Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from July 22, 2013 to Sep 17, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

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
Principles of method if other than guideline:
SPAN 20 used as solubilizer
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-880-7
EC Name:
-
Cas Number:
182311-45-1
Molecular formula:
C31H40O5
IUPAC Name:
4-(6-acryloyloxyhexyloxy)benzoic acid (4-(trans-4-propylcyclohexyl)phenyl ester)
Test material form:
solid: bulk
Radiolabelling:
no

Sampling and analysis

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.

Test solutions

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)): 0.03 and 0.003 mg/l
Dose 1: Test item: 0.001 mg/L , Vehicle: 0.03 mg/L
Dose 2: Test item: 0.0001 mg/L , Vehicle: 0.003 mg/L
Vehicle Control: test item: - , Vehicle: 0.03 mg/L

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Common carp Cyprinus carpio (Lot No. 90325)
Supplier: Commercial Breeding Farm (Japan)
Dates purchased Jul 17, 2013
Feeding and acclimatization:
After receiving the fish at the Institute of Ecotoxicology Co.,
Ltd., those with a total length of approx. 8.0 ± 4.0 cm were
selected.
Mean bodyweight 3.07 ± 0.14 g
Mean total length 5.5 ± 0.2 cm
Mortality of fish during the experiment
High exposure level 0%
Low exposure level 0%
Control 0%

Lipid contents (by chloroform/methanol extraction method)
Before experiment 5.2% (Mean value, n=2)
After experiment 5.2 % (Mean value, n=2)

Study design

Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d

Test conditions

Test temperature:
26.5 ° +/- 0.5 °C
pH:
7.7 +/- 0.1
Dissolved oxygen:
DO oftest water: 7.3 ± 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 at nominal concentrations of 0.01 and 0.001 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 0.01 mg/L:
analytically measured concentrations:

day 7: 0.00837 mg/L
day 14: 0.00907 mg/L
day 21: 0.00832 mg/L
day 23: 0.00887 mg/L
day 28: 0.00912mg/L


nominal concentration 0.001 mg/L
analytically measured concentrations:

day 7: 0.000973 mg/L
day 14: 0.000905 mg/L
day 21: 0.000882 mg/L
day 23: 0.000912 mg/L
day 28: 0.000926 mg/L
Details on estimation of bioconcentration:
according to guideline

Results and discussion

Bioaccumulation factoropen allclose all
Conc. / dose:
0.01 mg/L
Temp.:
25 °C
pH:
7.7
Type:
BCF
Value:
4 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
7 d
Calculation basis:
steady state
Conc. / dose:
0.001 mg/L
Temp.:
25 °C
pH:
7.7
Type:
BCF
Value:
38 dimensionless
Basis:
not specified
Time of plateau:
7 d
Calculation basis:
steady state
Details on kinetic parameters:
Steady state was reached within 7 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

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 4 and 38 (mean 12).