4-[difluoro(3,4,5-trifluorophenoxy)methyl]-2',3,5-trifluoro-4''-propyl-1,1':4',1''-terphenyl

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:

Sep 22 - Oct 02, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-3-fluoro-4'-propyl-1,1'-biphenyl

EC Number:

619-490-8

Cas Number:

303186-36-9

Molecular formula:

C27H22F8O2

IUPAC Name:

4-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-3-fluoro-4'-propyl-1,1'-biphenyl

Test material form:

solid: bulk

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Trace elements (mg/L):
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003

Macro nutrients (mg/L):
Na2EDTA x 2H20 2.50

Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75


After preparation, the reconstituded water was aerated for 24 hours.

- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after an aeration for 24 hours.



References:

ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

14 ° dH (about 250 mg/L CaCO3)

Test temperature:

20 – 21°C

pH:

7.7 +/- 0.1

Dissolved oxygen:

at least 90 %

Nominal and measured concentrations:

Nominal 100 mg/L

Details on test conditions:

-- Preparation
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a nutsch filter (pore size >10 - <16 µm). The filtrate was used for the study.

-- Analysis
The analysis of a saturated aqueous solution revealed that the solubility of the test item in water is < 0.01 mg/L. So the concentrations of the solution could not be determined analytically.

-- Administration
At the start of the experimental phase, 5 Daphnia magna were placed into 10 ml of reconstituted water (control group) or test medium (test material group). The Daphnia magna were not fed, and the control medium and test medium were not aerated during the test.
The test vessels were labeled to assure an unmistakable identification.

-- Dose levels
A single test material concentration of 0.1 g/L was tested in an open static system.

-- Observation schedule
The mobility was determined by visual control and recorded after 24 and 48 hours.

-- pH and oxygen concentration
The pH-values and dissolved oxygen concentration (02) were measured in the control and all test material concentrations at the beginning and at the end of the experimental part.

-- Temperature
During the experimental part, the temperature was registered in a control vessel with an electronic thermometer containing a maximum and minimum memory display.

-- Archive statement
All raw data, specimens and the final report are stored in the archives of the Merck KGaA, Institute of Toxicology.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hours EC50 to Daphnia magna exceeded the solubility (< 0.01 mg/L) of the test material in reconstituted water and, thus, could not be determined in this test.

Executive summary:

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test item in Daphnia magna to provide a rational basis for hazard estimation for the test item in aquatic environments.

Study design

For this purpose, juvenile Daphnia magna were exposed to an aqueous test material preparation over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia per concentration (test medium group). In addition, a control group of 20 Daphnia in reconstituted water was used.

Daphnia magna were exposed to a test material concentration of nominal 100 mg/L (limit test) in an open static system.

Results

After exposure to a saturated aqueous solution of the nominal concentration of 0.1 g/L for 48 hours to Daphnia magna the following results were obtained:

   

Nominal concentration Immobilization immobilized / exposed
[g/L]	24 hours	48 hours
0.0	0/20	0/20
0.1	0/20	0/20

Daphnia magna exposed to an aqueous preparation of the nominal concentration of 100 mg/L of the test item were not affected.

The test material concentration in the aqueous medium was not quantified at the start and the end of this study due to the very low water solubility (< 0.01 mg/L) and the fact that no toxicity was observed up to the limit of water solubility (< 0.01 mg/L).

For the test material the following nominal EC50 values for Daphnia magna were determined:

24 h EC₅₀> 100 mg/L

48 h EC₅₀> 100 mg/L

Conclusions

An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hours EC50 to Daphnia magna exceeded the solubility (< 0.01 mg/L) of the test material in reconstituted water and, thus, could not be determined in this test.