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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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
Guideline:
other: Japanese METI Guideline according Test methods for New Chemical Compounds
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6-(3-tetrapropenyl-2,5-dioxopyrrolidin-1-yl)hexanoic acid
EC Number:
800-770-5
Cas Number:
1424148-99-1
Molecular formula:
C22H39NO4
IUPAC Name:
6-(3-tetrapropenyl-2,5-dioxopyrrolidin-1-yl)hexanoic acid
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.