Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1995-07-25 to 1995-10-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study according a Japanese Guideline (no details given), well and detailed reported, deficiencies in translation from Japanese
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Japanese METI Guideline according Test methods for New Chemical Compounds
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 100%
Lot No. OP 2/94
brown, viscous liquid
Mp -20 to -30 deg C
Bp 185 deg C
Water solubility: ambigous results
Methanol solubility: >100 g/L
Radiolabelling:
no

Sampling and analysis

Details on sampling:
Sampling twice a week, in total 16 times for determination of substance concentration in water. 4 Samplings for the analysis of the test itemin fish (after 2, 4, 6 and 8 weeks after intial exposure (0 d). Sampling in control fish at begin and end of the test

Test solutions

Vehicle:
yes
Details on preparation of test solutions, spiked fish food or sediment:
Dsipersant HCO-40, test item and 20 times its volume of HCO-40 were kneaded together preparing a stock solution by dilution with ion exchange water of 2000 mg/L

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Supply: Sugishima Fish Hatchery
Rearing for two days to remove fish with abnormalities, Acclimatization at 25 +/- 2 deg C applying a drug to remove parasites, afterwards rearing for 57d in flowing water
Body weight: average 25.2 g
Body length: 9.9 cm
Lipid content: average 3.5%
Feed: pellet shaped compound feed for carp
2 concentration groups with 11 fish at start of exposure
Control group: 5 fish

Study design

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

Test conditions

Hardness:
not given
Test temperature:
25 +/- 2 deg C
pH:
not given
Dissolved oxygen:
7.0 to 7.6 mg/L
TOC:
not given
Details on test conditions:
Quantity of test water: 579 L/d was supplied at 2 ml / min, 100l glas water tanks
Nominal and measured concentrations:
1st concentration group: 0.6 mg/L
2nd concentration group: 0.06 mg/L
Details on estimation of bioconcentration:
Measurement of the test item in the test water (sampling see above) and measurement in fish. Whole fish was cut in pieces and extracted with acetonitrile / phosphoric acid after homogenization. After the workup procedure, the test item was determinded with HPLC (see above)

Results and discussion

Bioaccumulation factoropen allclose all
Type:
BCF
Value:
8.6 L/kg
Basis:
whole body w.w.
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: test item conc. in fish LODm (LOQm = 3*LODm)
Remarks:
Conc.in environment / dose:0.6 mg/L (Group 1)
Type:
BCF
Value:
< 15 L/kg
Basis:
whole body w.w.
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: Min. BCF (Group 1) based on the LOQm test item in fish and measured test item conc. in water is BCF=15
Remarks:
Conc.in environment / dose:0.6 mg/L (Group 1)
Type:
BCF
Value:
25 L/kg
Basis:
whole body w.w.
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: test item conc. in fish is < LODm
Remarks:
Conc.in environment / dose:0.06 mg/L (Group 2)
Type:
BCF
Value:
< 158 L/kg
Basis:
whole body w.w.
Time of plateau:
14 d
Calculation basis:
steady state
Remarks on result:
other: Min. BCF (Group 2) based on the LOQm test item in fish and measured test item conc. in water is BCF=158
Remarks:
Conc.in environment / dose:0.06 mg/L (Group 2)
Details on kinetic parameters:
none available
Metabolites:
not monitored
Results with reference substance (positive control):
no reference substance used

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Tetra-PSCA has shown a low bioaccumulation potential in an 8 week Fish BCF test. Most concentrations in the fish were below the Limit of Quantification of the Analytical method (LOQ m) or even below the LOD m (Limit of Detection). Two concentrations of the test item in water were tested (0.6 and 0.06 mg/L) and of each group one BCF could be calculated: BCF=8.6 L/kg wwt for the concentration group 1 (water conc. 0.6 mg/L) and BCF=25 L/kg wwt for concentration group 2 (water conc. 0.06 mg/L). These both BCF are below the minimum BCF which can be calculated from the LOQm for test item concentration in fish which is 8.9 µg/g and the test water concentration of the two groups. The minimum BCF which can be reliably calculated are 15 L/kg wwt for Group 1 (water conc. 0.6 mg/L) respectively 158 L/kg wwt for Group 2 (water conc. 0.06 mg/L). This means that the BCF (Group 1) is < 15 L/kg wwt and <158 L/kg wwt (Group 2) as no fish concentrations were measured in this test which would result in a higher BCF as these minimum BCF.