Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2011-02-24 to 2011-02-24
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
GLP compliance:
yes (incl. QA statement)
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):
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 was done according to guideline.
- Chemical name of vehicle: Tween 80
- Concentration of vehicle in test medium
Test solution 1: 0.003 mg/L test material, 0.012 mg/L Tween 80
Test solution 2: 0.0003 mg/L test material, 0.0012 mg/L Tween 80
Control: 0.012 mg/L Tween 80
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 2.88 +/- 0.26 g
Length: 6.7 +/- 0.2 cm
Lot: 110112
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
Test temperature:
24.8 +/- 0.2 °C
pH:
7.8 +/- 0.1
Dissolved oxygen:
7.8 +/- 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, 26, and 28. The analytical values show that the nominal concentrations were maintained at about 100 % using Tween 80, 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 with acetonitrile and n-hexane. The extract was analysed with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.
Nominal and measured concentrations:
nominal concentration
0.003 mg/L:
analytically measured concentrations:
day 7: 0.00244 mg/L;
day 14: 0.00259 mg/L
day 21: 0.00249 mg/L
day 26: 0.00251 mg/L
day 28: 0.00250 mg/L


nominal concentration
0.0003 mg/L:
analytically measured concentrations:
day 7: 0.000259 mg/L;
day 14: 0.000297 mg/L
day 21: 0.000262 mg/L
day 26: 0.000261 mg/L
day 28: 0.000259 mg/L
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.003 mg/L
Temp.:
24.8 °C
pH:
7.7
Type:
BCF
Value:
206 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
21 d
Calculation basis:
steady state
Remarks on result:
other: with Tween 80
Conc. / dose:
0 mg/L
Temp.:
24.8 °C
pH:
7.7
Type:
BCF
Value:
218 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
21 d
Calculation basis:
steady state
Remarks on result:
other: with Tween 80
Elimination:
not specified
Remarks on result:
not measured/tested
Details on kinetic parameters:
steady state was reached within 21 days Due to the low uptake, no depuration phase was considerd 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 mean steady state BCF value was 213.
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 0.003 and 0.0003 mg/L were used in this study. Tween 80 was used as vehicle at concentrations of 0.012 and 0.0012 mg/L. 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 206 and 221. 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 mean steady state BCF value was 213.

Description of key information

The informtion for this endpoint study record was obtained from an experimental study.


The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 305.


The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The mean steady state BCF values was 213.

Key value for chemical safety assessment

BCF (aquatic species):
213 dimensionless

Additional information

 


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 0.003 and 0.0003 mg/L were used in this study. Tween 80 was used as vehicle at concentrations of 0.012 and 0.0012 mg/L. 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 206 and 221. 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 mean steady state BCF value was 213.