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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2010-10-24 to 2010-12-22
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)
Specific details on test material used for the study:
Batch: D010022789
Purity: >99.9%
Radiolabelling:
no
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 26, 28, and 30
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 26, 28, and 30
- 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:
According to guideline
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):
Test solution 1: 0.0005 mg/L test material, 0.0015 mg/L Tween 80
Test solution 2: 0.00005 mg/L test material, 0.00015 mg/L Tween 80
Control: 0.0015 mg/L Tween 80
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 3.08 +/- 0.30 g
Length: 6.6 +/- 0.3 cm
Lot: 100823
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
30 d
Total depuration duration:
0 d
Test temperature:
24.3 ° +/- 0.2 °C
pH:
7.8 +/- 0.2
Dissolved oxygen:
7.7 mg/L +/- 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, 28 and 30. The analytical values show that the nominal concentrations were maintained at about 100% using Tween 80, respectively. At days 0, 7, 14, 21, 26, 28, and 30 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
0.0005 mg/L:
analytically measured concentrations:
day 7: 0.000463 mg/L;
day 14: 0.000515 mg/L
day 21: 0.000508 mg/L
day 26: 0.000447 mg/L
day 28: 0.000453 mg/L
day 30: 0.000480 mg/L

nominal concentration
0.00005 mg/L:
analytically measured concentrations:
day 7: 0.0000497 mg/L;
day 14: 0.0000521 mg/L
day 21: 0.0000523 mg/L
day 26: 0.0000463 mg/L
day 28: 0.0000436 mg/L
day 30: 0.0000423 mg/L
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.001 mg/L
Temp.:
24 °C
pH:
7.7
Type:
BCF
Value:
661 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:0.0005 mg/L
Conc. / dose:
0 mg/L
Temp.:
24 °C
pH:
7.7
Type:
BCF
Value:
789 dimensionless
Basis:
normalised lipid fraction
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: analytical concentration
Remarks:
Conc.in environment / dose:0.00005 mg/L
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 test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 661 and 789 (mean 722).

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 steady state BCF values were at 661 and 789 (mean 722).

Key value for chemical safety assessment

BCF (aquatic species):
722 dimensionless

Additional information