1-bromoheptadecafluorooctane

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 January 2017 - 27 January 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 201 (Alga, Growth Inhibition Test)

Version / remarks:

2006

Deviations:

no

Remarks:

There were no deviations from the study plan.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

Version / remarks:

EC No 761/2009

GLP compliance:

yes (incl. QA statement)

Remarks:

See study Report Annex 5

Test material

Test material information

Constituent 1

Reference substance name:

1-bromoheptadecafluorooctane

EC Number:

207-028-4

EC Name:

1-bromoheptadecafluorooctane

Cas Number:

423-55-2

Molecular formula:

C8BrF17

IUPAC Name:

1-bromoheptadecafluorooctane

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:PFOBV42001- Expiration date of the lot/batch:99.8%- Purity test date:01 January 2018STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Room temperature in the dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: - Sampling method: Samples were taken from the solvent control and the 0.020 mg/L test group from the bulk test preparation at 0 hours and from the pooled replicates at 72 hours for quantitative analysis. - Sample storage conditions before analysis: The samples were analyzed on the day of receipt

Test solutions

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: A nominal amount of test item (20 mg) was dissolved in a final volume of 10 mL of dimethylformamide to give a 20 mg/10 mL solvent stock solution from which a dilution was made to give a further solvent stock solution of 2.0 mg/10 mL. An aliquot (200 μL) of the 2.0 mg/10 mL solvent stock solution was dispersed in 2 liters of culture medium with the aid of magnetic stirring for approximately 10 minutes prior to inoculating with 21.8 mL of algal suspension to give the required test concentration of 0.020 mg/L. - Controls:The control and the solvent control groups were maintained under identical conditions but not exposed to the test item.- Chemical name of vehicle (organic solvent, emulsifier or dispersant):dimethylformamide. - Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):100 μL/L

Test organisms

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM - Common name: green algae - Strain: Pseudokirchneriella subcapitata - Source (laboratory, culture collection): CCAP 278/4 - Method of cultivation: liquid cultures ACCLIMATION - Acclimation period: sufficient to ensure exponential growth - Culturing media and conditions (same as test or not): same as test - Any deformed or abnormal cells observed: none

Study design

Test type:

static

Water media type:

other:

Limit test:

no

Total exposure duration:

72 h

Remarks on exposure duration:

standard

Post exposure observation period:

N/A

Test conditions

Hardness:

not reported

Test temperature:

24 ± 1 ºC

pH:

7.8 - 10

Dissolved oxygen:

N/A

Salinity:

N/A

Nominal and measured concentrations:

nominal concentration 0.020 mg/L (limit of solubility in teat media). Measured concentrations; 0 hours 0.015 mg/L; 72 hours < LOQ (0.00061 mg/L). As the 72-Hour measured concentration was less than the LOQ, a value of half the LOQ was used in the calculation of the geometric mean measured concentration = 0.0022 mg/L.

Details on test conditions:

TEST SYSTEM - Test vessel: 250 mL glass conical flasks - Initial cells density: 5.00 × 103 cells per mL - No. of vessels per concentration (replicates): 6 - No. of vessels per control (replicates): 6 - No. of vessels per vehicle control (replicates): 6 GROWTH MEDIUM - Standard medium used: yes AAP Medium as described in the OECD 201 Test guideline OTHER TEST CONDITIONS - Adjustment of pH: - Photoperiod: continuous illumination - Light intensity and quality: warm white lighting (380 – 730 nm) - Temperature: 24 ± 1 °C under - Rotation: shaken at approximately 150 rpm for 72 hours. EFFECT PARAMETERS MEASURED (with observation intervals if applicable): - Determination of cell concentrations: cell densities determined using a Coulter® Multisizer Particle Counter. Triplicate determinations were made for each sample., TEST CONCENTRATIONS - Spacing factor for test concentrations: not applicable – limit test - Justification for using less concentrations than requested by guideline: not toxicity observed at concentrations up to the limit of solubility in the test medium - Test concentrations: control, solvent control (DMF) and nominal concentration of 0.020 mg/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 0.022 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

> 0.022 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 0.022 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

0.25 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

growth rate

Details on results:

This study showed that there were no toxic effects at the limit of solubility.

Results with reference substance (positive control):

ErC50 (0 – 72 h) : 1.4 mg/L; 95% confidence limits 1.2 – 1.5 mg/L EyC50 (0 – 72 h) : 0.60 mg/L; 95% confidence limits 0.52 – 0.69 mg/L No Observed Effect Concentration (NOEC) based on growth rate: 0.25 mg/L No Observed Effect Concentration (NOEC) based on yield: 0.25 mg/L Lowest Observed Effect Concentration (LOEC) based on growth rate: 0.50 mg/L Lowest Observed Effect Concentration (LOEC) based on yield: 0.50 mg/L

Reported statistics and error estimates:

A Student’s t-test incorporating Bartlett's test for homogeneity of variance on the growth rate and yield data after 72 hours for the solvent control and the 0.020 mg/L test concentration to determine any statistically significant differences between the test and control groups.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes