Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-511 

EPA Docket EPA-HQ-OPPT-2011-0942 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-511 

A-002 Initial Review Engineering Report for 

 PMN P-11-511 

A-003 Initial Review Exposure Report for 

 PMN P-11-511 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-11-511 

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SAT Report

PMN Number: P-11-0511

SAT Date: 7/29/2011

Print Date: 11/1/2011

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3 Health: ; Eco: chroonic concerns only

 Persistence Bioaccum Toxicity Comments

1 31

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: SENS-S,L; MUTA; ONCO (UNCERT); DEVEL; REPRO; LIVER; 

KIDNEY; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0511

FATE: Estimations for low weight 

 with MP < 25 C (E)

log Kow = 7.18 (E) 

S = 0.011 mg/L at 25 C (E)

VP = 4.4E-2 torr at 25 C (E)

BP = 250 C (E)

H = 3.12E+0 (E)

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log Koc = 4.28 (E)

log Fish BCF = 4.04 (E)

log Fish BAF = 5.77 (E) 

POTW removal (%) ≥ 90 via sorption, stripping and biodeg

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = strong

Volatilization half-life from a standard river = 1 hrs

Volatilization half-life from a standard lake = 6 da

Atmospheric Oxidation Half-life = 0.61 hr via OH radical

Atmospheric Oxidation Half-life = 0.31 hr via ozone

PBT Potential: P1B3

*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Expect poor absorption via all routes (pchem); expect 

poor oxidation of the . Concern for eye and 

skin irritation, more severe with repeated exposure dermal sensitization 

; reproductive toxicity possible liver toxicity and lung 

toxicity in the form of chemical pneumonia. Concern for skin and lung sensitization, 

mutagenicity, oncogenicity (marginal), developmental toxicity, male reproductive, liver, and 

kidney toxicity based on the product.

 Test Data: PMN substance: (-) Salmonella with and without 

activation; (-) E. coli with and without activation

Analog: skin irritation in rabbits; rat oral LD0 = 5000 mg/kg; slight eye irritation in rabbits; rat 

inhalation LC0 = 2.06 mg/L; (-) for skin sensitization in a mouse local lymph node assay at 50% 

ai; rabbit dermal LD0 = 5000 mg/kg

28-day dermal study in rabbits dosed with 2 mL/kg, progressive skin 

irritation

 dermal sensitizer in humans

rat oral devel/repro screen LOEL = 100 mg/kg, mild liver changes at 

all doses

 rat oral devel/repro screen NOEL = 150 mg/kg, lower fertility index with 

a longer mean mating time at 1000 mg/kg

: mild eye irritation in rabbits; mild skin irritation in rabbits

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value 0.001

daphnid _ chronic value 0.001

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algal _ chronic value 0.014

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

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

SAR chemical class = MW 208 (representative structure); log Kow = 7.18 (EPI); 

S = 0.009 mg/L at 25 C; pH7; 100% active ingredients and mean measured concentrations; 

hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1

SARs neutral organic chemicals

SAR Class new chemicals category: neutral 

organics

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

for PMN P-11-511 

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TEST DATA REVIEW ENGINEERING REPORT

P-11-0511

Post-Focus Draft Revision 1 9/22/2011

ENGINEER: Prothero \ EV

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: LABEL: 

 

 

 

Consumer Use: No

SAT (concerns): (7/29/2011):

Related Cases and Misc SAT Info:

Ecotox Related Cases: /// Human Health Related Cases: 

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Migration to groundwater: Slow

PBT rating: P1 B3 T1 .

Health: 1-2, Dermal, Inhalation

Eco: 3, Water (All releases to water with a CC = 1 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims: 

P2 REC:

EXPOSURE-BASED REVIEW: Yes (0 criteria met)

1) # of workers exposed: 12 >1000? No 

2) >100 workers with > 10 mg/day inhalation exposure: No 

3) (a) >100 workers w/1-10 mg/day inh. exp. & >100 days/yr: No 

 (b) Routine Dermal Cont: > 250 workers & > 100 days/yr: No

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P-11-0511

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

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RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Inhalation:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes

2) (a) Exposure level > 1 mg/day? No

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

Dermal:

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Inhalation:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-11-0511

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis: 

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A-003 

Initial Review Exposure Report 

for PMN P-11-511 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0511 Reviewer: Bevington/SS 

 

 

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 PDM 

Days 

Exceede

d 

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 

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

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

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

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

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) 

Fish Ingestion Dose (mg/kg/day) 

Inhalation Dose (mg/kg/day) 

Groundwater Dose (mg/kg/day) 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: 

 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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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

 μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): μg/m3

Max 24 Hour Average Air Concentration (Stack): μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) NA 1 day 71.80 0.55 

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 Release Height: 3.00 m 

Inside Stack 

Diameter: 

0.10 Length of Release 

Opening: 

10.00 m 

Stack Gas Exit 

Velocity: 

0.10 Width of Release 

Opening: 

10.00 m 

Stack Gas 

Temperature: 

293.00 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: 

 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) 

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY:MFG: Max LADD 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

 μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): μg/m3

Max 24 Hour Average Air Concentration (Stack): μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) NA 1 day 71.80 0.55 

Inhalation Comments: 

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8/5/11 page of 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: 3.00 m 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

10.00 m 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

10.00 m 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites 

 Release Activity: 

 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0511 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

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 

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 mg/kg/day mg/kg/day 

LADCpot mg/L mg/kg 

Acute 

ADRpot mg/kg/day mg/kg/day 

SIC Code Comments: 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0511 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:4 Number of Release Sites 

 Release Activity: 

 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: 

Site Release: 

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

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0511 

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

SCENARIO #: 4 Number of Sites: RELEASE ACTIVITY

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

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 

ALL 10 

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 mg/kg/day mg/kg/day 

LADCpot mg/L mg/kg 

Acute 

ADRpot mg/kg/day mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0511 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 4 RELEASE ACTIVITY

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

SIC CODE RESULTS 

COC (μg/L) 

Percent of 

Year COC 

Exceeded 

Number of 

Days COC 

Exceeded 

Release 

days/year 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

High/Avg 

Analysis 

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