Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-11-0549 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

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 Table of Contents 

1. Sanitized SAT Report for P-11-0549 

2. Sanitized Engineering Report for P-11-0549 

3. Sanitized Exposure Report for P-11-0549 

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Sanitized SAT Report for P-11-0549 

 

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log Fish BCF = 1.19 (E)

log Fish BAF = 1.329 (E) 

POTW removal (%) = 90 via sorption and stripping

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = moderate

Volatilization half-life from a standard river = 1 hr

Volatilization half-life from a standard lake = 5 da

Atmospheric Oxidation Half-life = 4 hrs via OH radical

Atmospheric Oxidation Half-life = 160 hrs via ozone

PBT Potential: P2B1

*CEB FATE: Migration to ground water = moderate

 Health:

 Health Summary: Absorption is good through the lungs and GI tract based 

on physical/chemical properties. Dermal absorption is not expected because the PMN material is 

very volatile and will evaporate from the skin before it can be absorbed. Based on the submitted 

studies, there is concern for cardiac sensitization, developmental toxicity, neurotoxicity. There 

is also concern for reproductive toxicity and oncogenicity (hormone related) by analogy to other 

small fluorinated compounds. Moderate concern. 

 Test Data: negative in Salmonella and E coli

negative for chromosome aberrations in human peripheral blood lymphocytes

acute (2-hr) inhalation study in rats, 21,000 ppm - no deaths

acute (4-hr) inhalation study in rats, 102,878 ppm - no deaths, tremors and rales

cardiac sensitization study in dogs - NOEL = 12,500 ppm, LOEL = 25,000 ppm

not a skin irritant in rabbits

5-day inhalation study in rats - NOEL = 1000 ppm, degeneration of the olfactory epithelium, 

neutrophilic infiltration and liminal cellular debris in the nasal cavity at 10,000 and 50,000 ppm

28-day inhalation study in rats - NOEL = 2500 ppm; changes in serum chemistry parameters at 

5000 and 10,000 ppm; no histological changes in the nasal cavity

90-day inhalation study in rats - NOEL = 1500 ppm; abnormal gait, aggressive behavior, ear 

twithching, hyperactivity, low posture, tremors, hyperreactivity in males at 10,000 ppm; 

neurobehavioral changes in males at 10,000 ppm; microscopic changes in anterior nose, teeth, 

femur; decreased body weights, food consumption, and food efficiency at 10,000 ppm

inhalation developmental toxicity study in rats - NOEL = 1500 ppm; reduced fetal and maternal 

weights at 10,000 ppm

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 20

daphnid 48-h LC50 12

green algal 96-h EC50 12

fish _ chronic value 2.2

daphnid _ chronic 1.5

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value

algal _ chronic 

value

4.1

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; 

SAR chemical class = fluorohydrocarbon; MW 164; log Kow = 2.92 (EPI), 2.30 (M); liquid 

with mp = -90.5 C (M); S = 387 mg/L at 25 C (P); pH7; effective concentrations based on 

100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and 

TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

150

SARs neutral organic chemicals

SAR Class fluorohydrocarbon new chemicals category: neutral 

organics

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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Sanitized Engineering Report for P-11-0549 

 

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Sanitized Exposure Report for P-11-0549 

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6/22/2012 

STANDARD REVIEW EXPOSURE REPORT 

 

 Chemical ID: P-11-0549 Reviewer: Cinalli/BC 

 

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary 

Exposure 

Scenario1

Water Landfill Stack Air Fugitive Air

Drinking Water Fish Ingestion

ADR LADD ADR LADD 7Q104

CC = 

225

PDM 

Days 

Exceeded

LADD ADR LADD ADR LADD

Release 

activity(ies)2; 

exposure 

calculation(s)3

mg/kg/day mg/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Repack/Blend: 

max acute eco

--- --- --- --- --- --- --- --- --- 1.91E+00 ---

Repack/Blend: 

Max LADD

--- --- --- --- --- --- --- --- --- ---

4.18E-03

PROC 1-FOAM: 

Max ADR: max 

acute eco

1.30E-01 --- 1.44E-02 --- 2.68E+03 --- --- 4.78E-02 --- 2.86E+00 ---

PROC 1-FOAM: 

PDM1

--- --- --- --- 2.19E+03 --- --- --- ---

---

PROC 1-FOAM: 

Max LADD

--- 2.20E-04 --- 1.45E-05 --- --- 3.17E-04 --- --- ---

4.52E-03

PROC 2: Max 

ADR: max acute 

eco

4.72E-02 --- 5.21E-03 --- 9.66E+02 --- --- 9.38E-02 --- 3.77E+00 ---

PROC 2: PDM1 --- --- --- --- 9.66E+02 --- --- --- ---

---

PROC 2: Max 

LADD

--- 8.09E-05 --- 5.31E-06 --- --- 6.96E-04 --- 4.07E-04 ---

6.60E-03

PROC 3: max 

acute eco

--- --- --- --- --- --- --- 4.78E-02 --- 4.96E-02 ---

PROC 3: Max 

LADD

--- --- --- --- --- --- --- --- 8.24E-04 ---

3.52E-04

PROC 4: Max 

ADR: max acute 

eco

1.30E-01 --- 1.39E-02 --- 2.58E+03 --- --- 2.50E-01 --- 6.79E+00 ---

PROC 4: Max 

LADD

--- 5.40E-05 --- 3.54E-06 --- --- 4.64E-04 --- 2.71E-04 ---

2.98E-03

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6/22/2012 

USE 1 FOAM: 

Max ADR: max 

acute eco

4.31E-02 --- 2.47E-03 --- 9.43E+02 --- --- --- --- 1.66E+00 ---

USE 1 FOAM: 

Max LADD

--- 1.92E-05 --- 1.26E-06 --- --- --- --- 2.55E-04 ---

1.47E-02

USE 2: max 

acute eco

--- --- --- --- --- --- --- 5.94E+00 --- 6.28E+00 ---

USE 2: Max 

LADD

--- --- --- --- --- --- --- --- 1.30E-03 ---

5.51E-04

USE 3: Max 

ADR: max acute 

eco

2.67E-02 --- 1.53E-03 --- 5.85E+02 --- --- --- --- 1.80E-01 ---

USE 3: PDM1 --- --- --- --- 5.85E+02 --- --- --- ---

---

USE 3: Max 

LADD

--- 3.46E-05 --- 2.27E-06 --- --- 8.34E-05 --- 1.08E-03 ---

4.60E-04

USE 4: max 

acute eco

--- --- --- --- --- --- --- --- --- 3.27E+00 ---

USE 4: Max 

LADD

--- --- --- --- --- --- --- --- --- ---

7.13E-02

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 

2 Release activities are from engineering report's Manufacturing (Mfg), Processing (Proc) and Use release activity 

labels. Multiple release activities are combined in one exposure scenario if their releases occur at same location. 

3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic 

Dilution Model (PDM). There may be one, two, or all three exposure calculations per exposure scenario. 

 CC is the aquatic concentration of concern. 

4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily 

streamflow of the seven consecutive days of lowest flow within a ten year period. 

Remarks: 

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria 

Parameter Exp Based Persistent Exceedance Value

Drinking (Surface) Water Dose (mg/kg/day) No NA

Fish Ingestion Dose (mg/kg/day) No NA

Inhalation Dose (mg/kg/day) Yes NA 7.13E-02

Groundwater Dose (mg/kg/day) No NA

Surface Water Release After Treatment (kg/yr) NA

Total Release After Treatment (kg/yr) NA

Consumer Use? No

 

 

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6/22/2012 

 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0549 Assessor: Cinalli/SS

ENVIRONMENTAL RELEASES

Scenario#:14 Number of Release Sites: 

Release Activity: USE 1 FOAM: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases:

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr:

Per Site Release:

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 

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STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0549 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 14 Number of Sites: RELEASE ACTIVITY:USE 1 

FOAM: Max LADD

SIC-CODE DESCRIPTION: POTW's (All facilities)

SIC-CODE (S): 4952 EXPOSED POPULATION: Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT 

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

 0.00 15.30

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 125.56 44.02 26.80 22.53 N/A N/A N/A N/A

ALL 10 11.11 1.94 1.06 0.96 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking 

Water Units Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 1.70E-06 1.92E-05 mg/kg/day 1.12E-07 1.26E-06 mg/kg/day

LADCpot 8.73E-05 9.86E-04 mg/L 1.34E-03 1.51E-02 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: 

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 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0549 Assessor: Cinalli/SS

ENVIRONMENTAL RELEASES

Scenario#:15 Number of Release Sites: 

Release Activity: USE 2 FIREFIGHTING: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases:

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr:

Per Site Release:

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

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