Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-662 

EPA Docket EPA-HQ-OPPT-2011-0942 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-662 

A-002 Initial Review Engineering Report for 

 PMN P-11-662 

A-003 Initial Review Exposure Report for 

 PMN P-11-662 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-662 

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SAT Report

PMN Number: P-11-0662

SAT Date: 10/12/2011

Print Date: 11/1/2011

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 1 1 PMN

3 1 Hyd Pdt

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: No releases to water

Fate: ; Hyd Pdt negl

P2Rec Comments:

Comment: No Comment

Keywords:

 Keywords: 

IRR-E,S,MM

SENS-S,L

MUTA

Summary of Assessment:

 Fate:

Fate Summary: P-11-0662

FATE: 

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 with MP < 25 C (E)

S = Reacts

Hydrolysis half-life = min-hr

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = PMN 90-99 via hydrolysis; then Hyd Pdt 90 via sorption

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: PMN P1B1; Hyd Pdt P3B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption of the low molecular weight fraction 

is poor all routes, based on physical/chemical properties. There are 

concerns for irritation to the eye, skin, and mucous membranes, and dermal and respiratory 

sensitization, based on There also is concern for mutagenicity, based on 

 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 *

daphnid _ chronic value *

algal _ chronic value *

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for nonionic polymers; SAR 

chemical class = polymer-nonionic ; S = 

reacts with water at 25 C; 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)

* NES

SARs polymer-nonionic

SAR Class polymer-nonionic

Ecotox Factors Comments: 

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A-002 

Initial Review Engineering Report 

for PMN P-11-662 

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p110662.eng

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0662

Focus Ready Draft 10/31/2011

ENGINEER: Macek \ EV \ EV

PV (kg/yr): 

Revision Notes / Assessment Overview: 

SUBMITTER: 

USE: 

OTHER USES: 

MSDS: Label: 

 

 

CRSS :

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Consumer Use: No

SAT (concerns) (10/12/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

Migration to groundwater: Negligible

PBT rating: P3B1T1 PMN: P1B1T1; Hyd Pdt: P3B1T1

Health: 1-2 Dermal, Drinking Water, Inhalation

Eco: 1 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 2C

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 claims: 

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0662

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Number of Sites/ Location: 

TSE

Days/yr: 

Basis:

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.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

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p110662.eng

Dermal:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0662

Number of Sites/ Location: 

 Days/yr: 

Basis:

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.

 

W

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

 

 

 

Dermal:



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A-003 

Initial Review Exposure Report 

for PMN P-11-662 

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October 31, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0662 Reviewer: Delpire/JB 

 

 

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 = 

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 

Max ADR 5.55E-02 --- --- --- --- --- --- --- --- --- --- 

Max LADD --- 2.38E-04 --- --- --- --- --- --- --- --- --- 

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: 

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October 31, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0662 Assessor: Delpire/JB 

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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October 31, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0662 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY : Max 

ADR 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 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 50 288.00 123.84 78.18 66.05 30.66 71.30 112.94 133.69 

ALL 10 39.60 13.29 7.76 7.57 222.98 664.41 1137.89 1166.45 

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 3.28E-05 2.38E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 1.68E-03 1.22E-02 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 5.96E-03 5.55E-02 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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October 31, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0662 Assessor: Delpire/JB 

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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October 31, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0662 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY Max 

LADD 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 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 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A 

ALL 10 39.60 13.29 7.76 7.57 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 3.28E-05 2.38E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 1.68E-03 1.22E-02 mg/L 0.00 0.00 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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