United States
Environmental Protection Agency

P-17-0175
Office of Chemical Safety and
Pollution Prevention

Limited Standard Review of P-17-0175
Program Manager:
Technical Integrators:
Day 90:
Management Lead:
RAD Dispo:

07/17/2017
06/21/2017

TABLE OF CONTENTS
TABLE OF CONTENTS .............................................................................................................................1
1

SUMMARY ....................................................................................................................................3

2

BACKGROUND ...............................................................................................................................4
2.1
PMN STRUCTURE AND CHEMICAL CATEGORIES ......................................................................................................4
2.2
REGULATORY HISTORY .......................................................................................................................................4
2.2.1 Why This Case is in Standard Review .......................................................................................................... 4
2.2.2 “Same-as” and Analogous Cases ................................................................................................................. 4
2.3
CHEMICAL IDENTITY ...........................................................................................................................................6
2.4
PHYSICAL/CHEMICAL PROPERTIES AND FATE INFORMATION ......................................................................................7
2.4.1 Physical / Chemical Properties .................................................................................................................... 7
2.4.2 Fate Information.......................................................................................................................................... 7
2.5
CONCERNS IDENTIFIED AT SAT ............................................................................................................................9
2.5.1 Human Health Toxicity Concerns ................................................................................................................. 9
2.5.2 Aquatic Toxicity Concerns .......................................................................................................................... 10
2.6
TOXICITY TEST DATA AVAILABLE.........................................................................................................................10

3

RELEASES AND EXPOSURES .......................................................................................................... 10
3.1
ENVIRONMENTAL RELEASES ..............................................................................................................................10
3.2
EXPOSURES ....................................................................................................................................................10
3.2.1 Exposure Routes of Concern Identified at SAT ........................................................................................... 10
3.2.2 Occupational Exposures ............................................................................................................................ 10
3.2.3 General Population Exposures ................................................................................................................... 11
3.2.4 No Consumer Exposures are Predicted ...................................................................................................... 11

4

TOXICITY / HAZARD SUMMARIES ................................................................................................. 11
4.1
4.2

5

HUMAN HEALTH SUMMARY ..............................................................................................................................11
ENVIRONMENTAL (AQUATIC) HAZARD SUMMARY .................................................................................................12

RISK ASSESSMENT ....................................................................................................................... 13
5.1
HUMAN HEALTH RISK DISCUSSION .....................................................................................................................13
5.1.1 Potentially Exposed or Susceptible Populations ........................................................................................ 13

 Limited Standard Review of P-17-0175
5.1.2 Effects Level Used to Assess Human Health Risk ....................................................................................... 13
5.1.3 Occupational Risk Discussion..................................................................................................................... 13
5.1.4 General Population Risk Discussion ........................................................................................................... 14
5.2
ENVIRONMENTAL (AQUATIC) RISK DISCUSSION .....................................................................................................15

6

CONCLUSIONS ............................................................................................................................. 16
6.1
HUMAN HEALTH CONCLUSIONS .........................................................................................................................16
6.1.1 Occupational Health Conclusion ................................................................................................................ 16
6.1.2 General Population Health Conclusions .................................................................................................... 16
6.2
RECOMMENDATIONS .......................................................................................................................................16
6.2.1 Fate Testing Recommendations ................................................................................................................ 16
6.2.2 Human Health Recommendations............................................................................................................. 17
6.2.2.1

7

Potential Testing for Other Possible

Degradation Products ............................................... 17

REFERENCES ................................................................................................................................ 17

TABLES
Table 1. General Population Risk from Drinking Water Ingestion Exposures ............................................. 15
FIGURES
Figure 1. Structure of P-17-0175...................................................................................................................... 4
Figure 2. Potential Degradation Pathways for P-17-0175 ............................................................................... 9
P-17-0175 LIST OF ATTACHMENTS
Chemistry Report 04/13/2017 ...................................................................................................................... A-1
Focus Report 04/24/2017 .............................................................................................................................. A-3
Fate SR P-17-0175 05/08/2017 ...................................................................................................................... A-9
Fate SR P-17-0175 pathway diagram 05/08/2017 ......................................................................................... A-13
SAT Report 04/14/2017 ................................................................................................................................. A-14
Engineering Report 04/17/2017 .................................................................................................................... A-18
Exposure Report 04/21/2017 ........................................................................................................................ A-26
Toxicity Studies TABLE 2015 ............................................................................................... A-27
Preliminary
Hazard Profile for PMNs
Only 2015/07/01 updated 2017/05/02 NO NEW DATA
....................................................................................................................................................................... A-31
Final Ecotoxicity SR Memo P-17-0175 05/22/2017 ....................................................................................... A-46
RAD SOP
MOE Extrapolation Factors DD Signed 12/22/2015 ............................................................ A-49
Scaling Factors for Drinking Water RAD Exposure Tech Team 07/13/2016 .................................................. A-50

Standard Review Team for P-17-0175
Assignment
Branch

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Staff

Phone

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1 SUMMARY
BACKGROUND
P-17-0175 is a
fluorinated polymer with
(
identified as a degradation product of concern (structure on page 4). The PMN will be imported for
Processing at 1 site and Used at 800 unknown sites as a leveling agent for coatings applied to aluminum
printing plates. Human health concerns were low for the intact PMN but high for the degradation product.
Aquatic toxicity and aquatic risk are predicted to be low for the intact PMN. Workers can be exposed by
the dermal route however there are no inhalation exposures. The general population can be exposed by
ingestion of drinking water. The intact PMN is predicted to degrade at a very slow rate (decades to
centuries) and release
(see degradation pathway diagram on page 9).
ASSESSMENT APPROACH
As a worst case a
oral toxicity LOAEL of 10 mg/kg-bw/day for reduced body weight in males from an
oral 90-day study in rats is used to assess health risk. The acceptable Margin of Exposure (MOE) is
adjusted using
data in humans (see attached file “RAD SOP
MOE Extrapolation Factors” for
explanation of adjustment).
UNCERTAINTIES
The General Population assessment is a worst case assessment assuming that
can be released from
the intact PMN prior to any potential drinking water exposures however this degradation is likely to take
decades. Based on the potential degradation pathways shown in Figure 2 on page 9 the likelihood of
general population exposure to
is not high.
RISK CONCLUSIONS
Occupational risk for systemic effects to unprotected workers who are exposed during Processing for up
to 4 hours per incident via the dermal route is NOT supported as discussed in section 5.1.3 on page 13.
will not be released from the intact PMN during the 4-hour dermal exposure duration.
General Population risk for systemic effects from exposure via drinking water ingestion to
released
from the intact PMN is NOT supported. As noted in section 5.1.4 on page 14 it is unlikely that the intact
PMN will be degraded and release
and expose the general population via ingestion of drinking
water.
RECOMMENDATIONS
Testing
Tiered fate testing is recommended and discussed in section 6.2.1 on page 16.
Additional testing of the PMN or potential degradation product of concern,
will not be useful to
assess potential risk of the PMN substance. Identification (as mentioned in Fate Testing above) and testing
of any other potential degradation products
may be useful.

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2 BACKGROUND
2.1

PMN Structure and Chemical Categories

Per the Chemistry Report dated 04/13/2017 (attached) the structure of the PMN substance is shown
below. The Focus Report dated 04/24/2017 (attached) states that the PMN fits the Ecotox Chemical
Category of Non-ionic Polymers.
Figure 1. Structure of P-17-0175
Chemical Categories
The PMN substance fits the following TSCA New
Chemical Categories as described in the TSCA New
Chemicals Program Chemical Categories Report at
http://www.epa.gov/oppt/newchems/pubs/npcchemi
calcategories.pdf.
Health Chemical Category
None
Ecotox Chemical Category
Non-ionic Polymers
Ecotox SAR
Non-ionic Polymers

2.2

Regulatory History

Submitter:
RAD Dispo Date:
Day 90:

Agfa Corporation, DIC International (USA) LLC
06/21/2017, 11 am
07/02/2017

2.2.1 Why This Case is in Standard Review
Per the Focus Report dated 04/24/2017 (attached) P-17-0175 was put into a limited standard review for
fate and human health and ecotoxicity concerns based on
(
and
for the degradation product. For the PMN there is concern for lung toxicity by waterproofing of
lung membranes. For the potential incomplete incineration product, based on test data for the analog
concerns are liver toxicity, blood toxicity, and male reproductive toxicity.

2.2.2 “Same-as” and Analogous Cases

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.

.

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2.3

Chemical Identity

Per the Chemistry Report dated 04/13/2017 (attached) the following identity information is provided on
the PMN substance.
Chem. Name

CASRN
Trade Name
MWs
PV (kg/yr)
Intended Use
(per Submission)
Other Uses (per
ICB CCD)
P2 Claim
Mfg &/or Import
PBT Calls
SAT Ratings
Physical States
Neat
Mfg
Processing
End Use

60
Leveling agent for coatings applied to aluminum printing plates.

None provided
Imported
PMN P3 B1 T1,
PMN HH 1-2, Eco 1;
Liquid
Not Known (Imported)
Solution, 0.15% PMN material in coating formulation
Solid: PMN substance entrained within dried/cured coating

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2.4

Physical/Chemical Properties and Fate Information

When acceptable measured physical / chemical and fate data are available those data are used to describe
the chemical. Estimations are used if no data are available. Estimations can be made using predictive
methods like EPISuite™ (https://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation-programinterface) or can be based on professional judgment by analogy to chemicals of the same class. This high
molecular weight polymer is not appropriate for evaluation using EPISuite™. Estimations are based on
professional judgment and properties of analogous materials.

2.4.1 Physical / Chemical Properties
Based on professional judgment and properties of similar high molecular weight fluorinated polymers, the
PMN substance is estimated to be non-volatile (VP <0.000001 Torr), insoluble in water (Water Soluble
<0.000001 g/L, and have a high boiling point (>500 OC).

2.4.2 Fate Information
The following fate information, along with the potential degradation pathways diagram (Figure 2) was
provided by the Fate Assessor for this case (Standard Review Fate P-17-0175, and Standard Review Fate P17-0175 pathway diagram 05/08/2017 both attached).
Fate of the PMN in Wastewater Treatment
There were no data submitted on the fate of the PMN substance in wastewater treatment. Due to its high
molecular weight and negligible water solubility it is expected to be highly removed in biological
wastewater treatment by adsorption to sludge with little removal by volatilization of biodegradation (90%
removal estimated).
Fate in the Atmosphere
There were no data submitted on the fate of the PMN substance in air. According to a model of
gas/particle partitioning of semivolatile organic compounds in the atmosphere, the PMN substance, which
has a estimated vapor pressure of < 0.000001 Torr (E) at 25 deg C, is expected to exist solely in the
particulate phase in the ambient atmosphere. Particulate‐phase PMN may be removed from the air by wet
and dry deposition.
Fate in Water
There were no data submitted on the fate of the PMN substance in water. Based on its high molecular
weight and negligible water solubility, the PMN is expected to adsorb very strongly to suspended solids
and sediment. Based on its low volatility, volatilization from water surfaces is not expected to occur. Based
on the general observations on biodegradability of high molecular weight synthetic organic polymers, the
PMN is expected to biodegrade very slowly in the environment with a half‐life of greater than months.
Fate in Soil
Data on fate of the PMN substance in soil (activated sludge) were submitted. Based on its high molecular
weight and low water solubility, the PMN is expected to adsorb very strongly to soil with negligible
migration to groundwater. Volatilization of the PMN from moist soil surfaces is not expected to be an
important fate process given its very low vapor pressure and water solubility. Based on the general
observations on biodegradability of high molecular weight synthetic organic polymers, measured data for
the PMN (OECD 301C (MITI): 4%/28d NRB) the PMN is expected to biodegrade very slowly in the
environment with a half‐life of greater than months.

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Persistence
Neither biotic nor abiotic environmental transformation processes are expected to result in significant
rates of degradation of the PMN. Based on its structure the PMN is expected to have high persistence with
an environmental half life of greater than months (P3). However, it is possible that over a longer period of
time, the PMN substance could biodegrade, to release
Biodegradation has been observed with
other
with half lives in the order of decades

The rates and pathways appear to be influenced by environmental conditions,
presence of co‐substrates and microbial population.
ENVIRONMENTAL FATE OF PERFLUORO DEGRADATION PRODUCTS
There is a substantial body of evidence supporting the very long (decades to centuries or longer) half-lives
of many perfluoro-containing chemicals in environmental compartments. Numerous published articles
and extensive monitoring results demonstrate that these compounds degrade very slowly. As discussed on
EPA's Internet site "Risk Management for
under TSCA"1 EPA is
particularly concerned about
These are persistent in the
environment, bioaccumulative in wildlife and humans, and are toxic to laboratory animals and wildlife,
producing reproductive, developmental, and systemic effects in laboratory tests.

1

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Figure 2. Potential Degradation Pathways for P-17-0175

2.5

Concerns Identified at SAT

Per the SAT Report dated 04/14/2017 (attached) the following human health and aquatic toxicity concerns
were identified for the PMN substance.

2.5.1 Human Health Toxicity Concerns
Per the Human Health Report as incorporated into the SAT Report dated 04/14/2017
(attached) For the PMN there is concern for lung toxicity by waterproofing of lung
membranes. For the potential incomplete incineration product, based on test data for
the analog
(
right), concerns are liver toxicity, blood
toxicity, and male reproductive toxicity.
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2.5.2 Aquatic Toxicity Concerns
Per the Ecotox Report as incorporated into the SAT Report dated 04/14/2017 (attached) ecotoxicity
hazard concerns for the intact PMN substance were low based on SAR predictions for nonionic polymers,
however ecotoxicity concerns are high for effects of the potential degradation products to terrestrial wild
mammals and birds based on test data for
with potential toxicity to
terrestrial mammals. Potential risks to the environment for the intact PMN were low based on the
predicted low ecotoxicity hazards. Potential risks to the environment from the degradation product
cannot be quantified.

2.6

Toxicity Test Data Available

No human health or aquatic toxicity test data were submitted with the PMN

Toxicity data for the degradation product of concern,
potential human health risk of the PMN.

were used to assess

3 RELEASES AND EXPOSURES
3.1

Environmental Releases

Per the Engineering Report dated 04/17/2017 (attached) the following environmental releases are
predicted for P-17-0175.
PROCESSING: Coating for Optical Fibers, 1 unknown site, 24 d/yr
Cleaning Liquid Residuals from Bottles Used to Transport the Raw Material
Uncertain media: Water or Incineration or Landfill
High End: 0.015 kg/site-day over 24 ds/yr from 1 site
Equipment Cleaning
Incineration:
Conservative: 0.05 kg/site-day over 24 days/yr from 1 site
USE: Printing Plate Use, 800 unknown sites, 240 d/yr
Losses during development: Submission estimates 37.5% of coating is removed during development and
sent to POTW following pH correction (5-9) and some solids removal (settling).
Water following POTW treatment at 90% removal rate
Output 2: 0.00012 kg/site-day over 240 days/yr from 800 sites

3.2

Exposures

3.2.1 Exposure Routes of Concern Identified at SAT
The SAT Report dated 04/14/2017 (attached) identified dermal, inhalation, and ingestion as routes of
concern for human health risk.

3.2.2 Occupational Exposures
Per the Engineering Report dated 04/24/2017 the only occupational exposures are via dermal contact, as
listed below. The PMN is imported and there is no Manufacturing scenario.

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PROCESSING: Coating for Optical Fibers, 1 unknown site, 24 d/yr, 56 workers
ONLY DERMAL EXPOSURES
Inhalation exposures to dried plate coating are not expected based on past cases.
Dermal: Unloading Liquid Raw Material from Transport Containers (Bottles), Exposure to Liquid at
30% concentration
High End Potential Dose Rate: 530 mg/day over 24 days/yr
USE: Printing Plate Use, 800 unknown sites, 24 days/yr
NO EXPOSURES
Inhalation exposures to dried plate coating are not expected based on past cases.
Dermal exposures not expected because the PMN arrives in the dried coating; EPA also assumes
workers are not exposed to the spent developer solution.

3.2.3 General Population Exposures
Per the Exposure Report dated 04/21/2017 (attached) the general population can be exposed via
ingestion of drinking water during the Processing and Use scenarios as shown below. There are no
inhalation exposures (releases were below modeling thresholds) or fish ingestion exposure (PMN has a
low bioaccumulation potential, BCF < 280).
PROCESSING: Coating for Optical Fibers, 1 unknown site
Adult ADR 0.00000427 mg/kg/day
USE: Printing Plate Use, 800 unknown sites
Adult ADR 0.0000000342 mg/kg/day

3.2.4 No Consumer Exposures are Predicted

4 TOXICITY / HAZARD SUMMARIES
4.1

Human Health Summary

For the Parent PMN
Per the Human Health Report as incorporated into the Focus Report, the predicted absorption of the
parent PMN is nil all routes based on physical /chemical properties of high molecular weight polymers.
For the Potential Degradant
Exposures are assessed using data for
GI Tract: Absorption of

(see section 2.5).

via the oral route is good based on toxicokinetics data.

Lungs: Using an established SOP 2, EPA expects good absorption of
via the lungs based on molecular
weight (< 1000) and good solubility (> 1 g/L) by analogy to
(below), which has a water solubility of
9.5 g/L (http://www.epa.gov/sites/production/files/2014-04/documents/
factsheet_contaminant_pfos_
march2014.pdf). No solubility data for
were located.

2

EPA estimated absorption through lungs based on the 2-2-16 SOP “Making Absorption Calls in the PMN Program, which is
available on the CBI LAN at G:\RAD\RAD Procedures\Absorption Info

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Skin:

absorption through skin is likely to be poor to nil based on analogous data available for
(below), with estimated absorption of << 1%. 3

The Human Health Summary in the Focus Report dated 04/24/2017 (attached), describes uncertain
concern for waterproofing of the lungs for the PMN based on surfactancy properties if the PMN is sprayapplied, however the PMN is not spray-applied.
EPA identified similar high molecular weight fluorinated polymers having the potential perfluoro
degradation products
and
The identities of those cases are 3rd party CBI however the
evaluations of toxicity data on
and
developed for those cases are included in the
assessment of this case. Data on
showed mortality, liver, blood, kidney, and pancreas, and
potential thyroid, reproductive and developmental toxicity. Health concerns for
include liver,
blood, thyroid and nasal effects as well as reproductive and developmental toxicity. There are also
concerns for immunosuppression and oncogenicity based on data for
and
.
A table of toxicity data for
and
along with data summaries are included as attachments
to this assessment. This table was provided by the Human Health Assessor for the previous submission of
an analogous high molecular weight fluorinated polymer.
Toxicity Data Used to Assess Human Health Risks
Based on the toxicity tests described in the attached table of toxicity data for
and
EPA
used the LOAEL of 10 mg/kg-bw/day from the 90-day repeated dose oral toxicity study in rats testing
to estimate risks because the effect is considered adverse (> 10% body weight reduction) and of
the two possible degradation products
and
this value for
is the more health
conservative value.

4.2

Environmental (Aquatic) Hazard Summary

Per the Final Ecotoxicity SR Memo P-17-0175 2017-05-22 (attached) ecotoxicity hazard concerns were low
for the intact PMN, P-17-0175, based on SAR nearest analog predictions for nonionic polymers with an
average molecular weight of >1,000 g/mol, which were no effects at saturation (NES) for acute and
chronic aquatic toxicity endpoints. Ecotoxicity hazard concerns are high for effects of the potential
degradation products to terrestrial wild mammals and birds based on data testing
and
in
mammals. Hazards to aquatic organisms were not identified as a concern for the intact PMN or potential
degradation products.

3

Absorption Email & Memo for an analog,

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RAD, AB1 10/16/2015 attached

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5 RISK ASSESSMENT
5.1

Human Health Risk Discussion

5.1.1 Potentially Exposed or Susceptible Populations
EPA is statutorily required under TSCA to consider potentially exposed or susceptible populations4.
Workers may be potentially exposed by dermal contact to the PMN substance during Processing.
Members of the workforce at certain life stages (e.g., pregnant women, older adults) could be deemed
susceptible as they may experience different effects for a given dose of a chemical than those experienced
by other individuals in the general population, due to physiological, medical or biological differences.
Groups of concern that may be potentially exposed or susceptible include: the fetus, infants, older
children, adolescents, and the elderly.
Risk is assessed to Workers of all ages including women of childbearing age and to the General Population.
Members of the General Population can be exposed through ingestion of drinking water. Risks to
subpopulation groups (sub-grouped by age per Exposure Factors Handbook, 20115 including Adults ≥ 21
yrs old, Infants <1 year old, Babies 1-2 years old, and Small Children 3-5 years old) via Drinking Water
ingestion are assessed using Scaling Factors applied to the Adult dose (attached).

5.1.2 Effects Level Used to Assess Human Health Risk
As stated in section 2.5.1 on page 9, the intact PMN does not present human health concerns however the
potential degradation product,
does present human health concerns. As a worst case a
oral
toxicity LOAEL of 10 mg/kg-bw/day for reduced body weight in males from an oral 90-day study in rats is
used to assess human health risk. The acceptable Margin of Exposure (MOE) is adjusted using
data
in humans (see attached file “RAD SOP
MOE Extrapolation Factors” for explanation of adjustment).

5.1.3 Occupational Risk Discussion
As stated in section 3.2.2, per the Engineering Report dated 04/24/2017 the Processing scenario is
predicted to result in dermal occupational exposures. The exposure duration defaults in the EPA/OPPT 2Hands Dermal Contact with Liquids Model assume 1 to 4 hours duration based the expectation that the
worker will, at a minimum, thoroughly wash hands at lunch or end of the day. Inhalation exposures are
not predicted during Processing based on both the low vapor pressure (<0.0001 torr) and the processing
description which states that inhalation exposures to the PMN in the already-dried plate coating are not
expected based on past cases.
No inhalation or dermal exposures are predicted during the Use scenario because the PMN arrives in the
dried coating and EPA also assumes workers are not exposed to the spent developer solution.
No Predicted Risk to Unprotected Workers via Dermal Exposure
Potential risks for systemic effects from exposure to
to unprotected workers exposed via the
dermal route are not likely because
will not be released from the intact PMN during the 4-hour
exposure duration (as shown in the potential degradation pathway, Figure 2 on page 10, the intact PMN
4

H.R.2576 - Frank R. Lautenberg Chemical Safety for the 21st Century Act
https://www.congress.gov/bill/114th-congress/house-bill/2576
5
U.S. EPA. 2011. Exposure Factors Handbook: 2011 Edition. National Center for Environmental Assessment, Washington, DC;
EPA/600/R-09/052F. http://www.epa.gov/ncea/efh

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which is insoluble in water, will not degrade and release
dermal exposure by workers.).

in the 4 hour time frame assumed for

5.1.4 General Population Risk Discussion
Section 3.2.3 explains that the general population can be exposed to the PMN via ingestion of drinking
water. This is a worst case assessment assuming that
can be released from the intact PMN prior
to any potential drinking water exposures. Based on the potential degradation pathways shown in
Figure 2 on page 9 the likelihood of immediate general population exposure to
is not high and
might occur only after decades to centuries in the environment.
Subpopulation Drinking Water doses are derived by applying Drinking Water Scaling Factors (attached) to
the Adult Drinking Water dose. The Scaling Factors were provided by the Exposure Assessment Tech.
Team and are based on Exposure Factors Handbook (2011) drinking water ingestion rates (EFH Table 3-1).
As shown in Table 1 the MOEs are acceptable (>230,000) for all exposure scenarios.

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Table 1. General Population Risk from Drinking Water Ingestion Exposures
File: P-17-0175 MOE Calcs 07-19-2017.xls
General Population Risk MOE Calculations for P-17-0175 using the
systemic toxicity LOAEL of 10 mg/kg-bw/day
from the 90-day ORAL repeated dose toxicity study in rats based on decreased body weights of 11% in males. The
Acceptable MOE is adjusted to a range of 10,800 to 230,000 for this LOAEL-based assessment using
half-life
data in rats and monkeys (see Standard Review for explanation).
MOE = (NOAEL x Abs Rate) / ((PDR x Abs Rate) / BW)
Shaded rows indicate MOE is less than the high range of the adjusted MOE (230,000)
LOAEL

Acute

Exposure

Margin of

Exposure

LOAEL

Route

Dose

Route

Exposure3

Scenarios
and Values1

(mg/kgbw/day)

Absorption
Rate2

Rate
(mg/kg/day)

Absorption
Rate2

(LOAEL/
PMN Dose)

PROCESSING: Coating for Optical Fibers, 1 unknown site
Ingestion of Drinking Water
ADR Adults ≥21 yrs

10

x

100%

÷

0.00000427

x

100%

=

2341920

ADR Infants ≤1 yr (Scaling Factor=4.17)

10

x

100%

÷

0.00001781

x

100%

=

561612

ADR Babies 1-2 yrs (Scaling Factor=1.63)

10

x

100%

÷

0.00000696

x

100%

=

1436761

ADR Pregnant Women (Scaling Factor=1.02)
ADR Lactating Women (Scaling Factor=1.31)

10
10

x
x

100%
100%

÷
÷

0.00000436
0.00000559

x
x

100%
100%

=
=

2296000
1787725

Ingestion of Drinking Water
ADR Adults ≥21 yrs

10

x

100%

÷

0.00000003

x

100%

= 292397661

ADR Infants ≤1 yr (Scaling Factor=4.17)

10

x

100%

÷

0.00000014

x

100%

=

ADR Babies 1-2 yrs (Scaling Factor=1.63)

10

x

100%

÷

0.00000006

x

100%

= 179385068

ADR Pregnant Women (Scaling Factor=1.02)
ADR Lactating Women (Scaling Factor=1.31)

10
10

x
x

100%
100%

÷
÷

0.00000003
0.00000004

x
x

100%
100%

= 286664373
= 223204321

USE: Printing Plate Use, 800 unknown sites

70119343

1

General Population Adult ingestion and inhalation doses are from the 04/21/2017 Exposure Report. The values are generated
using E-FAST which assumes a 100% absorption rate, and uses an adult male body weight of 80 kg. Drinking Water supopulation
doses are derived using Drinking Water Scaling Factors provided by the Exposure Assessment Tech. Team and are based on
Exposure Factors Handbook (2011) drinking water ingestion rates (EFH Table 3-1).
2

Absorption rates for specific exposure routes expressed as percentages: Per RAD memo for perfluoro analog Skin: <<1% based on
PFOS (a worst case analogue for the PMN substances); Lung: 100% * (No Information but likely to be equal to GI absorption); GI
Tract: 100% * based on PFOS (a worst case analogue for the PMN substances).
3

Based on
half-life data a range of adjusted Acceptable Margins of Exposure for LOAEL-based assessments is 10,800 to
230,000. See Standard Review text for adjustment.

5.2

Environmental (Aquatic) Risk Discussion

Potential risks to the aquatic environment for the intact PMN were low based on the predicted low
ecotoxicity hazards. Potential risks to the terrestrial environment from the perfluoro degradation products
cannot be quantified however numerous studies indicate high concern for terrestrial wildlife from
exposure to highly-persistent perfluoro-containing chemicals.

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6 CONCLUSIONS
6.1

Human Health Conclusions

6.1.1 Occupational Health Conclusion
Risk for systemic effects to unprotected workers who are exposed during the Processing scenario for up to
4 hours per incident via the dermal route is not supported as discussed in section 5.1.3 on page 13.

6.1.2 General Population Health Conclusions
General population risk for systemic effects from ingestion exposure to
released from the intact is
NOT supported. As noted in section 5.1.4 on page 14 it unlikely that the intact PMN will be degraded and
release
and expose the general population via ingestion of drinking water.

6.2

Recommendations

6.2.1 Fate Testing Recommendations
Note, per the Fate Assessor for this case, the list of testing recommendations may be shortened after
discussion.
I.
Characterization
A. Initial characterization of the PMN materials is required prior to any fate testing. The
characterization should include analysis for all starting materials/residuals/impurities. A total
fluorine analysis is also required to determine if there are other unknown fluorochemicals present
that may complicate the interpretation of fate test data.
B. Absorbance of light in the UV/VIZ range (220‐800 nm) is required to evaluate the potential for
direct photolysis. The UV/VIZ absorbance spectra should be measured following the OECD 101 or
other appropriate test guideline.
II.
Fate Testing
A. Different microbial populations and processes in different environments require testing in each
media to understand the environmental fate for the PMN substance. Fate testing should be
conducted following standard EPA and OECD protocols with appropriate modifications and
amendments for the PMN substance. Examples of standard protocol modifications currently used
for testing difficult to test and perfluoro chemical polymers include, but are not limited to,
identifying and quantify degradation products at the lowest possible levels, methods for dosing
and extracting low solubility chemicals, analysis of rates of formation and decline of multiple
intermediates and end products, and additional QA/QC requirements. In all fate tests, analysis of
the individual chemicals present in starting material and degradation products should be included
in modified test protocols. Test protocols should be submitted to EPA for review prior to test
initiation.
B. If the UV/VIZ absorption spectra test shows absorbance in the 220‐800 nm range a direct
photolysis test (OECD 316 – Photochemical Transformation in Water) or other measured data
sufficient to evaluate direct photolysis mechanisms, rates and pathways is needed. Direct
photolysis may be incorporated into indirect photolysis tests with appropriate modifications of the
indirect test protocols.

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C. Indirect Photolysis testing is required determine if the PMN substance may degrade in sunlight
under environmental conditions. This testing should follow modified OCSPP 835.5270 Indirect
Photolysis Screening Test or OCSPP 835.2410, Photodegradation in Soil protocols, including
sufficient QA/QC samples to allow evaluation of direct photolysis.
D. Inherent biodegradability testing is needed to determine if biodegradation in contact with
wastewater treatment microbial populations can occur, (OECD 302B Inherent Biodegradability:
Zahn‐Wellens/EMPA test).
Potential Biodegradation Mechanisms and Pathways in Other Environmental Media
In order to determine the potential biodegradation mechanisms and pathways in other environmental
media with different physical and chemical conditions and microbial populations in those media additional
testing is required. Data from the inherent biodegradation with sewage microbes test may inform further
testing but because soil, sludge, and sediment microbial population can degrade chemicals by different
mechanisms and at different rates, inherent biodegradation test data is not sufficient to evaluate
processes which may occur in these systems. Additional tiered testing to evaluate biodegradation in
aerobic and anaerobic soil and sediment, and anaerobic sludge should be conducted regardless of the
results of the initial testing.
This testing should include:
A. OECD 307 Aerobic and Anaerobic Transformation in Soil
B. OCSPP 835.3280 Part C: Mineralization and Transformation in Anaerobic Digester Sludge
C. OCSPP 835.4300 Aerobic Aquatic Metabolism
D. OCSPP 835.4400 Anaerobic Aquatic Metabolism
Bioaccumulation Testing
If degradation testing shows that products are formed which may be of concern for toxicity or
bioaccumulation they should be evaluated in additional testing:
A. OECD 305 Bioaccumulation in Fish: Aqueous and Dietary Exposure
B. OECD 315 Bioaccumulation in Sediment Dwelling Benthic Oligochaetes
C. OECD 317 Bioaccumulation in Terrestrial Oligochaetes

6.2.2 Human Health Recommendations
6.2.2.1 Potential Testing for Other Possible Perfluoro-containing
Degradation Products
Additional testing of the PMN or potential degradation product of concern,
will not be useful to
assess potential risk of the PMN substance. Identification (as mentioned in Fate Testing above) and testing
of any other potential degradation products (C4-C8) may be useful.

7 REFERENCES
The following are the references cited in the fate narrative and potential degradation pathways diagram.

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