# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-511

EPA Docket EPA-HQ-OPPT-2011-0942

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-511 A-002 Initial Review Engineering Report for PMN P-11-511 A-003 Initial Review Exposure Report for PMN P-11-511

# A-001 Structure Activity Team (SAT) Report
for PMN P-11-511

## SAT Report PMN Number: P-11-0511 SAT Date: 7/29/2011 Print Date: 11/1/2011

Related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 3 Health: ; Eco: chroonic concerns only

Persistence Bioaccum Toxicity Comments 1 31

Exposure Based Review : Health: N o Ecotox: Yes Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: SENS-S,L; MUTA; ONCO (UNCERT); DEVEL; REPRO; LIVER; KIDNEY; AQUATOX Summary of Assessment :
Fate : Fate Summary: P-11-0511 FATE: Estimations for low weight with MP < 25 C (E) log Kow = 7.18 (E) S = 0.011 mg/L at 25 C (E) VP = 4.4E-2 torr at 25 C (E) BP = 250 C (E) H = 3.12E+0 (E)

### log Koc = 4.28 (E) log Fish BCF = 4.04 (E) log Fish BAF = 5.77 (E) POTW removal (%) ≥ 90 via sorption, stripping and biodeg Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = strong Volatilization half-life from a standard river = 1 hrs Volatilization half-life from a standard lake = 6 da Atmospheric Oxidation Half-life = 0.61 hr via OH radical Atmospheric Oxidation Half-life = 0.31 hr via ozone PBT Potential: P1B3 *CEB FATE: Migration to ground water = slow

Health : Health Summary: Expect poor absorption via all routes ( p che m ); expect p oor oxidation of the . Concern for eye and skin irritation, more severe with repeated exposure dermal sensitization ; reproductive toxicity p ossible liver toxicity and lung toxicity in the form of chemical pneumonia. Concern for skin and lung sensitization, mutagenicity, oncogenicity (marginal), developmental toxicity, male reproductive, liver, and kidney toxicity based on the product. Test Data: PMN substance: (-) Salmonella with and without activation; (-) E. coli with and without activation Analog: skin irritation in rabbits; rat oral LD0 = 5000 mg/kg; slight eye irritation in rabbits; rat inhalation LC0 = 2.06 mg/L; (-) for skin sensitization in a mouse local lymph node assay at 50% ai; rabbit dermal LD0 = 5000 mg/kg 28-day dermal study in rabbits dosed with 2 mL/kg, p rogressive skin irritation dermal sensitizer in humans rat oral devel/repro screen LOEL = 100 mg/kg, mild liver changes at all doses rat oral devel/repro screen NOEL = 150 mg/kg, lower fertility index with a longer mean mating time at 1000 mg/kg : mild eye irritation in rabbits; mild skin irritation in rabbits
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 0.001 daphnid

_ chronic value 0.001

### algal

_ chronic value 0.014 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; SAR chemical class = MW 208 (representative structure); log Kow = 7.18 (EPI); S = 0.009 mg/L at 25 C; p H7; 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SARs neutral organic chemicals SAR Class new chemicals category: neutral organics
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-11-511

### TEST DATA REVIEW ENGINEERING REPORT P-11-0511 Post-Focus Draft Revision 1 9/22/2011

ENGINEER: Prothero \ EV PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS : LABEL :

Consumer Use : N o SAT (concerns): (7/29/2011):

Related Cases and Misc SAT Info: Ecotox Related Cases: /// Human Health Related Cases:Migration to groundwater : Slow PBT rating: P 1 B 3 T 1

. Health: 1-2, Dermal , Inhalation Eco: 3, Water (All releases to water with a CC = 1 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2B

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

POLLUTION PREVENTION CONSIDERATIONS : P2 Claims :

P2 REC:

EXPOSURE-BASED REVIEW: Yes (0 criteria met) 1) # of workers exposed: 12 >1000? N o 2) >100 workers with > 10 mg/day inhalation exposure: N o 3) (a) >100 workers w/1-10 mg/day inh. exp. & >100 days/yr: N o (b) Routine Dermal Cont: > 250 workers & > 100 days/yr: N oP-11-0511



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

## RELEASE TOTAL

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

Dermal:

Inhalation:



## INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes 2) (a) Exposure level > 1 mg/day? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o
Dermal:Inhalation:



## INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): Yes 2) (a) Exposure level > 1 mg/day? Yes (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N oP-11-0511



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

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

# A-003 Initial Review Exposure Report
for PMN P-11-5118/5/11 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR) Chemical ID: P-11-0511 Reviewer: Bevington/SS

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 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

--- --- --- --- --- --- --- --- --- ---

--- --- --- --- --- --- --- --- ---

--- --- --- --- --- --- --- --- --- ---

--- --- --- --- --- --- --- --- ---

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). Th ere 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: 

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

Parameter Exp Based Persistent Exceedance Value Drinking (Surface) Wate r Dose (mg/kg/day) Fish Ingestion Dose (mg/kg/day) Inhalation Dose (mg/kg/day) Groundwater Dose (mg/kg/day) Surface Water Release After Treatment (kg/yr) Total Release After Treatment (kg/yr) Consumer Use?



### Fate test recommendations?:8/5/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0511 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: 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:8/5/11 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-11-0511

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY
RELEASE DESCRIPTION:
METHOD OF CALCULATION: Screen3
EXPOSED POPULATION: Adult

Number of Sites: Per Site Fugitive Release: kg/site/day Fugitive Release Days per Year: days % Removal via Fugitive Release: % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): μg/m 3

Per Site Stack Release: kg/site/day Stack Release Days per Year: days
% Removal via Stack Release: %
Total Stack Release: kg/yr Max Annual Average Air Con centration (Stack): μg/m 3 Max 24 Hour Average Air Concentration (Stack): μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) NA 1 day 71.80 0.55

Inhalation Comments:8/5/11 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 Release Height: 3.00 m
Inside Stack Diameter: 0.10 Length of Release Opening: 10.00 m

Stack Gas Exit Velocity: 0.10 Width of Release Opening: 10.00 m

Stack Gas Temperature: 293.00

Meteorological and Terrain Information:
Surrounding Land Use: Rural Terrain Height: 0.00 m
Distance to Residence of Interest: 100.00 m Meteorological Class: Full Stability Class: NA Wind Speed: NA

Downwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m8/5/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0511 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: 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)

Remarks:8/5/11 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-11-0511

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 2 RELEASE ACTIVITY:MFG: Max LADD
RELEASE DESCRIPTION:
METHOD OF CALCULATION: Screen3
EXPOSED POPULATION: Adult

Number of Sites: Per Site Fugitive Release: kg/site/day Fugitive Release Days per Year: days % Removal via Fugitive Release: % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): μg/m 3

Per Site Stack Release: kg/site/day Stack Release Days per Year: days
% Removal via Stack Release: %
Total Stack Release: kg/yr Max Annual Average Air Con centration (Stack): μg/m 3 Max 24 Hour Average Air Concentration (Stack): μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) NA 1 day 71.80 0.55

Inhalation Comments:8/5/11 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: 3.00 m
Inside Stack Diameter: 0.10 m Length of Release Opening: 10.00 m

Stack Gas Exit Velocity: 0.10 m/sec Width of Release Opening: 10.00 m

Stack Gas Temperature: 293.00 K

Meteorological and Terrain Information:
Surrounding Land Use: Rural Terrain Height: 0.00 m
Distance to Residence of Interest: 100.00 m Meteorological Class: Full Stability Class: NA Wind Speed: NA

Downwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m8/5/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0511 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites Release Activity: 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:8/5/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0511

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY

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)

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

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 mg/kg/day mg/kg/day
LADC pot mg/L mg/kg
Acute
ADR pot mg/kg/day mg/kg/day

SIC Code Comments:8/5/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0511 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:4 Number of Release Sites Release Activity: 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:
Site Release: (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/5/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0511

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

SCENARIO #: 4 Number of Site s: RELEASE ACTIVITY

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)

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
ALL 10

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 mg/kg/day mg/kg/day
LADC pot mg/L mg/kg
Acute
ADR pot mg/kg/day mg/kg/day

SIC Code Comments:8/5/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0511

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4 RELEASE ACTIVITY
SIC CODE DESCRIPTION:
ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis