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Proactive Disclosure

Proactive Disclosure

## Environmental and Workplace Health

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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 1

Environmental media (indirect exposure)
Air

- based on the maximum

total concentration of NP (0.070 μg/m 3 ) 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

m 3/day by an average Canadian adult weighing 70.9 kg (EHD, 1998) 0.00 0 016 - NPEs are much less

volatile and would not be expected to partition appreciably to air 7.5 × 10 5

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 El mira 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 dri nking water in very limited sampling from other countries were much lower (Section 2.3.3.7) 3.1× 10

Soil

- based on content of 0.000

- levels in sludge

- 4.8× 10NP+NP1EO+NP2EO in soil immediately after application of sewage sludge in Switzerland (5.9 mg/kg) (Marcomini et al., 1989)

- ass umes mean intake of 30 mg/day of soil by an adult weighing 70.9 kg (EHD, 1998) 002 5 amended soil in other studies are somewhat lower

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 containi ng 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 0.017

- these data do not include NPE

- no information on whether samples were in contact with 698collected at a Toronto market (0.53 mg/kg) (Ramarathnam et al., 1993)

- assumes a total consumpti on 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) 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)
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 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) 857reportedly 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) 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 m oisturizer 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 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 3.2 × 10 3(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) quantitatively account for this probable difference

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

- a ssumes 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% withi n 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 8Laundry 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/cm 3 , 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

cm 2 (Health Canada, 1995)

- body weight of 70.9 kg is assumed for an ave rage Canadian adult (EHD, 1998) [(0.28) (1.13 g/cm 3 ) (1/7 days) (1/540) (4.99 × 10

- 3 cm) (1547 cm 2) (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 i n 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 liqui d 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/cm 2 (Versar Inc., 1986)

- the exposed surface area (whole body minus head and hands) is assumed to be 16 015 cm 2 (Health Canada, 1995)

- body weight of 70.9 kg is assumed for an average Canadian adult (EHD, 1998) 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× 10[(0.28) (1/day) (0.1) (4 × 10

- 5 mg/cm 2) (16 015

cm 2)] / (70.9 kg)
Household cl eaner 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

m 3, a breathing rate of 1.3 m 3/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 hou r) (0.04) (1.3

m 3/hour) (360/365 days)] / (70.9 kg) ( 20 m 3 ) 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 cm 2 (both palms), a product density of 0.88 g/cm 3 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 cm 2) (0.88 g/cm 3 ) (2.1 × 10

- 3 cm) (1000 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 21mg/g)] / (70.9 kg)
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 cm 2 (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/cm 3 (Versar Inc., 1986)

- body weight of 7 0.9 kg is assumed for an average Canadian adult (EHD, 1998) [(0.03) (7/365 days) (220

cm 2) (9.81 × 10

- 3 cm) (1240 mg/cm 3 )] / (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)

- assumi ng 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

m 3, a breathing rate of 1.3 m 3/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

m 3/hour) (1/365 days)] / (70.9 kg) (20 m 3 ) 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) 0.0013

- assu mes that the NP/NPEs are absorbed across the skin to the same extent as 2.1× 10- assuming an event frequency of 1 event per year, an exposed surface area of 190 cm 2 (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/cm 3 (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/cm 3 ) (190 cm 2) (6.55 × 10

- 3 cm) (1000 mg/g)] / (70.9 kg) 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 differen ce

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 1 2 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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