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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:
2011-08-22 to 2011-09-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study performed according to internationally accepted test guidelines for toxicity to algae (OECD 201) and conform CLP requirements
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PFW100113
- Expiration date of the lot/batch: 2012-12-01
- Analytical purity: 99.3 %
- Impurities (identity and concentrations): not reported

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: not reported

OTHER SPECIFICS:
- Name of test material (as cited in study report): DMDEE (Morpholine, 4,4'-(oxydi-2,1-ethanediyl)bis-)
- Substance type: pale yellow liquid
- Physical state: liquid
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control and 100 mg/l
- Sample storage conditions before analysis: all 0-hour and 48-hour samples stored at approximately -20 °C prior to analysis
- Four replicates were sampled and pooled for analysis in both treatments
Vehicle:
no
Details on test solutions:
- 200 mg of test substance was dissolved in reconstituted water and the volume adjusted to 2 litres to give the required test concentration of 100 mg/l
- the solutions were inverted several times to ensure adequate mixing and homogeneity

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: not reported
- Source: not reported
- Age at study initiation (mean and range, SD): the main part of daphnids was 24 hours old, although some of the young may have been up to 25 hours old
- Method of breeding: adult Daphnia were maintained in 150 ml glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20 °C
- Feeding during test
- Food type: mixture of algal suspension (Desmodesmus subspicatus) and Tetram® flake food suspension
- Amount: not reported
- Frequency: daily

ACCLIMATION
- Acclimation period: one day prior to initiation of test gravid adults were isolated to produce young
- Acclimation conditions (same as test or not): yes
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg/l CaCO3
Test temperature:
21-22 °C
pH:
at initiation of test: 7.7 in control and 8.4 in 100 mg/l
after 48 hours exposure: 8.0 in control and 8.1 in 100 mg
Dissolved oxygen:
at initiation of test: 9.1 mg/l O2 in control and 9.05 mg/l O2 in 100 mg/l
after 48 hours exposure: 8.65 mg/l O2 in control and 8.6 mg/l O2 in 100 mg
Salinity:
Not applicable.
Nominal and measured concentrations:
nominal concentrations: 0 and 100 mg/l
measured concentrations: < LOQ in control, both at initiation and after 48 hours, and 114 and 118 mg/l at initiation, and 119 and 110 mg/l (after 48 hours) (samples of 100 mg/l were pooled 2 by 2)
Details on test conditions:
TEST SYSTEM
- Test vessel: jars
- Type (delete if not applicable): covered, to reduce evaporation
- Material, size, headspace, fill volume: glass, 250 ml, headspace not defined, 200 ml
- Aeration: not during test, only prior to test until dissolved oxygen concentration was approximately air-saturation value
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- no feeding during test

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Culture medium different from test medium: yes:
* culture medium Elendt M7 medium, pH 8.0 ± 0.2 and not adjusted
* test medium: reconstituted water, pH 7.8 ± 0.2 and adjusted if necessary, conductivity < 5 µS/cm^-1
- Intervals of water quality measurement:
* temperature was recorded daily (Hanna Instruments HI 93510 digital thermometer)
* dissolved oxygen and pH were recorded at start and termination of the test (Hach HQ30d Flexi Handheld meter)

OTHER TEST CONDITIONS
- Adjustment of pH: the pH of the test medium was adjusted with NaOH or HCl
- Photoperiod: 16h:8h light:dark, with 20 minutes dawn and dusk transition periods

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- immobilisation (defined as unable to swim for approximately 15 seconds after gentle agitation) or adverse reactions
- at 24 and 48 hours after the start of exposure

TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test
- Range finding study
- Test concentrations: 0.10, 1.0, 10 and 100 mg/l
- Results used to determine the conditions for the definitive study: no immobilisation or adverse reactions were observed at the test concentrations of 0.10, 1.0, 10 and 100 mg/l
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
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: zero immobilisation
Details on results:
- Color differences: all control and 100 mg/l test preparations were observed to be clear colourless solutions throughout the duration of the test.
Results with reference substance (positive control):
- analysis of immobilisation by means of maximum-likelihood probit method (Finney, 1971)
- EC50 (24h) = 1.5 mg/l, 95 % C.I. 1.3-1.8 mg/l
- EC50 (48h) = 0.99 mg/l, 95 % C.I. 0.85-1.1 mg/l
- NOEC (24 and 48h) = 0.56 mg/l (based upon zero immobilisation at this concentration)
- the results were within the normal ranges for this reference item
Validity criteria fulfilled:
yes
Conclusions:
In this study, Daphnia magna were exposed to a single concentration of 100 mg/l of test substance for 48 hours. Based on immobilisation, the EC50 was found to be > 100 mg/l after 48 hours of exposure.

Description of key information

The key value for acute toxicity to invertebrates was obtained from a study exposing Daphnia magna to a single test concentrations during 48 hours under GLP conditions and according to OECD 202 (limit test). 

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

A study investigating the acute toxicity of the test substance to aquatic invertebrates was available. The study of Vryenhoef and Mullee (2011) performed by Harlan Laboratories exposed Daphnia magna to 100 mg/l of test substance during 48 hours and observed mobility. The results showed an EC50(48h) of > 100 mg/l.