1,1,1,2,2,3,3-heptafluoro-3-[(trifluorovinyl)oxy]propane

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

PPVE

IUPAC Name:

PPVE

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.