Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-12-149 

EPA Docket EPA-HQ-OPPT-2012-0450 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-12-149 

A-002 Initial Review Engineering Report for 

 PMN P-12-149 

A-003 Initial Review Exposure Report for 

 PMN P-12-149 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-12-149 

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SAT Report

PMN Number: P-12-0149

SAT Date: 1/27/2012

Print Date: 3/1/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 3 Health: ; Eco: chronic concerns only

 Persistence Bioaccum Toxicity Comments

2 32

Exposure Based Review:

Health:

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LIVER; THYROID; REPRO; 

UNCERT-DEVEL-NEURO;AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-12-0149

FATE: Estimations for typical 

Liquid with MP < 25 C (E)

log Kow = 5.93 (E) 

S = 0.232 mg/L at 25 C (E)

VP < 1.0E-6 torr at 25 C (E)

BP = Dec. >190 C (M)

H < 1.00E-8 (E)

log Koc = 3.67 (E)

log Fish BCF = 3.58 (E)

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log Fish BAF = 3.63 (E) 

POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg = wk-mo

Sorption to soils/sediments = v.strong

PBT Potential: P2B3

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Expect poor absorption via all routes (pchem/analog). By 

analogy to substituents unspecified) there is 

concern for liver and thyroid effects, reproductive effects, and developmental neurotoxicity 

effects.The information for comes from the 

. The NOAEL/benchmark dose for liver and thyroid effects from 

28-day and 90-day studies is 22.9 mg/kg based on liver weight increase. A NOAEL o f 10 

mg/kg for reproductive toxicity is based on a decrease in the fertility index in a 2-generation 

dietary study in rats. In addition an increase in pup mortality was also noted. A LOAEL of 0.9 

mg/kg from a study where neonatal mice were exposed on day 10 via gavage is based on 

changes in spontaneous behavior and learning and memory defects. Animals were then 

observed for effects at the age of 3 months.

 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 0.021 or *

daphnid _ chronic 

value

0.030 or *

algal _ chronic 

value

*

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 579; solid with mp 189 C (P); log Kow = 5.93 (EPI); S = 

0.006 mg/L at 20 C (P); pH7; effective concentrations based on 100% active ingredients and 

mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

2 or *

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SARs neutral organic chemicals

SAR Class

Ecotox Category Neutral Organics

 

 

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A-002 

Initial Review Engineering Report 

 for PMN P-12-149 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0149

Focus Ready Draft 2/6/2012

ENGINEER: Austin \ BCS

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: 

MSDS: No Label: No

TLV/PEL:

MSDS not provided.

CRSS :

SAT (concerns) (01/27/2012):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Analog: 

Migration to groundwater: Negligible

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PBT rating: P2B3T2 .

Health: 1-2 Dermal, Inhalation

Eco: 3 Water (All releases to water with a CC = 2 ppb)

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 claims: 

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EXPOSURE-BASED REVIEW: Yes (0 criteria met)

1) # of workers exposed: 9 >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

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0149

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0149

PROC/USE: 

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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A-003 

Initial Review Exposure Report 

 for PMN P-12-149 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-12-0149 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 

CC = 2 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)3 

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

Max ADR 

--- --- --- --- --- --- --- 2.53E+00 --- --- --- 

Max LADD 

--- --- --- --- --- --- --- --- 5 .88E-02 --- --- 

 Max 

ADR 

--- --- --- --- --- --- --- 2.49E+00 --- --- --- 

Max 

LADD 

--- --- --- --- --- --- --- --- 5 .74E-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 No 

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

Inhalation Dose (mg/kg/day) Yes Yes 5.88E-02 

Groundwater Dose (mg/kg/day) No No 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: (default is NA)

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0149 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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-12-0149 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY: Max ADR 

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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 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): 7.54 μg/m3

Max 24 Hour Average Air Concentration (Stack): 1.38E+04 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.54E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 3.02E-03 N/ A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 2.53 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m /sec Width of Release 

Opening: 

N/A 

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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0149 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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-12-0149 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY 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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m 3

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): 800.00 μg/m3

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

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.88E-02 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 0.32 N/ A 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m /sec Width of Release 

Opening: 

N/A 

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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0149 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: : Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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-12-0149 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 3 RELEASE ACTIVITY: : Max ADR 

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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 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): 7.44 μg/m3

Max 24 Hour Average Air Concentration (Stack): 1.36E+04 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.47E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.98E-03 N/ A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 2.49 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m /sec Width of Release 

Opening: 

N/A 

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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0149 Assessor: Bevington/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:4 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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-12-0149 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 4 RELEASE ACTIVITY: : 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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m 3

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): 780.00 μg/m3

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

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.74E-02 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 0.31 N/ A 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m /sec Width of Release 

Opening: 

N/A 

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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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