1-Ethoxy-2,3-difluoro-4-(trans-4-propylcyclohexyl)-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:

Jun 30 - Aug 16, 2004

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, 23, 25, 28
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 23, 25, 28
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods): LC analysis.
Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. The analysis was performed using LC.

Vehicle:

yes

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

According to guideline

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 20
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):
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
Control: Test item: --, Vehicle: 0.2 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Lot No. 40626 from 2004-05-26
Weight: 0.8 +/- 0.09 g
Length: 4.6 +/- 0.20 cm

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

28 d

Total depuration duration:

> 42 d

Test temperature:

25.6 +/- 0.4 °C

pH:

7.2 +/- 0.1

Dissolved oxygen:

7.1 +/- 0.4 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, 25 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, 23, 25 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted The extract was analysed with LC.A depuration was followed from day 28 up to day 42.

Nominal and measured concentrations:

nominal concentration 0.02 mg/L:
analytically measured concentrations: day 0: 0.0193 mg/L, day 7: 0.0172 mg/L. day 14: 0.0180 mg/L. day 21: 0.0199 mg/L. day 23: 0.0203 mg/L. day 25: 0.0205 mg/L. day 28: 0.0164 mg/L. nominal concentration 0.002 mg/L
analytically measured concentrations: day 0: 0.00197 mg/L. day 7: 0.00199 mg/L. day 14: 0.00180 mg/L. day 21: 0.00199 mg/L. day 23: 0.00200 mg/L. day 25: 0.00198 mg/L. day 28: 0.00188 mg/L

Details on estimation of bioconcentration:

according to guideline

Key result

Conc. / dose:

0.02 mg/L

Type:

BCF

Value:

1 162 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

14 d

Calculation basis:

steady state

Conc. / dose:

0.002 mg/L

Type:

BCF

Value:

1 221 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

7 d

Calculation basis:

steady state

Details on kinetic parameters:

steady state was reached within 7 days
Depuration phase dropped below 100 at day 42

Metabolites:

none

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 steady state BCF values were at 1162 and 1221 (mean 1191). The test material showed no relevant bioaccumulation at concentrations at or above the water solubility (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 course of the study at about 100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 1162 and 1221 (mean 1191). After depuration the BCFs dropped to values below 100 after day 42.

Conclusion

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 1162 and 1221 (mean 1191).

Description of key information

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 1162 and 1221 (mean 1191).

Key value for chemical safety assessment

BCF (aquatic species):

1 190 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 course of the study at about 100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 1162 and 1221 (mean 1191). After depuration the BCFs dropped to values below 100 after day 42.

Conclusion

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 1162 and 1221 (mean 1191).