# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-12-182

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-182 A-002 Initial Review Engineering Report for PMN P-12-182 A-003 Initial Review Exposure Report for PMN P-12-182

# A-001 Structure Activity Team (SAT) Report
for PMN P-12-182

## SAT Report PMN Number: P-12-0182 SAT Date: 2/28/2012 Print Date: 5/2/2012

Related cases : Health related cases: Ecotox related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 3 Health: ; Eco: significant mitigation of toxicity expected, i.e., ~43x 1-2
Persistence Bioaccum Toxicity Comments 3 11

Exposure Based Review : Health: N o Ecotox: Yes
Routes of exposure : Health: Drinking Water Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: IRR-E,L,MM LUNG AQUATOX-A,C Summary of Assessment :
Fate : Fate Summary: P-12-0182 FATE:

VP < 1.0E-6 torr at 25 C (E)
H < 1.00E-8 (E) POTW removal (%) = 90-99 via sorption

### Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil all routes, based on physical/chemical p roperties. There is concern for irritation to the eye, lung, and mucous membranes, based on amines, There also is concern for lung toxicity from cationic binding to lung membranes.
Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.72 daphnid 48-h LC50 0.22 green algal 96-h EC50 0.053 fish

_ chronic value 0.040 daphnid

_ chronic value 0.016
algal

_ chronic value 0.013
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for polycationic polymers with SAR chemical class = p olyme r - cationic - ; ; liquid (P); S > 1000 g/L at 20 C (P); 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; significant mitigation of toxicity expected in the presence of 10 mg TOC/L; MF ~43x;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 56 with mitigation

SARs p olycationic polymers SAR Class p olyme r -cationicEcotox Category Polycationic Polymers
Ecotox Factors Comments:

### SAT Chair: J. Kwiat

# A-002 Initial Review Engineering Report
for PMN P-12-182

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0182 Focus Ready Draft 3/8/2012
ENGINEER: Arnold \ JAS PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

MSDS: No Label: No

TLV/PEL: none established.

CRSS :

### Consumer Use:
SAT (concerns) (02/28/2012): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Migration to groundwater: Negligible PBT rating: P3B1T1 . Health: 1-2 Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 56 ppb with mitigation), XB Testing (Testing desired)

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0182

### Manufacturing:

Number of Sites/ Location: Days/yr:

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.

### OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0182

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.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

# A-003 Initial Review Exposure Report
for PMN P-12-1823/7/2012 Page 1 of 5



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-12-0182 Reviewer: Flessner/SD

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 =

56 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

Mfg: Max ADR: max acute eco 7.00E-01 --- --- --- 1.45E+04 --- --- --- --- --- ---

Mfg: Max LADD --- 5.28E-04 --- --- --- --- --- --- --- --- ---

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 th ree 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: 

### Results Table: Exposure Based (X B)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value Drinking (Surface) Wate r Dose (mg/kg/day) No NA Fish Ingestion Dose (mg/kg/day) No NA Inhalation Dose (mg/kg/day) No NA Groundwater Dose (mg/kg/day) No NA Surface Water Release After Treatment (kg/yr) Total Release After Treatment (kg/yr) No NA Consumer Use? No 

### Fate test recommendations?: (default is NA)3/7/2012 Page 2 of 5

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0182 Assessor: Flessner/SD
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: Mfg: 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:3/7/2012 Page 3 of 5

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0182

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY:Mfg: Max ADR
SIC-CODE DESCRIPTION: SIC-CODE (S): 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 27.73 83.75 123.55 152.37
ALL 10 1549.34 8352.88 1.45E+04 1.73E+04

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 9.48E-06 5.30E-04 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.86E-04 2.72E-02 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 7.00E-03 0.70 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:3/7/2012 Page 4 of 5

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0182 Assessor: Flessner/SD
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: Mfg: 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:3/7/2012 Page 5 of 5

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0182

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

SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY:Mfg: Max LADD
SIC-CODE DESCRIPTION: SIC-CODE (S): 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 N/A N/A N/A N/A
ALL 10 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 9.45E-06 5.28E-04 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.85E-04 2.71E-02 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: