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Diss Factsheets

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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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 2015-12-21 to 2016-02-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
HCO-40 used as solubilizer
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch:EF14003651
Purity: 99.99%
Radiolabelling:
no
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 4, 7, 11, 14, 18, 21, 25, 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.
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)): 0.0015 and 0.00015 mg/l
Dose 1: Test item: 0.00148 mg/L , Vehicle: 15 mg/L
Dose 2: Test item: 0.000148 mg/L , Vehicle: 1.5 mg/L
Vehicle Control: test item: - , Vehicle: 15 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 8.5 g
Length: 9.0 cm
Lot: 150608c
Date: 2015-08-06
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d
Test temperature:
23 - 24.2 °C
pH:
7.3-7.9
Dissolved oxygen:
6.1 - 7.5 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, 4, 7, 11, 14, 18, 21, 25 and 28. The analytical values show that the nominal concentrations of 0.0015 and 0.00015 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 with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.
Nominal and measured concentrations:
nominal concentration 0.0015 mg/L:
analytically measured concentrations:

day 4: 0.00130 mg/L;
day 7: 0.00142 mg/L;
day 11: 0.00141 mg/L;
day 14: 0.00153 mg/L;
day 18: 0.00128 mg/L;
day 21: 0.00148 mg/L;
day 25: 0.00132 mg/L;
day 28: 0.00141 mg/L;


nominal concentration 0.00015 mg/L:
analytically measured concentrations:

day 4: 0.000134 mg/L;
day 7: 0.000150 mg/L;
day 11: 0.000142 mg/L;
day 14: 0.000150 mg/L;
day 18: 0.000128 mg/L;
day 21: 0.000146 mg/L;
day 25: 0.000139 mg/L;
day 28: 0.000156 mg/L;
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.002 mg/L
Temp.:
24 °C
pH:
7.7
Type:
BCF
Value:
38 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
14 d
Calculation basis:
steady state
Conc. / dose:
0 mg/L
Temp.:
24 °C
pH:
7.7
Type:
BCF
Value:
81 dimensionless
Basis:
not specified
Time of plateau:
14 d
Calculation basis:
steady state
Details on kinetic parameters:
Steady state was reached within 14 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 38 and 81 (mean 55).
Executive summary:

Purpose


The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions.


 


Study Design


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. Two environmental concentrations of the test material of 0.0015 and 0.00015 mg/L were used in this study. HCO-40 was used as vehicle. The exposure was maintained during the couse of the study at about 100% of the nominal concentrations. The concentrations have been verified analytically using a HPLC method with UV detection.


 


Results


No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 38 and 81 (mean: 55). Due to the low bioaccumulation potential, no depuration phase was required.


 


Conclusion


The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 38 and 81 (mean 55).

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 test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 38 and 81 (mean 55).

Key value for chemical safety assessment

BCF (aquatic species):
55 dimensionless

Additional information