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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2007-12-19 to 2008-03-19
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
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:
Name: 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl
Puritiy: 99.8 %
Radiolabelling:
no
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 5, 7, 14, 21, 28, 35
- Sampling intervals/frequency for test medium samples: days 0, 5, 7, 14, 21, 28, 35
- Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. Further analysis performed by HPLC method with UV detection.
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): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 1.0 mg/l

Dose 1: Test item: 0.0025 mg/L ,
Dose 2: Test item: 0.00025 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Cyprinus carpio
Lot: 071022c
Weight: 6.8 g
Length: 8.2 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 d
Hardness:
250 mg/L
Test temperature:
25.0 ° +/- 0.4 °C
pH:
7.0
Dissolved oxygen:
7.0 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, 5, 14, 21, and 28. The analytical values show that the nominal concentrations of 0.0025 and 0.000252 mg/L were maintained during the experimental phase.
At days 0, 5, 14, 21, 25 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 and the extract was analysed.

Due to the low bioaccumulation potential, no depuration phase was required.
Nominal and measured concentrations:
nominal concentration 0.0025 mg/L:
Solubilizer used: HCO-40, 1.0 mg/L

analytically measured concentrations:
day 4: 0.00249 mg/L
day 7: 0.00246mg/L;
day 14: 0.00244 mg/L
day 21: 0.00249mg/L
day 28: 0.00241 mg/L
day 35: 0.00248 mg/L

nominal concentration 0.00025 mg/L
Solubilizer used: HCO-40, 1 g/L
analytically measured concentrations:
day 4: 0.000255 mg/L
day 7: 0.000247mg/L;
day 14: 0.000247 mg/L
day 21: 0.000252mg/L
day 28: 0.000247 mg/L
day 35: 0.000245 mg/L
Reference substance (positive control):
yes
Remarks:
Anilin
Details on estimation of bioconcentration:
according to guideline
Conc. / dose:
0.003 mg/L
Type:
BCF
Value:
287 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:0.0025 mg/L
Conc. / dose:
0 mg/L
Type:
BCF
Value:
268 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:0,00025 mg/L
Remarks on result:
other: mot performed due to low potential for bioaccumulation
Details on kinetic parameters:
steady state was reached within 21 days
Due to the low uptake, no depuration phase was 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 steady state BCF values were at 287 and 268 (mean 277). The test material showed no relevant bioaccumulation (BCF < 2000).
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 0.0025 and 0.00025 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 1.0 mg/L. The exposure was maintained during the couse of the study. The concentrations have been verified analytically using HPLC/UV.


 


Results


No signs of toxicity were observed throughout the study. The analysis reveals steady state BCFs of 287 and 268. 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 287 and 268 (mean 277). The test material showed no relevant bioaccumulation (BCF < 2000).

Description of key information

The test material showed no relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 287 and 268 (mean 277). The test material showed no relevant bioaccumulation (BCF < 2000).

Key value for chemical safety assessment

BCF (aquatic species):
277 dimensionless

Additional information