p120181.eng

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0181

Focus Ready Draft 3/5/2012

ENGINEER: Jon \ JD

PV (kg/yr): 500

SUBMITTER: Henkel

USE: Cure initiator in adhesive formulations.

OTHER USES: 8 - Activator for human histone

deacetylase-8 on a fluorescent substrate. 

- Reactant for the preparation of of

2-amidinotetrahydroisoquinolines. 

 - Preparation of.

MSDS: Yes Label: No

Gen Eqpt: Eye/face protection: Safety goggles or safety

glasses with side shields. // Skin protection: Use

chemical resistant, impermeable clothing

Respirator: If ventilation is not sufficient to

effectively prevent buildup of dust, appropriate

NIOSH/MSHA respiratory protection must be provided. NIOSH

approved respiratory with particulate filter. Do not

inhale dust.

Health Effects: Inhalation: Dusts of this product may

cause irritation of the nose, throat, and respiratory

tract. May be harmful if inhaled. // Skin contact: May

cause irritation. May be harmful if absorbed through skin.

 // Eye contact: May cause irritation. // Ingestion: May

be harmful if swallowed.

TLV/PEL:

none established.

CRSS :

Chemical Name: Benzamide,

N-[(cyclohexylamino)thioxomethyl]-

S-H20: 0.0142 g/L @

VP: 1.0E-6 torr @

MW: 262.00 %<500 %<1000

Physical State and Misc CRSS Info:

Neat: Solid Mfg: Solid Proc/Form: Solution: 2% PMN

material End Use: Destroyed. Submitted Data: MP = 63-67

°C (DSC); WS = Insoluble. The IR, 1H-NMR and 13C-NMR

spectra are included with the PMN submission. Literature

Data: MP = 71-72 °C (STN Prop file). Estimated Data: BP

= 442 °C (EPI); VP = 3.5E-7 torr (EPI); WS = 0.0142 g/L

(EPI), 0.037 g/L (ACD); logP = 3.94 (EPI), 3.33 (ACD).

Consumer Use: No

SAT (concerns) (02/24/2012):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: Analogs: 

Migration to groundwater: Slow

PBT rating: P1B1T2 .

Health: 1-2 Dermal, Drinking Water, Inhalation

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

Page 1
p120181.eng

OCCUPATIONAL EXPOSURE RATING: 2-3C

NOTES & KEY ASSUMPTIONS:

POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0181

Manufacturing: Batch

Number of Sites/ Location: 1

Henkel Salisbury NC Salisbury NC 28147

Days/yr: 5

Basis: The submission lists 1 site, 5 batches/site-yr and

maximum of 100 kg/batch.

Process Description: Raw materials are charged to

reaction vessel while in a water bath (5-10C) -->

Solution is warmed for reflux (77C) --> Cooled to 5-10C

and additional reactants are added --> Washed with HCl

--> Washed with Deionized water --> Organic portion dried

 --> Solids are collected via vacuum filtration and

washed with dichloromethane --> Solid dissolved in

ethanol --> Gravity filtration --> Recrystallization -->

Transport to processing area (solid, 100%) (per

submission, past cases)

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.

Water or Air or Incineration or Landfill

Output 2: 1.0E+0 kg/site-day over 2 days/yr from 1 site

or 2.1E+0 kg/yr

Page 2
p120181.eng

to: Water, incineration, air or land (model)

from: Loading Solid Product into Transport Containers

basis: User-Defined Loss Rate Model. EPA/OPPT Generic

Model to Estimate Dust Releases from Transfer/Unloading

Operations of Solid Powders estimates 0.5% PV released to

water, incineration, air or land.

Incineration

Conservative: 2.0E+0 kg/site-day over 5 days/yr from 1

site

or 1.0E+1 kg/yr

to: Off-site Incineration (submission)

from: Equipment Cleaning Losses of Liquids from Multiple

Vessels

basis: EPA/OPPT Multiple Process Vessel Residual Model,

CEB standard 2% residual. Submission indicates a total of

0.3kg/batch sent to off-site incineration from washes and

waste. CEB model is more conservative and presented here.

RELEASE TOTAL

1.2E+1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Basis: The submission estimates 2 workers exposed during

manufacturing. CEB assumes standard default of 3

workers/site.

Inhalation:

Exposure to Particulate (Class I)

Upper Bound: 1.5E+2 mg/day over 5 days/yr

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

Basis: Loading Solid Product into Transport Containers;

OSHA PNOR PEL-Limiting Model.

NOTE: The respirator class is: I. Particulate (including

solid or liquid droplets).

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit

 or data not specific to industry): Yes

2)a) Exposure level > 1 mg/day? Yes

 OR

 b) Hazard Rating for health of 2 or greater? 1-2 No

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Solid at 100.00% concentration

High End: 3.1E+3 mg/day over 5 days/yr

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

Basis: Loading Solid Product into Transport Containers;

EPA/OPPT Direct 2-Hand Dermal Contact with Solids Model.

INITIAL REVIEW ENGINEERING REPORT CBI: Yes

PMN: 12-0181

Processing: Formulation of Adhesive

Number of Sites/ Location: 1

Henkel Salisbury NC Salisbury NC 28147

Page 3
p120181.eng

Days/yr: 25

Basis: The submission states the PMN is formulated at the

manufacturing site and estimates 25 exposure days. The

PMN is formulated from 100% solid to a 2% liquid. CS

calculates 20 kg/site-batch.

Process Description: PMN product (solid, 100%)

transferred to processing area --> mixing vessel -->

final thread-sealing formulation (liquid, <2%) -->

formulation dispensed into bottles via automated machine

(per submission and past cases)

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.

Water or Air or Incineration or Landfill

Output 2: 1.0E+0 kg/site-day over 2 days/yr from 1 site

or 2.1E+0 kg/yr

to: Water, incineration, air or land (model)

from: Unloading Solid Raw Material from Transport

Containers

basis: User-Defined Loss Rate Model. EPA/OPPT Generic

Model to Estimate Dust Releases from Transfer/Unloading

Operations of Solid Powders estimates 0.5% PV released to

water, incineration, air or land.

Water or Incineration or Landfill

Output 2: 2.1E+0 kg/site-day over 2 days/yr from 1 site

or 4.2E+0 kg/yr

to: Uncertain

from: Cleaning Solid/ Powder Residuals from Containers

Used to Transport the Raw Material

basis: EPA/OPPT Solid Residuals in Transport Containers

Model, CEB standard 1% residual. Submission does not

address container cleaning during formulation.

Water or Incineration or Landfill

Conservative: 2.0E-1 kg/site-day over 25 days/yr from 1

site

or 5.0E+0 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. Submission does not address

equipment cleaning during formulation.

RELEASE TOTAL

1.1E+1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 6

Basis: The submission estimates up to a total of 6

workers exposed from 2 activites.

Inhalation:

Exposure to Particulate (Class I)

Typical: 9.5E-1 mg/day over 25 days/yr

Worst Case: 3.2E+0 mg/day over 25 days/yr

Page 4
p120181.eng

Number of workers (all sites) with inhalation exposure: 6

Basis: Unloading Solid Raw Material from Transport

Containers; EPA Small Volume Handling Model, less than 54

kg of PMN handled per site-day.

NOTE: The respirator class is: I. Particulate (including

solid or liquid droplets).

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit

 or data not specific to industry): Yes

2)a) Exposure level > 1 mg/day? Yes

 OR

 b) Hazard Rating for health of 2 or greater? 1-2 No

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Solid at 100.00% concentration

High End: 3.1E+3 mg/day over 25 days/yr

Number of workers (all sites) with dermal exposure: 6

Basis: Unloading Solid Raw Material from Transport

Containers; EPA/OPPT Direct 2-Hand Dermal Contact with

Solids Model.

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0181

Use: Threadlocking Adhesive

Number of Sites/ Location: 200

unknown site(s)

Days/yr: 250

Basis: Submission did not provide an estimate for the

number of use sites. CEB referred to past cases P11-250,

P10-0154, and P10-0151, which referenced P09-0532

(different submitter, adhesive for OEM parts and

construction) where the submitter estimated 500-1050

sites. Both P10-0154 and P10-0151 estimated 1000 sites

for a PV of 2,500 kg/yr while P11-250 assumed 200 sites

for PV of 500 kg/yr. Based on 250 days/yr and a PMN

concentration of 2%, CS calculates a use rate of 0.5kg or

500g of adhesive per site-day. Assuming each assembly

requires 0.1ml of adhesive, each end use site could

produce 5,000 parts per day.

Process Description: Adhesive formulation containing PMN

(liquid, <2%) --> customer sites --> formulation applied

by automated equipment to threaded parts in small amounts

--> polymerization; PMN destroyed (per P10-0151 and CRSS)

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.

Water or Incineration or Landfill

High End: 4.5E-4 kg/site-day over 33 days/yr from 200

sites

or 3.0E+0 kg/yr

to: Uncertain

from: Cleaning Liquid Residuals from Bottles Used to

Transport the Raw Material

Page 5
p120181.eng

basis: EPA/OPPT Small Container Residual Model, CEB

standard 0.6% residual. Submission does not address

non-submitter controlled sites.

Water or Incineration or Landfill

Conservative: 1.0E-4 kg/site-day over 250 days/yr from 200

sites

or 5.0E+0 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. Submission does not address

non-submitter controlled sites.

RELEASE TOTAL

8.0E+0 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 600

Basis: The submission did not provide estimates for final

use. CEB assumes standard default minimum of 3

workers/site.

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

Exposure to Liquid at 2.00% concentration

High End: 3.5E+1 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 600

Basis: Unloading Liquid Raw Material from Bottles;

EPA/OPPT 2-Hand Dermal Contact with Liquids Model.

Page 6