Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-594 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for

 PMN P-11-594 

A-002 Initial Review Engineering Report for 

 PMN P-11-594 

A-003 Initial Review Exposure Report for 

 PMN P-11-594 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-594 

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SAT Report

PMN Number: P-11-0594

SAT Date: 8/30/2011

Print Date: 1/4/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 3

 Persistence Bioaccum Toxicity Comments

1 1 2 PMN

1 1 Hyd Pdt

Exposure Based Review:

Health: Yes Exposure based testing (health): Inhalation Only

Ecotox: Yes

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ; ; Hyd Pdt

P2Rec Comments:

Comment: No Comment

Keywords:

 Keywords: 

IRR/POSS CORR-E,S,L,MM

THYROID

DEVEL NEURO

AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-11-0594

FATE: Estimations for typical hydrolysis product 

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Liquid with MP < 20C (E)

log Kow = 1.49 (E); 

S = 4.2 g/L at 25 C (E)

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

BP > 400 C (E)

H < 1.00E-8 (E)

log Koc = 3.21 (E)

log Fish BCF = 0.65 (E)

log Fish BAF = 0.502 (E) 

POTW removal (%) = PMN 90-99 via hydrolysis; then Hyd Pdt 0-90 via sorption

Time for complete ultimate aerobic biodeg = unknown

Sorption to soils/sediments = low to moderate

PBT Potential: PMN P1B1; Hyd Pdt P1B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Expect moderate absorption with reaction all routes, 

based on physical/chemcal properties. formation in the body is possible. There is 

concern for irritation and possible corrosion to all exposed tissues from the reactive 

constituents. There also is concern for thyroid toxicity based on formation, as well as 

developmental neurotoxicity based on the thyroid toxicity.

 Test Data: Analog test data 

Negative in Salmonella with and without activation; 

Negative in E. coli with and without activation;

Rat oral LD0 2000 mg/kg; 

Rat dermal LD0 = 2000 mg/kg;

Mild eye irritation in rabbits

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.63

daphnid 48-h LC50 2.8

green algal 96-h EC50 0.79

fish _ chronic value 0.021

daphnid _ chronic 

value

0.028

algal _ chronic 

value

0.48

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

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

chemical class = MW 479; liquid; log Kow = 4.65 (EPI); S = reacts slowly 

(hours-days) 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

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

 for PMN P-11-594 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0594

Focus Ready Draft 9/15/2011

ENGINEER: Avcin \ CLM

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: 

MSDS: Yes Label: No

Gen Eqpt: Provide eyewash station and safety shower. //

Chemical resistant gloves // Approved safety goggles;

face shield. // Suitable protective clothing and eye/face

protection

Respirator: If exposure limits are exceeded or

respiratory irritation is experienced, NIOSH/MSHA

approved respiratory protection should be worn. Supplied

air respirators may be required for non-routine or

emergency situations.

Health Effects: May cause skin and eye burns. May be

harmful if swallowed. May be harmful if inhaled.

INGESTION: This product hydrolyzes in the stomach to form

ethanol. SKINl May cause chemical burns. INHALATION: May

cause irritation to the respiratory system. EYES: May

cause chemical burns.

TLV/PEL:

none established for PMN

CRSS :

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Consumer Use: No

SAT (concerns) (08/30/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: Analogs: 

 Human Health Related Cases: 

Migration to groundwater: Negligible

PBT rating: P1B1T2 PMN: P1B1T2 // Hyd Pdt: P1B1

Health: 2 Dermal, Drinking Water, Inhalation

Eco: 3 Water (All releases to water with a CC = 2.00 ppb)

OCCUPATIONAL EXPOSURE RATING: 1B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER

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POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0594

Number of Sites/ Location: 

Days/yr: 

Basis

Process Description: 

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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.

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0594

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.

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RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: 

CALL TO: 

Organization: 

Date: 

Time: 

Phone: 

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A-003 

Initial Review Exposure Report 

 for PMN P-11-594 

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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0594 Reviewer: Cinalli/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 = 2 

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: max 

acute eco 

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

PDM1 --- --- --- --- --- --- --- --- --- 

 Max LADD --- --- --- --- --- --- --- --- --- 

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) NA 

Fish Ingestion Dose (mg/kg/day) NA 

Inhalation Dose (mg/kg/day) NA 

Groundwater Dose (mg/kg/day) NA 

Surface Water Release After Treatment (kg/yr) NA 

Total Release After Treatment (kg/yr) NA 

Consumer Use? 

Fate test recommendations: 

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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0594 Assessor: Cinalli/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: N/A N/A 

Per Site Release: N/A N/A 

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

Remarks: 

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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0594 

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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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0594 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 1 RELEASE ACTIVITY: Max ADR 

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 

2.00 High 

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September 14, 2011 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0594 Assessor: Cinalli/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: N/A N/A 

Per Site Release: N/A N/A 

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

Remarks: 

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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0594 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY 

PDM1 

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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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0594 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: PDM1 

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 

2.00 High 

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September 14, 2011 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0594 Assessor: Cinalli/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: N/A N/A 

Per Site Release: N/A N/A 

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

Remarks: 

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September 14, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0594 

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

SCENARIO #: 3 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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