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:
from 2005-02-07 to 2005-04-20
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
Principles of method if other than guideline:
HCO-40 was used as solubilizer
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Batch:S000033
Purity: 99.5% (GC)
Radiolabelling:
no
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
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
Water: Extraction with CH2Cl2 with further GC analysis.
Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. The analysis was performed using HPLC.
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): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.5 and 0.05 mg/l
Dose 1: Test item: 0.50 mg/L , Vehicle: 500 mg/L
Dose 2: Test item: 0.05 mg/L , Vehicle: 50 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 7.1 g
Length: 8.4 cm
Lot: 050113c
Date: 2005-02-24
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d
Test temperature:
25 ° +/- 2 °C
pH:
7.4 - 7.5
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, and 28. The analytical values show that the nominal concentrations of 0.5 and 0.05 mg/L were maintained at about 100% using solubiliser, respectively. At days 0, 7, 14, 21 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. Due to the low bioaccumulation potential, no depuration phase was required.
Nominal and measured concentrations:
nominal concentration 0.5 mg/L:
analytically measured concentrations:

day 4: 0.500 mg/L;
day 7: 0.497 mg/L;
day 14: 0.491 mg/L
day 21: 0.505 mg/L
day 28: 0.510 mg/L

nominal concentration 0.05 mg/L
analytically measured concentrations:

day 4: 0.0490 mg/L;
day 7: 0.0483 mg/L
day 14: 0.0487 mg/L
day 21: 0.0488 mg/L
day 28: 0.0472 mg/L
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.5 mg/L
Temp.:
25 °C
pH:
7.5
Type:
BCF
Value:
7 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
4 d
Calculation basis:
steady state
Conc. / dose:
0.05 mg/L
Temp.:
25 °C
pH:
7.5
Type:
BCF
Value:
19 dimensionless
Basis:
not specified
Time of plateau:
4 d
Calculation basis:
steady state
Details on kinetic parameters:
Steady state was reached within 4 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
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 7 and 19 (mean 12).

Description of key information

Aquatic bioaccumulation of ECHA Substance was investigated in a flow-through system set up according to OECD guideline 305. The study was performed using solubilizer to achive maximum exposure. The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 7 and 19 (mean 12). Therefore it can be considered that the substance does not bioaccumulate in organisms after 28 days exposure via the aqueous phase.

Key value for chemical safety assessment

BCF (aquatic species):
12 dimensionless

Additional information