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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 - 11 May 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

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 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
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: 20 mL samples were taken from both test aquaria at study initiation, and after 48 and 96 hours.
- 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: A stock solution prepared by homogenizing the substance in reconstituted test water, composition according to ISO/DIS 7346/1. The homogenate was then transferred to the test chambers and stirred with a glass rod to assure complete solubilization.
- Controls: Water blank
- Evidence of undissolved material: None. Test solutions were clear and homogeneous during the test.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Strain: Hamilton-Buchanan
- Source: Bio International B.V, Postbus 63, NL-5845 ZH, St. Anthonis, The Netherlands
- Age at study initiation: 225 days
- Length at study initiation: 2.7 cm (range, 2.5 - 2.8 cm, SD ±0.10, N=7)
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14 days (fish were obtained from supplier ca. 5 months prior to acclimation)
- Acclimation conditions: Same as test
- Type and amount of food: TetraMin, Tetra Werke, Melle (Germany), twice daily ad libitum

Study design

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

Test conditions

Hardness:
2.5 mM Ca2+/Mg2+
Test temperature:
21.8 - 22.5 °C
pH:
7.4 - 8.0
Dissolved oxygen:
5.0 - 9.8
Nominal and measured concentrations:
Nominal, blank and 100 mg/L
Measured,
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquarium in a thermostatted water bath (22 °C), 20cm x 20cm x 15 cm (6 liters), calibrated to 4 liters.
- Type: open
- Fill volume: 4 liters
- Aeration: aeration by glass capillary when dissolved oxygen content was <5..5 mg/L (48 h for test solution, 72 h for control). Bubble rate was ca. 3/s
- No. of organisms per vessel: Seven
- No. of vessels per concentration: One
- No. of vessels per control: One

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water, composition according to ISO/DIS 7346/1

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 12 hours
- Light intensity: ca. 700 lux above test chambers

EFFECT PARAMETERS MEASURED: Mortality and visible alterations in appearance and behavior at 3, 6, 24, 48, 72 and 96 hours after test initiation.

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.
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: No mortality or sublethal effects observed
Details on results:
- Behavioural abnormalities: No effect
- Observations on body length and weight: No effect
- Other biological observations: No effect
- Mortality of control: None
- Other adverse effects control: No effect
- Abnormal responses: No effect
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test solution was clear and homogeneous during the test. No particulate matter was observed.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
no mortality in controls, test substance concentration ca. 100% of nominal, DO conc. >60% of saturation
Conclusions:
The LC50 of MV31-K-salt to Danio rerio was >100 mg/L (OECD 203). No mortality or sublethal effects were observed.
Executive summary:

Toxicity of MV31-K-salt to fish was assessed in a limit test on Danio rerio done according to OECD203. Measured concentrations of MV31-K-salt were essentially identical to the nominal concentration of 100 mg/L. No signs of undissolved material were present. No mortality or sublethal effects were observed in either controls or exposed animals. The LC50 of MV31-K-salt to Danio rerio was >100 mg/L.

The test was conducted according to internationally accepted guidelines and was compliant with GLP criteria. It is considered reliable without restriction. It is suitable for Risk Assessment, Classification & Labelling, and PBT Analysis.