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:
10 October - 15 October 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
DAPHTOXKIT F™ magna supplied by MicroBioTests Inc.
GLP compliance:
no
Remarks:
The study was performed in House according to OECD TG and ISO standards and in the spirit of GLP but without QA audit.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Deoxyribonuclease (Phosphodiesterase) PPW37486

Analytical monitoring:
no
Details on sampling:
- Concentrations: 20, 100, 200, 300, 400 mg/L
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia
- Strain: Daphnia magna Straus
- Source: MicroBioTests Inc. Daphnia magna have been developed by the research teams at the Laboratory for Biological Research in Aquatic Pollution (LABRAP) at the Ghent University in Belgium.
- Age at study initiation (mean and range, SD): less than 24 hours
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
ISO 6341
Test temperature:
20-25°C
pH:
Within limits
Nominal and measured concentrations:
20, 100, 200, 300, 400 mg/L
Details on test conditions:
TEST SYSTEM
The test was conducted according to DAPHTOXKIT F MAGNA Crustacean Toxicity Screening Test for Freshwater with a test system supplied by MicroBioTests Inc.
http://www.microbiotests.be/SOPs/Daphtoxkit%20magna%20F%20SOP%20-%20A5.pdf

- Test vessel: The bioassays are conducted in disposable multiwell test plates with 30 test wells.
- Type: open
- Material, size, headspace, fill volume: 10 mL
- Aeration: The Standard Freshwater (ISO medium) must be aerated for at least 15 minutes prior to using it.
- No. of organisms per vessel: 20 (5 daphnia per well)
- No. of vessels per concentration and control (replicates): Each plate is provided with 4 wells for the controls and 4 wells (A,B,C,D) for each toxicant concentration.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium, formula according to ISO 6341

Composition :
vial 1 : NaHCO3 (129.5 mg - dissolved in 2 L = 67.75 mg/L)
vial 2 : CaCl2.2H2O (588 mg - dissolved in 2 L = 294 mg/L)
vial 3 : MgSO4.7H2O (246.5 mg - dissolved in 2 L = 123.25 mg/L)
vial 4 : KCl (11.5 mg - dissolved in 2 L = 5.75 mg/L)
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.89 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
32.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.27 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
Details on results
- Mortality of control: 0
- Other adverse effects control: No
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: No
Daphnia were considered to be immobile if they were unable to swim within 15 seconds following gentle touch of the animal with a pin.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the test, testing of phosphodiesterase batch PPW37486 to Daphnia magna revealed an 48h EC50 value of 32.9 mg/L (0.89 mg aep/L). The NOEC (48h) was determined to be 10 mg/L (0.27 mg aep/L).
Executive summary:

The purpose of this study was to screen deoxyribonuclease (phosphodiesterase), batch PPW37486, for the test material concentration estimated to immobilise 50% of the Daphnia magna after 24 and 48 hours exposure. DAPHTOXKIT F™ magna was supplied by MicroBioTests Inc. The testing of the Phosphodiesterase, batch PPW37486 was performed as a screening with a broad range of concentrations 20, 100, 200, 300, 400 mg/L. The acceptance criterion for a valid test is that the spontaneous immobility in the control is below or equal to 10%.

Under the conditions of the test, testing of phosphodiesterase batch PPW37486 to Daphnia magna revealed an 48h EC50 value of 32.9 mg/L (0.89 mg aep/L). The NOEC (48h) was determined to be 10 mg/L (0.27 mg aep/L).

Description of key information

Under the conditions of the test, testing of phosphodiesterase batch PPW37486 to Daphnia magna revealed an 48h EC50 value of 32.9 mg/L (0.89 mg aep/L). The NOEC (48h) was determined to be 10 mg/L (0.27 mg aep/L).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.89 mg/L

Additional information