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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to established testing guidelines without GLP compliance. Furthermore, study detail is lacking.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: MITI - Japan
Deviations:
not specified
Principles of method if other than guideline:
Flow-through exposure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. -1.4. for Bisphenol A.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
As per IUCLID5 Sections 1.1. -1.4. for Bisphenol A.
Radiolabelling:
not specified

Sampling and analysis

Details on sampling:
No data

Test solutions

Details on preparation of test solutions, spiked fish food or sediment:
A dispersant (HCO-40) was used to prepare the test substance dosing solutions.

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
No data

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

Hardness:
No data
Test temperature:
No data
pH:
No data
Dissolved oxygen:
No data
TOC:
No data
Salinity:
No data - fresh water
Details on test conditions:
No data
Nominal and measured concentrations:
15 µg/l (15.0 - 15.5 µg/l) and 150 µg/l (145.9 - 155.7 µg/l)
Reference substance (positive control):
not specified
Details on estimation of bioconcentration:
No data

Results and discussion

Lipid content
Remarks on result:
other: No data
Bioaccumulation factoropen allclose all
Type:
BCF
Value:
ca. 20 - ca. 68
Basis:
whole body w.w.
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:15 mg/L
Type:
BCF
Value:
ca. 5 - ca. 13.3
Basis:
whole body w.w.
Calculation basis:
steady state
Remarks on result:
other: Conc.in environment / dose:150 mg/L
Depuration
Elimination:
not specified
Details on kinetic parameters:
No data
Metabolites:
No data
Results with reference substance (positive control):
No data
Details on results:
No data
Reported statistics:
No data

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
The bioconcentration Factor (BCF) for Bisphenol A ranged approximately 5 to 68-fold for concentrations of 15 to 150 mg/L. BCF was only 5 - 13.3 at 150 mg/L suggesting a potential to plateau at higher Bisphenol A concentrations. These findings suggest the potential for Bisphenol A to bioconcentrate in aquatic organisms is low to moderate and may be concentration limited. Therefore, it is expected that 2-Acetone polymer with phenol (BPA-Tars) will have similar bioconcentration potential.
Executive summary:

Bisphenol A, a structural analog of 2 -Acetone polymer with phenol (BPA-Tars) was evaluated for bioconcentration potential in Oryzias latipes (orange-red killfish) using a MITI test guideline and flow-through exposure for an eight-week period. The bioconcentration Factor (BCF) for Bisphenol A ranged approximately 5 to 68-fold for concentrations of 15 to 150 mg/L. BCF was only 5 - 13.3 at 150 mg/L suggesting a potential to plateau at higher Bisphenol A concentrations. These findings suggest the potential for Bisphenol A to bioconcentrate in aquatic organisms is low to moderate and may be concentration limited. Therefore, it is expected that 2-Acetone polymer with phenol (BPA-Tars) will have similar bioconcentration potential.