# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-11-481

EPA Docket EPA-HQ-OPPT-2012-0182

# 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

# A-001

Structure Activity Team (SAT) Report

for PMN P-11-481

## 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)

### 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); 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 2

### ( p pb)

SARs esters

SAR Class ester new chemicals category: esters

Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002

Initial Review Engineering Report

for PMN P-11-481INITIAL 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.

Page 1POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT

PMN: 11-0481

Page 2Page 3p110481.eng

INITIAL REVIEW ENGINEERING REPORT

PMN: 11-0481

Page 4Page 5

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:

Page 6Concerning what?

PMN: 11-0481

Page 7

# A-003

Initial Review Exposure Report

for PMN P-11-4819/16/2011 Page of



### STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-0481 Reviewer: Delpire/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 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 Manufact uring (Mfg), Processing (Proc) and Use release activity

labels. Multiple release activities are combined in one exposu re 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.9/16/2011 Page of9/16/2011 Page of

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-0481

gh9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

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:9/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-04819/16/2011 Page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-11-0481