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ARCHIVED - Environmental Screening Assessment Report on Polybrominated Diphenyl Ethers (PBDEs) - Draft for Public Comments

References

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Table 6: Summary of toxicity studies used in the derivation of CTVs for the risk quotient analysis of PBDEs
Species, Life StagesCompo-
sition

of Test Material
Test DurationTest
Concentrations
Study
Design
Effect
Level
References
Daphnia magna <24 hours old at test initiationPeBDE:
33.7% tetraBDE
54.6% pentaBDE
11.7% hexaBDE
21 daysNominal: 0, 1.9, 3.8, 7.5, 15 and 30 µg/L
Measured: 0, 1.4, 2.6, 5.3, 9.8 and 20 µg/L
flow-through using well water
20 ± 1 C, pH 7.9-8.3, DO >= saturation, hardness 128-136 mg/L as CaCO3, alkalinity 174-176 mg/L as CaCO3, conductance 310-315 µmhos/cm
40 animals per treatment
GLP, protocol based on OECD 202, TSCA Title 40 and ASTM E1193-87
21-day LOEC (mortality/immobility) = 20 µg/L
21-day NOEC (mortality/immobility) = 9.8 µg/L
96-hour EC50 (mortality/immobility) = 17 µg/L
7- to 21-day EC50 (mortality/immobility) = 14 µg/L
21-day EC50 (reproduction)= 14 µg/L
21-day LOEC (growth) = 9.8 µg/L
21-day NOEC (growth ) = 5.3 µg/L
LOEC (overall study) = 9.8 µg/L
NOEC (overall study) = 5.3 µg/L
CMABFRIP 1998
Lumbriculus variegatus adultPeBDE:
0.23% triBDE
36.02% tetraBDE
55.10% pentaBDE
8.58% hexaBDE (Great Lakes Chemical Corporation 2000c)
28 daysNominal: 0, 3.1, 6.3, 13, 25 and 50 mg/kg dw of sediment
Analysis of test concentrations at days 0, 7 and 28 indicated they were well maintained throughout the test. Results based on nominal concentrations.
flow-through using filtered well water
23 ± 2 C, pH 7.9-8.6, DO 6.0-8.2 mg/L, hardness 130 mg/L as CaCO3
artificial sediment: pH 6.6, water holding capacity 11%, mean organic matter <2%, 83% sand, 11% clay, 6% silt
80 animals per treatment
GLP, protocol based on Phipps et al. (1993), ASTM E1706-95b and U.S. EPA OPPTS No. 850.1735
28-day LOEC (survival/reproduction) = 6.3 mg/kg dw of sediment
28-day NOEC (survival/reproduction) = 3.1 mg/kg dw of sediment
28-day EC50 (survival/reproduction) >50 mg/kg dw of sediment
growth (dry weights) not significantly different from solvent control and not concentration-dependent
Great Lakes Chemical Corporation 2000a
Zea mays corntPeBDE:
0.23% triBDE
36.02% tetraBDE
55.10% pentaBDE
8.58% hexaBDE
(Great Lakes Chemical Corporation 2000c)
21 daysNominal: 0, 62.5, 125, 250, 500 and 1000 mg/kg soil dw or 0, 50.0, 100, 200, 400 and 800 mg/kg soil ww, assuming 20% soil moisture content
Analysis of test concentrations indicated they were well maintained throughout the test. Results reported based on nominal concentrations.
artificial soil: 92% sand, 8% clay and 0% silt, pH 7.5, organic matter content 2.9%
watering with well water using subirrigation, 14:10 light:dark photoperiod, 16.0-39.9 C, relative humidity 19-85%
40 seeds per treatment
GLP, protocol based on U.S. EPA OPPTS Nos. 850.4100 and 850.4225 and OECD 208 (based on 1998 proposed revision)
no apparent treatment-related effects on seedling emergence
21-day LC25, LC50 (seedling emergence) > 1000 mg/kg soil dw
mean shoot height significantly reduced at 250, 500 and 1000 mg/kg soil dw relative to controls
21-day EC25, EC50 (mean shoot height) > 1000 mg/kg soil dw
mean shoot weight significantly reduced at 62.5, 125, 250, 500 and 1000 mg/kg soil dw relative to controls
21-day EC25 (mean shoot weight) = 154 mg/kg soil dw
21-day EC50 (mean shoot weight) > 1000 mg/kg soil dw
21-day LOEC (mean shoot weight) = 62.5 mg/kg soil dw
21-day EC05 and (estimated) NOEC (mean shoot weight) = 16.0 mg/kg soil dw
Great Lakes Chemical Corporation 2000b
RatPeBDE (DE-71):
45-58.1% pentaBDE
24.6-35% tetraBDE
(Sjodin 2000; Zhou et al. 2001)
90 days maximum exposure with recovery periods of 6 and 24 weeksIn diet: 0, 2, 10 and 100 mg/kg bw per day (doses adjusted weekly based on mean body weight of animals)30 male and 30 female Sprague-Dawley CD rats per treatmentdecreased food consumption and body weight, increased cholesterol, increased liver and urine porphyrins at 100 mg/kg bw dose
increased absolute and relative liver weights at 10 and 100 mg/kg bw, with return to normal ranges after 24-week recovery period
compound-related microscopic changes to thyroid and liver at all dosage levels
microscopic thyroid changes reversible after 24 weeks
microscopic liver changes still evident at all dosage levels after 24-week recovery period
liver cell degeneration and necrosis evident in females at all dosage levels after 24-week recovery
LOAEL (liver cell damage) = 2 mg/kg bw
NOAEL could not be determined, as a significant effect was observed at the lowest dose tested
Great Lakes Chemical Corporation 1984
Daphnia magna <24 hours old at test initiationOBDE:
5.5% hexaBDE
42.3% heptaBDE
36.1% octaBDE
13.9% nonaBDE
2.1% decaBDE
(European Communities 2002b)
21 daysNominal: 0, 0.13, 0.25, 0.5, 1.0 and 2.0 µg/L
Measured: 0, *, *, 0.54, 0.83 and 1.7 µg/L
* two lowest concentrations could not be measured
flow-through using filtered well water
20 1 C, pH 8.2-8.5, DO 77% saturation, hardness 132-136 mg/L as CaCO3
20 animals per treatment
GLP, protocol based on OECD 202, ASTM E1193-87 and TSCA Title 40
21-day LOEC (survival, reproduction, growth) > 2.0 µg/L (nominal) or 1.7 µg/L (measured)
21-day NOEC (survival, reproduction, growth) >= 2.0 µg/L (nominal) or 1.7 µg/L (measured)a
21-day EC50 (survival, reproduction, growth) > 2.0 µg/L (nominal) or 1.7 µg/L (measured)
CMABFRIP 1997d
Eisenia fetida adult earthwormOBDE (DE-79):
78.6% bromine content
56 daysNominal: 0, 94.0, 188, 375, 750 and 1500 mg/kg dry soil
Measured: 0 , 84.9, 166, 361, 698 and 1470 mg/kg dry soil
artificial soil: sandy loam, 69% sand, 18% silt, 13% clay, 8.0% organic matter (4.7% carbon), pH 6.0 0.5
17-21 C, 16:8 light:dark photoperiod, pH 5.9-6.8, soil moisture 22.0-33.5%
40 animals per treatment
GLP, protocol based on U.S. EPA OPPTS 850.6200, OECD 207 and proposed OECD (2000) guideline
28-day LOEC (mortality) > 1470 mg/kg dry soil
28-day NOEC (mortality)>= 1470 mg/kg dry soila
28-day EC10, EC50 (survival) > 1470 mg/kg dry soil
56-day LOEC (reproduction) > 1470 mg/kg dry soil
56-day NOEC (reproduction) >=1470 mg/kg dry soila
56-day EC10, EC50 (reproduction) > 1470 mg/kg dry soil
Great Lakes Chemical Corporation 2001c
Lumbriculus variegatus adultOBDE (DE-79):
78.6% bromine content.
28 daysNominal: 0, 94, 188, 375, 750 and 1500 mg/kg dw of sediment
Measured: (i) 2% OC: < 0.354, 76.7, *, *, 755 and 1340 mg/kg dw sediment (ii) 5% OC: <12.5, 90.7, *, *, 742 and 1272 mg/kg dw sediment
concentrations were not measured
80 animals per treatment
flow-through using filtered well water, hardness 128-132 mg/L as CaCO3
Two trials with different artificial sediments: (i) 6% silt, 9% clay, 85% sand, 2% TOC, water holding capacity 9.3%, 23 ± 2 C, pH 7.6-8.4, DO >= 45% saturation (3.8 mg/L); (ii) 6% clay, 14% silt, 80% sand, 5% TOC, water holding capacity 13.9%, 23± 2 C, pH 7.5-8.3, DO >= 64% saturation (5.4 mg/L)
GLP, protocol based on Phipps et al. (1993), ASTM E1706-95b and U.S. EPA OPPTS 850.1735
28-day LOEC (survival/reproduction, growth) > 1340 (2% OC) or 1272 (5% OC) mg/kg dw of sediment
28-day NOEC (survival/reproduction, growth)>= 1340 (2% OC) or 1272 (5% OC) mg/kg dw of sedimenta
28-day EC50 (survival/reproduction, growth) > 1340 (2% OC) or 1272 (5% OC) mg/kg dw of sediment

For 2% TOC study:
average individual dry weights for treatments statistically lower than in control; not considered treatment-related by authors, as average biomass in treatments comparable to control
Great Lakes Chemical Corporation 2001a,b
RabbitOBDE (Saytex 111):
0.2% pentaBDE
8.6% hexaBDE
45.0% heptaBDE
33.5% octaBDE
11.2% nonaBDE
1.4% decaBDE
(Breslin et al. 1989)
Days 7-19 of gestationBy gavage: 0, 2.0, 5.0 and 15 mg/kg bw per day26 New Zealand White rabbits per treatment
offspring examined on day 28 of gestation
no evidence of teratogenicity
LOAEL (maternal, increased liver weight, decreased body weight gain) = 15 mg/kg bw per day
NOAEL (maternal) = 5.0 mg/kg bw per day
LOAEL (fetal, delayed ossification of sternebrae) = 15 mg/kg bw per day
NOAEL (fetal) = 5.0 mg/kg bw per day
Breslin et al. 1989
Eisenia fetida adult earthwormDBDE:
97.90% decaBDE
28 and 56 daysNominal soil concentrations: 0, 312, 650, 1260, 2500 and 5000 mg/kg soil dw
Mean measured concentrations: DL, 320, 668, 1240, 2480 and 4910 mg/kg dw
artificial sandy loam soil: 69% sand, 18% silt, 13% clay, 8% TOM, 4.7% TOC, pH adjusted to 6.0 ± 0.5, 60% moisture content, 26% water holding capacity28-day LOEC (survival) > 4910 mg/kg dry soil (mean measured)
28-day NOEC (survival) >= 4910 mg/kg dry soil (mean measured)a
28-day EC10, EC50 (survival) > 4910 mg/kg dry soil (mean measured)
56-day LOEC (reproduction) > 4910 mg/kg dry soil (mean measured)
56-day NOEC (reproduction) >= 4910 mg/kg dry soil (mean measured)a
56-day EC10, EC50 (reproduction) > 4910 mg/kg dry soil (mean measured)
ACCBFRIP 2001cs
Lumbriculus variegatus adultDBDE:
97.3% decaBDE
2.7% other (not specified)
(composite from three manufacturers)
28 daysNominal: 0, 313, 625, 1250, 2500 and 5000 mg/kg dw of sediment
Mean measured: (i) 2.4% OC: < 1.16, 291, *, *, 2360 and 4536 mg/kg dw; (ii) 5.9% OC: < DL, 258, *, *, 2034 and 3841 mg/kg dw
* 625 and 1250 mg/kg concentrations were not measured
80 animals per treatment
flow-through using filtered well water, hardness 128-132 mg/L as CaCO3
two trials with different artificial sediments: (i) 6% silt, 9% clay, 85% sand, 2.4% TOC, water holding capacity 9.3%, 23 ± 2 C, pH 7.7-8.6, DO >= 36% saturation (3.1 mg/L); (ii) 6% clay, 14% silt, 80% sand, 5.9% TOC, water holding capacity 13.9%, 23± 2 C, pH 7.7-8.6, DO >=56% saturation (4.8 mg/L)
gentle aeration from day 7 to test end
GLP, protocol based on Phipps et al. (1993), ASTM E1706-95b and U.S. EPA OPPTS 850.1735
28-day NOEC (survival/reproduction, growth) >= 4536 (2.4% OC) or 3841 (5.9% OC) mg/kg dw of sedimenta
28-day LOEC (survival/reproduction, growth) > 4536 (2.4% OC) or 3841 (5.9% OC) mg/kg dw of sediment
28-day EC50 (survival/reproduction, growth) > 4536 (2.4% OC) or 3841 (5.9% OC) mg/kg dw of sediment
ACCBFRIP 2001a,b
RatDBDE (Dow-FR-300-BA):
77.4% decaBDE
21.8% nonaBDE
0.8% octaBDE
30 daysIn diet: 0, 0.01, 0.1 and 1.0% (nominal or measured not specified)
Dosage approximately equivalent to 0, 8, 80 and 800 mg/kg bw per day
5 male Sprague Dawley rats per treatment2" LOAEL (enlarged liver, thyroid hyperplasia) = 80 mg/kg bw per day
NOAEL = 8 mg/kg bw per day
Norris et al. 1974

Abbreviations used: ASTM = American Society for Testing and Materials; DL = detection limit; DO = dissolved oxygen; EC50 = median effective dose; EPA = Environmental Protection Agency; GLP = Good Laboratory Practice; LC50 = median lethal dose; LOAEL = Lowest-Observed-Adverse-Effect Level; LOEC = Lowest-Observed-Effect Concentration; NOAEL = No-Observed-Adverse-Effect Level; NOEC = No-Observed-Effect Concentration; OC = organic carbon; OECD = Organisation for Economic Co-operation and Development; OPPTS = Office of Prevention, Pesticides and Toxic Substances; TOC = total organic carbon; TOM = total organic matter; TSCA = Toxic Substances Control Act
a Study identified that the highest concentration (or dose) tested did not result in statistically significant results. Since the NOEC or NOAEL could be higher, the NOEC or NOAEL are described as being greater than or equal to the highest concentration (or dose) tested.

Table 7 (1 of 2): Summary of Data Used in Risk Quotient (Q) Analysis of PBDEs
Commercial
Products
Pelagic organismsBenthic organisms
EEV a
(µg/L)
CTVb
(µg/L)
AFcENEV
(µg/L)
Q
(EEV/
ENEV)
EEV d
(mg/kg dw)
CTVe
(mg/kg dw)
AF cENEV
(mg/kg dw)
Q
(EEV/
ENEV)
PeBDE2 × 10 -45.31000.0534 × 10 -31.43.11000.03145.2
OBDE2 × 10 -41.71000.0170.013.0313401009.110.33
DBDENANANANANA3.1945361007610.04

 

Table 7 (2 of 2): Summary of Data Used in Risk Quotient (Q) Analysis of PBDEs
Commercial
Products
Soil organismsWildlife consumers
EEV f
(mg/kg dw)
CTVg
(mg/kg dw)
AF cENEV
(mg/kg dw)
Q
(EEV/
ENEV)
EEVh
(mg/kg
ww)
CTVi
(mg/kg
food ww)
AF jENEV
(mg/kg
ww food)
Q
(EEV/
ENEV)
PeBDE0.035-0.070161000.27m0.13-0.261.2508.410000.0084149
OBDE0.03-0.0614701006.3m0.005-0.010.32562.910000.065.4
DBDE0.31-0.62491010021m0.02-0.030.03>33610000.3360.09

a Stapleton and Baker (2001).
b CMABFRIP (1997d, 1998).
c AF (application factors): 10 applied for extrapolation from laboratory to field conditions, intraspecies and interspecies variations in sensitivity; 10 applied because components of PeBDE and OBDE are bioaccumulative and persistent.
d PeBDE: Due to a lack of empirical data characterizing PeBDE sediment concentrations in Canada and due to uncertainty in concentrations throughout North America, data from Sweden were used as a surrogate for Canadian data. Concentrations of PeBDE-related components (tetraBDE and pentaBDE) totalled 1.4 mg/kg dw in sediments from Sweden in a heavily industrialized area downstream from a polymer processing site involved with the production of circuit boards (Sellström 1996). This value is used as the EEV. Although climate and local hydrological regimes may be different in the two countries, polymer processing facilities also exist in Canada. The European Union risk assessment of PeBDE also used this value to assess local risk from a polyurethane production site (European Communities 2000). OBDE: PBDEs found in OBDE are very poorly characterized in North America. Therefore, measured OBDE concentrations from Europe were used as a surrogate for Canadian data. Concentrations of OBDE up to 3.03 mg/kg dw have been reported for sediments in the UK downstream of a warehouse facility. This value is used as the EEV (Environment Agency 1997; European Communities 2002a,b). DBDE: There has been insufficient sampling conducted to properly characterize DBDE concentrations in sediments in North America. Concentrations of DBDE in UK sediments up to 3.19 mg/kg dw were determined, with the highest concentration located near a foam manufacturer downstream of a wastewater treatment plant (Law et al. 1996; Allchin et al. 1999). As a surrogate for the Canadian environment, this value is taken as the EEV.
e Great Lakes Chemical Corporation (2000a, 2001a,b); ACCBFRIP (2001a,b).
f Due to the lack of measured data, the EEVs were estimated for tilled agricultural soil and pastureland based on the equation (Bonnell Environmental Consulting 2001): EEVsoil = (Csludge × ARsludge × T) / (Dsoil × BDsoil) where:
EEVsoil = EEV for soil (mg/kg);
Csludge = concentration in sludge (mg/kg);
ARsludge = application rate to soils (kg/m2 per year, default value = 0.5);
Dsoil = sludge is mixed in soil to a depth of 0.2 m (depth of tillage) in agricultural soils and 0.1 m in pastureland (European Communities 1994);
BDsoil = bulk density of soil (kg/m3, default value = 1700); and
T = number of years sludge is applied to soils (assumed 10 years).
This equation assumes the following:
no PBDE loss due to erosion;
no PBDE transformation (including transformation of highly brominated PBDEs to tetra- to hexaBDE congeners);
no PBDE input from atmospheric deposition; and
no background PBDE accumulation in the soil. In order to calculate the EEVs for PeBDE, a concentration of 2.380 mg/kg dw (total tetraBDE, pentaBDE and hexaBDE) reported in biosolids from a California wastewater treatment facility was used (La Guardia et al. 2001). The EEVs for OBDE were calculated using measured PBDE concentrations (total of hexaBDE, heptaBDE and octaBDE) of 2.08 mg/kg dw in biosolids reported by La Guardia et al. (2001). This biosolids sample was taken from a Massachusetts wastewater treatment facility. To calculate the EEVs for DBDE, a PBDE concentration of 21.22 mg/kg dw (total of nona- and decaBDE) in biosolids was used. This concentration was also reported for a Massachusetts wastewater treatment facility biosolid sample (La Guardia et al. 2001).
g Great Lakes Chemical Corporation (2000b, 2001c); ACCBFRIP (2001c).
h Johnson and Olson (2001); Allchin et al. (1999); Sellström et al. (2001); Lindberg et al. (2003). PeBDE: Johnson and Olson (2001) measured a total PBDE (i.e., BDEs 47, 99, 100, 153 and 154) concentration of 1250 µg/kg ww in mountain whitefish from the Spokane River in an area receiving drainage from urbanized areas. No sources other than those typically associated with urbanization (e.g., sewage discharge and urban runoff) are known to exist upstream of the sampling sites (Johnson, pers. comm. 2003). Although these data are from the United States, such a scenario could exist in Canada, and therefore, the concentration 1250 µg/kg ww in mountain whitefish is used as the EEV. OBDE: Due to very limited sampling for PBDEs found in OBDE in Canadian biota, the concentration of OBDE of 325 µg/kg ww in dab from the River Tees, UK, was used as the EEV (Allchin et al. 1999). Although this concentration was determined in liver tissues, it was assumed to equal the concentration of OBDE on a whole body basis. DBDE: There is also a similar lack of data characterizing PBDEs found in DBDE in Canadian biota. DBDE was detected in 18 of 21 analyzed eggs of peregrine falcons (Falco peregrinus) from Sweden, at concentrations from 28 to 430 µg/kg lipid weight (lw) (Sellström et al. 2001; Lindberg et al. 2003). The value 430 µg/kg lw (or 0.43 mg/kg lw) will be used as the EEV. Since the mean lipid content of these 21 eggs was 5.94% (de Wit 2003), the EEV is converted to 0.03 mg/kg ww.
i Studies reporting dietary or oral exposure were used for the evaluation of secondary poisoning. The results of these studies are usually expressed as a concentration in food (mg/kg) or a dose (mg/kg body weight [bw] per day) causing low or no observed effects. For derivation of a CTVfood and ENEVfood, the results were expressed as a concentration in food (in units mg/kg food), requiring information on the effect level (CTVtotal daily intake, mg/kg bw per day) in units of daily food intake (DFI, kg ww/day) and body weight (bw, kg ww) for the receptor species being considered. CTVfood = (CTVtotal daily intake × bw) / DFI. This equation assumes that all substance is exposed via food, and that the substance is completely bioavailable for uptake by the organism. There are no available data characterizing the toxicity of PBDEs to wildlife species; therefore, data derived using rodents and rabbits were used as surrogates. Interspecies scaling using data for a typical adult mink was used to extrapolate to determine a food concentration protective of this species. This calculation involved the use of a typical adult body weight (i.e., 0.6 kg) and daily food ingestion rate (0.143 kg ww/day) of a female American mink (Mustela vison) (CCME 1998). References for toxicity data used in the calculation of the CTVfood include Great Lakes Chemical Corporation (1984), Breslin et al. (1989) and Norris et al. (1974).
j To derive the ENEVs, the CTVs were divided by a factor of 10 to account for extrapolation from laboratory to field conditions, a factor of 10 to extrapolate from a rodent to a wildlife species and a further factor of 10 since components of PeBDE and OBDE are bioaccumulative and persistent, and DBDE congeners are persistent and there is a weight of evidence indicating debromination to bioaccumulative PBDEs.
k Not applicable. An ENEV was not derived for pelagic organisms and a risk quotient analysis was not conducted. Based on the available DBDE studies and the toxicity of other less brominated PBDEs, it was considered very unlikely that effects for DBDE will be observed in aquatic organisms up to the substance's water solubility limit.
l Adjusted to 4% organic carbon.
m Adjusted to 2% organic carbon.

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