# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-12-149

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-149 A-002 Initial Review Engineering Report for PMN P-12-149 A-003 Initial Review Exposure Report for PMN P-12-149

# A-001 Structure Activity Team (SAT) Report for PMN P-12-149

## SAT Report PMN Number: P-12-0149 SAT Date: 1/27/2012 Print Date: 3/1/2012
Related cases : Health related cases: Ecotox related cases :
Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 3 Health: ; Eco: chronic concerns only

Persistence Bioaccum Toxicity Comments 2 32

Exposure Based Review : Health: Ecotox: Yes Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: LIVER; THYROID; REPRO; UNCERT-DEVEL- N EURO;AQUATOX Summary of Assessment : Fate : Fate Summary: P-12-0149 FATE: Estimations for typical Liquid with MP < 25 C (E) log Kow = 5.93 (E) S = 0.232 mg/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP = Dec. >190 C (M) H < 1.00E-8 (E) log Koc = 3.67 (E) log Fish BCF = 3.58 (E)

### log Fish BAF = 3.63 (E) POTW removal (%) = 90 via sorption Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = v.strong PBT Potential: P2B3 *CEB FATE: Migration to ground water = negl
Health : Health Summary: Expect poor absorption via all routes ( p che m /analog). By analogy to substituents unspecified) there is concern for liver and thyroid effects, reproductive effects , and developmental neurotoxicity effects.The information for comes from the . The NOAEL/benchmark dose for liver and thyroid effects from 28-day and 90-day studies is 22.9 mg/kg based on liver weight increase. A NOAEL o f 10 mg/kg for reproductive toxicity is based on a decrease in the fertility index in a 2-generation dietary study in rats. In addition an increase in pup mortality was also noted. A LOAEL of 0.9 mg/kg from a study where neonatal mice were exposed on day 10 via gavage is based on changes in spontaneous behavior and learning and memory defects. Animals were then observed for effects at the age of 3 months.
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 0.021 or * daphnid

_ chronic value 0.030 or * algal

_ chronic value * 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 579; solid with mp 189 C (P); log Kow = 5.93 (EPI); S = 0.006 mg/L 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) 2 or *

### SARs neutral organic chemicals SAR Class Ecotox Category N eutral Organics

# A-002 Initial Review Engineering Report for PMN P-12-149

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0149 Focus Ready Draft 2/6/2012 ENGINEER: Austin \ BCS PV (kg/yr):

SUBMITTER:
USE:

OTHER USES:
MSDS: No Label: No
TLV/PEL: MSDS not provided.

CRSS :

SAT (concerns) (01/27/2012): Related Cases and Related Cases and Misc SAT Info: Ecotox Analog: Migration to groundwater: Negligible

### PBT rating: P2B3T2 . Health: 1-2 Dermal, Inhalation Eco: 3 Water (All releases to water with a CC = 2 ppb)
OCCUPATIONAL EXPOSURE RATING: 1A
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: P2 claims:

### EXPOSURE-BASED REVIEW: Yes (0 criteria met) 1) # of workers exposed: 9 >1000? No 2) >100 workers with >10 mg/day inhalation exposure: No 3) (a) >100 workers w/1-10 mg/day inh. exp. & >100 days/yr: No (b) Routine Dermal Cont: >250 workers & >100 days/yr: No
INITIAL REVIEW ENGINEERING REPORT PMN: 12-0149

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: 12-0149
PROC/USE:

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-12-1492/3/12 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR) Chemical ID: P-12-0149 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 CC = 2 PDM Days Exceede d LADD ADR LADD ADR LADD

Release activity(ies) 2 ; exposure calculation(s) 3 mg/kg/day m g/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day m g/kg/day mg/kg/day m g/kg/day mg/kg/day

Max ADR --- --- --- --- --- --- --- 2.53E+00 --- --- ---

Max LADD --- --- --- --- --- --- --- --- 5 .88E-02 --- ---

Max ADR --- --- --- --- --- --- --- 2.49E+00 --- --- ---

Max LADD --- --- --- --- --- --- --- --- 5 .74E-02 --- ---

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) No No Fish Ingestion Dose (mg/kg/day) No No Inhalation Dose (mg/kg/day) Yes Yes 5.88E-02 Groundwater Dose (mg/kg/day) No No Surface Water Release After Treatment (kg/yr) Total Release After Treatment (kg/yr) Consumer Use? 

### Fate test recommendations?: (default is NA)2/3/12 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0149 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: Max ADR Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (k g/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:2/3/12 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-12-0149
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 1 RELEASE ACTIVITY: Max ADR 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): 0.00 μg/ m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 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): 7.54 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 1.38E+04 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) 5.54E-04 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 3.02E-03 N/ A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 2.53 N/A NA 1 day 71.80 0.55

Inhalation Comments:2/3/12 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

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

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

Do wnwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m2/3/12 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0149 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: Max LADD Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (k g/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:2/3/12 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-12-0149
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 2 RELEASE ACTIVI TY 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): 0.00 μg/ m 3

Max 24 Hour Average Air Concentration(Fugitive): N/A 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 Concen tration (Stack): 800.00 μg/m 3 Max 24 Hour Average Air Concentration (Stack): N/A 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) 5.88E-02 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 0.32 N/ A 30.00 75.00 NA NA Acute ADR pot

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

Inhalation Comments:2/3/12 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

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

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

Do wnwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m2/3/12 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0149 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: : Max ADR Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (k g/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:2/3/12 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-12-0149
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 3 RELEASE AC TIVITY: : Max ADR 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): 0.00 μg/ m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 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): 7.44 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 1.36E+04 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) 5.47E-04 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 2.98E-03 N/ A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 2.49 N/A NA 1 day 71.80 0.55

Inhalation Comments:2/3/12 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

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

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

Do wnwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m2/3/12 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0149 Assessor: Bevington/SS
ENVIRONMENTAL RELEASES
Scenario#:4 Number of Release Sites: Release Activity: Max LADD Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (k g/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:2/3/12 page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-12-0149
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 4 RELEASE ACTIVITY: : 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): 0.00 μg/ m 3

Max 24 Hour Average Air Concentration(Fugitive): N/A 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 Concen tration (Stack): 780.00 μg/m 3 Max 24 Hour Average Air Concentration (Stack): N/A 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) 5.74E-02 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 0.31 N/ A 30.00 75.00 NA NA Acute ADR pot

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

Inhalation Comments:2/3/12 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

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

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

Do wnwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m