3,3,4,4,4-pentafluorobut-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:

March 2018 - May 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 2004

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,4-pentafluorobut-1-ene

EC Number:

206-775-3

EC Name:

3,3,4,4,4-pentafluorobut-1-ene

Cas Number:

374-27-6

Molecular formula:

C4H3F5

IUPAC Name:

3,3,4,4,4-pentafluorobut-1-ene

Test material form:

gas

Specific details on test material used for the study:

Information as provided by the Sponsor.

Identification: 3,3,4,4,4-pentafluorobut-1-ene (CAS No 374-27-6)
Batch: 31101
Purity: 99.753%
Physical state/Appearance: colorless gas
Expiry Date: 26 November 2018
Storage Conditions: room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Analysis of the test preparations was carried out by Total Organic Carbon analysis. Samples were taken from the control and each test group from the bulk test preparation at 0 hours (fresh media) and from the pooled replicates at 48 hours (old media).
Duplicate samples were taken and stored frozen for further analysis if necessary.

Test solutions

Details on test solutions:

Total Organic Carbon analysis of the test preparations at 0 hours (fresh media) showed measured concentrations in the samples ranged from less than the limit of quantification of the analytical method used, which was determined as 1.0 mg Carbon/L, to
2.6 mg Carbon/L and at 48 hours (old media) ranged from less than the limit of quantificationto 2.1 mg Carbon/L. The measured carbon content in the 100% v/v saturated solution was 2.6 mg C/L. Given the molecular formula of the test item (C4H3F5), the carbon content is 32.9%, therefore the calculated concentration of test item in the test solution at the start of the test was: 2.6 / 32.9 x 100 = 7.9 mg/L.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Twenty daphnids were used (four replicates of five animals). The test was carried out using first instar Daphnia magna derived from in-house laboratory cultures. The daphnids were not individually identified, received no food during exposure and the test vessels were not aerated.

Study design

Test type:

static

Water media type:

other: Reconstituted water (Elendt M7 medium)

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

21C. Measured with a Hanna Instruments HI 93510 digital thermometer.

pH:

7.9-8.1

Dissolved oxygen:

7.1-9.0 O2/L

Nominal and measured concentrations:

The saturated solution was prepared by bubbling the test item at approximately 40 mL/minute for 15 minutes through 11 liters of diluent whilst stirring using a magnetic stirrer to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 1.0, 3.2, 10 and 32% v/v saturated solution. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.

Details on test conditions:

There was a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods. Throughout the test the light intensity was observed to be in the range 706 to 723 Lux. Any immobilization 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 immobilized if they were unable to swim within 15 seconds after gentle agitation.

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 7.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

7.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The measured carbon content in the 100% v/v saturated solution was 2.6 mg C/L. Given the molecular formula of the test item (C4H3F5), the carbon content is 32.9%, therefore the calculated concentration of test item in the test solution at the start of the test was: 2.6 / 32.9 x 100 = 7.9 mg/L.

Results with reference substance (positive control):

A positive control used potassium dichromate as the reference item at concentrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L. Exposure conditions for the positive control were similar to those in the definitive test. Analysis of the immobilization data was carried out using the Binomial Distribution method at 24 hours and the Trimmed Spearman-Karber method at 48 hours. All statistical analysis was carried out using the ToxRat Professional computer software package with results based on the nominal test concentrations.

24h EC50: 0.79 mg/L
24h NOEC: 0.56 mg/L
24h LOEC: 1 mg/L
48h EC50: 0.75 mg/L
48h NOEC: 0.56 mg/L
48 LOEC: 1 mg/L

The NOEC is based upon equal to or less than 10% immobilization at this concentration. The results from the positive control with potassium dichromate were within the normal range for this reference item.

Reported statistics and error estimates:

An estimate of the EC50 values was given by inspection of the immobilization data. The Lowest Observed Effect Concentration (LOEC) and the NOEC at 24 and 48 hours were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction. LOEC and NOEC results were calculated using the ToxRat Professional computer software package (TOXRAT).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The test was considered valid given that none of the control daphnids showed immobilization or other signs of disease or stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels.

Conclusions:

Exposure of Daphnia magna to the test item gave EC50 values based on the nominal test concentrations of greater than 100% v/v saturated solution. The NOEC was 100% v/v saturated solution. This study showed that there were no toxic effects at saturation. The measured carbon content of the 100% v/v saturated solution was equivalent to a test item concentration of 7.9 mg/L.

Executive summary:

The 48h EC50 was determined to be > 7.9 mg/L and the 48h NOEC was 7.9 mg/L.