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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:
07 April 2010 - 23 April 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was carried out according to OECD guideline 202 and GLP. However, the concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
A dilution factor of 2.5 was chosen to encompass the effect levels and the no observable effect levels. This did not affect the study results.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
yes
Remarks:
A dilution factor of 2.5 was chosen to encompass the effect levels and the no observable effect levels. This did not affect the study results.
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
All concentralions and the control were analytically verified in the fresh media (0 h) and old media (48 h) by analysis of organic carbon (DOC,) accordlng to DIN EN 1484) For the old media, separale replicates of the limit concentration and the control without test organisms were prepared and lncubated under test conditions.
Vehicle:
no
Details on test solutions:
The stock soIution (80 mg/L was welghed out} was freshly prepared with dilution water, treated with ultrasound for 1 h at 45 °C and thereafter stirred with approximately 1100 rpm for 1 h at room temperature. From this stock solution the following nominal test concentrations were prepared: 0.82 - 2.1 - 5.1 - 13 - 32 - 80mg/L (dilution factor 2.5).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain:Daphnia magna STRAUS (Clone 5)
- Source: Institut fuer Wasser-, Boden- und Lufthygiene (WaBoLu) and bred in the test laboratory
- Age at study initiation: 2 - 24h
- Feeding during test: No

ACCLIMATION
- Acclimation period: At least 2h in dilution water
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
262 mg CaCO3/L
Test temperature:
20.5 °C
pH:
7.6 - 7.9
Dissolved oxygen:
7.2 - 8.9 mg/L
Nominal and measured concentrations:
Nominal concentrations: 0 (blank control), 0.82, 2.1, 5.1, 13, 32.0, 80.0 mg/L (dilution factor 2.5).
Measured concentrations: (mean DOC concentration of duplicate measurements) at t = 0h: 4.3 (blank control), 5.5, 6.1, 7.5, 10, 19 and 39 mg DOC/L
Measured concentrations: (mean DOC concentration of duplicate measurements) at t = 48h: 6.5 (blank control), 5.5, 5.9, 7.4, 11, 19 and 41 mg DOC/L
TOC content of the substance taken from the study report of the ready biodegradability test (Brunswik-Titze, 2004): 48.85% (measurement by IFU Gewerbliches Institut für Fragen des Umweltschutzes GmbH, Grießheimer Weg 7a, D-79423 Heitersheim, Germany)
From the DOC measurementsit can be concluded that the DOC concentrations were maintained during the test.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (4 cm ID x 7 cm H), 50 mL capacity
- Fill volume: 20 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
ISO Test water according to OECD 202

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: 20 µE/m^2/s

EFFECT PARAMETERS MEASURED: Immobilisation after 24 and 48h

TEST CONCENTRATIONS
- Spacing factor for test concentrations:2.5
- Range finding study A non GLP preliminary range finding test was conducted under static test conditions with the nominal test concentrations of 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: 100% immobility was observed at 100 mg/L (nominal) and 55% immobility was observed at 10 mg/L (nominal).
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
12 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL 11 - 13 mg/L

Table: Immobilization rates of the definitive test after 24 and 48h of exposure

 Nominal concentration (mg/L)                      Immobilisation (%)       
               24 h         48 h     
               Replicates         Replicates   
   1  2  3  4  Mean  1  2  3  4  Mean
80  60  100  80  80  80  100 100  100  100  100
32  40  100  100  20  65  80 100  100  80  90
13  40  40  0  20  25  60  60  60  60  60
5.1  0  0  0  0  0  0  0  0  0  0
 2.1  0  0  0  0  0  0  0  0  0  0
 0.82  0  0  0  0  0  0  0  0  0  0
 Control  0  0  0  0  0  0  0  0  0  0
Validity criteria fulfilled:
yes
Remarks:
1) No observed effects in control group. 2) The dissolved oxygen concentration was > 3 mg/L.
Conclusions:
The nominal 48h-EC50 value to Daphnia magna was 12 mg/L
Executive summary:

The acute toxicity of the test substance to Daphnia magna was investigated according to OECD guideline 202 and GLP.

The nominal 96h-LC50 value to Daphnia magna was 12 mg/L

From the DOC analysis it can be concluded that the DOC concentrations were maintained during the test.

The validity criteria were fulfilled.

The concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.

Description of key information

The nominal 48h-EC50 value to Daphnia magna was 12 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
12 mg/L

Additional information

The acute toxicity of the test substance to Daphnia magna was investigated according to OECD guideline 202 and GLP.

The nominal 48h-EC50 value to Daphnia magna was 12 mg/L.

From the DOC analysis it can be concluded that the DOC concentrations were maintained during the test.

The validity criteria were fulfilled.

The concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.