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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:
06 June 2012 - 07 august 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Jeffcat ZR-50
- Chemical name: 2-propanol, 1-(bis(3-(dimethylamino)propyl)amino)-
- Physical state: liquid
- Analytical purity: > 99%
- Lot/batch No.: PFW100207
- Expiration date of the lot/batch: not supplied
- Storage condition of test material: room temperature in the dark
Analytical monitoring:
yes
Details on sampling:
- A sample of each test concentration was taken for analysis at 0 and 48 h to determine the stability of the test item under test conditions.
- Samples were stored at -20 °C prior to analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Preparation of stock solution of 100 mg/L in ISO medium
- Stock and test solutions were inverted several times to ensure adequate mixing and homogeneity.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: not reported
- Source: not reported, breeding performed at study laboratory
- Age at study initiation (mean and range, SD): 1st instar, < 24 h old
- Method of breeding:
* in 150 mL glass beakers containing Elendt M7 medium
* temperature controlled room at approximately 20 °C
* light cycle: 16:8 light:dark with 20 min dusk and dawn periods
* feeding frequency: daily
* food type: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
* parthenogenetic reproduction
* gravid adults isolated day before initiation of test; young produced overnight were less than 24 hours old
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg/L CaCO3
Test temperature:
21 °C to 22°C (blank control)
pH:
pH at start: 8.0 (blank control), 8.4 (10 mg/L), 8.6 (18 mg/L), 8.8 (32 mg/L) and 9.1 (32, 56 and 100 mg/L)
pH at end: 8.5 (blank control) and 9.0 (56 mg/L)
Dissolved oxygen:
oxygen concentration at start: 9.2 mg/L (blank control) and 9.1 mg/L (100 mg/L)
oxygen concentration at end: 8.8 and 8.7 mg/L (blank control and 56 mg/L)
Salinity:
not applicable
Nominal and measured concentrations:
Nominal: control + 0.1-1.0-10-100 mg/L
Analysis of the test preparations at 48 hours showed measusred test concentrations to range from 98% to 103% of nominal and so results were based on nominal test concentrations only. It was therefore considered that the test item was stable under test conditions.
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass
- Material, size, fill volume: glass jars, 250 mL, 200 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water
- Reconstituted water was used as test medium (containing CaCl2.2H2O, MgSO4.7H2O, NaHCO3, KCl)
- Intervals of water quality measurement during the test: 0 and 48 hours
* water temperature: daily
* dissolved oxygen and pH: at start and termination of test

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light:dark with 20 minutes for dusk and dawn

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.8
- Range finding study: yes
- Test concentrations during range finding study: 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study:
* Range finding: no immobile daphnia were observed at the test concentrations of 1.0, 1.8, 3.2, 5.6 and 10 mg/L. However immobilization was observed at 10 and 100 mg/L.
* Initial experiment: no immobilization was observed at the test concentrations employed in the test.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
26 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 23-30
Details on results:
- EC50 (24h) value is 47 mg/L with 95 % C.I. from 39-57 mg/L
- NOEC after 24 and 48 hours were 18 mg/L and 10 mg/L resp.
Results with reference substance (positive control):
The actual responses in this reference test potassium dichromate were within the ranges of the expected responses at the different concentrations. Hence, the sensitivity of the used batch of D. magna was in agreement with the historical data collected in the test laboratory.
The 24h EC50 was 0.75 mg/L (95% CL: 0.56-1.0).
48 h: EC50 (mg/l) = 0.45 (95% CL: 0.42-0.48)
Reported statistics and error estimates:
EC50 values and associated confidence limits at 24 and 48 h and the slope of the response curve and its standard error were calculated by the maximum-likelihood probit method using the ToxCalc computer software package. Analysis of the immobilization data was done by the geometric mean method at 24 h and the trimmed Spearman-Karber method (Hamilton et al 1977) at 48 h based on the nominal test concentrations.
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-Hour EC50 value of 26 mg/L with 95% confidence limits of 23 -30 mg/L. The No Observed Effect Concentration at 48 hours was 10 mg/L. The lowest Observed Effect Concentration was consdered to be 18 mg/L.

Description of key information

A limit test was performed under GLP conditions and according to OECD TG 202. An EC50 of 26 mg/L was found for juvenile Daphnia magna after an exposure period of 48 hours in a static test (Huntsman, 2012).

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
26 mg/L

Additional information

A reliable (K1) study is available to cover this endpoint.