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Diss Factsheets

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 13th January 2006 to 22nd March 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was done according to OECD Guideline for Testing of Chemicals 305E and certified by GLP. However, the use of solvents and dispersants is not recommended in the Guideline but both were used here.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-tert-butylcyclohexyl ethyl carbonate
EC Number:
267-184-4
EC Name:
2-tert-butylcyclohexyl ethyl carbonate
Cas Number:
67801-64-3
Molecular formula:
C13H24O3
IUPAC Name:
2-tert-butylcyclohexyl ethyl carbonate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 2-tert-butylcyclohexyl ethyl carbonate
- Physical state: Colorless transparent liquid
Specific details on test material used for the study:
- Storage condition of test material: Cool and dark condition
Radiolabelling:
no

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test organisms: Five occasions during the uptake phase to the exposed group and on two occasions at start and end of the test to the control group.
- Sampling intervals/frequency for test medium samples: Before feeding and at the same time as the fish sampling to the exposed group.

Test solutions

Vehicle:
yes
Details on preparation of test solutions, spiked fish food or sediment:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle: Dimethyl sulfoxide
- Dispersants: 10 times volume of HCO-40

Test organisms

Test organisms (species):
Cyprinus carpio

Study design

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

Test conditions

Test temperature:
First concentration group: 24.8 - 25.0°C
Second concentration group: 24.7 - 24.8°C
Control group: 24.5°C
pH:
First concentration group: 7.7
Second concentration group: 7.8
Control group: 7.9
Dissolved oxygen:
First concentration group: 7.1 - 7.4 mg/L
Second concentration group: 7.1 - 7.5 mg/L
Control group: 7.5 - 7.7 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 70L glass vessel
- Renewal rate of test solution: 2000 mL/min.
- No. of organisms per vessel: First and second concentration groups: 37, Control group: 12
- No. of vessels per concentration: 1
- No. of vessels per control / vehicle control: 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Ground water
- pH: 8.0
- Total hardness (Ca, Mg): 13.2 mg/L
- Conductivity: 264μS/cm

OTHER TEST CONDITIONS
- Photoperiod: 14 hours light and 10 hours dark

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 10.0 mg/L, 5.00 mg/L, 2.50 mg/L, 1.25 mg/L and control
- Results used to determine the conditions for the definitive study: LC50 = 3.86 mg/L (after 96 hours)
Nominal and measured concentrations:
Nominal concentrations:
First concentration group: 10 μg/L, Second concentration group: 1 μg/L,
Mesured concentrations at steady state:
Peak1 at first concentration group: 9.33 μg/L, Peak 1 at second concentration group: 0.958 μg/L
Peak2 at first concentration group: 9.06 μg/L, Peak 2 at second concentration group: 0.939 μg/L

Results and discussion

Lipid contentopen allclose all
Lipid content:
3.29 %
Time point:
start of exposure
Lipid content:
3.9 %
Time point:
end of exposure
Bioaccumulation factoropen allclose all
Key result
Conc. / dose:
10 µg/L
Temp.:
24.8 - 25 °C
pH:
7.3
Type:
BCF
Value:
120 L/kg
Basis:
normalised lipid fraction
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:Peak1 at first concentration group
Key result
Conc. / dose:
1 µg/L
Temp.:
24.7 - 24.8 °C
pH:
7.3
Type:
BCF
Value:
120 L/kg
Basis:
normalised lipid fraction
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:Peak1 at second concentration group
Conc. / dose:
10 µg/L
Temp.:
24.8 - 25 °C
pH:
7.3
Type:
BCF
Value:
110 L/kg
Basis:
normalised lipid fraction
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:Peak2 at first concentration group
Conc. / dose:
1 µg/L
Temp.:
24.7 - 24.8 °C
pH:
7.3
Type:
BCF
Value:
130 L/kg
Basis:
normalised lipid fraction
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:Peak2 at second concentration group
Details on results:
- Mortality of test organisms: No
- Behavioural abnormalities: No

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Bioconcentration factor (BCF) of the test substance at steady state showed from 110 to 130.
Executive summary:

The study was performed to assess the bioaccumulation in fish of the test substance according to the OECD 305. The test was done by flow-through fish test using Cyprinus carpio for 28 days. Concentrations of the test group were set at 10 μg/L (first concentration group) and 1 μg/L (second concentration group) in a vehicle mixture of HCO-40 and dimethyl sulfoxide. The analysis of the test substance was done by GC-MS and we could find 2 peaks for the test substance. Bioconcentration factor (BCF) of the test substance at steady state are below,

Peak 1 (first concentration group, 10 μg/L nominal) : 120

Peak 1 (second concentration group, 1 μg/L nominal) : 120

Peak 2 (first concentration group, 10 μg/L nominal) : 110

Peak 2 (second concentration group, 1 μg/L nominal) : 130

Despite the use of vehicle the results are consistent between the two concentration levels and the study is considered suitable for use in risk assessment.