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Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-09-29 to 2010-12-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
EC Number:
283-130-2
EC Name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
Cas Number:
84540-37-4
Molecular formula:
C23H30
IUPAC Name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
Specific details on test material used for the study:

Puritiy: > 99.94 %
Radiolabelling:
no

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 4, 7, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 4, 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.

Test solutions

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)): 10 mg/l

Dose 1: Test item: 0.001 mg/L ,
Dose 2: Test item: 0.0001 mg/L

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Cyprinus carpio
Lot: 100215c
Weight: 7.5 g
Length: 8.5 cm

Study design

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

Test conditions

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, 4, 14, 21, and 28. The analytical values show that the nominal concentrations of 0.001 and 0.0001 mg/L were maintained during the experimental phase.
At days 0, 4, 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 0.0010 mg/L:
Solubilizer used: HCO-40, 10 mg/L

analytically measured concentrations:
day 4: 0.000918 mg/L
day 7: 0.000962 mg/L;
day 14: 0.000972 mg/L
day 21: 0.000970 mg/L
day 28: 0.000990 mg/L


nominal concentration 0.0001 mg/L
Solubilizer used: HCO-40, 10 g/L
analytically measured concentrations:
day 4: 0.000101 mg/L
day 7: 0.000102mg/L;
day 14: 0.000100 mg/L
day 21: 0.0000998mg/L
day 28: 0.0000988 mg/L

Reference substance (positive control):
no
Details on estimation of bioconcentration:
according to guideline

Results and discussion

Bioaccumulation factoropen allclose all
Conc. / dose:
0.001 mg/L
Type:
BCF
Value:
> 35 - < 60 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: HCO-40 used as solubilizer @10 mg/L
Conc. / dose:
0 mg/L
Type:
BCF
Value:
> 26 - < 51 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: HCO-40 used as solubilizer @10 mg/L
Depuration
Remarks on result:
other: mot performed due to low potential for bioaccumulation
Details on kinetic parameters:
steady state was reached within 14 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

Applicant's summary and conclusion

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 45.8 and 36.4 (mean 41). The test material showed no relevant bioaccumulation (BCF < 2000).
Executive summary:

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.

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 45.8 and 36.4 (mean 41). The test material showed no relevant bioaccumulation (BCF < 2000).

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