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 1p120181.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 2p120181.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 3p120181.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 4p120181.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 5p120181.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.

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