# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-08-722

EPA Docket EPA

- HQ

- OPPT -2011-0577

# Index

A-001 Structure Activity Team (SAT) Report for

PMN P-08-722

A-002 Initial Review Engin eering Report for

PMN P-08-722

A-003 Initial Review Exposure Report for

PMN P-08-722

# A-001

Structure Activity Team (SAT) Report

for PMN P-08-722

# A-002

Initial Review Engineering Report

for PMN P-08-722Support - P-08-0722 Engineering.2.txt

INITIAL REVIEW ENGINEERING REPORT

PMN: 08-0722

Post-Focus Draft Revision 2 4/5/2011

ENGINEER: Jon \ AH

PV (kg/yr): 25,000

Revision Notes / Assessment Overview: Based on a fax

Oct/27, the totes are either returned for refilling with

same chemical or incinerated.| New revision based on

March 15 fax letter and phone message left by Mr. Larson

on April/4, the solvent wash from eqiupments will not be

discharged to water.|

SUBMITTER: Gelest

USE: Pigment treatment (95%) and surface treatment (5%).

Synthetic sequence: P-08-0722 -> surface-treated particles. STN file CA: no references

found. Alloxysilane FGEW = 149

OTHER USES: None found.

MSDS: Yes Label: No

Gen Eqpt: combustible, wear chemical worker's goggles,

rubber, neoprene or nitrile gloves, do not wear contact

lenses

Respirator: air-supplied or combination organic vapor

acid gas respirator if exposure exceeds TLV

Health Effects: eye: will cause immediate or delayed

severe eye irritation // skin: may produce irritation or

contact dermatitits // inhalation: may irritate the

respiratory tract

TLV/PEL:

none established

CRSS : Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.

-(1-oxododecyl)-.omega.-[3-(triethoxysilyl)propoxy]-

S-H20: Reacts g/L @

VP: 1.0E-6 torr @

MW: 448.00 95.00%<500 100.00%<1000 Physical State and Misc CRSS Info:

Neat: Liquid Mfg: Liquid Proc/Form: NK End Use: Destroyed.

NAVG = 448 with 95% <500 and 100% <1000 (GPC, spectrum

not provided). The MW of the structure as drawn with n=1

is 448. The submitter states that for 75-85% of the PMN

substance n = 1-4 with the remainder n>4. MSDS is

provided for a >90% solution of PMN substance in

unreacted feedstock. Submitted data: none. Estimated data

(EPI for structure as drawn with n=1 and mp entered as

20°C): bp 443°C, vp = 7.18E-7 torr. The PMN substance is

expected to react with water. Alkoxysilane FGEW (3 EtO-Si,

as drawn): 448/3 = 149

Consumer Use: No

SAT (concerns) (09/26/2008):

Related Cases and Related Cases and Misc SAT Info:

Page 1Support - P-08-0722 Engineering.2.txt

Migration to groundwater: Negligible

PBT rating: P1B1T1 Silanol, n=1

Health: 1-2 Dermal, Inhalation

Eco: 3 Water (All releases to water with a CC = 1ppb), XB

Testing (No Testing desired)

OCCUPATIONAL EXPOSURE RATING: 1A

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

Synthetic sequence --> P08-0722. The submitter

was contacted for additional information, see contact

report. (Note: The submitter will fax in an amendment to

correct the PV) This IRER assessed releases and exposures

to PMN during manufacturing and use as surface (5%) or

pigment treatment (95%). The PMN may be used for two

different purposes, but both processes have similar

operation where the PMN is incorporated onto inorganic

particles. Therefore, only a single use operation is

assessed. For manufacturing, releases were assessed to

incineration, per submission. For use, uncertain releases

were assessed to incineration (submitter estimate) and

water (worst case) due to SAT concern for water release.

Note for incineration, PV << 200,000 kg/yr. Release to

land is not required, and fugitive air release is

expected to be negligible. Dermal exposure was assessed

for both operations. Inhalation exposure is expected to

be negligible, as VP << 0.01 torr.

POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: No



INITIAL REVIEW ENGINEERING REPORT

PMN: 08-0722

Manufacturing

Page 2Support - P-08-0722 Engineering.2.txt

Number of Sites/ Location: 1

Gelest, Inc Morrisville PA 19067

Days/yr: 10

Basis: Submission states 100% PMN in product, 10

batches/yr and 2,500 kg/batch. For a total of 1

manufacturing sites, (Per fax letter 3/15/2011)

Process Description: Reactants --> Reaction Vessel -->

Strip --> 100% PMN liquid packaged in steel drums or

totes (technical contact, submission)

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. Note for incineration, PV << 200,000

kg/yr. Release to water is not expected per submission.

Release to land is not required, per SAT. Fugitive air

release is expected to be negligible, as VP << 0.01 torr.

Incineration

Conservative: 2.5E+1 kg/site-day over 10 days/yr from 1

site

or 2.5E+2 kg/yr

to: off-site incineration (submission)

from: Equipment Cleaning Losses of Liquids from a Single,

Large Vessel

basis: EPA/OPPT Single Vessel Residual Model, CEB

standard 1% residual. Submission estimates up to 0.

2kg/batch PMN (<< 0.01%) may be incinerated off-site. CEB

default of 1% residual is assessed as conservative.

RELEASE TOTAL 2.5E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 6

Basis: Technical contact estimates 3 workers/site.

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

Exposure to Liquid at 100.00% concentration

High End: 1.8E+3 mg/day over 10 days/yr

Number of workers (all sites) with dermal exposure: 3

Basis: Loading Liquid Product into Drums; EPA/OPPT 2-Hand

Dermal Contact with Liquids Model.



INITIAL REVIEW ENGINEERING REPORT

PMN: 08-0722

Use: Incorporating onto Inorganic Particles

Number of Sites/ Location: 1

unknown site

Page 3Support - P-08-0722 Engineering.2.txt

Days/yr: 250

Basis: Submission indicates 1 use site and 100% PMN

liquid in raw material. CEB standard default of 250

days/yr is assumed.

Process Description: 100% liquid PMN unloaded from totes

or drums --> blender or roll mills, PMN deposited onto

surfaces of inorganic particles --> PMN destroyed, per

CRSS. Inorganic particles packaged. (submission,

technical contact)

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. Note for incineration, PV << 200,000

kg/yr. Release to land is not required, per SAT. Fugitive

air release is expected to be negligible as VP << 0.01

torr. Technical contact estimates releases to off-site

inceration, however, due to uncertainties at

non-submitter controlled site, releases are assessed to

incineration or water due to SAT concern for water

release.

Incineration

High End: 6.2E+0 kg/site-day over 120 days/yr from 1 site

or 7.5E+2 kg/yr

to: uncertain

from: Cleaning Liquid Residuals from Drums Used to

Transport the Raw Material

basis: EPA/OPPT Drum Residual Model, CEB standard 3%

residual. Technical contact indicates totes are shipped

back to the submitter site and reused, resulting in no

releases. However, drum residues may be incinerated. Due

to uncertainties, CEB assesses release to incineration or

water due to SAT concern for water release. Based on a

fax Oct/27, the totes are either returned for refilling

with same chemical or incinerated.

Incineration or Landfill

Conservative: 1.0E+0 kg/site-day over 250 days/yr from 1

site

or 2.5E+2 kg/yr

to: uncertain

from: Equipment Cleaning Losses of Liquids from a Single,

Large Vessel

basis: EPA/OPPT Single Vessel Residual Model, CEB

standard 1% residual. Solvent will not be released to

water (per Mr. Larson April/4)

RELEASE TOTAL 10.0E+2 kg/yr - all sites



OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 3

Basis: Submitter estimates 2 workers at the use site.

CEB default minimum of 3 workers/site is assessed.

Inhalation:

negligible (VP < 0.001 torr)

Page 4Support - P-08-0722 Engineering.2.txt

Dermal:

Exposure to Liquid at 100.00% concentration

High End: 1.8E+3 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 3

Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT

2-Hand Dermal Contact with Liquids Model.



Page 5

# A-003

Initial Review Exposure Report

for PMN P-08-722