Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-12-51 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-12-51 

A-002 Initial Review Engineering Report for 

 PMN P-12-51 

A-003 Initial Review Exposure Report for 

 PMN P-12-51 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-12-51 

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SAT Report

PMN Number: P-12-0051

SAT Date: 11/22/2011

Print Date: 2/6/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1

 Persistence Bioaccum Toxicity Comments

1 11

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: No releases to water

Fate: ; 1 not 4 (biodegrades)

P2Rec Comments:

Comment: No Comment

Keywords:

 Keywords: 

IRR-E,S,L,MM

SOLV IRR

SOLV NEURO

Summary of Assessment:

 Fate:

Fate Summary: P-12-0051-52

FATE: 

log Kow = -2.58 (E) 

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

BP = 371 C (E)

H < 1.00E-8 (E)

log Koc = 1.00 (E)

log Fish BCF = 0.50 (E)

log Fish BAF = -0.05 (E) 

POTW removal (%) = 90 via biodeg 

Time for complete ultimate aerobic biodeg = d-wk

Sorption to soils/sediments = low

PBT Potential: P1B1

*CEB FATE: Migration to ground water = negligible (biodegrades)

 Health:

 Health Summary: Absorption is good all routes, based on analogs. There is 

concern for irritation to all exposed tissues, based on the and information in the 

PMN MSDS. There also are concerns for solvent irritation and solvent neurotoxicity.

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 >100

daphnid 48-h LC50 >100

green algal 96-h EC50 >100

fish _ chronic value >10

daphnid _ chronic 

value

>10

algal _ chronic 

value

>10

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for

 log Kow = -2.58 (EPI); 

pH7; effective concentrations based on 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)

1000

SARs

SAR Class

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Ecotox Category none

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

for PMN P-12-51 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0051 0052

Focus Ready Draft 12/5/2011

ENGINEER: El-Zoobi \ AH

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS :

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Consumer Use: No

SAT (concerns) (11/22/2011):

Migration to groundwater: Negligible

PBT rating: P1B1T1

Health: 1-2 Dermal, Drinking Water, Inhalation

Eco: No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1C

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0051 0052

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0051 0052

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A-003 

Initial Review Exposure Report 

 for PMN P-12-51 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-12-0051C Reviewer: Tobias/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 = 

1000 

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

 Max 

ADR 

2.60E01 --- 3.05E-03 --- --- --- --- --- --- --- --- 

Max 

LADD 

--- 1.57E-03 --- 2.13E-05 --- --- --- --- --- --- --- 

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 

7.37E+03 

Fate test recommendations?: (default is NA)

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0051 Assessor: Tobias/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: : 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) 

Remarks: 

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12/2/2011 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-12-0051 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY Max 

ADR 

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-12-0051 Assessor: Tobias/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: 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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12/2/2011 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-12-0051 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY: Max 

LADD 

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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