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:
2004-11-19 to 2005-01-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 305.
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)
Radiolabelling:
no
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 26, 28- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 26, 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: 0.1 mg/L , Vehicle: 0.5 mg/LDose 2: Test item: 0.01 mg/L , Vehicle: 0.05 mg/LControl: Test item: --, Vehicle: 0.5 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Lot No. 40726 from 2004-07-26Weight: 2.11 +/- 0.21 gLength: 5.7 +/- 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:
0
Hardness:
250 mg/L
Test temperature:
24.7 ° +/- 0.4 °C
pH:
7.2 +/- 0.1
Dissolved oxygen:
7.3 +/- 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, 26 and 28. The analytical values show that the nominal concentrations of 0.1 and 0.01 mg/L were maintained at about 100% using SPAN 20, respectively. At days 0, 7, 14, 21, 26 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.
Nominal and measured concentrations:
nominal concentration 0.1 mg/L: analytically measured concentrations: day 0: 0.0926 mg/Lday 7: 0.0913 mg/L day 14: 0.0995 mg/Lday 21: 0.0102 mg/Lday 26: 0.0876 mg/Lday 28: 0.0102 mg/Lnominal concentration 0.01 mg/Lanalytically measured concentrations:day 0: 0.00856 mg/Lday 7: 0.00967 mg/L day 14: 0.00955 mg/Lday 21: 0.00826 mg/Lday 26: 0.00817 mg/Lday 28: 0.00985 mg/L
Details on estimation of bioconcentration:
according to guideline
Type:
BCF
Value:
48 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
21 d
Calculation basis:
steady state
Remarks on result:
other: analytical concentration
Remarks:
Conc.in environment / dose:0.1 mg/L
Type:
BCF
Value:
213 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
21 d
Calculation basis:
steady state
Remarks on result:
other: analytical concentration
Remarks:
Conc.in environment / dose:0.01 mg/L
Details on kinetic parameters:
steady state was reached within 21 days
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 BCF values were at 48 and 213 (mean 101). The test material showed no relevant bioaccumulation (BCF < 2000).

Description of key information

BCFs from OECD TG 305 compliant GLP study: 48 and 213 (mean 101).
The test material showed no relevant bioaccumulation (BCF < 2000).

Key value for chemical safety assessment

BCF (aquatic species):
101 dimensionless

Additional information