1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-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:

from 2009-08-13 to 2009-10-06

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

Principles of method if other than guideline:

Tween 80 used as solubilizer

GLP compliance:

yes (incl. QA statement)

Radiolabelling:

no

Details on sampling:

- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 23, 28
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 23, 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 (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.0225 and 0.00225 mg/L
Dose 1: Test item: 0.0075 mg/L , Vehicle: 0.0225 mg/L
Dose 2: Test item: 0.00075 mg/L , Vehicle: 0.00225 mg/L
Vehicle Control: test item: - , Vehicle: 0.0225 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 3.88 +/- 0.33 g
Length: 7.40 +/- 0.20 cm
Lot: 90325
Date: 2009-03-25

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

28 d

Test temperature:

25 +/- 2 °C

pH:

7.7 +/- 0.0

Dissolved oxygen:

7.4 +/- 0.1 mg/L

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, 23 and 28. The analytical values show that the nominal concentrations of 0.0075 and 0.00075 mg/L were maintained at about 100 % using solubiliser, respectively. At days 0, 7, 14, 21, 23 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted using organic solvents. The extract was analysed with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.

Nominal and measured concentrations:

nominal concentration 0.0075 mg/L:
analytically measured concentrations:
day 7: 0.00691 mg/L
day 14: 0.00701 mg/L
day 21: 0.00686 mg/L
day 23: 0.00690 mg/L
day 28: 0.00711 mg/L

nominal concentration 0.00075 mg/L
analytically measured concentrations:
day 7: 0.000690 mg/L
day 14: 0.000709 mg/L
day 21: 0.000694 mg/L
day 23: 0.000713 mg/L
day 28: 0.000742 mg/L

Details on estimation of bioconcentration:

according to guideline

Key result

Conc. / dose:

0.007 mg/L

Temp.:

25 °C

pH:

7.7

Type:

BCF

Value:

89 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

21 d

Calculation basis:

steady state

Key result

Conc. / dose:

0.001 mg/L

Temp.:

25 °C

pH:

7.7

Type:

BCF

Value:

99 dimensionless

Basis:

not specified

Time of plateau:

21 d

Calculation basis:

steady state

Details on kinetic parameters:

Steady state was reached within 21 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 89 and 99 (mean 94).

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 0.0075 and 0.00075 mg/L were used in this study. TWEEN 80 was used as vehicle at concentrations of 0.0225 and 0.00225 mg/L. The exposure was maintained during the course 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 89 and 99 (mean: 94). 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 89 and 99 (mean 94).

Description of key information

Aquatic bioaccumulation of ECHA 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. The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 89 and 99 (mean 94).

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):

94 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 0.0075 and 0.00075 mg/L were used in this study. TWEEN 80 was used as vehicle at concentrations of 0.0225 and 0.00225 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 89 and 99 (mean: 94). 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 89 and 99 (mean 94).