# Documents in Support of a

Significant New Use Rule for

Premanufacture Notice (PMN) P-11-0549

Docket ID Number

EPA-HQ-OPPT-2015-0220

# 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

# Sanitized SAT Report for P-11-0549

## 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 p p m - no deaths acute (4-hr) inhalation study in rats, 102,878 p p m - no deaths, tremors and rales cardiac sensitization study in dogs - N OEL = 12,500 p p m , LOEL = 25,000 p p m not a skin irritant in rabbits 5-day inhalation study in rats - N OEL = 1000 p p m , degeneration of the olfactory epithelium, neutrophilic infiltration and liminal cellular debris in the nasal cavity at 10,000 and 50,000 p p m 28-day inhalation study in rats - N OEL = 2500 p p m ; changes in serum chemistry parameters at 5000 and 10,000 p p m ; no histological changes in the nasal cavity 90-day inhalation study in rats - N OEL = 1500 p p m ; abnormal gait, aggressive behavior, ear twithching, hyperactivity, low posture, tremors, hyperreactivity in males at 10,000 p p m ; neurobehavioral changes in males at 10,000 p p m ; microscopic changes in anterior nose, teeth, femur; decreased body weights, food consumption, and food efficiency at 10,000 p p m inhalation developmental toxicity study in rats - N OEL = 1500 p p m ; reduced fetal and maternal weights at 10,000 p p m

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

## 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); p H7; 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 ( p pb) 150

SARs neutral organic chemicals

SAR Class fluorohydrocarbon new chemicals category: neutral organics Ecotox Category

Ecotox Factors Comments:

SAT Chair: Becky Jones

# Sanitized Engineering Report for P-11-0549

# Sanitized Exposure Report for P-11-0549

### 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

Scenario 1 Water Landfill Stack Air Fugitive Air

Drinking Water Fish Ingestion

ADR LADD ADR LADD 7Q10 4

CC =

225 PDM

Days

Exceeded LADD ADR LADD ADR LADD

Release

activity(ies) 2 ;

exposure

cal culation(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

### 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

--- --- --- --- 2.5 5E

- 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 N A 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

### 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/sit e/day ) (kg/site/day) (kg/site/day)

Remarks:

### 6/22/2012

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 Dr inking Water Results Drinking

Water Units Fish Ingestion Results Fish Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 

### 1.70E

- 06 1.92E

- 05 mg/kg/day 1.12E

- 07 1.26E

- 06 mg/kg/day

LADC pot 

### 8.73E

- 05 9.86E

- 04 mg/L 1.34E

- 03 1.51E

- 02 mg/kg

Acute

ADR pot 

### N/ A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments:

### 6/22/2012

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)