# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notice (PMN)
P-12-373

EPA Docket EPA-HQ-OPPT-2012-0740

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-373 A-002 Initial Review Engineering Report for PMN P-12-373 A-003 Initial Review Exposure Report for PMN P-12-373

# A-001 Structure Activity Team (SAT) Report
for PMN P-12-373

## SAT Report PMN Number: P-12-0373 SAT Date: 6/5/2012 Print Date: 7/3/2012

Related cases : Yes Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 1

Persistence Bioaccum Toxicity Comments 1 1 2 PMN 3 1 2 Hyd Pdt

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Hyd Pdt negl Keywords : Keywords: SENS, IRR, ONCO, MUTA, DEVEL Summary of Assessment :
Fate : Fate Summary: P-12-0373 FATE: Solid S = Reacts Hydrolysis half-life = hr VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = PMN 90-99 via hydrolysis; then Hyd Pdt 90 via sorption Time for complete ultimate aerobic biodeg = Hyd Pdt > mo

### Sorption to soils/sediments = Hyd Pdt v.strong PBT Potential: PMN P1B1; Hyd Pdt P3B1 *CEB FATE: Migration to ground water = Hyd Pdt negl

Health : Health Summary: Absorption is nil all routes as the neat material and poor all routes for the low molecular weight fraction when in solution based on physical/chemical properties. Expect Michael addition to the acrylate. There is concern for dermal and respiratory sensitization and irritation based on both the acrylate and moieties. There is also concern for mutagenicity, oncogenicity, and developmental toxicity for the low molecular weight acrylates. Low moderate concern.

Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 * daphnid 48-h LC50 * green algal 96-h EC50 * fish

_ chronic value * daphnid

_ chronic value *
algal

_ chronic value *
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for nonionic polymers; SAR chemical class = p olyme r -nonionic solid with mp unknown (P); S = reacts with water at 20 C (P); p H7; 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 ( p pb) *

SARs nonionic polymers SAR Class p olyme r -nonionic Ecotox Category N onionic Polymers

Ecotox Factors Comments:
SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report
for PMN P-12-373file:///J|/INITENG/P12%20cases/p120373.eng.txt[7/2/2012 10:21:51 AM] 

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0373 Focus Ready Draft 6/14/2012
ENGINEER: Jon \ AG PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

Label: Nofile:///J|/INITENG/P12%20cases/p120373.eng.txt[7/2/2012 10:21:51 AM] 

### SAT (concerns) (06/05/2012): Related Cases and Related Cases and Misc SAT Info:
Migration to groundwater: Hyd Pdt Negligible PBT rating: P3B1T2 PMN: P1B1T2 // Hyd Pdt: P3B1T2 Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 1 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.file:///J|/INITENG/P12%20cases/p120373.eng.txt[7/2/2012 10:21:51 AM] 

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0373

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 0 Basis:

Inhalation:file:///J|/INITENG/P12%20cases/p120373.eng.txt[7/2/2012 10:21:51 AM] 

### Dermal:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0373file:///J|/INITENG/P12%20cases/p120373.eng.txt[7/2/2012 10:21:51 AM]

# A-003 Initial Review Exposure Report
for PMN P-12-3736/13/2012 Page 1 of 5



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-12-0373 Reviewer: Cinalli/BC

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Drinking Water Fish Ingestion ADR LADD ADR LADD 7Q10 4 CC = 1000 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 1.63E-05 --- --- --- --- --- --- --- --- --- ---

Max LADD --- 4.13E-07 --- --- --- --- --- --- --- --- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufact uring (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposu re 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:6/13/2012 Page 2 of 5

INITIAL REV I EW EXPOSURE REPORT

Chemical ID: P-12-0373 Assessor: Cinalli/BC

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: : 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:6/13/2012 Page 3 of 5

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0373

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY: Max ADR SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)
0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10
ALL 50 288.00 123.84 78.18 66.05 9.03E-03 2.10E-02 3.33E-02 3.94E-02
ALL 10 39.60 13.29 7.76 7.57 6.57E-02 0.20 0.34 0.34

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%
Cancer

LADD pot 3.22E-08 2.34E-07 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 1.65E-06 1.20E-05 mg/L 0.00 0.00 mg/kg
Acute

ADR pot 1.75E-06 1.63E-05 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:6/13/2012 Page 4 of 5

INITIAL REV I EW EXPOSURE REPORT

Chemical ID: P-12-0373 Assessor: Cinalli/BC

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: Release Activity: Max LADD 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:6/13/2012 Page 5 of 5

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0373

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

SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY Max LADD SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)
0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10
ALL 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A
ALL 10 39.60 13.29 7.76 7.57 N/A N/A N/A N/A

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%
Cancer

LADD pot 5.68E-08 4.13E-07 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 2.92E-06 2.12E-05 mg/L 0.00 0.00 mg/kg
Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: