EC) No. 440/2008 Method C.2 (2008). The test was conducted under static conditions over a period of 48 h.at IBACON GmbH, Rossdorf. Twenty daphnids were exposed to 5 concentrations ranging from 4.3 to 100 mg/L (nominal) and the control. The quantification of the test item in the test samples was performed using liquid chromatography with MS/MS detection. Water quality parameters (pH-value and dissolved oxygen concentration) were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled. The 48-hour NOEC was determined to be 16.3 mg test item/L. The 48-hour LOEC was determined to be 38.5 mg test item/L and the 48-hour EC50 value was calculated to be > 89.9 mg test item/L based on mean initial concentrations and >100 mg/L based on nominal concentrations.


Description of key information

In the acute immobilization test to Daphnia magna (STRAUS) the effects of the the test item were determined according to OECD 202 (2004) and Council Regulation (EC) No. 440/2008 Method C.2 (2008). The test was conducted under static conditions over a period of 48 h.at IBACON GmbH, Rossdorf. Twenty daphnids were exposed to 5 concentrations ranging from 4.3 to 100 mg/L (nominal) and the control. The 48-hour NOEC was determined to be 16.3 mg test item/L. The 48-hour LOEC was determined to be 38.5 mg test item/L (mean initial concentration). The 48-hour EC50 value was calculated to be > 89.9 mg test item/L based on mean inital concentrations and >100 mg/L based on nominal concentrations.

Key value for chemical safety assessment

Additional information