# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)

P-12-51

EPA Docket EPA-HQ-OPPT-2012-0182

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-51 A-002 Initial Review Engineering Report for PMN P-12-51 A-003 Initial Review Exposure Report for PMN P-12-51

# A-001 Structure Activity Team (SAT) Report
for PMN P-12-51

## SAT Report PMN Number: P-12-0051 SAT Date: 11/22/2011

Print Date: 2/6/2012

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 11

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: N o releases to water Fate: ; 1 not 4 (biodegrades)

P 2 Rec Comments : Comment: N o Commen t
Keywords : Keywords: IRR-E,S,L,MM SOLV IRR SOLV NEURO
Summary of Assessment :

Fate : Fate Summary: P-12-0051-52 FATE:
log Kow = -2.58 (E)

### VP < 1.0E-6 torr at 25 C (E) BP = 371 C (E) H < 1.00E-8 (E) log Koc = 1.00 (E) log Fish BCF = 0.50 (E) log Fish BAF = -0.05 (E) POTW removal (%) = 90 via biodeg Time for complete ultimate aerobic biodeg = d-wk Sorption to soils/sediments = low PBT Potential: P1B1 *CEB FATE: Migration to ground water = negligible (biodegrades)

Health : Health Summary: Absorption is good all routes, based on analogs. There is concern for irritation to all exposed tissues, based on the and information in the PMN MSDS. There also are concerns for solvent irritation and solvent neurotoxicity.

Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 >100 daphnid 48-h LC50 >100 green algal 96-h EC50 >100 fish

_ chronic value >10 daphnid

_ chronic value >10

algal

_ chronic value >10

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for log Kow = -2.58 (EPI); p H7; effective concentrations based on 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) 1000

SARs SAR Class

### Ecotox Category none

Ecotox Factors Comments:

SAT Chair: J. Kwiat

# A-002 Initial Review Engineering Report
for PMN P-12-51

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0051 0052 Focus Ready Draft 12/5/2011
ENGINEER: El-Zoobi \ AH PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

CRSS :

### Consumer Use: No
SAT (concerns) (11/22/2011): Migration to groundwater: Negligible PBT rating: P1B1T1 Health: 1-2 Dermal, Drinking Water, Inhalation Eco: No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1C

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

POLLUTION PREVENTION CONSIDERATIONS: P2 Claim:

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0051 0052

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0051 0052

# A-003 Initial Review Exposure Report
for PMN P-12-51

### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-12-0051C Reviewer: Tobias/BC

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 = 1000 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

Max ADR 2.60E01 --- 3.05E-03 --- --- --- --- --- --- --- ---

Max LADD --- 1.57E-03 --- 2.13E-05 --- --- --- --- --- --- ---

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: 

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

Parameter Exp Based Persistent Exceedance Value

7.37E+03



### Fate test recommendations?: (default is NA)INITIA L REV IEW EXPOSURE REPORT

Chemical ID: P-12-0051 Assessor: Tobias/BC

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:12/2/2011 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0051

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY Max ADR

SIC-CODE DESCRIPTION: SIC-CODE (S): EX POSED 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:INITIA L REV IEW EXPOSURE REPORT

Chemical ID: P-12-0051 Assessor: Tobias/BC

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:12/2/2011 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0051

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

SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY: Max LADD

SIC-CODE DESCRIPTION: SIC-CODE (S): EX POSED 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: