Document ID: EPA-HQ-OPPT-2010-0571-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-09-01T04:00Z

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Priority Substances List Assessment Report for Nonylphenol and its
Ethoxylates

3.0 Assessment of "Toxic" under CEPA 1999

3.3.1 Estimates of potential exposure to nonylphenol and its ethoxylates

Table 14 Reasonable worst-case/bounding estimates of intake of NP and
NPEs by adult Canadians

Exposure medium	Assumptions	Estimated

intake

(mg/kg-bw

per day)	Comments	Margin of

exposure   HYPERLINK
"http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl2-lsp2/nonylphenol
/nonylphenol_t14_600-eng.php" \l "ra1" \o "Ratio of the lowest effect
level identified in a study by relevant route of exposure (LOEL of 12
mg/kg-bw per day, the lowest average dose of NP for male rats exposed in
the diet across three generations in a reproductive study, at which
renal histopathological effects were observed in each generation) (NTP,
1997; Chapin et al., 1999) to the estimated intake."  1 

Environmental media (indirect exposure)

Air	- based on the maximum total concentration of NP (0.070 µg/m3)
measured in

ambient air in coastal New York/New Jersey in 1998 (Dachs et al., 1999)

- assumes a 24-hour inhalation volume of 16.2 m3/day by an average
Canadian

adult weighing 70.9 kg (EHD, 1998)	0.000 016	- NPEs are much less
volatile and would not be expected

to partition appreciably to air	7.5 × 105

Water	- based on maximum total NP1-17EO measured in surface waters
across Canada

between 1991 and 1998 (18.25 µg/L) in Canagagigue Creek upstream of
Elmira

wastewater control plant in Ontario (Bennie, 1998b)

- assumes mean consumption of 1.5 L/day of tapwater consumed as drinking

water plus that added to beverages by an average Canadian adult weighing
70.9

kg (EHD, 1998)	0.000 39	- levels measured in drinking water in very
limited

sampling from other countries were much lower

(Section 2.3.3.7)	3.1× 104

Soil	- based on content of NP+NP1EO+NP2EO in soil immediately after
application of

sewage sludge in Switzerland (5.9 mg/kg) (Marcomini et al., 1989)

- assumes mean intake of 30 mg/day of soil by an adult weighing 70.9 kg
(EHD,

1998)	0.000 002 5	- levels in sludge-amended soil in other studies are

somewhat lower	4.8× 106

Food

 	Packaging

- based on the estimate of potential level of NP in the diet from food
contact use

of TNPP of 19.8 ppb (0.0198 mg/kg) (The Society of the Plastics
Industry, Inc.,

1998a) and of NPEs and NP in the diet from the use of NPEs in food
contact

applications of 0.504 ppm (mg/kg) and 0.89 ppb (0.000 89 mg/kg),
respectively

(The Society of the Plastics Industry, Inc., 1998b)

- assumes mean consumption of 2.3 kg food/day by an average Canadian
adult

weighing 70.9 kg (EHD, 1998)	0.017	- these are considered reasonable
worst-case estimates;

for the principal food contact polymers containing

TNPP/NPE, The Society of the Plastics Industry, Inc.

estimated the extent of migration into the diet as a whole,

based on the TNPP/NPE levels, food contact applications

and, in the case of TNPP, migration estimates from

studies that simulated or exaggerated the actual food

contact uses of the polymers (using food simulating

solvents and time and temperature conditions recommended

by the U.S. Food and Drug Administration), and,

in the case of NPE applications, assuming that 100% of

the substance migrates into food (The Society of the

Plastics Industry, Inc., 1998a,b)	706

	Monitoring

- based on the mean content of NP in duplicate samples of uncured cooked
pork

collected at a Toronto market (0.53 mg/kg) (Ramarathnam et al., 1993)

- assumes a total consumption of 2.3 kg food/day, all of which contains
the above

level of NP, by an average Canadian adult weighing 70.9 kg (EHD, 1998)
0.017	- these data do not include NPE

- no information on whether samples were in contact with

food packaging source of NP/NPEs

- estimated mean intakes via food based on simple

bioaccumulation models were much lower; based on a soil

content of 5.9 mg/kg for NP+NP1EO+NP2EO (Marcomini

et al., 1989 [summarized in previous row]), log Kow of 4.2

(approx. mean for these NP/NPEs [Section 2.0]), and

assuming the resultant levels in food apply to the food

group as a whole, estimated mean intake was 0.0015

mg/kg-bw per day based on regression models of

bioconcentration in plants and biotransfer to beef and milk

(Travis and Arms, 1988), and <0.000 40 mg/kg-bw per day

based on a fresh weight bioconcentration factor of <0.006

for whole potatoes (Danish EPA, in U.K. Environment

Agency, 1998)	698

Subsistence populations	- based on maximum content of NP+NP1EO+NP2EO in
composite sample of

muscle from three fish species (5.78 mg/kg dw in Barbus barbus) and the

content of NP+NP1EO+NP2EO in muscle of a mallard duck (3.65 mg/kg dw)

from the Glatt Valley in Switzerland (where wastewater loadings were
reportedly

quite high)

- assumes water content of 75% in fish and 67% in duck (U.S. EPA, 1997a)

- assumes country food consumption recommended for high-use Amerindian

populations of 500 g/capita per day for fish and 200 g/capita per day
for small

game (Coad, 1994), by an average Canadian adult weighing 70.9 kg (EHD,

1998)	0.014	- available data for Canada are quite limited; levels of NP

in whole body of fish from Lake Ontario were much

lower (max. 0.043 mg/kg fresh weight) (Bennie, 1998b)	857

Direct (consumer products)

Skin moisturizer	- assumes a typical quantity of product used per event
for "body lotion" of 8 g and

a maximum event frequency of 2 times per day for users only (ECETOC,
1994)

- based on the upper bound of the concentration of the range of >3 to
10% within

which the concentration of NPE in skin moisturizer falls (McIntyre,
1996; see

Table 3)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.10) (8 g) (2/day) (1000 mg/g)]/(70.9 kg)	22.6	- assumes that the
NP/NPEs contained in such "leave on"

products are absorbed across the skin to the same extent

as via the gastrointestinal tract; as discussed in the text,

dermal absorption is likely lower, although available

data are inadequate to quantitatively account for this

probable difference	0.5

Face makeup	- assumes a typical quantity of product used per event for
"foundation" of 0.265 g

and a maximum event frequency of once per day for users only (U.S. EPA,

1997b)

- based on the upper bou nd of the concentration of the range of 0.1% or
less

within which the concentration of NPE in face makeup falls (McIntyre,
1996;

see Table 3)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.001) (265 mg) (1/day)]/(70.9 kg)	0.0037	- assumes that the NP/NPEs
contained in such "leave on"

products are absorbed across the skin to the same extent

as via the gastrointestinal tract; as discussed in the text,

dermal absorption is likely lower, although available

data are inadequate to quantitatively account for this

probable difference	3.2 × 103

Deodarant	- assumes a typical quantity of product used per event for
"underarm deodorants"

of 0.52 g and a maximum event frequency of 1.29 times per day for users
only

(U.S. EPA, 1997b)

- based on the upper bound of the concentration of the range of >1 to 3%
within

which the concentration of NPE in deodorant falls (McIntyre, 1996; see
Table 3)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.03) (520 mg) (1.29/day)]/(70.9 kg)	0.28	- assumes that the NP/NPEs
contained in such "leave on"

products are absorbed across the skin to the same extent

as via the gastrointestinal tract; as discussed in the text,

dermal absorption is likely lower, although available

data are inadequate to quantitatively account for this

probable difference	43

Fragrance	- assumes a typical quantity of product used per event for
"colognes & toilet

water" of 0.65 g and a maximum event frequency of 1.71 times per day for
users

only (U.S. EPA, 1997b)

- based on the upper bound of the concentration of the range of >3 to
10% within

which the concentration of NPE in fragrances falls (McIntyre, 1996; see
Table 3)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.10) (650 mg) (1.71/day)]/(70.9 kg)	1.57	- assumes that the NP/NPEs
contained in such "leave on"

products are absorbed across the skin to the same extent

as via the gastrointestinal tract; as discussed in the text,

dermal absorption is likely lower, although available

data are inadequate to quantitatively account for this

probable difference	8

Laundry detergent	Active (from exposure while hand washing delicate
fabrics)

- based on a maximum concentration of 28% NPE in liquid laundry
detergent

(World Wildlife Fund Canada, 1997)

- assuming a frequency of use of once per week, a density of product of

1.13 g/cm3, a dilution fraction of 1:540 and a film thickness on skin of

4.99 × 10-3 cm (Versar Inc., 1986)

- the exposed surface area (2 hands and 1/4 of arms) is assumed to be
1547 cm2

(Health Canada, 1995)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.28) (1.13 g/cm3) (1/7 days) (1/540) (4.99 × 10-3 cm) (1547 cm2)
(1000 mg/g)] / (70.9 kg)	0.0091	- assumes that the NP/NPEs are absorbed
across the skin

to the same extent as via the gastrointestinal tract; as

discussed in the text, dermal absorption is likely lower,

although available data are inadequate to quantitatively

account for this probable difference	 

	Passive (exposure from detergent left on clothing, etc.)

- based on a maximum concentration of 28% NPE in liquid laundry
detergent

(World Wildlife Fund Canada, 1997)

- assuming a frequency of event of 365 days per year, a transfer factor
of 0.1 and

an amount of product deposited on fabric of 4 × 10-5 mg/cm2 (Versar
Inc., 1986)

- the exposed surface area (whole body minus head and hands) is assumed
to be

16 015 cm2 (Health Canada, 1995)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.28) (1/day) (0.1) (4 × 10-5 mg/cm2) (16 015 cm2)] / (70.9 kg)
0.00025	- assumes that the NP/NPEs are absorbed across the skin

to the same extent as via the gastrointestinal tract; as

discussed in the text, dermal absorption is likely lower,

although available data are inadequate to quantitatively

account for this probable difference	1.3× 103

Household cleaner	Inhalation

- based on a maximum concentration of 5% NPE in all-purpose spray
cleaner

(World Wildlife Fund Canada, 1997)

- assuming a mass of 76 g is used per event, a 0.47-hour duration of
exposure,

an overspray fraction of 0.04, a room volume of 20 m3, a breathing rate
of

1.3 m3/hour for an average adult during light-level activity and a
frequency of

use of 360 days per year (Versar Inc., 1986)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.05) (76 000 mg) (0.47 hour) (0.04) (1.3 m3/hour) (360/365 days)] /
(70.9 kg) ( 20 m3)	0.065	- assumes that the NP/NPEs are absorbed across
the lung

to the same extent as via the gastrointestinal tract	 

	Dermal

- based on a maximum concentration of 5% NPE in all-purpose spray
cleaner

(World Wildlife Fund Canada, 1997)

- assuming an event frequency of 360 days per year, an exposed surface
area of

400 cm2 (both palms), a product density of 0.88 g/cm3 and a film
thickness on

the hands of 2.1 × 10-3 cm (Versar Inc., 1986)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.05) (360/365 days) (400 cm2) (0.88 g/cm3) (2.1 × 10-3 cm) (1000
mg/g)] / (70.9 kg)	0.51	- assumes that the NP/NPEs are absorbed across
the skin

to the same extent as via the gastrointestinal tract; as

discussed in the text, dermal absorption is likely lower,

although available data are inadequate to quantitatively

account for this probable difference	21

Latex or oil-based paints	- based on a maximum concentration of 3% NPE
in latex paint (WHO, 1998)

- assuming an event frequency of 7 days per year, an exposed surface
area of

220 cm2 (10% of face, hands and forearms), a film thickness on the hands
of

9.81 × 10-3 cm and a product density of 1240 mg/cm3 (Versar Inc., 1986)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.03) (7/365 days) (220 cm2) (9.81 × 10-3 cm) (1240 mg/cm3)] / (70.9
kg)	0.022	- assumes that the NP/NPEs are absorbed across the

s ki n to the same extent as via the gastrointestinal

tract; as discussed in the text, dermal absorption is

likely lower, although available data are inadequate

to quantitatively account for this probable difference	545

Spray paints	Inhalation

- based on a maximum concentration of 3% NPE in paints (WHO, 1998)

- assuming a mass of 460 g is used per event, a 0.17-hour duration of
exposure,

an overspray fraction of 0.73, a room volume of 20 m3, a breathing rate
of

1.3 m3/hour for an average adult during light-level activity and a
frequency of

use of 1 event per year (Versar Inc., 1986)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.03) (460 000 mg) (0.17 hour) (0.73) (1.3 m3/hour) (1/365 days)] /
(70.9 kg) (20 m3)	0.0043	- assumes that the NP/NPEs are absorbed across
the lung

to the same extent as via the gastrointestinal tract	 

	Dermal

- based on a maximum concentration of 3% NPE in paints (WHO, 1998)

- assuming an event frequency of 1 event per year, an exposed surface
area of

190 cm2 (10% of both hands and forearms), a film thickness on the skin
of

6.55 × 10-3 cm and a product density of 0.9 g/cm3 (Versar Inc., 1986)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)

[(0.03) (1/365) (0.9 g/cm3) (190 cm2) (6.55 × 10-3 cm) (1000 mg/g)] /
(70.9 kg)	0.0013	- assumes that the NP/NPEs are absorbed across the skin

to the same extent as via the gastrointestinal tract; as

discussed in the text, dermal absorption is likely lower,

although available data are inadequate to quantitatively

account for this probable difference	2.1× 103

Spermicides	- the amount of NP9EO applied as used in contraceptive
preparations ranges from

50 to 140 mg per vaginal application (Talmage, 1994)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD,
1998)	0.71-1.97	- this is an estimated intake per event

- assumes that the NP/NPEs are absorbed across the

vaginal epithelium to the same extent as via the

gastrointestinal tract	6

1 Ratio of the lowest effect level identified in a study by relevant
route of exposure (LOEL of 12 mg/kg-bw per day, the lowest average dose
of NP for male rats exposed in the diet across three generations in a
reproductive study, at which renal histopathological effects were
observed in each generation) (NTP, 1997; Chapin et al., 1999) to the
estimated intake.

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