Registration Dossier

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

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:
2006-08-21 to 2006-11-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: METI Guideline: Concentration Test on Chemical Substances in Fish
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:

Puritiy: > 99.0 %
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)): 12 mg/l

Dose 1: Test item: 0.2 mg/L ,
Dose 2: Test item: 0.02 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Cyprinus carpio
Lot: 060710c
Weight: 5.8 g
Length: 7.3 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 0.2 and 0.02 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 0.20 mg/L:
Solubilizer used: HCO-40, 12 mg/L

analytically measured concentrations:
day 4: 0.200 mg/L
day 7: 0.195 mg/L;
day 14: 0.196 mg/L
day 21: 0.198 mg/L
day 28: 0.201 mg/L


nominal concentration 0.02 mg/L
Solubilizer used: HCO-40, 12 g/L
analytically measured concentrations:
day 4: 0.0200 mg/L
day 7: 0.0199mg/L;
day 14: 0.0198 mg/L
day 21: 0.0200mg/L
day 28: 0.0200 mg/L

Reference substance (positive control):
no
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.2 mg/L
Type:
BCF
Value:
86 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: HCO-40 used as solubilizer @12 mg/L
Conc. / dose:
0.02 mg/L
Type:
BCF
Value:
69 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: HCO-40 used as solubilizer @12 mg/L
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
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 86 and 69 (mean 77). 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 86 and 69 (mean 77). 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 test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 86 and 69 (mean 77). The test material showed no relevant bioaccumulation (BCF < 2000).

Key value for chemical safety assessment

BCF (aquatic species):
77 dimensionless

Additional information