Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Sep - 28 Nov 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: “Bioconcentration test of chemical substances in fish and shellfish” specified in the Test Method Relating to New Chemical Substances (Kanpogyo No.5, Yakuhatsu No.615, 49 Kikyoku No.392
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Sampling and analysis

Details on sampling:
- Sampling intervals/frequency for test organisms: 3 fish were tested from the 1st and 2nd concentration groups, 2 fish were used for each analysis
- Sample storage conditions before analysis: 1 fish with aluminum foil and kept frozen in the plastic bag
- Details on sampling and analysis of test organisms and test media samples: See detailed analytical method in section "Any other information on materials and methods incl tables".

Test solutions

Vehicle:
yes
Remarks:
dimethyl sulfoxide
Details on preparation of test solutions, spiked fish food or sediment:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method:
1.00 g of the test substance and 20.0 g of the dispersant (hydrogenated castor oil HCO-40) were dissolved in dimethyl sulfoxide to obtain the constant volume of 100 mL. This solution was diluted with water to obtain the constant volume of 5.0 L to prepare 200 ppm (W/V) of stock solution.
- Controls:
yes

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name:
Carp
- Strain:
Oryzias latipes
- Length at study initiation (length definition, mean, range and SD):
10.3 ± 0.2 cm (average)
- Weight at study initiation (mean and range, SD):
0.29 g (average); 24.5 ± 2.7 g
- Lipid content at test initiation (mean and range, SD):
3.8 ± 0.4%

ACCLIMATION
- Acclimation period: 25°C for 20 days

Quarantine:
- Quarantine conditions: Fish were treated with a medicated bath of Terramycin solution (100 ppm)
- Quarantine duration: 24 hours under static conditions (2 times).

Study design

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

Test conditions

Test temperature:
25.0 ± 1.0 °C (24.5±1.0°C)
Details on test conditions:
TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume:
Glass aquaria, volume 100 L
- Type of flow-through:
Water flow 300 mL/min (432 L/day)
Nominal and measured concentrations:
1st concentration group: 0.5 ppm
2nd concentration group: 0.05 ppm
Reference substance (positive control):
not specified

Results and discussion

Lipid content
Remarks on result:
other:
Remarks:
no information were given in the report
Bioaccumulation factoropen allclose all
Conc. / dose:
0.5 other: ppm
Type:
BCF
Value:
> 303 - < 327 dimensionless
Time of plateau:
56 d
Remarks on result:
other: 56 days after the test
Remarks:
a mean of 315
Conc. / dose:
0.05 other: ppm
Type:
BCF
Value:
> 492 - < 518 dimensionless
Time of plateau:
56 d
Remarks on result:
other: 56 days after the test
Remarks:
a mean of 505
Depuration
Remarks on result:
other: no information were given in the report
Rate constants
Remarks on result:
other:
Remarks:
no information were given in the report

Any other information on results incl. tables

Test results

Number of days after the test

1st concentration group

2nd concentration group

A

B

BCF (bioconcentration factor)

A’

B’

BCF (bioconcentration factor)

3

A

98

A’

258

B

96

B’

200

7

A

237

A’

390

B

163

B’

548

14

A

331

A’

550

B

272

B’

612

21

A

350

A’

458

B

322

B’

487

28

A

323

A’

462

B

299

B’

542

42

A

293

A’

580

B

269

B’

504

56

A

303

A’

518

B

327

B’

492

(Note 1) A, B in the 1st concentration group and A' and B' in the 2nd concentration group are the marks attached to the sample fish at the time of measurement of accumulation.

Applicant's summary and conclusion

Conclusions:
The BCF was determined to be 505 (mean of 492 and 518) after 56 days at 0.05 ppb.