1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

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:

12 Oct - 22 Dec 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

EC Number:

817-766-4

Cas Number:

91891-42-8

Molecular formula:

C6F12O

IUPAC Name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MA-3-HO-ANL 1600356
- Expiration date of the lot/batch: 31 Aug 2020
- Purity test date: 05 Feb 2018
- Purity: 93.1%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature container flushed with nitrogen
- Stability under test conditions: Yes

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All concentrations sampled
- Volume: 42.5 mL, a complete vial (see sampling method). Generally only one replicate at each concentration was measured.
- Sampling method: Extra sample vials without daphnia were made to be sacrificed for analytic monitoring (one for t=0h and one for t=24h) and incubated under similar conditions to the vials containing daphnia. The vials containing daphnia were sampled for t=48 h.
- Sample storage conditions before analysis: Samples were analyzed on the day of sampling.

Test solutions

Vehicle:

no

Details on test solutions:

- Method: The test substance is volatile. Therefore, 42.5mL air-tight vials were completely filled with medium and closed with a septum-sealed screw cap. MA-3 (2.5 µL) was then injected through the septum with gas-tight syringe to achieve a loading rate of 100 mg/L. Thereafter the septum was sealed using parafilm. Vials were rotated slowly for four days, and then centrifuged at 500g for 90 minutes to pull dissolved test substance into a single drop at the bottom of the vial. A dilution series was also made of additional 100% saturated samples.
- Controls: Blank only
- Evidence of undissolved material: Test solutions were clear and colorless. Undiluted (100% saturated) samples contained a visible small droplet of undissolved test substance at the bottom of the vials.

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).
- Source: In-house laboratory culture with a known history, at least third generation, obtained by
acyclical parthenogenesis under specified breeding conditions.
- 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 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. Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

180 mg CaCO3 in the medium

Test temperature:

19 - 21 °C

pH:

7.9 - 8.1

Dissolved oxygen:

8.3 - 9.2 mg/L

Nominal and measured concentrations:

See table 1

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass VOA vials closed with faced septa, completely filled. Fill volume ca. 42.5 mL
- 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

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2CrO7)

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

73 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI, 53-99 µg/L

Details on results:

Microscopic examination on Replicate C (Table 2) of the 100% saturated solution group showed no undissolved material adhering to immobilized organisms.

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Dose-response test: Yes
- ECx: 48-hr EC50 = 0.40 mg/L (95% CI, 0.33 mg/L to 0.48 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 (48-hr EC50 between 0.28 and 0.90 mg/L.) The reference substance test was conducted between the rangefinder and final test (42 days before final testing)

Reported statistics and error estimates:

The 24 and 48h-EC50-value was calculated from the percentages of affected daphnids and the logarithms of the corresponding test substance concentrations using the Spearman-Karber method (non-linear, without trimming).
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.

Any other information on results incl. tables

Table 2., Immobilization of daphnids as a function of dilution (percent of saturated solution)

Time (hr)	Replicate	Control (0% saturated solution)	4.6% saturated solution	10% saturated solution	22% saturated solution	46% saturated solution	100% saturated solution
24	A	0	5¹	0	0	0	4
	B	0	0	0	0	0	5
	C	0	0	0	1²	0	4
	D	0	1¹	0	0	0	0
	Total	0	6¹	0	1	0	13
	% effect	0	30	0	5	0	65
48	A	0	5¹	0	0	0	5
	B	0	0	0	0	0	5
	C	0	0	0	0	0	5
	D	0	1¹	0	0	0	0³
	Total	0	6¹	0	0	0	15
	% effect	0	30	0	0	0	75

1, Immobile daphnia were stuck to the septum of the vial. Value not used for determination of effects concentration

2, Organism recovered mobility by end of test

3, Additional sample analysis showed considerably lower concentration in this vial v. another measurement (Table 1).

Table 3, Average concentrations

Percentage of 100 mg/L loading solution	Average concentration (µg/L)
0	not detected
4.6	7.4
10	19
22	31
46	14
100	169

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

<10% immobilization in controls, DO >3mg/L in all test vessels

Conclusions:

The EC50 of MA-3 to D. magna is 73 µg/L (95% CI, 53 - 99 µg/L) (OECD202).

Executive summary:

Toxicity of MA-3 to D. magna was assessed in a test conducted according to OECD 202. The test substance was not soluble at the limit of 100 mg/L and is extremely volatile. Water soluble fractions at 100 mg/L were made in closed VOA vials with septum closures. Dilution series were made using gas-tight syringes into further VOA vials. Four replicates were prepared of negative controls and at each concentration. Vials at the full loading rate intentionally contained undissolved test material, which was consolidated into a droplet by centrifugation before addition of daphnids. Test substance concentrations were determined at test initiation, 24 hrs, and 48 hrs. Initial and 24-hour concentrations were taken in separate abiotic vials set up for that purpose, while 48-h concentrations were taken from a single replicate. No significant immobilization was observed in any of the dilutions, with complete immobilization occuring in three of the four replicates of undiluted WAF. No test substance was found attached to immobilized organisms by microscopic examination of the third replicate. No immobilization was observed in the fourth replicate, although test substance concentration was less than observed in a different replicate of undiluted medium. The EC50 based on arithmatic mean concentration was 73 µg/L (95% CI, 53 - 99 µg/L).

The test was conducted according to an internationally accepted guideline and was GLP compliant. Test substance concentrations were analytically confirmed. However, the test substance could not be maintained consistently in dilutions, and one replicate with undissolved test material showed inconsistent effects and measured concentration. This test is therefore considered reliable with restrictions. It is suitable for Risk Assessment, Classification & Labeling, and PBT Analysis.