## Support Documents for Significant New Use Rule (SNUR) on
Premanufacture Notice (PMN)

P-11-608

EPA Docket EPA-HQ-OPPT-2011-0942

## 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

## A-001 Structure Activity Team (SAT) Report

for PMN P-11-608

### 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: N o
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)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: N ot absorbed through the skin as the neat material, p oo r absorption through the skin if in solution, p oor absorption from the lung and GI tract ( p che m ); 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; p H7; 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( p pb) SARs

SAR Class

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

## A-002
Initial Review Engineering Report

for PMN P-11-608p110608.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 Page 1p110608.eng 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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## A-003
Initial Review Exposure Report

for PMN P-11-608Page 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 be low 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).