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Ecological Screening Assessment Report on Perfluorooctane Sulfonate, Its Salts and Its Precursors that Contain the C8F17SO2 or C8F17SO3, or C8F17SO2N Moiety

Appendix 5: Risk Quotients for PFOS

Appendix 5: Risk Quotients for PFOS Comparing Concentrations in South Hudson Bay Polar Bears to Effects in Laboratory Mammal Toxicity
Test Organism/ Study TypeReferenceEffectCritical
Effect
Level
Concen-
tration
in Serum
(CTV)
(mg.L-1
Serum)
Concen-
tration
in Liver
at
Critical
Effect
(CTV)
(µg.kg-1
ww Liver)
AFFootnote aENEV
(ug.kg-1
Liver)
EEVFootnote b
(µg.kg-1 Liver)
Q
(EEV/
ENEV)
Rat receiving 0, 0.5, 2, or 5 ppm PFOS-K salt in diet for 104 weeks (2 years)Covance 2002 Microscopic changes in liverLOEL (m/f)= 2.0 ppm diet (0.06 to 0.23 mg.kg-1 bw/d)13.9 mg.L-140 800 (40.8 µg.g-1)1004083 7709.24
Monkeys administered
0.03, 0.15, 0.75 mg.kg-1
bw/d PFOS for 26 weeks
Covance Labs 2002aThymic atrophy, reduced
serum HDLP, cholesterol, triiodot-
yhronine,
total bilirubin
LOEL (m/f) = 0.03
mg.kg-1 bw/d
14.5 mg.L-119 800 (19.8 µg.g-1)1001983 77019.04
2 Generation- rat

F0 dosing 0.1, 0.4, 1.6, 3.2 mg.kg-1 bw/d; oral gavage males: from 6 weeks before, to end of mating. Females: from 6 weeks before mating through to the 21st day of lactation (DL21).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F0 males:
reduced body weight gains
F0 male:
NOEL = 0.1 mg.kg-1 bw/d
10.5 mg.L-184 900 (84.9 µg.g-1)108 4903 7700.44
2 Generation- rat

F0 dosing 0.1, 0.4, 1.6, 3.2 mg.kg-1 bw/d; oral gavage males: from 6 weeks before, to end of mating. Females: from 6 weeks before mating through to the 21st day of lactation (DL21).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F0 males:
reduced body weight gains
F0 male:
LOEL = 0.4 mg.kg-1 bw/d
45.4 mg.L-1176 000 (176
µg.g-1)
404 4003 7700.85
2 Generation- rat

F0 dosing 0.1, 0.4, 1.6, 3.2 mg.kg-1 bw/d; oral gavage males: from 6 weeks before, to end of mating. Females: from 6 weeks before mating through to the 21st day of lactation (DL21).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F0 female:
reduced body weight gains during precoh-
abitation
F0 female:
NOEL = 0.4 mg.kg-1 bw/d
18.9 mg.L-158 000 (58 µg.g-1)105 8003 7700.65
2 Generation- rat

F0 dosing 0.1, 0.4, 1.6, 3.2 mg.kg-1 bw/d; oral gavage males: from 6 weeks before, to end of mating. Females: from 6 weeks before mating through to the 21st day of lactation (DL21).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F0 female:
reduced body weight gains during precoh-
abitation
F0 female:
LOEL = 1.6 mg.kg-1 bw/d
82 mg.L-1184 000 (184 µg.g-1)4018 4003 7700.2
2 Generation- rat

F1: 0.1, 0.4 mg.kg-1 bw/d; oral gavage males: from 22 days after birth to the end of mating (started 90 days after birth). Females: from 22 days after birth through to DL 21 (for F2).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F1: significantly reduced litter sizes and both viability and lactation indices. Reductions in development including delayed eye opening, surface righting, pinna unfolding and air righting reflex.F1:
NOEL = 0.4 mg.kg-1 bw/d
NA57.6 ppm105 760 (5.76 pm)3 7700.65
2 Generation- rat

F1: 0.1, 0.4 mg.kg-1 bw/d; oral gavage males: from 22 days after birth to the end of mating (started 90 days after birth). Females: from 22 days after birth through to DL 21 (for F2).
Argus Research Lab 2000 #418-008 (also cited as US EPA OPPT AR-226 0569)F1: significantly reduced litter sizes and both viability and lactation indices. Reductions in development including delayed eye opening, surface righting, pinna unfolding and air righting reflex.F1:
LOEL = 1.6 mg.kg-1 bw/d
NA70.4 ppm401 760 (1.75 ppm)3 7702.14
Rat-Oral gavage 42 days precoh-
abitation to day
21 of lactation; cross fostering study. Doses 0 and 1.6 mg.kg-1 bw/d
Argus Research Lab 2000 #418-014Maternal: LOEL decrease in body weight gain, reduced gestation time, delivery time and litter size Offspring: LOEL increased mortality, reduced body weight, increased hepatocyte peroxisomes, increased type II pneumo cytes and lamellar bodies in the lung.Maternal LOEL at dose 1.6 mg.kg-1 bw/d Offspring LOEL at maternal dose of 1.6 mg.kg-1 bw/d (level in liver of offspring at this dose was 70.4 µg.g-1= 70 400 µg.kg-1 from study ARL 418-008) 70 400 (70.4 ppm)401 7603 7702.14

Footnotes

Footnote A

AF of 10 applied for interspecies variability and lab-to-field extrapolation,  multiplicative with generic factor of 10 for extrapolation from LOECto NOEC OR study specific factor of 4 where study information was available.

Return to footnote a referrer

Footnote B

EEV is maximum concentration of PFOS in Canadian polar bears, South Hudson Bay.

Return to footnote b referrer

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