# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notices (PMN) P-12-196

EPA Docket EPA-HQ-OPPT-2012-0740

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-196 A-002 Initial Review Engineering Report for PMN P-12-196 A-003 Post Focus Exposure Report for PMN P-12-196

# A-001 Structure Activity Team (SAT) Report for PMN P-12-196

## SAT Report PMN Number: P-12-0196 SAT Date: 3/6/2012 Print Date: 5/31/2012
Related cases : Health related cases: Ecotox related cases :
Concern levels : 

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

Persistence Bioaccum Toxicity Comments 2 31

Exposure Based Review : Health: Yes Ecotox: Yes Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: LIVER, UNCERT-HEALTH, AQUATOX-C Summary of Assessment : Fate : Fate Summary: P-12-0196 FATE: Estimations for low weight MW 286 Liquid with MP < 25 C (E) log Kow = 7.49 (E) S = 0.012 mg/L at 25 C (E) VP = 7.8E-6 torr at 25 C (E) BP > 400 C (E) H = 6.43E-6 (E) log Koc = 6.28 (E) log Fish BCF = 3.89 (E) log Fish BAF = 3.58 (E)

### POTW removal (%) = 90 via sorption Time for complete ultimate aerobic biodeg ≥ mo Sorption to soils/sediments = v.strong Volatilization half-life from a standard river = 240 hrs Volatilization half-life from a standard lake = 77 da Atmospheric Oxidation Half-life = 6.4 hr via OH radical PBT Potential: P2B3 *CEB FATE: Migration to ground water = negl
Health : Health Summary: Absorption of the lower molecular weight components is p oor all routes based on physical/chemical properties. There is uncertain concern for health effects. The PMN material may cause adverse liver effects. 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 0.001 daphnid

_ chronic value 0.001 algal

_ chronic value 0.013 or * Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs neutral organic chemicals; SAR chemical class = ; MW 286; log Kow = 7.49 (EPI, smaller structure); liquid (M); S = 0.012 mg/L 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) 1

SARs neutral organic chemicals SAR Class Ecotox Category N eutral Organics
Ecotox Factors Comments:

### SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report for PMN P-12-196

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0196 Focus Ready Draft 3/15/2012 ENGINEER: Hall \ JD PV (kg/yr):

SUBMITTER:
USE:

OTHER USES:

MSDS: No Label: No
TLV/PEL:

CRSS :

Consumer Use: No SAT (concerns) (03/06/2012): Related Cases and Related Cases and Misc SAT Info:

### Ecotox Related Cases: Migration to groundwater: Negligible PBT rating: P2B3T1 . Health: 1-2 Dermal, Inhalation Eco: 3 Water (All releases to water with a CC = 1 ppb.)
OCCUPATIONAL EXPOSURE RATING: 1A
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: None.

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0196

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.

RELEASE TOTAL

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

Inhalation:

Dermal:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0196

### 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.

RELEASE TOTAL

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

Dermal:

# A-003 Initial Review Exposure Report for PMN P-12-1965/11/12 page of



### POST FOCUS EXPOSURE REPORT This updated assessment is based on Test Da ta Engineering Report, Post-Focus Draft

Revision 1, dated 5/9/2012.

Chemical ID: P-12-0196 Reviewer: Wong/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 = 1 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 --- --- --- --- --- --- --- 1.44E-04 --- --- --- Max LADD --- --- --- --- --- --- --- --- 3 .15E-08 --- ---

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) No No Groundwater Dose (mg/kg/day) No No Surface Water Release After Treatment (kg/yr) No No Total Release After Treatment (kg/yr) No No Consumer Use? No 

### Fate test recommendations?: (default is NA)5/11/12 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-12-0196 Assessor: Wong/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:5/11/12 page of

POST FOCUS EXPOSURE REPORT Chemical ID: P-12-0196
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 Concen tration (Stack): 4.28E-04 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 0.78 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) 3.15E-08 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 1.71E-07 N/ A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 1.44E-04 N/A NA 1 day 71.80 0.55

Inhalation Comments:5/11/12 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 m5/11/12 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-12-0196 Assessor: Wong/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:5/11/12 page of

POST FOCUS EXPOSURE REPORT Chemical ID: P-12-0196
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 2 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): 4.28E-04 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) 3.15E-08 N/A 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 1.71E-07 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:5/11/12 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