4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl

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:

2008-12-10 to 2009-03-18

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, 5, 7, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 5, 7, 14, 21, 28,
- Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. Further analysis performed by HPLC method with UV detection.

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): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 1.0 mg/L


Dose 1: Test item: 0.0015 mg/L,
Dose 2: Test item: 0.00015 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Cyprinus carpio
Lot: 081007c
Weight: 6.6 g
Length: 8.3 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:

0 d

Hardness:

250 mg/L

Test temperature:

25.0 +/- 0.4 °C

pH:

7.0

Dissolved oxygen:

saturated

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, 5, 14, 21, and 28. The analytical values show that the nominal concentrations of 0.0015 and 0.00015 mg/L were maintained during the experimental phase.
At days 0, 5, 14, 21, 25 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 and the extract was analysed.

Due to the low bioaccumulation potential, no depuration phase was required.

Nominal and measured concentrations:

nominal concentration 0.0015 mg/L:
Solubilizer used: HCO-40, 1.0 mg/L

analytically measured concentrations:
day 4: 0.00146 mg/L
day 7: 0.00154 mg/L;
day 14: 0.00151 mg/L
day 21: 0.00148 mg/L
day 28: 0.00150 mg/L
day 35: 0.00151 mg/L

nominal concentration 0.00015 mg/L
Solubilizer used: HCO-40, 1 mg/L
analytically measured concentrations:
day 4: 0.000150 mg/L
day 7: 0.000152 mg/L;
day 14: 0.000144 mg/L
day 21: 0.000150 mg/L
day 28: 0.000148 mg/L
day 35: 0.000147 mg/L

Reference substance (positive control):

no

Details on estimation of bioconcentration:

according to guideline

Key result

Conc. / dose:

0.002 mg/L

Type:

BCF

Value:

127 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

21 d

Calculation basis:

steady state

Remarks on result:

other: HCO-40 used as solubilizer @1 mg/L

Key result

Conc. / dose:

0 mg/L

Type:

BCF

Value:

109 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

21 d

Calculation basis:

steady state

Remarks on result:

other: HCO-40 used as solubilizer @1 mg/L

Remarks on result:

other: not performed due to low potential for bioaccumulation

Details on kinetic parameters:

steady state was reached within 21 days
Due to the low uptake, no depuration phase was necessary

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 test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 127 and 109 (mean 118). 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 0.0015 and 0.00015 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 1.0 mg/L. The exposure was maintained during the course of the study. The concentrations have been verified analytically using HPLC/UV.

 

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 127 and 109. 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 127 and 109 (mean 118). The test material showed no relevant bioaccumulation (BCF < 2000).

Description of key information

The informtion 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 305. The mean BCF of 118 was obtained. The test material showed no relevant bioaccumulation (BCF < 2000).

Key value for chemical safety assessment

BCF (aquatic species):

118 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 0.0015 and 0.00015 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 1.0 mg/L. The exposure was maintained during the course of the study. The concentrations have been verified analytically using HPLC/UV.

 

Results

No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 127 and 109. 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 127 and 109 (mean 118). The test material showed no relevant bioaccumulation (BCF < 2000).