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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Equivalent to a guideline study. Test procedure in accordance with generally accepted scientific standards and described in sufficient detail, apart from the temperature and some pages missing from the report as presently available.
Principles of method if other than guideline:
Method: other
GLP compliance:
no
Radiolabelling:
yes
Vehicle:
no
Details on preparation of test solutions, spiked fish food or sediment:
Test Medium: Water drawn from a 125 m bedrock well

STOCK AND TEST SOLUTION AND THEIR PREPARATION:  Stock solutions were prepared by diluting known amounts of labelled and unlabelled test substance with distilled water. Diluter stock solutions were prepared by further dilution with distilled water. Test solutions were prepared using an intermittent-flow proprtional diluter.

TEST CONCENTRATIONS: 0.06 and 0.6 mg/l nominal (0.058 ± 0.01; 0.55 ± 0.16 mg/l measured)
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISMS: Size: 19 ± 2 cm Weight: 39 ± 3 g Pretreatment: acclimated for 30 days before testing. Cumulative mortality less than 2% during holding period Feeding: Dry pelleted ration twice daily ad libitum
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water
Remarks:
well water
Total exposure / uptake duration:
49 d
Total depuration duration:
14 d
Hardness:
Hardness: 35 mg/l as CaCO3
Test temperature:
18 °C
pH:
pH: 7.1
Dissolved oxygen:
Dissolved Oxygen Concentration: > 6.0 mg/l (60% saturation)
Details on estimation of bioconcentration:
ENDPOINTS: Bioaccumulation, elimination rate over a 14 day depuration period, and distribution between edible and non-edible tissues.
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
71 dimensionless
Basis:
non-edible fraction
Conc. / dose:
0.06 mg/L
Type:
BCF
Value:
< 7 dimensionless
Basis:
whole body d.w.
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
31 dimensionless
Basis:
non-edible fraction
Conc. / dose:
0.6 mg/L
Type:
BCF
Value:
< 2 dimensionless
Basis:
whole body d.w.
Elimination:
yes
Parameter:
other: After 14 days depuration, carp that had been exposed to 0.058 and 0.55 mg/l test substance had eliminated all measurable 14-C residues.
Depuration time (DT):
14 d
Details on results:
BIOACCUMULATION AT 0.06 mg/l NOMINAL TEST CONCENTRATION: A mean fish concentration of 4.1 mg/kg, equivalent to BCF = 71,  was determined for non-edible tissues, although no meaningful trends in bioaccumulation were observed at 7 sampling points over the exposure period. 

Analysis of the gut, faeces and visceral tissues at Day 42 showed that 94% of residues were present in faecal matter, 1% in the gut and 5% in the remaining visceral tissues, indicating that the substance was ingested and eliminated with very little accumulation.  

Expressed on a whole-body basis, the mean fish concentration was < 0.41 mg/kg, equivalent to BCF < 7.

BIOACCUMULATION AT 0.6 mg/l NOMINAL TEST CONCENTRATION: A similar pattern to the lower test concentration was observed. 
The mean fish concentration determined for non-edible tissues, equivalent to BCF = 31.  Analysis on Day 42 showed 83% in faecal matter, 2% in the gut and 15% in the remaining visceral tissues.  

Expressed on a whole-body basis, the mean fish concentration was < 1.0 mg/kg, equivalent to BCF < 2.

Measured values close to limits of detection, especially for whole body.
Conclusions:
The test substance did not bioaccumulate in the edible tissues of carp. Some accumulation of the test substance was
observed in the visceral tissues, although analysis revealed that most of this was associated with ingesta and faecal
material, indicating that the the substance was ingested and eliminated with very little accumulation.

Description of key information

BIOACCUMULATION AT 0.06 mg/l NOMINAL TEST CONCENTRATION: A mean fish concentration of 4.1 mg/kg, equivalent to BCF = 71,  was determined for non-edible tissues, although no meaningful trends in bioaccumulation were observed at 7 sampling points over the exposure period. 

Analysis of the gut, faeces and visceral tissues at Day 42 showed that 94% of residues were present in faecal matter, 1% in the gut and 5% in the remaining visceral tissues, indicating that the substance was ingested and eliminated with very little accumulation.  

Expressed on a whole-body basis, the mean fish concentration was < 0.41 mg/kg, equivalent to BCF < 7.  

BIOACCUMULATION AT 0.6 mg/l NOMINAL TEST CONCENTRATION: A similar pattern to the lower test concentration was observed. 

The mean fish concentration determined for non-edible tissues, equivalent to BCF = 31.  Analysis on Day 42 showed 83% in faecal matter, 2% in the gut and 15% in the remaining visceral tissues.  

Expressed on a whole-body basis, the mean fish concentration was < 1.0 mg/kg, equivalent to BCF < 2.

Key value for chemical safety assessment

Additional information