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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:
Apr 11-13, 2006
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)
Deviations:
no
Principles of method if other than guideline:
none
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Remarks:
The water solubility was determined in the corresponding study (reference 4.8-1).
Vehicle:
no
Details on test solutions:
Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Trace elements (mg/L):
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003

Macro nutrients (mg/L):
Na2EDTA x 2H20 2.50

Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75


After preparation, the reconstituded water was aerated for 24 hours.

- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after an aeration for 24 hours.



References:

ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Strain: Straus
- Source: in house
- Age at study initiation (mean and range, SD): not older than 24 hours
- Feeding during test: yes
- Food type: suspension of fresh water algae
- Amount: sufficient
- Frequency: once a week

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
14 ° dH (about 250 mg/L CaCO3)
Test temperature:
21 °C
pH:
7.9- 8.0
Dissolved oxygen:
95-98 %
Nominal and measured concentrations:
100 mg/L
Details on test conditions:
-- Preparation
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the test material was solved in the vehicle, reconstituted water

-- Administration
At the start of the experimental phase, 5 Daphnia magna were placed into 10 ml of reconstituted water (control group) or test medium (test material group). The Daphnia magna were not fed, and the control medium and test medium were not aerated during the test.
The test vessels were labeled to assure unique identification.

-- Dose levels
A single test material concentration of 0.1 g/L was tested in an open static system.

-- Observation schedule
The mobility was determined by visual control and recorded after 24 and 48 hours.

-- pH and oxygen concentration
The pH-values and dissolved oxygen concentration (O2) were measured in the control and all test material concentrations at the beginning and at the end of the experimental part.

-- Temperature
During the experimental part, the temperature was registered in a control vessel with an electronic thermometer containing a maximum and minimum memory display.

-- Archive statement
All raw data, specimens and the final report are stored in the archives of the test facility.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
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
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
Details on results:
A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system. The solubility of the test item was determined to be >0.0114 mg/L.

The concentration of the test item and the immobilization data are shown in the following table:

 

Immobilized/Exposed Daphnia Magna

Nominal concentration [mg/L]

24 h

48 h

0

0/20

0/20

100

0/20

0/20

A dose group with nominal 100 mg/L of the test item (maximal water solubility 0.0114 mg/L) revealed no aquatic toxicity in this test system. No remarkable observations were made concerning the appearance of the solution of the test material preparation. The test medium was a clear preparation and stayed unchanged throughout the study.

Validity criteria fulfilled:
yes
Conclusions:
Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg per L of test item were not affected. For the test material the following EC50 values for Daphnia magna were determined: 24 h EC50 > 0,0114 mg/L (nominal > 100 mg/L) 48 h EC50 > 0,0114 mg/L (nominal > 100 mg/L)
Executive summary:

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test material in Daphnia magna to provide a rational basis for hazard estimation for the test item in aquatic environments.

Study design

For this purpose, juvenile Daphnia magna were exposed to an aqueous test material preparation over 48 hours, under defined conditions. The GLP study was performed as a limit test according to OECD TG 202.

Results

The follwing results have been obtained:

   

Nominal concentration Immobilization immobilized / exposed

[g/L]  24 hours  48 hours 
0.0  0/20 0/20 
0.1  0/20  0/20 

Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg per L of test item were not affected.

For the test material the following EC50 values for Daphnia magna were determined: 24 h EC50 > 0,0114 mg/L (nominal > 100 mg/L)

48 h EC50 > 0,0114 mg/L (nominal > 100 mg/L)

NOEC > 0.1 g/L (nominal)

LOEC > 0.1 g/L (nominal)

Conclusions

Under the given experimental conditions, the test material showed no aquatic toxicity. The 48 hours EC50 to Daphnia magna is > 100 mg/L.

Description of key information

A dose group with nominal 100 mg/L of the test item (maximal water solubility 0.0114 mg/L) revealed no aquatic toxicity in this test system.

Key value for chemical safety assessment

Additional information

A study was conducted according to OECD Guideline 202 in accordance with good laboratory practice. 20 Daphnias (Strauss) were exposed to the test item in different concentrations. Control experiments were run witth water without andy further additives. After 24 and 48 h the immobilized animals were determined. The test item had did not show any effect at a nominal concentration if 100 mg/L with a maximum water solubility of 0.0114 mg/L.