Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 April 2019 - 16 April 2020

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Fish length data indicates that the fish were 3.1 to 3.7 cm in length rather than within the range of 2.0 ± 1.0 cm as per the Study Plan.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

EC Number:

940-803-1

Molecular formula:

This is a multi-constituent susbstance there is no molecular formula or molecular weight range available

IUPAC Name:

Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

Test material form:

liquid

Specific details on test material used for the study:

Batch: W19011506
Purity: Approximately 30% active in water*
Physical State/Appearance: Opaque beige viscous liquid
Expiry Date: 18 January 2021

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Water samples were taken from the control and test group, from fresh and old media
throughout the 96-Hour test period, for quantitative analysis. All samples were stored frozen
prior to analysis. Duplicate samples were taken and stored frozen for further analysis if
necessary.
The concentration and stability of the test item in the test preparations were verified by
chemical analysis at 0, 24, 48, 72 and 96 hours

Test solutions

Vehicle:

no

Details on test solutions:

A nominal amount of test item (3334 mg) was added to the surface of 10 liters of test water
and stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a
dimple at the water surface. The stirring was stopped after 24 hours and the test dispersion
removed by mid-depth siphoning using a glass syphon.

Test organisms

Details on test organisms:

The definitive test was carried out using juvenile fathead minnow (Pimephales promelas).
Fish were bred and maintained in-house since 16 December 2019. Fish were maintained in a
glass tank with a "single pass" water renewal system. Fish were acclimatized to test
conditions from 20 January 2020 to 27 January 2020.

Study design

Test type:

static

Water media type:

freshwater

Remarks:

The test water was the same as that used to maintain the stock fish. Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener) giving water with a

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

0

Test conditions

Hardness:

140 mg/L as CaCO3

Test temperature:

20 °C to 22 °C

pH:

7.7-8.1

Dissolved oxygen:

6.9-9.9

Nominal and measured concentrations:

Analysis for ion 789 of the freshly prepared test media at 0, 24, 48 and 72 hours showed measured test concentrations of 23.2, 20.4, 16.8 and 20.4 mg ai/L
respectively and of the corresponding old or expired media at 24, 48, 72 and 96 hours showed
measured test concentrations of 18.6, 18.4, 18.2 and 19.3 mg ai/L respectively.
Analysis for ion 443 of the freshly prepared test media at 0, 24, 48 and 72 hours showed measured test concentrations of 11.8, 14.8, 8.2 and 9.7 mg ai/L respectively
and of the corresponding old or expired media at 24, 48, 72 and 96 hours showed measured
test concentrations of 10.0, 10.2, 9.5 and 9.7 mg ai/L respectively.
As values for both ions were not within 80 to 120% of nominal, it was considered appropriate
to calculate the results based on the geometric mean measured test concentrations only in
order to give a “worst case” analysis of the data. The geometric mean measured test
concentrations were determined to be 18.68 mg ai/L for ion 789 and 10.42 mg ai/L for
ion 443.

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

18.68 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: Ion 443

Basis for effect:

mortality (fish)

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

18.68 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: Ion 789

Basis for effect:

mortality (fish)

Effect concentrations 3

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 18.68 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: Ion 443

Basis for effect:

mortality (fish)

Effect concentrations 4

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 18.68 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: Ion 789

Basis for effect:

mortality (fish)

Details on results:

Exposure of fathead minnow to the test item based on the geometric mean measured test
concentrations gave an LC50 value of greater than 18.69 mg ai/L for ion 789 and 10.42
mg ai/L for ion 443. The No Observed Effect Concentration (NOEC) was 18.69 mg ai/L for
ion 789 and 10.42 mg ai/L for ion 443.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was ≥60% of ASV (5.2 mg O2/L) in the control and test vessels.