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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:
Sep 3 - Dec 4, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
Test temperature above the limit of 22°C (not critical)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Test material (Batch No. 1190567/006) provided by the sponsor Raschig GmbH
- Expiration date of the lot/batch: 31.08.2004
- Purity test date: not available

RADIOLABELLING INFORMATION (if applicable): not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble in water, stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

FORM AS APPLIED IN THE TEST (if different from that of starting material): not applicable

OTHER SPECIFICS: none

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
start end end of the experiment

Test solutions

Vehicle:
no
Details on test solutions:
Composition of M4-Medium (mg/L):
CaCI2*2H2O 179.00
MgSO4*7H2O 69.50
NaCl 16.10
KCI 0.65
Na2SiO3*9H2O 1.00
NaNO3 0.0274
KH2PO4 0.0143
K2HPO4 0.0184
FeSO4*7H2O 0.9955
H3BO3 2.8595
MnCl2*4H2O 0.3605
LiCl 0.3105
RbCl 0.0710
SrCl2*6H2O 0.1520
NaBr 0.0160
Na2MoO4*2H2O 0.0630
CuCl2*2H2O 0.0165
ZnCl2 0.0130
CoCl2*6H2O 0.0100
KI 0.00325
Na2SeO3 0.00219
NH4VO3 0.000575
Thiamine*HCl 0.0750
Cyanocobalamine 0.0010
Biotine 0.00075

Macro nutrients (mg/L):
Na2EDTA*2H2O 2.50

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

- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.8 ± 0.2

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Straus)
- Strain/clone: Berlin
- Justification for species other than prescribed by test guideline: not applicable
- Source: Umweltbundesamt Berlin, Germany
- Age of parental stock (mean and range, SD): no information
- Feeding during test: no
- Food type: not applicable
- Amount: not applicable
- Frequency: not applicable

ACCLIMATION
- Acclimation period: 30 minutes
- Acclimation conditions (same as test or not): same
- Type and amount of food: none
- Feeding frequency: not applicable
- Health during acclimation (any mortality observed): no

QUARANTINE (wild caught): nott applicable


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: not applicable

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L
Test temperature:
20 +/- 2 °C (with one exception: +1 °C)
pH:
7.8 ± 0.2
Dissolved oxygen:
> 95 %
Nominal and measured concentrations:
Nominal and measured concentration: 1000 mg/L (limit test)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker (50 mL)
- Type (delete if not applicable): no information available
- Material, size, headspace, fill volume: glass beaker (50 mL)
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): none
- Renewal rate of test solution (frequency/flow rate):none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not applicable

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water withe neriching minerals (CaCl2*2H2O: 179 mg/L; MgSO4*7H2O: 69.5 mg/L; NaCl: 16.1 mg/L; KCl: 0.65 mg/L)
- Total organic carbon: not available
- Particulate matter: no applicable
- Metals: see 'Details on test solution'
- Pesticides: none
- Chlorine: 'Details on test solution'
- Alkalinity: not available
- Ca/mg ratio: not available
- Conductivity: not available
- Salinity: not available
- Culture medium different from test medium: no
- Intervals of water quality measurement: not available

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16/8
- Light intensity: not available

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation at 24 and 48h

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: 0
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: 24h EC50i = 1.5 mg/L
- Limit test: no
- Dose-response test: yes
- EC50i: 1.5 mg/L
Reported statistics and error estimates:
not applicable as a limit tests was performed

Any other information on results incl. tables

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test material in Daphnia magna.

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

No immobilisation was observed.

The following values for Daphnia magna were determined:

24 h EC50 > 1000 mg/L 

48 h EC50 > 1000 mg/L 

NOEC = 1000 mg/L

Conclusions

Under the given experimental conditions, the 48 hours EC50 to Daphnia magna is > 1000 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

In a GLP study performed as a limit test according to OECD TG 202, the 48 hours EC50 to Daphnia magna was > 1000 mg/L.