trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 12, 2012 - January 9, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

The test material concentration in the reconstituted water was not quantified at the start and the end of this study due to the low water solubility.
The compound cannot be detected with standard analytical methods, due to the low water solubility (< 0.051 mg/L). The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test medium (reconstituted water and test material) was prepared freshly. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a single use syringe filter (pore size 0.2 µm). The filtrate was used for the study.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia
- Strain/clone: Daphnia magna Straus
- Source: IBACON GmbH (Rossdorf, Germany)
- Feeding during test: No

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not): yes
- Type and amount of food: The daphnids were fed with green algae whenever necessary, but at least once a week.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/mL

Test temperature:

21 °C

pH:

7.77 - 8.21

Nominal and measured concentrations:

nominal 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 4 control, 4 test material
- Type: open
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per vehicle control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: standard medium accordng to Elendt

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

Reference substance (positive control):

yes

Remarks:

data taken from another GLP study performed at the same test facility in 2013

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 24h EC50 > 0.051 mg/L (nominal > 100 mg/L)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 48h EC50 > 0.051 mg/L (nominal > 100 mg/L)

Details on results:

no mortality, no other remarkable observations

Results with reference substance (positive control):

- Results with reference substance valid? yes

- ECx:

24 h EC50 1.018 mg/L
48 h EC50 0.769 mg/L

Conclusion:
Under the given experimental conditions, the test material Art. 104864 (Potassium dichromate) showed a 24 h EC50 value which was within the range of the published data of 0.6 to 1.7 mg/L (Council Regulation (EC) No. 440/2008) and 0.6 to 2.1 mg/L (OECD Guideline No. 202).

Validity criteria fulfilled:

yes

Conclusions:

The test item, dissolved in reconstituted water, was tested in an open static test system. An aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system.
The 48 hours EC50 was > 0.051 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.

Executive summary:

The objective of this study was to evaluate the influence of the test material on the immobilization of Daphnia magna.

For this purpose, juvenile daphnids were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration and control group containing five daphnids each, i.e. 20 daphnids per concentration (test medium group) and control group. Daphnids were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system.

Daphnids exposed to an aqueous preparation of a nominal concentration of 100 mg/L were not affected.

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

24 h EC50      > 0.051 mg/L (nominal > 100 mg/L)

48 h EC50      > 0.051 mg/L (nominal > 100 mg/L)

The test material, solved in reconstituted water, was tested in an open static test system. An aqueous solution of 100 mg/L of the test item revealed no aquatic toxicity in the test system.The 48 hours EC50 was > 0.051 mg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.

Description of key information

No adverse effects on Daphnia magan were observed up to the limit of water solubility. Thus, the 48 -h EC50 is greater than 0.051 mg/L which corresponds to a nominal concentration of 100 mg/L.