Registration Dossier

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:
13 - 15 Feb 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP, no data on validity criteria

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
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
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
MV31-K-salt
IUPAC Name:
MV31-K-salt
Details on test material:
- Name of test material (as cited in study report): MV31 K-salt, Potassiumperfluoromethoxypropoxypropionate
- Substance type: Pure active substance
- Physical state: solid, grey granules
- Analytical purity: ca. 88 %
- Storage condition of test material: darkness at approximately 20 °C in a fume cupboard

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test solutions at study initiation and after 48 hours. Test results appear to be from composite samples.
- Sample storage conditions before analysis: No information

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were made directly in beakers by gravimetric addition of test substance, addition of M4 test medium, and homogenization using an Ultra Turrax.
- Controls: Water blank
- Evidence of undissolved material: None. Test solutions were clear.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Clone 5 (IRChA, France)
- Source: Testing lab stock culture
- Organism were bred and tested in Elendt M4 medium. During breeding, daphnids were fed three times per week with unicellular algae (Scenedesmus subspicatus) at 0.2 mg carbon / day / animal. The animals were used for breeding up to an age of 42 days.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
2.1 mM combined Ca2+ & Mg2+
Test temperature:
20.5 - 21.1 °C
pH:
7.9 - 8.0
Dissolved oxygen:
8.9 - 9.0 mg/L
Nominal and measured concentrations:
Nominal: 0 mg/L (control) and 100 mg/L
Measured:
Details on test conditions:
TEST SYSTEM
- Test vessel: 250-mL beakers filled with 200 mL medium
- Aeration: test medium aerated to saturation before test. No aeration during test.
- No. of organisms per vessel: ten
- No. of vessels per concentration (replicates): two
- No. of vessels per control (replicates): two

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium (standard formulation) used for breeding and testing.
- Ca/mg ratio: 4.0 (molar basis)

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16 hours illumination under fluorescent light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilization was observed at 24 and 48 hours. Those animals which were not able to swim within 15 seconds after gentle agitation of the test container were considered to be immobile. Immobile daphnids were removed from the chambers.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: None
- Justification for using less concentrations than requested by guideline: Limit test was conducted based on unspecified outcome of rangefinding test.

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Only concentration tested. No effect observed relative to controls
Details on results:
- Mortality in controls: No data provided.
- Other adverse effects control: No data provided
- 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

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Remarks:
mortality in control not stated
Conclusions:
The EC50 of MV31-K-salt to Daphnia magna is >100 mg/L (OECD202).
Executive summary:

Toxicity of MV31-K-salt to Daphnia magna was determinted in a limit test done according to OECD202. Duplicate test solutions were made at an analytically confirmed concentation of 100 mg/L. No immobilization was observed in exposed vessels relative to controls. The EC50 of MV31-K-salt to Daphnia magna is >100 mg/L.

The test was conducted according to internationally accepted guidelines and in accord with GLP criteria. Documentation as to handling of test organisms neglected some details, and in particular no data was provided on health among control organisms. This study is deemed reliable with restrictions, and is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.