1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-04-28 to 2004-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: METI Guideline: Concentration Test on Chemical Substances in Fish

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

no

Details on sampling:

- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 26, 28
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 26, 28
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
Water: Extraction with CH2Cl2 with further HPLC analysis.
Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. The analysis was performed using HPLC.

Vehicle:

yes

Details on preparation of test solutions, spiked fish food or sediment:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 20 (Sorbitan Monolaureate) used as solubilizer
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.2 and 0.02 mg/L
Dose 1: Test item: 0.02 mg/L , Vehicle: 0.2 mg/L
Dose 2: Test item: 0.002 mg/L , Vehicle: 0.02 mg/L
Vehicle Control: test item: - , Vehicle: 0.2 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 1.83 +/- 0.22 g
Length: 5.50 +/- 0.20 cm
Lot: 40311

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

28 d

Test temperature:

24.7 +/- 0.2 °C

pH:

6.5 +/- 0.2

Salinity:

According to guideline

Details on test conditions:

After acclimatisation period, the fish (Cyprinus carpio) were transferred into the test media under flow through conditions. Exposure concentrations were analytically verified at days 0, 7, 14, 21, 26 and 28. The analytical values show that the nominal concentrations of 0.02 and 0.002 mg/L were maintained at about 100 % using SPAN 20, respectively. At days 0, 7, 14, 21, 26 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted with acetonitrile and n-hexane. The extract was analysed with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.

Nominal and measured concentrations:

nominal concentration 0.02 mg/L:
analytically measured concentrations:
day 0: 0.0207 mg/L;
day 7: 0.0206 mg/L;
day 14: 0.0208 mg/L
day 21: 0.0217 mg/L
day 26: 0.0196 mg/L
day 28: 0.0208 mg/L

nominal concentration 0.002 mg/L
analytically measured concentrations:
day 0: 0.00192 mg/L
day 7: 0.00195 mg/L
day 14: 0.00191 mg/L
day 21: 0.00203 mg/L
day 26: 0.00200 mg/L
day 28: 0.00202 mg/L

Reference substance (positive control):

no

Details on estimation of bioconcentration:

according to guideline

Key result

Conc. / dose:

0.02 mg/L

Temp.:

24.7 °C

pH:

6.5

Type:

BCF

Value:

187 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

21 d

Calculation basis:

steady state

Key result

Conc. / dose:

0.002 mg/L

Temp.:

24.7 °C

pH:

6.5

Type:

BCF

Value:

214 dimensionless

Basis:

not specified

Time of plateau:

21 d

Calculation basis:

steady state

Details on kinetic parameters:

Steady state was reached within 28 days
Due to the low uptake, no depuration phase was necessary

Details on results:

- Mortality of test organisms: no effects
- Behavioural abnormalities: no effects
- Observations on body length and weight: no effects
- Other biological observations: no effects
- Bound residues forming a plateau: no
- Mortality and/or behavioural abnormalities of control: no
- Loss of test substance during test period: no
- Results with vehicle control: no effects

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 187 and 214 (mean 200). The test material showed no relevant bioaccumulation (BCF < 2000).

Executive summary:

Purpose

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions.

 

Study Design

The study was performed according to the OECD Guideline for Testing of Chemicals 305 (Bioconcentration: Flow-through Fish Test) adopted on June 14, 1996 using two test material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.02 and 0.002 mg/L were used in this study. SPAN 20 was used as vehicle at concentrations of 0.2 and 0.02 mg/L. The exposure was maintained during the couse of the study at about 100% of the nominal concentrations. The concentrations have been verified analytically using a HPLC method with UV detection.

 

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 187 and 214 (mean: 200). Due to the low bioaccumulation potential, no depuration phase was required.

 

Conclusion

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 187 and 214 (mean 200).

Description of key information

Aquatic bioaccumulation of the test substance was investigated in a flow-through system set up according to OECD guideline 305. The study was performed using solubilizer to achive maximum exposure. A BCF of 187 at a concentration of 20 μg/L was detected whereas at a concentration of 2 μg/L the BCF was 214 giving a mean steady state BCF of 200. Therefore, it can be considered that the substance does not bioaccumulate in organisms after 28 days exposure via the aqueous phase.

Key value for chemical safety assessment

BCF (aquatic species):

200 dimensionless

Additional information

Purpose

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions.

 

Study Design

The study was performed according to the OECD Guideline for Testing of Chemicals 305 (Bioconcentration: Flow-through Fish Test) adopted on June 14, 1996 using two test material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.02 and 0.002 mg/L were used in this study. SPAN 20 was used as vehicle at concentrations of 0.2 and 0.02 mg/L. The exposure was maintained during the couse of the study at about 100% of the nominal concentrations. The concentrations have been verified analytically using a HPLC method with UV detection.

 

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 187 and 214 (mean: 200). Due to the low bioaccumulation potential, no depuration phase was required.

 

Conclusion

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 187 and 214 (mean 200).