4,4,5,5,6,6,7,7,8,8,9,9,9-tridecafluorononyl methacrylate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Remarks:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at 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-tridecafluorooctyl methacrylate

EC Number:

218-407-9

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

Cas Number:

2144-53-8

Molecular formula:

C12H9F13O2

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

Details on test material:

- Purity: not reported

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Nominal test concentration was 0.05 mg/L. Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 0.020 to 0.023 mg/L (fresh media) and 0.0097 to 0.019 mg/L (old media).
- Sampling method: Samples of the solvent control (replicates R1 - R4 pooled) and the 0.050 mg/L test group (replicates R1 - R2 and R3 - R4 pooled) were taken at 0 hours (fresh media), 24 hours (old and fresh media) and 48 hours (old media).
- Sample storage conditions before analysis: Further samples were taken and stored at approximately - 20°C for further analysis if necessary.

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: An amount of test material (250 mg) was dissolved in dimethylformamide and the volume adjusted to 25 mL to give a 250 mg/25 mL solvent stock solution. An aliquot (500 µL of this solvent stock solution was added to reconstituted water and the volume adjusted to 5 litres to give a 1.0 mg/L stock solution. This stock solution was then centrifuged at 40000 g for 30 minutes to remove any dispersed test material and give a nominal test concentration of 0.050 mg/L. The solvent stock solution was prepared by dissolving 200 µL of dimethylformamide in to 2 litres of reconstituted water. Each stock solution and prepared concentration was inverted several times to ensure adequate mixing and homogeneity.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia
- Source: in-house laboratory cultures.
- Age at study initiation: less than 24 hours old
- Feeding during test: no

ACCLIMATION
- Type and amount of food: Each culture was fed daily with a suspension of algae (Chlorella sp.).

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

approximate theoretical total hardness of 250 mg/L as CaC03.

Test temperature:

20.1 °C to 21.1 ºC

pH:

7.8 ± 0.2

Salinity:

fresh water

Nominal and measured concentrations:

Nominal concentration of 0.050 mg/L
Measured test concentrations range from 0.020 to 0.023 mg/L (fresh media) and 0.0097 to 0.019 mg/L (old media)

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 ml glass jars
- Type: closed
- Material, size, headspace, fill volume: approximately 200 ml of test preparation
- Aeration: no
- Renewal rate of test solution: renewal at 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
a) CaCl2.2H2O 11.76 g/L
b) MgS04.7H20 4.93 g/L
c) NaHC03 2.59 g/L
d) KCI 0.23 g/L
An aliquot (25 mL) of each of solutions a-d was added to each litre (final volume) of deionised water. The reconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCI and was aerated until the dissolved oxygen concentration was approximately air-saturation value.

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 24 hr dark

EFFECT PARAMETERS MEASURED: Any immobilisation or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that Daphnia were considered to be immobilised if they were unable to swim for approximately 15 seconds after gentle agitation.

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: In the initial range-finding test Daphnia were exposed to a series of nominal test concentrations of 0.0065 and 0.065 mg/L.
- Results used to determine the conditions for the definitive study: yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.017 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

dissolved

Basis for effect:

mobility

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 0.017 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

dissolved

Basis for effect:

mobility

Reported statistics and error estimates:

The time-weighted mean measured test concentrations of the test media using the mean of the measured test concentrations of replicates Rl1 and R2 pooled and replicates R3 and R4 pooled were calculated.
An estimate of the EC50 values was given by inspection of the immobilisation data. The ECso values and associated confidence limits at 24 hours were calculated by the probit method (Finney 1971) using the ToxCalc computer software package (ToxCalc 1999) and at 48 hours by the trimmed Spearman-Karber method (Hamilton et at 1977) using the ToxCalc computer software package (ToxCalc 1999).
In order to give a worst case analysis of the data it was considered justifiable to calculate the results based on the time-weighted mean measured test concentration of the test media. The time-weighted mean measured test concentration was calculated to be 0.017 mg/L.

Any other information on results incl. tables

Range-finding Test: No immobilisation was observed at the test concentrations of 0.0065 and 0.065 mg/l throughout the duration of the test.

Definitive Test: No immobilisation was observed at the single concentration tested.

In order to give a worst case analysis of the data it was considered justifiable to calculate the results based on the time-weighted mean measured test concentration of the test media. The time-weighted mean measured test concentration was calculated to be 0.017 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
48-hour EC50 > 0.017 mg/L

Executive summary:

The toxicity of the test substance to Daphnia magna, was determined in a 48-hour, semi-static toxicity test. This study was conducted as a limit test at the concentration around solubility of the test item in dilution water to confirm the effect on the test organisms.

This experimental design conforms to a "Limit test" to confirm that at the highest attainable test concentration of 0.050 mg/l, no immobilisation or adverse reactions to exposure were observed. In order to give a worst case analysis of the data it was considered justifiable to calculate the results based on the time-weighted mean measured test concentration of the test media. The time-weighted mean measured test concentration was calculated to be 0.017 mg/L.

The 48-hour EC50 was determined to be greater than 0.017 mg/L

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