Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from J-CHECK, EnviChem and BCF authoritative database
Qualifier:
according to guideline
Guideline:
other: "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances"
Principles of method if other than guideline:
Bioaccumulation study was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively.
GLP compliance:
not specified
Radiolabelling:
not specified
Vehicle:
not specified
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Length at study initiation (lenght definition, mean, range and SD): 8
- Sex: MF
Route of exposure:
aqueous
Test type:
flow-through
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
6 wk
Test temperature:
25°C
pH:
6.0-8.5
Details on test conditions:
RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: TLm (48hr) 160 mg/l (160 ppm) (w/v), Rice fish (Oryzias latipes)
Nominal and measured concentrations:
Nominal concentrations:
1st concentration area: 0.5 mg/l (0.5 ppm) (w/v)
2nd concentration area: 0.05 mg/l (0.05 ppm) (w/v)
Reference substance (positive control):
not specified
Conc. / dose:
0.5 mg/L
Type:
BCF
Value:
> 0.7 - < 3.5 L/kg
Basis:
whole body w.w.
Time of plateau:
6 wk
Remarks on result:
other: Other details not known
Conc. / dose:
0.05 mg/L
Type:
BCF
Value:
<= 2.6 L/kg
Basis:
whole body w.w.
Time of plateau:
6 wk
Remarks on result:
other: Other details not known

Bioaccumulation test results:

 

 

2 W

3 W

4 W

6 W

1st Concentration area

 

Test substance concentration (ppm (w/v)

0.37

0.38

0.40

0.43

Bioconcentration factor (L/kg)  

3.5

2.7

2.4

2.1

0.7

1.9

1.9

1.5

2nd Concentration area

 

Test substance concentration (ppm (w/v)

0.045

0.047

0.048

0.050

Bioconcentration factor (L/kg)  

≤ 2.6

≤ 2.6

≤ 2.6

≤ 2.6

≤ 2.6

≤ 2.6

≤ 2.6

≤ 2.6

 

Validity criteria fulfilled:
not specified
Conclusions:
The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.7-3.5 L/Kg at a conc. of 0.5 mg/l and ≤ 2.6 L/Kg at a conc. of 0.05 mg/l, respectively.
Executive summary:

Bioaccumulation study was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to other guideline"Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively. Cyprinus carpio(length - 8 dimensionless)was used as a test organism for the study.Test chemical nominal conc. used for the study were 0.5mg/l and 0.05 mg/l, respectively. Range finding study involve the TLm (48 hr) 160 mg/l (w/v) on Rice fish (Oryzias latipes). The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.7-3.5 L/Kg at a conc. of 0.5 mg/l and ≤ 2.6 L/Kg at a conc. of 0.05 mg/l, respectively, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Description of key information

Bioaccumulation study was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical (authoritative database, 2018). The study was performed according to other guideline"Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively. Cyprinus carpio(length - 8 dimensionless)was used as a test organism for the study.Test chemical nominal conc. used for the study were 0.5mg/l and 0.05 mg/l, respectively. Range finding study involve the TLm (48 hr) 160 mg/l (w/v) on Rice fish (Oryzias latipes). The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.7-3.5 L/Kg at a conc. of 0.5 mg/l and ≤ 2.6 L/Kg at a conc. of 0.05 mg/l, respectively, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Key value for chemical safety assessment

BCF (aquatic species):
3.5 L/kg ww

Additional information

Experimental key study and various predicted data of the test chemical were reviewed for the bioaccumulation end point which are summarized as below:

 

In an experimental key study from authoritative databases (2018),bioaccumulation experiment was conducted on test organism Cyprinus carpio for 6 weeks for evaluating the bioconcentration factor (BCF value) of test chemical. The study was performed according to other guideline "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances", respectively under flow through conditions at a temperature of25°C and pH range 6.0-8.5, respectively. Cyprinus carpio (length - 8 dimensionless)was used as a test organism for the study. Test chemical nominal conc. used for the study were 0.5mg/l and 0.05 mg/l, respectively. Range finding study involve the TLm (48 hr) 160 mg/l (w/v) on Rice fish (Oryzias latipes). The bioconcentration factor (BCF value) of test chemical on Cyprinus carpio was determined to be in the range of 0.7-3.5 L/Kg at a conc. of 0.5 mg/l and ≤ 2.6 L/Kg at a conc. of 0.05 mg/l, respectively.

 

In a prediction done using the BCFBAF Program of Estimation Programs Interface was used to predict the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 5.785 L/kg whole body w.w (at 25 deg C).

 

Another predicted data was estimated using Bio-concentration Factor module (ACD (Advanced Chemistry Development)/I-Lab predictive module, 2017)) for predicting the bioconcentration factor (BCF) of test chemical.The bio-concentration Factor of the test chemical was estimated to be 1 dimensionless at pH range 1-14, respectively.

 

On the basis of above results for test chemical, it can be concluded that the BCF value of test chemical was evaluated to beranges from0.7 to 5.785, respectively,which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Categories Display