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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From April 29, 2004 to May 26, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ISO International Standard 6341
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): PARAD Substance 139.
- Molecular formula: C6H10O3.xH3O4P.
- Molecular weight: ~250.
- Physical state: Slightly yellowish viscous liquid.
- Batch No.: 31104251.
- Expiration date of the batch: December 31, 2004.
- Stability under test conditions: Stable.
- Storage condition of test material: At room temperature in the dark.
- Density: 1.4488.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: During the limit test singular samples for analysis were taken from nominally 100 mg/L and the blank-control.
- Sampling: Frequency: at t= 0 h and t= 24 h from freshly prepared solutions
and at t= 24 h and t= 48 h from the 24 h-old solutions.
Volume: 10 mL from the approximate centre of the test vessel.
- Storage Samples were stored in a freezer until analysis.
- Additionally, singular reserve samples of 10 mL were taken for possible analysis. If not used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.
Vehicle:
no
Details on test solutions:
PREPARATION OF TEST SOLUTIONS
The batch of the test substance tested was a slightly yellowish viscous liquid. The test substance was completely soluble in test medium at the concentrations tested. Preparation of test solutions started with a stock solution of 100 mg/L applying 15 mins of magnetic stirring to accelerate the dissolving of the test substance in the test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the stock in test medium. Test solutions were renewed after 24 h during the limit test. The final test solutions were all clear and colourless.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
- Source: In-house laboratory culture of the test facility with a known history.
- Age at study initiation: <24 h.
- Feeding during test: No feeding.

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
The temperature of the test medium was 20.2°C at the start of the test. The temperature continuously measured in a temperature control vessel varied between 18.7 and 20.4°C during the test, and complied with the requirements as laid down in the protocol (18-22°C, constant within 2°C).
pH:
Blank-control: 7.7 - 7.9
Test group: 6.2 - 6.5
Dissolved oxygen:
Blank-control: 9.0 - 9.1
Test group: 8.9 - 9.0
Nominal and measured concentrations:
Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24 h spent solutions. Recoveries ranged between 93 and 97% of nominal. Hence, further results were based on nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL, all-glass.
- Medium: ISO.
- Number of daphnia: 20 per concentration.
- Loading: 5 per vessel containing 80 mL medium.
- Light: 16 h photoperiod daily.
- Feeding: No feeding.
- Aeration: No aeration of the test solutions.
- Introduction of daphnia: Within 1 h after preparation of the test solutions.

EFFECT PARAMETERS MEASURED :
- Immobility (including mortality): At 24 h and at 48 h.
- pH and dissolved oxygen: At the beginning, after 24 h of exposure and at the end of the test, for all concentrations and the
control.
- Temperature of medium: Continuously in a temperature control vessel, beginning at the start of the test.
Reference substance (positive control):
yes
Remarks:
potassium dichromate (in a separate reference test)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
(EC50 could not be calculated because the test substance proved to be non-toxic)
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance: Valid.
- Concentrations used: blank control, 0.10, 0.18, 0.32, 0.56, 1.0 and 1.8 mg/L.
- Mortality: 40% at 1.0 mg/L and 100% at 1.8 mg/L, no mortality was observed at the remaining concentrations.
- EC50: 0.66 mg/L

RANGE-FINDING TEST

No immobilisation was observed during the 48 h test period in any of the concentrations tested. Hence, the 48h-EC50 appeared to be above nominally 100 mg/L. Analyses of samples taken from the test substance concentration of 100 mg/L during the simultaneously performed range-finding test with Carp showed that measured concentrations decreased from 96 mg/L at the start to 79 mg/L after 24 h and to 32 mg/L after 96 h of exposure. Consequently, it was decided to continue with renewal of test solutions after 24 h of exposure to maintain concentrations at > 80% relative to initial.

LIMIT TEST

Measured concentrations

Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24 h spent solutions. Recoveries ranged between 93 and 97% of nominal. Hence, further results were based on nominal concentrations.

Immobility

No significant effects (5%) were observed during the limit test. The immobilised daphnids observed in the 100 mg/L solution was not considered treatment related as a maximum response of 10% is acceptable for the control.

Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the EC50 of the test substance was determined to be >100 mg/L.
Executive summary:

An acute toxicity study in Daphnia magna was conducted with the test substance according to OECD Guideline 202, EU Method C.2 and ISO International Standard 6341 (1996), in compliance with GLP. Based on the findings of a range finding test, twenty Daphnids per concentration (four replicates, 5 per vessel) were exposed to a blank control and a test substance concentration of 100 mg/L for 48 h, applying a semi-static design. Test substance concentrations were verified analytically with HPLC-UV at t= 0 h and t= 24 h from freshly prepared solutions and and at t= 24 h and t= 48 h from 24 h-old solutions. Only 5% immobility was observed at 100 mg/L. This was not considered treatment related as a maximum response of 10% is acceptable for the control. Analytical measurements indicated recoveries ranging between 93 and 97% of nominal concentrations. All the validity criteria was met. Hence, the EC50 of the substance was determined to be >100 mg/L (Migchielsen IMJ, 2004).

Description of key information

The EC50 of the substance was determined to be >100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

An acute toxicity study in Daphnia magna was conducted with the test substance according to OECD Guideline 202, EU Method C.2 and ISO International Standard 6341 (1996), in compliance with GLP. Based on the findings of a range finding test, twenty Daphnids per concentration (four replicates, 5 per vessel) were exposed to a blank control and a test substance concentration of 100 mg/L (limit test) for 48 h, applying a semi-static design. Test substance concentrations were verified analytically with HPLC-UV at t= 0 h and t= 24 h from freshly prepared solutions and at t= 24 h and t= 48 h from 24 h-old solutions. No significant effects were observed during the limit test. The 5% immobilised daphnid observed in the 100 mg/l solution was not considered treatment related as a maximum response of 10% is acceptable for the control. Analytical measurements indicated recoveries ranging between 93 and 97% of nominal concentrations. All the validity criteria were met. Hence, the EC50 of the substance was determined to be >100 mg/L (Migchielsen, 2004).