Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 12, 1992 - October 28, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 305 C

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish)
Deviations:
yes
Remarks:
Test period in the study :6 weeks. In OECD TG 305C - 8 weeks.
Qualifier:
according to
Guideline:
other: Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:Cool dark place
- Stability under test conditions:Yes, Infrared absorption spectrum of the test substance before and after the exposure - both spectra are identical. Test substance is stable under storage condition.

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test medium samples:12 times, in total twice per week during the exposure period.
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods): First and second concentrations: Two, 3, 4 and 6 weeks after the exposure was started (two samples) - sampling was administrated. For control group, sampling was administrated before and at the end of exposure.

Test solutions

Vehicle:
no
Details on preparation of test solutions, spiked fish food or sediment:
PREPARATION AND APPLICATION OF TEST SOLUTION:
Preparation of stock solution:
First concentration zone: Test substance 4.0 g was dissolved in about 1 L ion exchanged water to prepare a stock solution.
Second concentration zone:The 400 mg of the test substance was dissolved in about 300 ml of ion exchanged water to prepare a stock solution.
They were placed in a 252 glass stock solution tank and supplied to the test tank.

FIRST CONCENTRATION :0.4 mg/L
SECOND CONCENTRATION : 0.04 mg/L.
Control group was set as a blank test.

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Source: Sugijima fish farm,86 Kiyoshimoto prefecture Yatsushiro-shi ku, County Ichibancho-cho 123-2
- Length at study initiation (length definition, mean, range and SD): 9.4 cm
- Weight at study initiation (mean and range, SD): 21.3 g
- Method of breeding: After bathing in the receiving tank, we bred for 13 days in flowing water bowl shape.
- Lipid content at test initiation (mean and range, SD): 3.7%
- Description of housing/holding area: Water bowl.
- Feeding during test: Yes
- Food type: Pellet formulated feed for carp (Nippon Shoku Feed Co., Ltd.)
- Amount: Approximately 2% equivalent weight of the test fish.
- Frequency: Fish were fed twice a day. Feeding was stopped the day before sampling of the test fish.

Study design

Route of exposure:
aqueous
Test type:
semi-static
Water / sediment media type:
other: Dechlorined tap water with activated carbon.
Total exposure / uptake duration:
ca. 6 wk

Test conditions

Test temperature:
25+-2ºC
Dissolved oxygen:
First concentration zone 6.5 - 7.5 mg/l
Second concentration zone 6.5 - 7.4 mg/l
Control area 7.3 - 7.8 mg /l reservoir
Details on test conditions:
TEST SYSTEM
- Test vessel: Aquarium with shape of bowl.
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 70 l
- No. of organisms per vessel: First and second concentration -12 fish were used and 5 control fish.


RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: 1. concentration = 0.4 mg, Second concentrations = 0.04 mg
- Results used to determine the conditions for the definitive study: LC50(48h) 80.1 mg/L, Rice fish (Oryzias latipes) (0.28 g)
Nominal and measured concentrations:
Nominal concentrations: 1st Concentration area: 0.4 mg/L and 2nd Concentration area: 0.04 mg/L
Reference substance (positive control):
no

Results and discussion

Lipid content
Lipid content:
ca. 3.7 %
Time point:
start of exposure
Bioaccumulation factoropen allclose all
Key result
Conc. / dose:
ca. 0.4 mg/L
Type:
BCF
Value:
ca. 3.8 - ca. 4.2 L/kg
Basis:
whole body w.w.
Remarks on result:
other: <= 3.8 - 4.2 L/kg
Key result
Conc. / dose:
ca. 0.04 mg/L
Type:
BCF
Value:
ca. 39 L/kg
Basis:
whole body w.w.

Any other information on results incl. tables

Table results:

 

2wk

3wk

4wk

6wk

BCF- bioconcentration factor

(First concentration)

<= 3.8

<= 3.8

<= 3.8

<= 3.8

4.2

4.0

<= 3.8

<= 3.8

BCF- bioconcentration factor (Second concentration )

39

39

39

39

39

39

39

39

Result of appearance observation - no abnormality was observed in the test fish.

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
Test substance was tested for bioacumulation. Bioacumulation factor was found to be less than 3.8 - 4.2 L/kg in the concentration 0.4 mg/L and 39 L/kg in the concentration of 0.04 mg/L.
Executive summary:

Test substance was tested for bioacumulation in the fish species Cyrpinus Carpio according the OECD TG305 C and following GLP principles. Before the test, the range finding study was carried out on the Rice fish (Oryziaslatipes -0.28 g) to find out the concentration of the test substance in the study. The evaluated LC 50 vale was LC50 (48 h)=80.1 mg/L. Test substance was dissolved. The solution was introduced into aquarium where fish were kept. The Dissolved oxygen concentration and temperature of water were analyzed. The concentrations of chemicals were analyzed and the bioconcentration factor was calculated. In the concentration of 0.4 mg/L of test substance, the BCF factor was less than 3.8 - 4.2 L/kg and in the concentration of 0.04 mg/L the BCF factor was 39 L/kg.