Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Bioaccumulation: aquatic/sediment.
Author:
National institute of technology & evaluation
Year:
2016
Bibliographic source:
Japan chemicals collborative knowledge database (J-check)

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Bioaccumulation: aquatic/sediment
Qualifier:
according to guideline
Guideline:
other: "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances".
Principles of method if other than guideline:
Bioaccumulation test was conducted for 28 days for estimating the bioconcentration factor (BCF) and lipid content of test substance Fluorescein sodium in test organism Cyprinus carpio.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
EC Number:
208-253-0
EC Name:
Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
Cas Number:
518-47-8
Molecular formula:
C20H12O5.2Na
IUPAC Name:
disodium 3-oxo-3H-spiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate
Constituent 2
Reference substance name:
Fluorescein sodium
IUPAC Name:
Fluorescein sodium
Test material form:
other: Orange reddish powder
Details on test material:
- Name of test material (as cited in study report): Disodium 2-(6-oxido-3-oxo-3H-xanthen-9-yl) benzoate
- Molecular formula (if other than submission substance):
C20H10Na2O5
C20H10O5.2Na
C20H12O5.2Na
- Molecular weight (if other than submission substance): 376.274 g/mol
- Smiles notation (if other than submission substance): c1(c2c(oc3c1ccc(c3)[O-])
cc(=O)cc2)c1c(cccc1)C(=O)[O-].[
Na+].[Na+]
- InChl (if other than submission substance): 1S/C20H12O5.2Na/c21-11-5-7-15-17(9-11)25-18-10-12(22)6-8-16(18)19(15)13-3-1-2-4-14(13)20(23)24;;/h1-10,21H,
(H,23,24);;/q;2*+1/p-2
- Structural formula attached as image file (if other than submission substance): No data available
- Substance type: Organic
- Physical state: Solid
- Analytical purity: No data available
- Impurities (identity and concentrations): No data available
- Composition of test material, percentage of components: No data available
- Isomers composition: No data available
- Purity test date: No data available
- Lot/batch No.: No data available
- Expiration date of the lot/batch: No data available
- Radiochemical purity (if radiolabelling): No data available
- Specific activity (if radiolabelling): No data available
- Locations of the label (if radiolabelling): No data available
- Expiration date of radiochemical substance (if radiolabelling): No data available
- Stability under test conditions: No data available
- Storage condition of test material: No data available
- Other: No data available
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No data available
Radiolabelling:
not specified

Sampling and analysis

Details on sampling:
No data available

Test solutions

Vehicle:
not specified
Details on preparation of test solutions, spiked fish food or sediment:
No data available

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
No data available

Study design

Test type:
not specified
Water / sediment media type:
not specified
Total exposure / uptake duration:
28 d

Test conditions

Hardness:
No data available
Test temperature:
No data available
pH:
No data available
Dissolved oxygen:
No data available
TOC:
No data available
Salinity:
No data available
Details on test conditions:
TEST SYSTEM
- Test vessel: No data available
- Type (delete if not applicable): No data available
- Material, size, headspace, fill volume:
- Aeration: No data available
- Type of flow-through (e.g. peristaltic or proportional diluter): No data available
- Renewal rate of test solution (frequency/flow rate): No data available
- No. of organisms per vessel: No data available
- No. of vessels per concentration (replicates): No data available
- No. of vessels per control / vehicle control (replicates): No data available
- Biomass loading rate: No data available













TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: No data available
- Particulate matter: No data available
- Metals: No data available
- Pesticides: No data available
- Chlorine: No data available
- Alkalinity: No data available
- Ca/mg ratio: No data available
- Conductance: No data available
- Holding medium different from test medium: No data available
- Intervals of water quality measurement: No data available
- Intervals of test medium replacement: No data available






OTHER TEST CONDITIONS
- Adjustment of pH: No data available
- Photoperiod: No data available
- Light intensity: No data available

RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations: LC50 (96 hr) >200mg/l, Rice fish (Oryzias latipes)
- Results used to determine the conditions for the definitive study: No data available
Nominal and measured concentrations:
Nominal concentrations-
1st concentration area: 0.46 mg/l
2nd concentration area: 0.046 mg/l
Reference substance (positive control):
not specified
Details on estimation of bioconcentration:
No data available

Results and discussion

Lipid contentopen allclose all
Lipid content:
4.14 %
Time point:
end of exposure
Lipid content:
2.94 %
Time point:
start of exposure
Bioaccumulation factoropen allclose all
Type:
BCF
Value:
<= 0.27 L/kg
Basis:
other: Test material
Remarks on result:
other: Conc.in environment / dose:0.46 mg/l
Type:
BCF
Value:
<= 0.27 L/kg
Basis:
other: test material
Remarks on result:
other: Conc.in environment / dose:0.046 mg/l
Details on kinetic parameters:
No data available
Metabolites:
No data available
Results with reference substance (positive control):
No data available
Details on results:
No data available
Reported statistics:
No data available

Any other information on results incl. tables

Table: Bioaccumulation test results.

 

 

6d

9d

13d

21d

28d

 

1stconcentration area

Test substance concentration (mg/l)

 

0.462

 

0.459

 

0.459

 

0.460

 

0.462

Bio-concentration factor (l/kg)

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

≤ 0.27

 

2ndconcentration area

Test substance concentration (mg/l)

 

0.0459

 

0.0457

 

0.0461

 

0.0457

 

0.0460

Bio-concentration factor (l/kg)

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

≤ 2.7

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
The test substance concentration in environment was 0.46 mg/l, 0.046 mg/l and bioconcentration (BCF) value of test substance was found to be ≤ 0.27 l/kg, respectively. Thus, the test substance have a low bioconcentration potential in test organism Cyprinus carpio during 28 day period.
Executive summary:

Bioaccumulation test was conducted for 28 days for estimating the bioconcentration factor (BCF) and lipid content of test substance Fluorescein sodium in test organism Cyprinus carpio.

 

The purity of test substance by HPLC was found to be 92.1% and water solubility value is ≥ 300 g/l at 20ᵒC (Flask method). The recovery ratio is given-

Test water: 100% (The test solution were input into analytical equipment directly.)

Fish: 93.8%

 

GLP compliance is followed for biodegradation study.Testing laboratory is Chemicals Evaluation and Research Institute, Japan.

 

Nominal concentrations used in the study are given-

1stconcentration area: 0.46 mg/l

2ndconcentration area: 0.046 mg/l

 

Range finding study was carried out onRice fish (Oryzias latipes) and the 96 hr LC50 value was found to be >200mg/l.

 

 

By analytical methods, thelimit of quantification was found to be-

Test water:

1stconcentration area: 11 µg/l

2ndconcentration area: 1.1 µg/l

Fish: 120 ng/g

 

The lipid content at the start and end of exposure was found to be 2.94% and 4.14%, respectively.

 

The test substance concentration in environment during a period of 28 days was 0.46 mg/l, 0.046 mg/l and bioconcentration (BCF) value of test substance was found to be ≤ 0.27 l/kg, respectively. Thus, the test substance have a low potential of bioaccumulation in test organismCyprinus carpio during 28 day period.