Potassium hexafluorophosphate

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:

2016-03-26 to 2016-03-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hexafluorophosphate

EC Number:

241-143-0

EC Name:

Potassium hexafluorophosphate

Cas Number:

17084-13-8

Molecular formula:

F6P.K

IUPAC Name:

potassium hexafluoro-λ⁵-phosphanuide

Test material form:

solid: crystalline

Details on test material:

- State of aggregation: solid
- Other: crystalline powder,
Colour: white
hygroscopic

Specific details on test material used for the study:

Appearance: white crystalline powder

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
At the start of the exposure (0 hours), sampling was carried out after preparation of the limit concentration.
At the end of the exposure (48 hours), samples were taken from additional replicates, which were prepared with test media, but without daphnids.
These additional replicates were incubated under test conditions until sampling.

method validation:
The fortified samples for the 1 x LOQ level were analysed directly
after preparation. The 20 x LOQ level was diluted factor 10 with
HPLC water prior to analysis. The blank samples were used as blank
solution for spectrophotometric analysis.

- Sampling method:
All samples were prepared as described in the test kit manual.
The limit test concentration was diluted factor 10 with HPLC water
prior to analysis. The control was used as blank solution.

- Sample storage conditions before analysis:
All original samples were stored at 6 ± 2 °C. Prepared samples were
stored at room temperature until analysis, if necessary.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
The limit concentration (100 mg/L of the test item were weighed out) was freshly prepared with dilution water (Elendt M4 medium as specified in Table 2) before the start of the exposure (at O hours).The limit concentration was mixed thoroughly by manual agitation.

- Evidence of undissolved material (e.g. precipitate, surface film, etc.):
not reported; soluble in accordance with water solubility

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: (Clone 5)
- Justification for species other than prescribed by test guideline:
- Source:
origin: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
breeder: Noack Laboratorien GmbH Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany

- Age of parental stock (mean and range, SD):
- Feeding during test
no

- Food type:
- Amount:
- Frequency:

ACCLIMATION
Acclimatisation of the daphnids was not necessary, because the dilution water was equivalent to the culture medium.

- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

no

Test conditions

Hardness:

178 mg CaCO3 / L20.3

Test temperature:

20.3 °C

pH:

start: 8.83
end: 7.60 - 7.65

Dissolved oxygen:

start: 9.95
end: 7.37 - 7.82

Salinity:

(freshwater)

Conductivity:

478 µS/cm

Nominal and measured concentrations:

nominal: 100 mg/L
measured:
start: 98.4, 98 mg/L
end (48h): 88.6, 89 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses


- Material, size, headspace, fill volume:
test volume 20ml

- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
static

- Renewal rate of test solution (frequency/flow rate):
static

- No. of organisms per vessel:
5
- No. of vessels per concentration (replicates):
3

- No. of vessels per control (replicates):
1

- No. of vessels per vehicle control (replicates):
no vehicle

- Biomass loading rate:
not reported

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of the Culture Medium Elendt M4 according to OECD 202, Annex 3 (2004)
other parameters see "test conditions"

- Culture medium different from test medium:
no

- Intervals of water quality measurement:
start and end of test

OTHER TEST CONDITIONS
- Adjustment of pH:
pH: see test "pH", adjustment not reported

- Photoperiod:
16 hours illumination,

- Light intensity:
light intensity of max. 20 pE•m-2 • s-1 (max. 1340 lx)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
immobilisation observation

VEHICLE CONTROL PERFORMED: yes/no
no vehicle

RANGE-FINDING STUDY
- Test concentrations:
1, 10, 100 mg/l, 48 h

- Results used to determine the conditions for the definitive study:
no immobilisation at all concentrations

Reference substance (positive control):

yes

Remarks:

Potassium dichromate p.a. (SIGMA)

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC0

Remarks:

limit test

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: measurement based on nominal which was analytically confirmed (<20%deviation)

Results with reference substance (positive control):

The percentage of immobility for the reference item was determined after 24 hours. The EC50-value with 95% confidence limits (Cl) was calculated by sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:

EC50: 1.95 mg/L (Cl: 1.14 - 3.30 mg/L)

The EC50-value of the reference item potassium dichromate after 24 hours is within the required concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The ECso-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Any other information on results incl. tables

The percentage of immobility, determined in the limit concentration and in the control after 24 and 48 hours under static conditions, is given.

   Immobilisation Rates after 24 and 48 hours of Exposure in the Definitive Test (n = 20,divided into 4 replicates with 5 daphnids each)

Nominal test item concentration [mg/L]	IMMOBILISATION [%]
	24 hours					48 hours
	Replicates					Replicates
	1	2	3	4	MV	1	2	3	4	MV
100	0	0	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0	0	0

In the limit concentration 100 mg/L of the test item PU-2015-627,
no effects onDaphnia magnawere observed.

EC10-, EC50- and EC100-Values

(based on the nominal concentration of the test item)

Effect levels	Test duration [hours]	Toxicity endpoint based on the nominal concentration the test item [mgiL]
EC10/50 / 100	24	> 100
	48	> 100

The study was performed according to OECD Guideline 202 (2004), which is equivalent to the Council Regulation (EC) No.440/2008 Method C.2 (2008).

The validity criteria were fulfilled:

 In the control group, no daphnids were immobilised or showed any signs of disease or stress, e.g. discoloration or unusual behaviour such as trapping on the surface of the water, during the 48-hour test period (required: not more than 10% of the daphnids in the control).

The dissolved 02 concentration at the end of the exposure period was k 7.37 mg/L (required: k 3 mg/L) in the test vessels of the limit concentration and the control.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No effects on daphnia after 48h were observed at the limit concentration of 100 mg/L.

Executive summary:

Potassium hexafluorophosphate effects on daphnia acute were tested according to OECD 202 for 48 hours in a limit test with analytical confirmation.

No effects on daphnia after 48h were observed at the limit concentration of 100 mg/L.