Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-34 

EPA Docket EPA-HQ-OPPT-2011-0942 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-34 

A-002 Initial Review Engineering Report for 

 PMN P-11-34 

A-003 Initial Review Exposure Report for 

 PMN P-11-34 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-34 

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SAT Report

PMN Number: P-11-0034

SAT Date: 10/29/2010

Print Date: 8/31/2011

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 2

 Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: IRR/CORR-E,S,MM,L; SENS-S; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0034

FATE: Estimations for low weight with one equivalent of each monomer MW 352 

C20H36N2O3

Liquid with MP < 25 C (E)

log Kow = 2.69 (E) 

S > 10 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 = 4.16 (E)

log Fish BCF = 1.44 (E)

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log Fish BAF = 1.52 (E) 

POTW removal (%) = 0-25 via biodeg

Time for complete ultimate aerobic biodeg = wk-mo

Sorption to soils/sediments = low

PBT Potential: P2B1

*CEB FATE: Migration to ground water = rapid

 Health:

 Health Summary: Not absorbed from the skin, poor absorption from the GI 

tract and good absorption from the lung (pchem). Concern for irritation and possible corrosion 

to all tissues and dermal sensitization.

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 7.3 phenol-amine SAR

daphnid 48-h LC50 1.6 phenol-amine SAR

green algal 96-h EC50 1.5 aliphatic amine SAR

fish _ chronic value 0.23 phenol-amine SAR

daphnid _ chronic value 0.21 phenol-amine SAR

algal _ chronic value 0.49 aliphatic amine SAR

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for aliphatic amines and 

phenol-amines; SAR chemical class = aliphatic amine, phenol-amine; MW 247 with 100% < 

1000 and 90% < 500; log Kow = 2.69 (EPI, representative structure); liquid (M); S = 22.4 g/L 

(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)

21 phenol-amine SAR

SARs aliphatic amines and 

phenol-amines

SAR Class aliphatic amine, phenol-amine

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-11-34 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0034

Post-Focus Draft Revision 1 7/27/2011

ENGINEER: Prothero \ JAS

PV (kg/yr): 9,500 Import Only

SUBMITTER: .

USE: 

OTHER USES: 

MSDS: Label: 

CRSS :

Chemical Name: Formaldehyde, polymer with .alpha.

-(2-aminomethylethyl)-.omega.

-(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)]

and 4-(1,1-dimethylethyl)phenol

S-H20: 22.4 g/L @

VP: 1.0E-6 torr @

MW: 247.00 90.00%<500 100.00%<1000

Physical State and Misc CRSS Info:

Neat: Liquid Mfg: NK: Import Proc/Form: Solution: 50-55%

PMN material, then Solution: 12.4% PMN material End Use:

Destroyed. NAVG = 247 with 90% < 500 and 100% < 1000 by

GPC. Submitted Data: None, all of the submitted

properties are for formulated material. Estimated Data:

BP = 428 °C (EPI); VP = 3.2E-7 torr (EPI); WS = 22.4 g/L

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(EPI); logP = 2.69 (EPI). The EPI estimations were

performed on the component consisting of one equivalent

of each feedstock and m=1, having a molecular weight of

353 g/mole and a molecular formula of C20 H36 O3. The

amine FGEW cannot be calculated or estimated due to the

unknown molecular weight of the amine containing

prepolymer. The amine FGEW will be less than the NAVG

molecular weight of 247.

Consumer Use: No

SAT (concerns) (10/29/2010):

Related Cases and Related Cases and Misc SAT Info:

Analogs: 

Migration to groundwater: Rapid

PBT rating: P2B1T1 '

Health: 2 Dermal, Inhalation

Eco: 2 Water (All releases to water with a CC = 21 ppb.)

OCCUPATIONAL EXPOSURE RATING: 1C

NOTES & KEY ASSUMPTIONS:

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

IRER Notes: PMN is import only -> MFG not assessed. Past

cases (same submitter, same use), and

 (similar use) were referenced for consistency.

Past case IRERs are generally consistent with this IRER,

with the following main differences: some use

applications were significantly different (e.g.,

automated, high-speed roll coating was possible in a past

case) and this PMN has corrosive characteristics that

reduce dermal exposure likelihood. // IRER Rev 1 Notes:

Updated release media (no release to water) per July 2011

amendment (BITR110701756458091) and future enactment of

SNUR for no release to water.

POLLUTION PREVENTION CONSIDERATIONS:

None

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0034

Use: stems

Number of Sites/ Location: 

Days/yr: 

Basis:

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Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

).

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

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Dermal:

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A-003 

Initial Review Exposure Report 

 for PMN P-11-34 

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7/27/2011 Page of 

POSTFOCUS EXPOSURE REPORT 

Case Number: P110034 Assessor: Delpire 

ENVIRONMENTAL RELEASES 

Scenario#: Number of Release Sites: 

Release Activity: 

Release Description: WATER LANDFILL INCINER LAND/INCIN FUGITIVE 

Total Releases: 

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

Release Days/yr: 

Per Site Release: 

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

Remarks: EAB DROP: Release information for this compound does not meet criteria for preparation 

of an exposure assessment in the Exposure Assessment Branch’s (EAB) Initial Review 

Exposure Report (this report). 

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