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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-09-20 - 2010-11-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17). The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 202 "Daphnia sp., Acute Immobilisation Test. and Reproduction Test".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
The stability of the test material in the test medium under the conditions of the study was shown in a separate analytical study prior to start of this study. Due to the absence of any adverse effects no analytical sampling was performed during the study.

Test solutions

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

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
none

Test conditions

Hardness:
14 ° dH (about 250 mg/L CaCO3)
Test temperature:
22°C
pH:
7.5 +/- 0.3
Dissolved oxygen:
>3 mg/L
Nominal and measured concentrations:
Nominal 100 mg/L
Details on test conditions:
-- Preparation
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours.

-- 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 an unmistakable 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 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

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system.

Any other information on results incl. tables

The concentration of 100 mg/L revealed no biological effects (EC0).

Due to the absence of toxic effects at the limit concentration, EC50 values cannot be calculated.

24 h EC50 >100 mg/L

48 h EC50 >100 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item solved in reconstituted water, was tested in an open static test system. Under the given conditions of this study the 48 h EC50 value was >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 study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia per concentration (test medium group). In addition, a control group of 20 Daphnia in reconstituted water was used.

Daphnia magna were exposed to a test material concentration of nominal 100 mg/L (limit test) in an open static system.

Results

After exposure to a saturated aqueous solution of the nominal concentration of 0.1 g/L for 48 hours to Daphnia magna the following results were 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/L of the test material were not affected.

The test material concentration in the aqueous medium was not quantified at the start and the end of this study because the stability of the test material in the test medium under the conditions of the study has been shown in a separate analytical study prior to start of this study and due to the fact that no toxicity was observed at the limit concentration (100 mg/L).

For the test material, the following nominal EC50 values for Daphnia magna were determined:

24 h EC50> 100 mg/L

48 h EC50> 100 mg/L

Conclusions

An aqueous solution of 100 mg/L test material revealed no aquatic toxicity in the test system. The 48 hours EC50 to Daphnia magna exceeded the limit concentration (>100 mg/L) and, thus, could not be determined in this test.