2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2022

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Series on Testing and Assessment No. 23 - Guidance Document On Aquatic Toxicity Testing Of Difficult Substances And Mixtures ENV/JM/MONO(2000)6/REV1 (2019).

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

EC Number:

639-791-8

Cas Number:

3345-29-7

Molecular formula:

C16H8F8

IUPAC Name:

2,2,3,3,8,8,9,9-octafluorotricyclo[8.2.2.2⁴,⁷]hexadeca-1(12),4,6,10,13,15-hexaene

Specific details on test material used for the study:

Batch n. 340421
Production date November 19, 2021
Expiry date November 19, 2024
Purity ≥98.00%

Sampling and analysis

Analytical monitoring:

yes

Remarks:

HPLC method

Test solutions

Vehicle:

yes

Remarks:

Due to low solubility of the test item in water, a solvent (acetonitrile) was used as carrier to add test substance in the test medium.

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

19.9 – 20.2°C.

pH:

negative control: 8.01 - 7.88
solvent control: 8.01 – 7.96
test item solution: 8.03 – 7.98

Dissolved oxygen:

negative control: 7.17 – 6.91 mg O2/L
solvent control: 6.66 – 6.84 mg O2/L
test item solutions: 6.86 – 7.12 mg O2/L.

Nominal and measured concentrations:

Daphnia were exposed to aqueous test media containing test
item at the only one nominal test item concentrations, 1.0 mg/L, corresponding to the maximum
water solubility (achieved with the help of acetonitrile solvent).
Negative control: reconstituted water without test item
Solvent control: reconstituted water without test item but with acetonitrile solvent

Details on test conditions:

Light intensity: 1381 - 1403 Lux.

Light regime: 16 hours light and 8 hours dark.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 0.58 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.58 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 5

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

0.58 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Effect concentrations 7

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 8

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.58 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

In the test control, 0% immobilization was observed and no daphnid was trapped on the test
water surface or showed other signs of disease or stress.

The analytical recoveries were referred to active ingredient nominal content declared on the
Certificate of Analysis supplied by the Sponsor (98.0%).
Since all analytical recoveries were not in the range 80 % - 120 % of the nominal concentrations,
the biological results were referred to the time-weighted arithmetic mean of PARYFREE® DIMER
measured concentrations, as recommended by OECD Guidance Document on testing of difficult
substances No. 23, 2019 (Table 4).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

A limit dose-response test was performed to evaluate the effect of the test item on Daphnia magna under semi-static conditions.

The actual test concentrations of active ingredient were analytically measured at the beginning, after 24 hours (in fresh and spent solutions) and end of the test period.

Analytical recoveries of active ingredient PARYLENE HT® during the test period are reported in the following table. The analytical recoveries were referred to active ingredient nominal content declared on the Certificate of Analysis supplied by the Sponsor (98.0%).

Since all analytical recoveries were not in the range 80 % - 120 % of the nominal concentrations, the biological results were referred to the time-weighted arithmetic mean of PARYFREE® DIMER measured concentrations, as recommended by OECD Guidance Document on testing of difficult substances No. 23, 2019.

The daphnids were observed for immobility after 24 and 48 hours of exposure.

In the negative control, 0% immobilization was observed and no daphnid was trapped on the test
water surface or showed other signs of disease or stress. These values comply with the validity
criteria of the test, that requires a maximum of 10% of daphnids immobilized or showing distress
signs in the negative control at the end of the test.

 

In addition, sub-lethal effects (daphnids behaviour and appearance) were also assessed after 24
hours of exposure and at the end of the test. No remarkable observations were made concerning the
appearance of daphnids in the negative and solvent control and in the test item medium.

The test solutions did not change throughout the whole test duration.The obtained experimental results allowed calculation of the EC10, EC20, EC50 values and the NOEC at 24 and 48 hours.

Results are expressed in terms of nominal test item concentration and time-weighted arithmetic mean of PARYLENE HT® measured concentrations.