# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-594

EPA Docket EPA-HQ-OPPT-2012-0182

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-594 A-002 Initial Review Engineering Report for PMN P-11-594 A-003 Initial Review Exposure Report for PMN P-11-594

# A-001 Structure Activity Team (SAT) Report
for PMN P-11-594

## SAT Report PMN Number: P-11-0594 SAT Date: 8/30/2011 Print Date: 1/4/2012

Related cases : Health related cases: Ecotox related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 3

Persistence Bioaccum Toxicity Comments 1 1 2 PMN 1 1 Hyd Pdt

Exposure Based Review : Health: Yes Exposure based testing (health): Inhalation Only Ecotox: Yes
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; ; Hyd Pdt

P 2 Rec Comments : Comment: N o Commen t Keywords : Keywords: IRR/POSS CORR-E,S,L,MM THYROID DEVEL NEURO AQUATOX-A,C Summary of Assessment :
Fate : Fate Summary: P-11-0594 FATE: Estimations for typical hydrolysis product

### Liquid with MP < 20C (E) log Kow = 1.49 (E); S = 4.2 g/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) log Koc = 3.21 (E) log Fish BCF = 0.65 (E) log Fish BAF = 0.502 (E) POTW removal (%) = PMN 90-99 via hydrolysis; then Hyd Pdt 0-90 via sorption Time for complete ultimate aerobic biodeg = unknown Sorption to soils/sediments = low to moderate PBT Potential: PMN P1B1; Hyd Pdt P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Expect moderate absorption with reaction all routes, based on physical/chemcal properties. formation in the body is possible. There is concern for irritation and possible corrosion to all exposed tissues from the reactive constituents. There also is concern for thyroid toxicity based on formation, as well as developmental neurotoxicity based on the thyroid toxicity. Test Data: Analog test data

N egative in Salmonella with and without activation; N egative in E. coli with and without activation; Rat oral LD0 2000 mg/kg; Rat dermal LD0 = 2000 mg/kg; Mild eye irritation in rabbits
Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.63 daphnid 48-h LC50 2.8 green algal 96-h EC50 0.79 fish

_ chronic value 0.021 daphnid

_ chronic value 0.028
algal

_ chronic value 0.48
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

### Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = MW 479; liquid; log Kow = 4.65 (EPI); S = reacts slowly (hours-days) 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

SARs SAR Class Ecotox Category
Ecotox Factors Comments:
SAT Chair: J. Kwiat

# A-002 Initial Review Engineering Report
for PMN P-11-594

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0594 Focus Ready Draft 9/15/2011
ENGINEER: Avcin \ CLM PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

MSDS: Yes Label: No Gen Eqpt: Provide eyewash station and safety shower. // Chemical resistant gloves // Approved safety goggles; face shield. // Suitable protective clothing and eye/face protection Respirator: If exposure limits are exceeded or respiratory irritation is experienced, NIOSH/MSHA approved respiratory protection should be worn. Supplied air respirators may be required for non-routine or emergency situations. Health Effects: May cause skin and eye burns. May be harmful if swallowed. May be harmful if inhaled. INGESTION: This product hydrolyzes in the stomach to form ethanol. SKINl May cause chemical burns. INHALATION: May cause irritation to the respiratory system. EYES: May cause chemical burns. TLV/PEL: none established for PMN

CRSS :

### Consumer Use: No

SAT (concerns) (08/30/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Analogs: Human Health Related Cases: Migration to groundwater: Negligible PBT rating: P1B1T2 PMN: P1B1T2 // Hyd Pdt: P1B1 Health: 2 Dermal, Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 2.00 ppb)

OCCUPATIONAL EXPOSURE RATING: 1B

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

### POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0594

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

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0594

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

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY:

CALL TO: Organization:

Date:

Time:

Phone:

# A-003 Initial Review Exposure Report
for PMN P-11-594September 14, 2011 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-11-0594 Reviewer: Cinalli/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 = 2 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: max acute eco --- --- --- --- --- --- --- ---

PDM1 --- --- --- --- --- --- --- --- --- Max LADD --- --- --- --- --- --- --- --- ---

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 Drinking (Surface) Wate r Dose (mg/kg/day) NA Fish Ingestion Dose (mg/kg/day) NA Inhalation Dose (mg/kg/day) NA Groundwater Dose (mg/kg/day) NA Surface Water Release After Treatment (kg/yr) NA Total Release After Treatment (kg/yr) NA Consumer Use? 

## Fate test recommendations:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594 Assessor: Cinalli/JB
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: Max ADR Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: N/A N/A
Per Site Release: N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594

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:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVITY: Max ADR
SIC CODE DESCRI PTION:
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

2.00 HighSeptember 14, 2011 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0594 Assessor: Cinalli/JB
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: PDM1 Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: N/A N/A
Per Site Release: N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594

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

SCENARIO #: 2 Number of S ites: RELEASE ACTIVITY PDM1
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:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: PDM1
SIC CODE DESCRI PTION:
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

2.00 HighSeptember 14, 2011 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0594 Assessor: Cinalli/JB
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: Max LADD Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: N/A N/A
Per Site Release: N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:September 14, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0594

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

SCENARIO #: 3 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:September 14, 2011 page of