Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-10-332 

EPA Docket EPA-HQ-OPPT-2011-0577 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-10-332 

A-002 Initial Review Engineering Report for 

PMN P-10-332 

A-003 Initial Review Exposure Report for 

PMN P-10-332 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-10-332 

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'ST UC UR ACTVT T AM REOR v 049 

Case #: P-i 0-0332 DCN:

SAT Date: 4/16/2010 SAT Chair: L. Keifer

Submitter: 

Chemical Name:

CAS RN: Trade Name:

None 

Structure

Molecular Formula: 

Molecular Wt. 420 WT%<500: 1T%<1000:

MP: BP: >400 1Eq. Wt:

fH20 Sol (gIL): 0.00139 V.P. <0.000001

jMax. Prod. Volume (kglyr): Physical State: Liquid

FUSE:

. f n Case Role Reae Cas Numbers Cae ol

Date: Results: Le~

7/

Page 10of3

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SAT Report

PMN Number: P-10-0332

SAT Date: 4/16/2010

Related cases: 

Health related cases:

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

Persistence Bioaccum Toxicity Comments

1 1

Exposure Based Review:

Health: 

Ecotox: 

Routes of exposure: Health: Dermal Inhalation

Ecotox: All releases to water

Fate:

P2Rec Comments:

Comment: P2REC: SAT: Forward with no comment

Keywords:

Keywords: SENS-S; AQUATOX

Summary of Assessment:

Fate:

Fate Summary: FATE: Estimations for typical MW 406

Liquid with MP < 25 'C (E)

log Kow = 6.93 (E)

S = 1.39 mg/L at 250 C (E)

VP < 1 OE-6 torr at 25 'C (E)

BP > 400 -C (E)

H < 1.00E-8 (E)

log Koc = 4.90 (E)

log Fish BCF = 2.61 (E)

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log Fish BAF =1.07 (E)

POTW removal (%) =75-90 via sorption and possible partial biodeg

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments =strong - v.strong

PBT Potential: P1131

*CEB FATE: Migration to ground water = negi

Health:

Health Summary: Expect poor absorption via all routes (analog). Concern

for dermal sensitization based on data for the starting 

Ecotox:

Test Test Test End Predicted Measured Comments

fish 96-h LC50 0.015

daphii 48-h LC50 0.03 5 _________

green algal 96-h EC50 0.10 __________

fish chronic value 0.001

daphnid _ chronic value 0.003

algal _ chronic value 0.005

Sewage Sludge 3-h EC50 _______

Sewage Sludge _Chronic Value ________ __________

Ecotox Values Comments: Predictions are based on SARs for 

MW 420; liquid

with mp <-50 C; log Kow = 4.90 (EPI); S =1.4 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 1

(ppb)

SARs 

___________________phenol-amines

SAR Class 

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

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~NCSAB SAT REPORT 

PMN: P-i10-0332 ICAS RN: Non(

Chemical Name: Analogs:

Production Volum

Structure:

Formula: 1Eq Wt:

Mol Weight: 419.65 Wt%<500: Wt%<1000

MP: B1P: >400 VP: <0.000001

H2O Sol (gIL): ______ 0.00131Physical State: LiquidLo :65

Endpoint (mgIL) Est. Value Meas. Value Comment

Fish 96-h 0 o

Daphnid -7-- 48-h 3 74 -D,1

Algal 96-h ,1 D) ___ 2L__ __ 1_ __

Fish ChV 'o)CLO- O o/

Daphnid ChV 0,00So 0c0 o0o07 o' 003

Algal ChV 6 O,0Co5 01-1t 0 ':

BCF______

CHEMICAL CLASS: ISAR: 

ECOTOX CONCERN (HJ M IL ICONCERN CONCENTRATIG 06

DATE j /.( ASSESSOR: .

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OPPT STRUCTURE ACTIVITY TEAM (SAT) MEETING DATE JJ/

ATTENDEES SIGNATURE

CHEMI STRY

__Paul Bickart __________

__Diana Darling __________

__Rich Engler _________

__Greg Fritz _ _ _ _ _ _ _ _ _

Daniel Lin IIIKathy Schechter

L,-,Richard Fehir

1LJustnR be~~ __ __ _

ENVRONENTL FATE

__Bob Boethling _________

__Jed Costanza __________

__Wen-Hsiung Lee___ ________

__Laurence Libelo__ _________

__David Lynch

___Andy Mamantov

HEALTH

izct herine Anitole

: MihaelCimino

-'Steve Cragg

__Leonard Keifer ___________

David Lai _________

lZJim Murphy

~Ronald Ward

~-Yin Tak Woo __ __ __ __ __ __

ENVIRONMENTAL EFFECTS

;;e'Krdon Cash

__Jeff Gallagher__ ________

__Maggie Johnson__ ________

__Sara Pollack __________

SAT CHAIR/OTHER

Rebecca Jones

kILeonard Keifer __Jim Kwiat "or__ __ _ __ _

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A-002 

Initial Review Engineering Report

for PMN P-10-332 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0332 

Focus Ready Draft 4/29/2010 

ENGINEER: Choudhary \ BCS/CLM 

PV (g/yr: YXDOES 6,00,00 

ON

SUBMITTER: 

USE: 

OTHER USES: 

MSDS: Yes Label: No

Gen Eqpt: 

Respirator: 

Health Effects: 

TLV/PEL:

CRSS

Chemical Name: 

S-H20: 0.00139 g/L @

VP: l.OE-6 torr @

MW: 420.00 W<500 t<1000

Physical State and Misc CRSS Info:

Neat: Mfg: Proc/Form: 

End Use: The structure shown on page

1 of this report is representative. 

Submitted Data:

Solubility in MEK = 600 g/L (Sub. Est.); Flash Point = 2200 C; Viscosity = 1600

cps; Density = 1.06 g/cc; Hydroxyl Number = 540 mg KOH/g; Acid Value = 17 mg

KOH/g. The IR and UV/Vis spectra are included in the PMN submission. Estimated

Data: BP = 555 OC (EPI); VP l.OE-13 torr (EPI); WS =0.00139 g/L (EPI); logP

=6.93 (EPI). 

Consumer Use: No

SAT (concerns) (04/16/2010):

Related Cases and Related Cases and Misc SAT Info:

Migration to groundwater: Negligible

PBT rating: PlBlTl

Health: 1-2 Dermal, Inhalation

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

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OCCUPATIONAL EXPOSURE RATING: 2-3C

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

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EXPOSURE-BASED REVIEW: 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0332

Manufacturing:

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. 

 

Output 2: 

to: 

from: 

basis: 

Output 2: 

to: 

from: 

basis: 

Conservative: 

to: 

from: 

basis: 

RELEASE TOTAL

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis: 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0332

Processing: 

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.

High End: 

to: 

from: 

basis: 

Conservative: 

to: 

from: 

basis: 

Output 2: 

to: 

from: 

basis: 

Output 2: 

to: 

from: 

basis: 

RELEASE TOTAL

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis: 

Inhalation:

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis: 

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis: 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0332

Use: 

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. Releases during spray

application were not assessed. 

 

Conservative: 

to: 

from: 

basis: 

 

High End: 

to: 

from: 

basis: 

 

RELEASE TOTAL

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis: 

Inhalation:

Exposure to 

Upper Bound:

Number of workers (all sites) with inhalation exposure:

Basis: 

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

OR

b) Hazard Rating for health of 2 or greater? 1-2 No

Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis: 

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CALL BY: Brandon Smith

Organization: ERG for CEB

CALL TO: 

Organization: 

Date: 04/21/2010

Time: 4:50pm

Phone: 

PMN: 10-0332

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A-003 

Initial Review Exposure Report

for PMN P-10-332 

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4/28/2010 Page 1 of 6 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-10-0332 Reviewer: Flessner/SD 

 

 

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 = 1 

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 

Use: max 

acute eco 

Use: PDM1 

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. 

Fate test recommendations?: OECD 303A simulation test, with fallback of ready biodegradation 

test if simulation test cannot be done. 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-10-0332 Assessor: Flessner/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Use: 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0332 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-10-0332 Assessor: Flessner/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Use: PDM1 

 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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4/28/2010 Page 5 of 6 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0332 

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4/28/2010 Page 6 of 6 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0332 

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