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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:
27-June-2017 to 29-June-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Version / remarks:
The test was conducted under the 1996 issuance of the guideline.
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 16437, 1,1,1,2,2,3,3-heptafluoro-3-[(trifluoroethenyl)oxy]propane, PPVE
- Physical state: Clear colourless liquid
- Analytical purity: 98.5%
- Storage condition of test material: At room temperature in the dark under nitrogen
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 115B1065A
- Physical state: clear colorless liquid
- Analytical purity: 98.7%
- Expiration date of the lot/batch: 26 Nov 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark under nitrogen
- Stability under test conditions: test substance undergoes slow hydrolysis in neutral or alkaline solution, but considered stable for test duration

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: negative control and saturated solution (limit test)
- Volume: 42.5 mL, a complete vial (see sampling method)
- Sampling method: extra sample vials were made to be sacrificed for analytic monitoring ((one for t=0h and one for
t=48h)
- Sample storage conditions before analysis: Samples were analyzed on the day of sampling.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance is extremely volatile. Therefore, 42.5mL air-tight vials were completely filled with medium and closed with a septum-sealed screw cap and parafilm. PPVE (2.8 μL) was then injected through the septum with gas-tight syringe. Vials were rotated slowly for seven days, and then centrifiged at 500g for 90 minutes to pull dissolved test substance into a single drop at the bottom of the vial.
- Controls: Blank only
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Test solutions were clear and colorless, with a visible small droplet of undissolved test substance at the bottom.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
- Source: In-house laboratory culture with a known history.
- Age of parental stock (mean and range, SD): > 2 weeks
- Age at study initiation: < 24 hrs
- Feeding during test: No
-Culturing: Adult daphnids were cultured in M7 medium. Adult daphnids in the cultures were held for at least 14 days, and were not more than 4 weeks old prior to collection of the juveniles for testing. During the period preceding the test, water temperatures were 18 - 22°C. Daphnids in the cultures were fed daily a suspension of freshwater algae. The adults were fed
prior to test initiation, but neonates were not fed during the test.

Study design

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

Test conditions

Hardness:
180 mg CaCO3 in the medium
Test temperature:
20°C
pH:
8.1 - 8.3
Dissolved oxygen:
7.9 - 8.9 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: 0.622 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:vials with screw cap and septum
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass vials, 42.5 mL volume, no headspace
- Aeration: no
- No. of organisms per vessel:five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates):four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium prepared using reverse-osmosis purified water (GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
- Intervals of water quality measurement: At the start of the test (0-hour), and at the end (48-hours)

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light; 8 hours dark

EFFECT PARAMETERS MEASURED: immobilization (including mortality) observed at 24 and 48 hours

RANGE-FINDING STUDY
- Test concentrations: 1.0%, 10% and 100% of a saturated solution prepared at 100 mg/L
- Results used to determine the conditions for the definitive study:Yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (K2CrO7)

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.622 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
0.622 mg/L was considered the maximum solubile concentration in test medium. Test conducted at a loading rate of 100 mg/L.
Details on results:
- Mobility: no immobilization of test organisms was observed
- Mobility of control: No immobilization observed
- Effect concentrations exceeding solubility of substance in test medium: Yes
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Dose-response test: Yes
- ECx: 48-hr EC50 = 0.59 mg/L (95% CI, 0.52 mg/L to 0.66 mg/L)
- Other: The sensitivity of Daphnia magna originating from the batch used in this test, for potassium dichromate fell within the expected range of sensitivity observed during previous years (n > 60; 48-hr EC50 between 0.3 and 1.0 mg/L.) The reference substance test was conducted 21 days prior to the testing of PPVE.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
the validity criteria of OECD TG 202 were fulfilled. Control immobilization was < 10% at the end of the test. The dissolved oxygen concentration was ≥ 3 mg/L in the control and test vessels at the end of the test.
Conclusions:
The 48-hour EC50 of PPVE to Daphnia magna was >0.622 mg/L which was considered the maximum soluble concentration in the test medium (OECD TG 202, EU Method C.2 and ISO 6341-15).
Executive summary:

The 48-hour EC50 of PPVE to Daphnia magna was examined in a static test conducted according to OECD TG 202, EU Method C.2, and ISO 6341-15. Test solutions were prepared as the control (0 mg/L) and at 100 mg/L. Analytically determined concentrations were < LOQ, and 0.622 mg/L, which was considered the maximum soluble concentration in the test medium. At 0.622 mg/L, no immobilization of the daphnids was observed by 48 hours. The 48-hour EC50 is > 0.622 mg/L.

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