Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-481 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-481 

A-002 Initial Review Engineering Report for 

 PMN P-11-481 

A-003 Initial Review Exposure Report for 

 PMN P-11-481 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-481 

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SAT Report

PMN Number: P-11-0481

SAT Date: 7/15/2011

Print Date: 12/5/2011

Related cases: CBI: Yes

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

1 2 1 PMN

Exposure Based Review:

Health: Yes

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: IRR-E,S; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0481

FATE: 

Liquid with MP = -11.5 C (M)

log Kow = 5.29 (E) 

S = 1.31 mg/L at 25 C (E)

VP = 3.4E-5 torr at 25 C (E)

BP = 375 C (E)

H < 1.00E-8 (E)

log Koc = 3.86 (E)

log Fish BCF = 3.16 (E)

log Fish BAF = 1.21 (E) 

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POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg = wk-mo

Sorption to soils/sediments = strong

PBT Potential: P1B2

*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Expect poor absorption via all routes (analog). Concern 

for skin and eye irritation based on submitted test data.

 Test Data: [Summaries only, submitted]: rat oral LD0 = 2000 mg/kg; 

rabbit dermal LD0 = 2000 mg/kg; mild eye irritation in rabbits; skin irritation in rabbits; no skin 

sensitization in guinea pigs using the Buehler assay; oral developmental toxicity study in rats-no 

repression of genes that would indicate testicular dysgenesis as is seen with phthalates

 Ecotox:

Test 

Organism

Tes

t 

Typ

e

Test End 

Point

Predicted Measured Comments

fish 96-

h 

LC50 0.51

daphnid 48-

h

LC50 0.74

green 

algal

96-

h

EC50 0.19

fish _ chronic 

value

0.019

daphnid _ chronic 

value

0.20

algal _ chronic 

value

0.14

Sewage 

Sludge

3-h EC50 _

Sewage 

Sludge

_ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for esters; SAR chemical class = 

ester; MW 318; log Kow = 5.29 (EPI); pH7; 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 2

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(ppb)

SARs esters

SAR Class ester new chemicals category: esters

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-11-481 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0481

Focus Ready Draft 7/25/2011

ENGINEER: Avcin \ JAS

PV (kg/yr): 

SUBMITTER: Ferro Corp.

USE:

use.

OTHER USES:

MSDS: Yes Label: No

Gen Eqpt: impervious gloves / safety glasses with

side-shields / lightweight protective clothing.

Respirator: none specified.

Health Effects: No hazards to be especially mentioned.

Avoid contact with the skin and the eyes.Avoid breathing

vapors or mists.

TLV/PEL:

none established.

CRSS :

 

 

 

Consumer Use: No

SAT (concerns) (07/15/2011):

Related Cases and Related Cases and Misc SAT Info:

Eco Analogs: // Health Analogs: .

Migration to groundwater: Slow

PBT rating: P1B2T1 .

Health: 1-2 Dermal, Inhalation

Eco: 3 Water (All releases to water with a CC = 2 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2-3C

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

 

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POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: 

 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0481

 

 

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p110481.eng

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0481

 

 

 

 

 

 

 

 

 

 

 

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CBI: No

MEMORANDUM of TELEPHONE CONVERSATION (Contains No TSCA

CBI)

CALL BY: Jason A. Sese

Organization: ERG for CEB

CALL TO: George Schaefer

Organization: Ferro

Date: 07/18/2011

Time: 11:15 am

Phone: 

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Concerning what?

PMN: 11-0481

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A-003 

Initial Review Exposure Report 

 for PMN P-11-481 

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STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0481 Reviewer: Delpire/BC 

 

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary 

Exposure 

Scenario1 

 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 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 Manufacturing (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 (ADR), 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 7Q10 streamflow, which is defined as the average daily 

streamflow of the seven consecutive days of lowest flow within a ten year period. 

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 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0481 Assessor: 

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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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Chemical ID: P-11-0481 Assessor: 

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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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Chemical ID: P-11-0481 Assessor: 

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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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Chemical ID: P-11-0481 Assessor: 

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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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 Chemical ID: P-11-0481 

 

 

 

 

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Chemical ID: P-11-0481 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:5 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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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Chemical ID: P-11-0481 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Chemical ID: P-11-0481 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:6 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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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 Chemical ID: P-11-0481 

gh 

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Chemical ID: P-11-0481 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:7 Number of Release Sites 

 Release Activity: 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 

 Non-sludge/Sludge 

Release Days/yr: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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 Chemical ID: P-11-0481 

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Chemical ID: P-11-0481 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:8 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: 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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 Chemical ID: P-11-0481 

 

 

 

 

 

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Chemical ID: P-11-0481 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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