1,1,1,3,3,3-hexafluoropropan-2-ol

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:

24 - 26 Jul 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)

Version / remarks:

13 Apr 2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Guidance No 23 on Aquatic Toxicity Testing of Difficult Substances and Mixtures

Version / remarks:

Sep 2000

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3,3-hexafluoropropan-2-ol

EC Number:

213-059-4

EC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Cas Number:

920-66-1

Molecular formula:

C3H2F6O

IUPAC Name:

1,1,1,3,3,3-hexafluoropropan-2-ol

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Remarks:

Gas chromatography

Details on sampling:

- Concentrations: Control and 100 mg/L at test start (0 h) and at test end (48 h)
- Sampling method: At the start of exposure, samples were taken from a separate replicate. At the end of exposure, samples were taken from the test solution.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution with a nominal concentration of 100 mg/L was prepared by adding 0.031 mL test item (calculated based on a density of 1.62 g/L) below the surface of 500 mL dilution water and stirring until the test item was dissolved (0.031 mL x 1.62 g/mL = 50.2 mg).
- Controls: Dilution water without test item.
- Evidence of undissolved material: The test solutions were colorless and clear at the start and end of exposure.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Clone A
- Source: The University of Sheffield, UK
- Age of parental stock: 17 d
- Age of daphnids at test start: < 24 h, produced by parents cultured in the test facility.
- Breeding conditions: The parent daphnids were bred in the same quality of water (dechlorinated tap water), water temperature (20 ± 1 °C) and photoperiod (16-hour light/8-hour dark) as used in the test. The parent animals used for the test were the same lot and their age and survival rate were 17 d and 100%, respectively. The parent animals used for the test were from the same lot and their age and survival rate were 17 d and 100%, respectively. The parent generation was fed once a day with 0.1 - 0.2 mgC (organic carbon content) Chlorella vulgaris/day per Daphnia.
- Feeding during test: No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

32 mg/L

Test temperature:

20.0 - 20.1 °C

pH:

Control: 7.9 (0 h), 7.8 (48 h)
Treatment: 7.8 (0 h), 7.7 (48 h)

Dissolved oxygen:

Control: 8.2 (0 h), 8.0 (48 h) dissolved oxygen concentration [mg/L]
Treatment: 8.3 (0 h), 8.1 (48 h) dissolved oxygen concentration [mg/L]

Conductivity:

13 mS/m

Nominal and measured concentrations:

Control, and 100 mg/L (nominal)
Control, and 97.3 mg/L (geometric mean measured)

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL Erlenmeyer flasks
- Type: Closed, without any headspace in order to avoid volatilisation of the test item.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water
- Total organic carbon: < 0.5 mg/L
- Particulate matter: < 1 mg/L
- Alkalinity: 36 mg/L
- Ca/Mg ratio: 9.1 mg/L Ca/2.2 mg/L Mg
- Conductivity: 13 mS/m
- Culture medium different from test medium: Culture medium same as test medium (dechlorinated tap water)
- Intervals of water quality measurement: The dissolved oxygen concentration, pH and temperature were measured at the start and end of exposure.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: Room light

EFFECT PARAMETERS MEASURED:
- Immobilization: After 24 and 48 h

RANGE-FINDING STUDY
- Test concentrations: Control and 100 mg/L
- Results used to determine the conditions for the definitive study: The final test concentration was decided from the results of the preliminary study.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 97.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: No abnormalities observed in the control and in the treatment.
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: It was confirmed by visual inspection that the solubility of the test item in dilution water was more than 100 mg/L because all test solutions were clear and colorless without any undissolved particles at the start and end of exposure.

Results with reference substance (positive control):

- Results with reference substance valid? Yes, the reported value was within the usual range [mean ± S.D.: 0.23 ± 0.06 mg/L, n = 100).
- EC50 (48 h): 0.15 mg/L
- Other: The 48 h acute immobilization test of the reference substance with the test organism is periodically conducted by the testing facility. The latest test dates from 04 - 06 Apr 2017.

Reported statistics and error estimates:

Since more than 50% immobility could not be obtained in the exposure level, the EC50 value was estimated as "> test concentration".

Any other information on results incl. tables

VALIDITY CRITERIA

The study met the validity criteria laid down by the guideline (Table 1).

 

Table 1: Validity criteria

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more that 10% of the daphnids should have been immobilized.	Immobilization was 0% in the control.	Yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	The dissolved oxygen concentration was 8.0 in the control and 8.1 mg/L in the treatment at the end of the test.	Yes

 

 

ANALYTICAL RESULTS

The measured concentration of test item in the test solution was 97.6 mg/L (97.6% of nominal concentration) at the start of the test and 97.1 mg/L (97.1% of nominal concentration) at the end of the test. Therefore, the measured concentration was maintained within ± 20% of the nominal concentration (Table 2).

 

Table 2. Measured concentrations of the test item in the test solutions.

Nominal concentration [mg/L]	Measured concentration [mg/L] (percentage of measured concentration versus nominal concentration %)
	Test start	Test end	Geometric mean
Control	n.d.	n.d.	-
100	97.6 (97.6)	97.1 (97.1)	97.3 (97.3)

n.d.: < 10.0 mg/L

 

 

BIOLOGICAL RESULTS

Immobilization was 0% in the control and 0% in the nominal limit concentration of 100 mg/L.

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.