# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-662

EPA Docket EPA-HQ-OPPT-2011-0942

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-662 A-002 Initial Review Engineering Report for PMN P-11-662 A-003 Initial Review Exposure Report for PMN P-11-662

# A-001 Structure Activity Team (SAT) Report
for PMN P-11-662

## SAT Report PMN Number: P-11-0662 SAT Date: 10/12/2011 Print Date: 11/1/2011

Related cases : 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 1 PMN 3 1 Hyd Pdt

Exposure Based Review : Health: N o Ecotox: Yes
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Hyd Pdt negl

P 2 Rec Comments : Comment: N o Commen t Keywords : Keywords: IRR-E,S,MM SENS-S,L MUTA

Summary of Assessment :
Fate : Fate Summary: P-11-0662 FATE:

### with MP < 25 C (E) S = Reacts Hydrolysis half-life = min -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 > mo Sorption to soils/sediments = v.strong PBT Potential: PMN P1B1; Hyd Pdt P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption of the low molecular weight fraction is poor all routes, based on physical/chemical properties. There are concerns for irritation to the eye, skin, and mucous membranes, and dermal and respiratory sensitization, based on There also is concern for mutagenicity, based on

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 ; S = reacts with water at 25 C; 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 ( p pb) * N ES

SARs p olyme r -nonionic SAR Class p olyme r -nonionic
Ecotox Factors Comments:

# A-002 Initial Review Engineering Report
for PMN P-11-662p110662.eng INITIAL REVIEW ENGINEERING REPORT PMN: 11-0662 Focus Ready Draft 10/31/2011 ENGINEER: Macek \ EV \ EV PV (kg/yr): Revision Notes / Assessment Overview:

SUBMITTER:
USE:

OTHER USES: MSDS: Label:

CRSS :

Page 1p110662.eng

Consumer Use: No SAT (concerns) (10/12/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Migration to groundwater: Negligible PBT rating: P3B1T1 PMN: P1B1T1; Hyd Pdt: P3B1T1 Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 1 No releases to Water
OCCUPATIONAL EXPOSURE RATING: 2C
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: P2 claims:

EXPOSURE-BASED REVIEW: No
INITIAL REVIEW ENGINEERING REPORT PMN: 11-0662

Page 2p110662.eng Number of Sites/ Location:

TSE 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 Tot. # of workers exposed via assessed routes: Basis:

Inhalation:

Page 3p110662.eng

Dermal:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0662

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.

W

Page 4p110662.eng

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

Inhalation:

Dermal:



Page 5p110662.eng

Page 6

# A-003 Initial Review Exposure Report
for PMN P-11-662October 31, 2011 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR) Chemical ID: P-11-0662 Reviewer: Delpire/JB

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 = 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 5.55E-02 --- --- --- --- --- --- --- --- --- --- Max LADD --- 2.38E-04 --- --- --- --- --- --- --- --- ---
1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manuf acturing (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposure scenario if their releases occur at same location. 3 Exposure calculations are Acute Dose Rate (A DR), 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 7Q 10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:October 31, 2011 page of

INITIA L REVIEW EX POSURE REPORT

Chemical ID: P-11-0662 Assessor: Delpire/JB

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:October 31, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0662

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

SCENARIO #: 1 Number of Sites: 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)

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 30.66 71.30 112.94 133.69
ALL 10 39.60 13.29 7.76 7.57 222.98 664.41 1137.89 1166.45

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 3.28E-05 2.38E-04 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 1.68E-03 1.22E-02 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 5.96E-03 5.55E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:October 31, 2011 page of

INITIA L REVIEW EX POSURE REPORT

Chemical ID: P-11-0662 Assessor: Delpire/JB

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:October 31, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0662

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

SCENARIO #: 2 Number of Sites: 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)

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 3.28E-05 2.38E-04 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 1.68E-03 1.22E-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: