Registration Dossier

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 1981 - Jan 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed by an experienced laboratory using the commercial product in manufacture at the time. The results are consistent with the predicted lack of accumulation based on octanol solubility, molecular weight, size and shape (highly folded) and negligible water solubility. The study was performed at water concentrations higher than its estimated solubility, and whether the analytical method detected the EBTBP molecule or some impurity in the commercial product can be questioned. EBTBP presents a substantial analytical challlenge given its extremely poor solubility in water, organic solvents, and lipid. The results clearly show lack of bioaccumulation.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Reference Type:
publication
Title:
A comparison of the fish bioconcentration factors for brominated flame retardants with their nonbrominated analogues.
Author:
Hardy et al.
Year:
2004
Bibliographic source:
Envion Toxicol Chem 23(3):656-61.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: In accordance with the "Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances" (Japan 1973. Law No. 117)
Principles of method if other than guideline:
Fish exposed to test substance via water. Water and fish sampled at intervals, and test substance concentrations determined. BCF calculated as ratio of test concentration in fish to water.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
light yellow crystalline powder with purity of 99%; identified via IR spectrum
Radiolabelling:
no

Sampling and analysis

Details on sampling:
2 fish at each of the 2 dose levels were analyzed at 2, 4, 6 and 8 weeks of exposure. Water samples collected at the same time points for analysis.

Test solutions

Vehicle:
yes
Details on preparation of test solutions, spiked fish food or sediment:
Test compound (1.0 g) and crystallized sugar (10 g) were ground together. The dispersant HCO-40 (20 g) was added to the mixture and mixted thoroughly. Ion exchanged water was added and filled to 1 L.

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Avg body weight = 21.1 g; avg body length 9.1 cm; lipid content = 4.8%

Study design

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

Test conditions

Test temperature:
21 +/- 1 degrees C
Dissolved oxygen:
~6.5 ppm over the duration of the test
Nominal and measured concentrations:
Nominal = 2.0 and 0.2 ppm
Measured = 2.09 (2 Wk), 2.05 (4 Wk), 2.05 (6 Wk) and 2.07 (8 Wk)
= 0.194 (2 Wk), 0.197 (4 Wk), 0.198 (6 Wk), 0.199 (8 Wk)

Results and discussion

Lipid content
Lipid content:
4.8 %
Time point:
start of exposure
Bioaccumulation factoropen allclose all
Type:
BCF
Value:
< 3.3 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: at 2, 4, 6, and 8 Wk exposure
Remarks on result:
other: n=2 fish/wk
Remarks:
Conc.in environment / dose:.0.2 ppm
Type:
BCF
Value:
< 0.3 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: 2 and 4 Wk
Remarks on result:
other: n=2 fish/wk
Remarks:
Conc.in environment / dose:2.0 ppm
Type:
BCF
Value:
< 0.3 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: 6 Wks
Remarks on result:
other: value in 1 of 2 fish at this timepoint
Remarks:
Conc.in environment / dose:2.0 ppm
Type:
BCF
Value:
0.4 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: 6 wks
Remarks on result:
other: value in 1 of 2 fish at this timepoint
Remarks:
Conc.in environment / dose:2.0 ppm
Type:
BCF
Value:
< 0.3 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: 8 Wks
Remarks on result:
other: value in 1 of 2 fish at this timepoint
Remarks:
Conc.in environment / dose:2.0 ppm
Type:
BCF
Value:
1.3 dimensionless
Basis:
whole body w.w.
Calculation basis:
other: 8 Wks
Remarks on result:
other: value in 1 of 2 fish at this timepoint
Remarks:
Conc.in environment / dose:2.0 ppm

Any other information on results incl. tables

Fish appeared normal throughout the exposure. No mortality.

Detection limit = 0.05 ppm (S/N=2)

% recovery from fish = 77.0%.

Mean water concentration for 8 weeks = 2.07 ppm at the 2.0 ppm nominal level, and 0.199 ppm for the 0.2 ppm level.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
EBTBP did not bioconcentrate in fish exposed to the substance in water over an 8 week period. The study was conducted according to Japanese guidelines in effect at the time of the study's performance. A dispersant was used.
Executive summary:

EBTBP did not bioconcentrate in fish(Cyprnus carpio)when tested over an 8-week period. The bioconcentration factor (BCF) was < 3.3 at a water concentration of 0.2 ppm (w/v) and 1.3 at a water concentration of 2.0 ppm (w/v) after an 8-week exposure period with a continuous flow system. A semi static dose range-finding study conducted in Orange-red killifish (Oryzias latipes) for this study provided a 48 hr LC50 of > 500 ppm (w/v).  This study was conducted according to Japanese MITI guidelines and Good Laboratory Practices guidelines.