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Diss Factsheets

Administrative data

bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 February - 31 March, 2008
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
see below
according to guideline
other: "Method for Testing the Degree of Accumulation of Chemical substances in Fish Body" stipulated in the "Testing Methods for New Chemical Substances" (November 21, 2003, No. 1 12 1002, MHLW; November 13, 2003, No.2, METI; No.031121002, MOE, Japan)
Principles of method if other than guideline:
The following items can be regarded as 'not in compliance with OECD-guidelines":
- fish are somewhat too large in size
- temperature should be measured daily/continuously
- TOC and hardness have not been measured
However, no clinical effects were observed during the test period, indicating that temperature, TOC and hardness of dilution water did not negatively affect the fish. The range for fish length varies between guidelines, i.e. 2.0-8.0 for OECD and 4.0-12.0 for CSCL, indicating that this range is not of great importance. More important is the variation of fish weight: 'In any one test, select fish of similar weight such that the smallest are no smaller than two-thirds of the weight of the largest.' Information on fish weight was not reported but variation in fish length was relatively small (6.5-8.5 cm).

- duration stability test?
- how often are stock solutions prepared?
The report does not describe the stability of stock solutions and the frequency of preparation of stock solutions. Therefore it cannot be known if the parent compouds were dosed or possible degradants.
GLP compliance:

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): S-500
- Substance type: yellow powder
- Physical state: solid
- Lot/batch No.: MF1456-2345
- Stability under test conditions: stable (confirmed by IR)
- Storage condition of test material: dark storage place at room temperature

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test organisms: after 6, 12, 17, 21 and 28 days: each time 4 fish, divided in 2 groups.
- Sampling intervals/frequency for test medium samples: after 3, 6, 12, 17, 21 and 28 days: each time 1 sample
- Sample storage conditions before analysis: not applicable

Test solutions

Details on preparation of test solutions, spiked fish food or sediment:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Using dispersants. Test sample and sugar candy (30x) were ground up. Then hydrogenated castor oil HCO-40 (25x) and HCO-100 (25x) were added and the mixture was ground up again. Polyvinyl alcohol (degree of polymerization about 500; 10x) was dissolved in ion-exchanged water and added to the mixture. Then ion-exchanged water was added to the mixture to prepare 500 mg/L stock solution. The stock solution was diluted with ion-exchanged water to 50 mg/L and 5 mg/L solutions for the 100 µg/L and 10 µg/L dose, respectively.
- Controls: Sugar candy (1500 mg/L), HCO-40 (1250 mg/L), HCO-100 (1250 mg/L) and polyvinyl alcohol (500 mg/L) dissolved in ion-exchanged water.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): dispersant
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): see above
- Evidence of undissolved material (e.g. precipitate, surface film, etc): not indicated

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Common name: carp
- Strain: TFC-071226 (lot no.)
- Source: own culture
- Age at study initiation (mean and range, SD): yearling fish, about 7 months
- Length at study initiation (lenght definition, mean, range and SD): 6.5 - 8.5 cm
- Weight at study initiation (mean and range, SD): not indicated
- Weight at termination (mean and range, SD): not indicated
- Method of breeding: not indicated
- Health status: not indicated
- Description of housing/holding area: not indicated; 70-L glass tank for test
- Feeding during test
- Food type: fry, with >=43.0% proteins content and >=3.0% lipid content
- Amount: 2% of total body weight
- Frequency: twice a day in halves

- Acclimation period: 23 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: 2% of total body weight, fasting 24 hours before sampling
- Feeding frequency: twice a day in halves
- Health during acclimation (any mortality observed): not indicated

Study design

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

Test conditions

15 mg/L (Ca, Mg)
Test temperature:
23.8 - 24.3 deg Celsius
7.9 - 8.0
Dissolved oxygen:
7.8 - 8.2 mg/L
0.3 mg/L
Not applicable.
Details on test conditions:
- Test vessel:
- Material, size, headspace, fill volume: 70 L glass tank
- Aeration: not indicated
- Type of flow-through (e.g. peristaltic or proportional diluter): not indicated
- Renewal rate of test solution (frequency/flow rate): flow rate 2.0 mL/min for stock solution and 1000 mL/min for dilution water, 1443 L/day of test water were supplied.
- No. of organisms per vessel: 28 fish exposed to 100 µg/L dose or 10 µg/L dose; 12 control fish.
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
- Biomass loading rate: 28 fish exposed to 100 µg/L dose or 10 µg/L dose; 12 control fish.

- Source/preparation of dilution water: groundwater
- Particulate matter: <1 mg/L
- Metals: total <0.08 mg/L
- Pesticides: total <0.0025 mg/L
- Chlorine: <0.02 mg/L
- Alkalinity: 100 mg/L
- Conductance: 272 µS/cm
- Holding medium different from test medium: no
- Intervals of water quality measurement: not indicated
- Intervals of test medium replacement: 1-2 times/week

- Adjustment of pH: no
- Photoperiod: 14 hours/day artificial light of white fluorescent lamp
- Light intensity: unknown

A 96-hours semi-static acute toxicity test with orange-red killifish (Oryzias latipes) was conducted.
Mean weight of fish: 0.27 g; mean length of fish: 3.2 cm. Number of fish: 10 per level.
- Test concentrations: 50 mg/L, control, and control dispersants.
- Results used to determine the conditions for the definitive study: 96-h LC50 > 50 mg/L. The test was not performed at higher concentrations as a precipitate was formed.
Nominal and measured concentrations:
Each concentration of the test item in test water was maintained at more than 84% of each nominated concentration
Reference substance (positive control):
Details on estimation of bioconcentration:
BCF = Cf / Cw
Cf = concentration of test item in fish (subtract FB) (ng/g)
Cw = average concentration of test item in water (µg/L)
FB = average concentration of test item or blank in control fish analyzed before and after experiment (µg/g)

Steady state of BCF is defined as reached when the variation of BCFs in three successive analyses at intervals of more than 48 hours is within +/-20%. When BCFs are less than 100, it is evaluated that a steady-state has been reached after 28 days even if the variation of BCFs are over +/-20%.

Results and discussion

Lipid contentopen allclose all
Lipid content:
3.43 %
Time point:
start of exposure
Lipid content:
4.06 %
Time point:
end of exposure
Bioaccumulation factoropen allclose all
<= 1.9
whole body w.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Result based on peak 3 (component B)
Remarks: environment / dose:100 µg/L
<= 1.1
whole body w.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Result based on peak 4 (component A)
Remarks: environment / dose:100 µg/L
<= 18
whole body w.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Result based on peak 3 (component B)
Remarks: environment / dose:10 µg/L
<= 8.3
whole body w.w.
Time of plateau:
28 d
Calculation basis:
steady state
Remarks on result:
other: Result based on peak 4 (component A)
Remarks: environment / dose:10 µg/L
Details on results:
- Mortality of test organisms: not observed
- Behavioural abnormalities: not observed
- Observations on body length and weight: not indicated
- Mortality and/or behavioural abnormalities of control: not observed
- Results with vehicle control: not indicated

Any other information on results incl. tables

Peak 1 (component D) and 2 (component C) of the test item were excluded from quantitative object, but those peaks were monitored in chromatograms of HPLC analysis for test fish. As a result, the remarkable peak was not detected in peak position of peak 1 and 2. And it is speculated that logPow is low because elution time of peak 1 and 2 are early in comparison with elution time of peak 3 (component B) and 4 (component A) in HPLC analysis of reversed phase chromatography. It is thought that those bioconcentration potential are low similarly to peak 3 and 4.

Applicant's summary and conclusion

Validity criteria fulfilled:
The bioconcentration potential is low. The BCF values are <= 1.9 at the 100 µg/L dose and <=18 at the 10 µg/L dose.