Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-608 

EPA Docket EPA-HQ-OPPT-2011-0942 

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Index 

A-001 Structure Activity Team (SAT) Report for 

PMN P-11-608 

A-002 Initial Review Engineering Report for 

 PMN P-11-608 

A-003 Initial Review Exposure Report for 

 PMN P-11-608 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-608 

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SAT Report

PMN Number: P-11-0608

SAT Date: 9/7/2011

Print Date: 10/3/2011

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

1 1 1 PMN

1 1 1 Hyd Pdt 

1 1 1 Hyd Pdt 

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ; Hyd Pdt moderate – rapid; 

 Hyd Pdt negl

Keywords:

 Keywords: IRR-E,S,MM,L; MUTA (UNCERT); DEVEL (UNCERT); 

AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0608

FATE: Estimations for hydrolysis product MW 125 

log Kow = 0.12 (E)

log Koc = 2.10 (E)

log Fish BCF = 0.50 (E)

log Fish BAF = 0.01 (E)

FATE: Estimations for hydrolysis product MW 152 

log Kow = 1.49 (E)

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log Koc = 1.94 (E)

log Fish BCF = 0.07 (E)

log Fish BAF = 1.70 (E)

PMN Substance: Solid with MP = 236-239 C (M)

S = Reacts slowly/4.1 mg/L at 25 °C (ICB/E)

Hydrolysis Half-life = hr

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

BP = Dec. >253 C (M)

H < 1.00E-8 (E)

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

 Hyd PDt 90 via biodeg

Time for complete ultimate aerobic biodeg = Hyd Pdt wk; Hyd Pdt da-wk

Sorption to soils/sediments = Hyd PDt low – moderate, Hyd Pdt low

PBT Potential: PMN P1B1; Hyd PDt P1B1; Hyd Pdt P1B1

*CEB FATE: Migration to ground water = Hyd Pdt moderate – rapid; 

 Hyd Pdt negl

 Health:

 Health Summary: Not absorbed through the skin as the neat material, poor

absorption through the skin if in solution, poor absorption from the lung and GI tract (pchem); 

expect poor hydrolysis in the stomach. Concern for irritation to all tissues based on the 

groups. Uncertain concern for mutagenicity and developmental toxicity based on the 

moiety.

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.47

daphnid 48-h LC50 0.64

green algal 96-h EC50 0.43

fish _ chronic value 0.012

daphnid _ chronic value 0.035

algal _ chronic value 0.22

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for 

 MW 152,100 with 

0% < 1000; 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 1

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(ppb)

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

for PMN P-11-608 

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p110608.eng

INITIAL REVIEW ENGINEERING REPORT : 

PMN: 11-0608

Focus Ready Draft 9/19/2011

ENGINEER: Hall \ DDH

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: 

 

CRSS :

 

 

 

Consumer Use: 

SAT (concerns) (09/07/2011):

Related Cases and Related Cases and Misc SAT Info:

Migration to groundwater: Hyd Pdt Amine moderate-rapid,

Hyd Pdt Ketone negl

PBT rating: P1B1T1 P1B1T1 for PMN, Hyd Pdt Amine, and Hyd

Pdt Ketone

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Health: 1-2 Dermal, Inhalation

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

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

No Pollution Prevention information provided by the

submitter.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT : 

PMN: 11-0608

 

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INITIAL REVIEW ENGINEERING REPORT : 

PMN: 11-0608

 

 

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INITIAL REVIEW ENGINEERING REPORT : 

PMN: 11-0608

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A-003 

Initial Review Exposure Report 

for PMN P-11-608 

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Page 1 of 1 

 

POST FOCUS EXPOSURE REPORT 

Release information for this compound does not meet criteria for preparation of an exposure assessment; 

were eliminated and the were below the threshold for exposure 

assessment 

Case Number: P11-608 Assessor: 

 

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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