Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Test phase 2005-11-01 to 2005-11-29. Report complete 2005-12-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Radiolabelling:
no

Test solutions

Vehicle:
yes
Details on preparation of test solutions, spiked fish food or sediment:
Test material was dissolved in ion exchanged water to give a 50 mg/l first concentration level starting solution. This starting solution for the first concentration level was also used to produce the second concentration level.

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Kitamura Carp Farming, 12-388 Gunchiku, Yashiro, Kumamoto
- Length at study initiation: 5.0 to 8.1 cm (av. 6.5cm)
- Feeding during test: Fed once a day with an amount corresponding to 1.2% of fish test weight.

ACCLIMATION
- Acclimation period: 2005-10-03 to 2005-11-01

Study design

Route of exposure:
aqueous
Test type:
semi-static
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d

Test conditions

Test temperature:
25 +/- 2 degree C
pH:
7.2 to 7.3
Dissolved oxygen:
At least 60% of saturated concentration (7.1 to 8.0 mg/l)
Details on test conditions:
TEST SYSTEM
- Test vessel: Water tank
- Material, size: Glass 100L tank
- Renewal rate of test solution (frequency/flow rate): 4.0 ml/min (first concentration level, control level) and 0.4 ml/min (second concentration level)
- No. of organisms per vessel: 36 fish for first concentration level and second concentration level, 24 fish for control level

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Ion-exchanged water
- Conductance: 12 mS/m
- Intervals of water quality measurement: Temperature and pH measured every 6 months.

OTHER TEST CONDITIONS
- Photoperiod: 16h light/day

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: Acute Toxicity Study Test concentrations 6.25, 12.5, 25.0, 50.0, 100 mg/l
- Results used to determine the conditions for the definitive study: 96h LC50 >100 mg/l

Results and discussion

Lipid contentopen allclose all
Lipid content:
3.1 %
Time point:
start of exposure
Remarks on result:
other: Average value of 6 fish
Lipid content:
2.8 %
Time point:
end of exposure
Remarks on result:
other: Average value of 6 fish
Bioaccumulation factoropen allclose all
Type:
BCF
Value:
< 1.9 dimensionless
Basis:
whole body d.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: first concentration level
Remarks:
Conc.in environment / dose:0.5 mg/l
Type:
BCF
Value:
< 19 dimensionless
Basis:
whole body d.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: second concentration level
Remarks:
Conc.in environment / dose:0.05mg/l
Details on results:
- Mortality of test organisms: none
- Behavioural abnormalities: none


Any other information on results incl. tables

Recovery from test water

Test water with the same concentration as the first concentration level and second concentration level was prepared using the water for testing

and a recovery test was carried out. The test water containing no test material was prepared, a blank test was carried out in the same manner

and it was found that there was no peak observed at the test material position on the chromatogram. The average of 2 points for the second

concentration level were defined as the recovery rate and used for correction when a test material concentration in test water was determined.

Recovery from fish body

A test material solution was added to a fish body homogenate and a recovery test was carried out. A fish body homogenate having no test

material added was subjected to a blank test by the same procedure and it was found that there was no peak observed at the test material on

the chromatogram. The average of two points was defined as the recovery rate and used for correction when a test material concentration in

the fish body was deteremined.

Results: Rate of Recovery

 Rate of recovery from water %  96% at concentration level 1 (0.5 mg/l), 91.7% at concentration level 2 (0.05 mg/l) (Mean = 94.2%)
 Rate of recovery from fish body  83.8% and 81.1% from spiked fish body (200 ug added) (Mean 82.5%)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The accumulation factor was less than the detection limit for all measurements throughout the study and it was considered that a steady state was achieved. The accumulation factor in the steady state was less than 1.9 times for the first concentration level and less than 19 times for the second concentration level.
Executive summary:

Introduction

This study was undertaken to assess the bioaccumulation potential of the test material to Carp in a Flow through Fish Test. The method used was designed to be compatible with the following Guidelines:

- Bioconcentration: Flow-Through Fish Test (June 14, 1996), OECD Guidelines for Testing of Chemicals 305.

- Accumulation Test of Chemical Substance in Body of Fish, On Test Methods Concerning New Chemical Substances, Pharmaceutical and Food Safety Bureau No. 1121002, 13/11/2003 Manufacturing Industries Bureau No. 2, Notification Number 031121002 of the Environmental Policy Bureau, 21/11/2003

Results & Conclusions

The accumulation factor was less than the detection limit for all measurements throughout the study and it was considered that a steady state was achieved. The accumulation factor in the steady state was less than 1.9 times for the first concentration level and less than 19 times for the second concentration level.