3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 797.1330 (Daphnid Chronic Toxicity Test)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

Remarks:

The study was conducted according to the guideline in effect at the time of study conduct.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

EC Number:

211-477-1

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Cas Number:

647-42-7

Molecular formula:

C8H5F13O

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol

Details on test material:

- Purity: 99.94%

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 0.65, 1.3, 2.5, 5 and 10 mg/L (nominal)
- Sampling Times: Days 0, 3, 7, 10, 14, 17, 91 and 21
- Sampling method: Test solution samples were analysed as received, diluted 4x into methanol (5 mL test solution + 15 mL methanol).
- Sample storage conditions before analysis: All samples and back-up samples were stored refrigerated when not in use.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION: On day 0 and on each renewal day (Monday, Wednesday, and Friday), a primary stock solution of 15 mg/L was prepared by adding 0.0375 mL of test substance and bringing this up to 4.18 L in Haskell Well Water in a 4 L Erlenmeyer flask with a stir bar and stopper providing no headspace and stirring for approximately 5-15 minutes, sonicating for approximately 20-36 minutes and stirring for approximately 29-38 minutes . At test start, the stock solution was colourless with no visible precipitate.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: Parent Daphnia magna were reared at Haskell Laboratory in 1000-mL Pyrex beakers which contained 1000 mL of filtered fish tank water at approximately 20°C. Each beaker contained 8-10 adults.
- Age of parental stock: 24 days
- Food type: during test, daphnids were fed green algae (Pseudokirchneriella subcapitata) and yeast, cereal leaves and trout chow (YCT) mixture
- Amount: during test: 62,500 cells/mL and 3 mL/L YCT on renewal days, 62,500 cells/mL on non-renewal days
- Frequency: daily

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test conditions

Hardness:

Total alkalinity range: 80 - 88 mg/L as CaCO3
EDTA hardness range: 117 - 131 mg/L as CaCO3

Test temperature:

Range of 20.6 - 21.6ºC

pH:

Range of 7.6 - 8.1

Dissolved oxygen:

Range of 5.4 - 9.0 µg/L

Salinity:

fresh water

Nominal and measured concentrations:

Nominal: 0, 0.65, 1.3, 2.5, 5, and 10 mg/L
Measured: 0, 0.557, 1.11, 2.16, 4.46, and 8.57 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass bottles (250 mL) containing approximately 250 mL of test solution capped with a Mininert™ valve closure
- Renewal rate of test solution: renewed every Monday, Wednesday, and Friday
- No. of organisms per vessel: 2
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates): 5


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark with approximately 25-30 minutes of transitional light preceding and following the 16 hour light interval
- Light intensity: approximately 17 - 40 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations were made daily on the number of surviving adult daphnids, occurrence of sublethal effects, and production of live or immobile young. The criterion for immobility was the inability to swim within 15 seconds after gentle agitation of the test vessel. Immobile daphnids (adults and young) were discarded on renewal days. Live or immobile young were counted and removed on renewal days. At the end of the test (21 days), the length of all surviving adult daphnids was measured to the nearest 0.1 mm by use of a calibrated ocular micrometer in the eyepiece of a dissecting microscope. The surviving adult daphnids were then weighed.

The data were analysed to determine the chronic toxicity of the test substance in terms of its no observable-effect concentration (NOEC), lowest-observed-effect concentration (LOEC), and maximum-acceptable-toxicant concentration (MATC). Endpoints evaluated were immobility of adult Daphnia magna at 21 days, total number of live young produced per surviving female at 21 days, total number of immobile young produced per surviving female at 21 days, and length and dry weight of surviving females at test end (21 days). Analyses are reported based on mean, measured concentrations.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

2.16 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: adult survival, total live young per female, total immobile young per surviving female and length and weight of surviving females at day 21

Effect concentrations 2

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

3.87 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 3

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

4.46 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: adult survival, total live young per female, total immobile young per surviving female and length and weight of surviving females at day 21

Effect concentrations 4

Duration:

21 d

Dose descriptor:

other: MATC

Effect conc.:

3.1 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: adult survival, total live young per female, total immobile young per surviving female and length and weight of surviving females at day 21

Reported statistics and error estimates:

Adult survival at 21 days was determined using all adult data (i.e., including male daphnids). All other endpoint calculations used only data for females surviving to test end at 21 days. Analyses are reported based on mean, measured concentrations and were conducted using SAS Version 9.3. In the statistical output, hypothesis testing calculations may be based on either nominal (0, 0.65, 1.3, 2.5, 5.0 10.0 mg/L) or mean measured (not detected, 0.557, 1.11, 2.16, 4.46, and 8.57 mg/L) test concentrations, however, reported endpoints are based on mean measured test concentrations. All statistical tests were calculated at a significance level of p = 0.05. Analysis of length data indicated that the NOEC for length was less than the lowest mean measured test concentration of 0.56 mg/L. However, examination of the data indicates that the reduction in length at the lowest concentration was less than 5% when compared to the control. In addition, the mean measured 2.16 mg/L test concentration exhibited a mean length measurement that was essentially equivalent to the control values. Therefore, the NOEC for length should be 2.16 mg/L.

Any other information on results incl. tables

Mean, Measured Concentrations (mg a.s./L)	Mean (Standard Deviation)
	Percent Adult Survival (# males/#females)^a	First Reproduction Day^b	Total Live Young^c	Total Immobile Young^d	Adult Female Length (mm)^e	Adult Female Dry Weight (mg)^e
Dilution Water Control	90 (3/6)	7.0 (0.0)	112	0	4.3 (0.1)	0.77 (0.11)
0.557	100 (3/7)	8.6 (1.5)	101	0	4.1 (0.2)	0.65 (0.17)
1.11	80 (3/5)	7.4 (0.9)	95	0	4.0 (0.2)	0.62 (0.23)
2.16	90 (4/5)	7.5 (0.6)	88	0.4	4.2 (0.1)	0.61 (0.21)
4.46	10 (0/1)	7.8 (0.8)	69	1	3.9 (NA)	0.02 (NA)
8.57	0	9 (NA)	-	-	-	-

a Percent of adult daphnids alive at the end of the test.

b First day that reproduction was observed.

c Sum of live young produced per surviving female adult in 21 days.

d Sum of immobile young produced per surviving female adult in 21 days.

e Per surviving female adult.

NA not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).

The NOEC for the test substance in a 21-day, flow-through, chronic test using waterfleas, Daphnia magna, was 2.16 mg/L based upon mean, measured concentrations of test substance and adult survival, total live young per female, total immobile young per surviving female and length and weight of surviving females.

Executive summary:

The effect of the test substance on the survival, growth, and reproduction of Daphnia magna was assessed in a chronic, unaerated 21-day static-renewal, zero headspace test in accordance with the appropriate Good Laboratory Practice standards and test guidelines (U.S. EPA OPPTS (OSCPP) 850.1300, Public Draft; OECD Test Guideline 211). The mean measured concentrations tested were: 0.557, 1.11, 2.16, 4.46, and 8.57 mg active substance/L.

The 21-day NOEC (no-observed-effect concentration) for the test substance using Daphnia magna neonates exposed for 21 days under static-renewal was 2.16 mg a.s./L based on reproductive endpoints at the end of the study. The MATC (maximum-acceptable-toxicant concentration), and LOEC (lowest-observed-effect concentration) were 3.10 and 4.46 mg a.s./L, respectively. The EC₅₀ for adult survival was 3.87 mg a.s./L.