1-Methyl-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl] -benzene

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:

Jul 30,2010 - Mar 01, 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

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)

Analytical monitoring:

no

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 (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Strauss)
Breeder: known
Age: not older than 24 hours

This species is internationally accepted for this type of study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

14 ° dH (about 250 mg/L CaCO3)

Test temperature:

22°C

pH:

7.8 - 8

Dissolved oxygen:

at least 80 %

Nominal and measured concentrations:

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

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 material in water is < 0.01 mg/L. Therefore, 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.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

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

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

Details on results:

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

Results with reference substance (positive control):

The sensitivity of the test system is demonstrated periodically. The positive control was carried out with potassium dichromate.

Validity criteria fulfilled:

yes

Conclusions:

An aqueous solution of nominal 100 mg/L of the test material 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:

The objective of this study was to determine the acute toxicity of the test material using Daphnia magna.

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.

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 test material 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 material 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.

Description of key information

The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 202. An aqueous solution of nominal 100 mg/L of the test material 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.

EC50 (48h) > 100 mg/L