1-fluoro-3-(trans-4-propylcyclohexyl)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:

18 MAR 2015 - 20 APR 2015

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz

Analytical monitoring:

no

Vehicle:

yes

Remarks:

reconstituted water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium (reconstituted water and test item) was prepared freshly. Therefore, the calibrated flask with test medium will stirred with a magnetic stirrer for 24 hours. Then the formulation was given into a separating funnel for 1 hour. The middle layer was centrifuged at 4100g for further 2 hours. The middle layer after centrifugation was used for the study.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Method of breeding: individually
- Source: original IBACON GmbH (Roßdorf, Germany), the clone was bred in the laboratories of Merck KGaA
- Age of parental stock (mean and range, SD): until they were about 6 weeks old
- Age at study initialisation: not older than 24 hours
- Feeding during test : no
- Food type: unicellular green algae Desmodesmus subspicatus
- Amount: ad libitum
- Frequency: three times per week (during breeding)

ACCLIMATION
- Acclimation period: not necessary, bred in-house
- Acclimation conditions (same as test or not): yes

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

about 2.5 mmol/L (about 250 mg/L CaCO3)

Test temperature:

21.2 -21.9°C

pH:

7.9 ± 0.3

Dissolved oxygen:

8.11 - 8.19 mg/L

Nominal and measured concentrations:

0, 100 mg/L nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: test tubes
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 mL, glass
- Volume of solution: 20 mL
- Aeration: 24 hours after preparation, no aeration during test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water (ELENDT M4)
The water was composed according to ELENDT (1990). The reconstituted water contained the following chemicals (analytical grade), which were dissolved in fully demineralized water to obtain the following concentrations:

Main components mg/L
CaCl2 * 2H2O 293.80
MgSO4 * 7H2O 123.30
NaHCO3 64.80
KCl 5.80
Na2SiO3 * 9H2O 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
Na2EDTA*2H2O 2.5000

Vitamins mg/L
Thiamin 0.07500
B12 0.00100
Biotin 0.00075

- Culture medium different from test medium: no
- Intervals of water quality measurement: 48 h

OTHER TEST CONDITIONS
- Adjustment of pH: 7.9
- Photoperiod: 16h light / 8h dark
- Intensity: 657 Lux and 672 Lux at the end of the study.


VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (Study no.: 14_DA324_N0, Gado, 2014)

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: EC50(24h) > 9.74 µg/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: EC50(48h) > 9.74 µg/L

Details on results:

Water temperature, pH-values and oxygen concentrations were inconspicuous during the study.

Results with reference substance (positive control):

Results with reference substance valid? Yes
- Limit test: No
- Test item concentrations: 0.31, 0.46, 0.69, 1.02 and 1.52 mg/L
- ECx: 24h EC50: 1.221 mg/L (1.050 1.524 mg/L)
48h EC50: 0.819 mg/L (0.721 -0.931 mg/L)

Validity criteria fulfilled:

yes

Remarks:

In the control group 0% of the introduced daphnids died. The dissolved oxygen concentration at the end of the test was >3 mg/L. Thus, the validity criteria were fulfilled.

Conclusions:

Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system.
The 48h EC50 was > 9.74 µg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.

Executive summary:

The study was performed according to OECD Guideline 202 following GLP as a limit test.

Purpose

The objective of this toxicity study was to provide information on the influence of the test item on the mobility of Daphnia magna and to serve as basis for classification and labeling purposes.

Study design

For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) over 48 hours, in an open static system. The daphnids were observed for immobilization 24 and 48 hours after placing in the aqueous test item solution. The study comprised of one test item group with four test vessels containing five daphnids each, i.e. 20 daphnids in total. Additionally, one control group (20 daphnids) was used.

Results

The test item concentration in the reconstituted water was not quantified at the start and the end of this study. Because of the low water solubility (9.74 µg/L), the compound cannot be detected with standard analytical methods and 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.

After exposure of daphnids to a nominal concentration of 100 mg/L for 48 hours, the following results were obtained:

Test item    nominal concentration (mg/L)	Number of daphnids     immobilized / exposed		% of daphnids immobilized
	24 hours	48 hours	24 hours	48 hours
0	0/20	0/20	0%	0%
100	0/20	0/20	0%	0%

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

EC₅₀ values:

The following EC₅₀ values for daphnids were determined:

24h EC₅₀: > 9.74 µg/L (nominal > 100 mg/L)

48h EC₅₀: > 9.74 µg/L (nominal > 100 mg/L)

Conclusions

Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system.

The 48h EC₅₀ was > 9.74 µg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.

Description of key information

Key, acute immobilisation, D. magna, limit test, OECD 202, GLP: EC₅₀ > 100 mg/L (nominal) after 48 h.

Additional information

Acute immobilisation, OECD 202

Purpose

The objective of this toxicity study was to provide information on the influence of the test item on the mobility of Daphnia magna and to serve as basis for classification and labeling purposes.

Study design

For this purpose, juvenile daphnids were exposed to a nominal test item concentration of 100 mg/L (limit test) over 48 hours, in an open static system. The daphnids were observed for immobilization 24 and 48 hours after placing in the aqueous test item solution. The study comprised of one test item group with four test vessels containing five daphnids each, i.e. 20 daphnids in total. Additionally, one control group (20 daphnids) was used.

Results

The test item concentration in the reconstituted water was not quantified at the start and the end of this study. Because of the low water solubility (9.74 µg/L), the compound cannot be detected with standard analytical methods and 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.

After exposure of daphnids to a nominal concentration of 100 mg/L for 48 hours, the following results were obtained:

Test item    nominal concentration (mg/L)	Number of daphnids     immobilized / exposed		% of daphnids immobilized
	24 hours	48 hours	24 hours	48 hours
0	0/20	0/20	0%	0%
100	0/20	0/20	0%	0%

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

EC₅₀ values:

The following EC₅₀ values for daphnids were determined:

24h EC₅₀: > 9.74 µg/L (nominal > 100 mg/L)

48h EC₅₀: > 9.74 µg/L (nominal > 100 mg/L)

Conclusions

Under the conditions of the present study, an aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system.

The 48h EC₅₀ was > 9.74 µg/L (nominal > 100 mg/L) and, thus, could not be determined in this study.