# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)

P-11-546

EPA Docket EPA-HQ-OPPT-2011-0942

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-546 A-002 Initial Review Engineering Report for PMN P-11-546 A-003 Initial Review Exposure Report for PMN P-11-546

# A-001 Structure Activity Team (SAT) Report

for PMN P-11-546

## SAT Report PMN Number: P-11-0546 SAT Date: 8/9/2011 Print Date: 8/31/2011

Related cases : Health related cases: Ecotox related cases : Analogs:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 2

Persistence Bioaccum Toxicity Comments 3 12

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Drinking Water Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: UNCERT-MUTA, HEART, DEVEL, REPRO-M, IRR, KIDNEY, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-11-0546 FATE: Solid S = 6 g/L at 17 C (M) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 0 Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = low

### PBT Potential: P3B1 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: Absorption is nil through the skin based on p hysical/chemical properties and good through the lungs and GI tract based on analogs. There is concern for irritation by analogy to which is corrosive to the eyes but is not a dermal irritant. There is uncertain concern for mutagenicity also by analogy to which gave a weak positive for chromosome aberrations in human lymphocytes but is negative in an oral mouse micronucleus assay and negative in Salmonella and E coli. The N OEL for from a 28-day oral study in rats is 30 mg/kg (LOEL = 150 mg/kg) based on degeneration of the kidneys, necrosis of the heart muscle, and effects to the male reproductive organs. Cesium has been shown to cause cardiac problems and developmental toxicity. Low moderate concern.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 >100 daphnid 48-h LC50 11 green algal 96-h EC50 86 fish

_ chronic value >10 daphnid

_ chronic value 1.1 algal

_ chronic value 21 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for cesium compoumds; SAR chemical class = inorganic cesium with 65.2% Cs; MW 408; S = 6 g/L (M); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 110

SARs cesium compounds SAR Class inorganic desium with 65.2% Cs new chemicals category: none

Ecotox Factors Comments:

SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report

for PMN P-11-546

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0546 Focus Ready Draft 8/15/2011

ENGINEER: Prothero \ AH PV (kg/yr): 4,500 Import Only

SUBMITTER: Chemetall Foote Corporation
USE: Brazing (metal joining) agent, flux. CA 149:337513, 145:509515, 138:191600 - Brazing flux component. CA 145: 509516 - Component of active brazing flux. CA 137:173274 - Flux for soldering and/or brazing of aluminum and aluminum alloys.

OTHER USES: CA 152:598365 - Component in self-contraction reducing agent composition for high strength concrete. CA 136:6536 - Melt polycarbonate polymerization catalyst systems

MSDS: Yes Label: No
Gen Eqpt: Tightly sealed safety glasses, chemical resistant suit, protective neoprene gloves Respirator: In case of insufficient ventilation, wear suitable respiratory equipment. Respiratory protection mask with adequate filter according to OSHA Standard - 29 CFR: 1910.134 or ANSI Z88.2. Health Effects: Toxic by inhalation, in contact with skin and if swallowed. May cause skin irritation in susceptible persons. Dust contact with the eyes can lead to mechanical irritation TLV/PEL: Fluorides measured as the inhalable fraction of the aerosol 2.5 mg/m3 TWA ACGIH/OSHA

CRSS :

### Consumer Use: No

SAT (concerns) (08/09/2011): Migration to groundwater: Rapid PBT rating: P3B1T2 Health: 1-2 Drinking Water, Inhalation Eco: 2 Water (All releases to water with a CC = 110 ppb)

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER. PMN import only -> Mfg no assessed. Tech contact not available via phone. The submission provides no information on the potential processing and use of PMN after import; therefore, a same submitter, similar use past case, was used for key assumptions for this IRER. Similar use past cases are referenced for consistency:

POLLUTION PREVENTION CONSIDERATIONS: None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0546
Processing: Formulation

Number of Sites/ Location: 1 unknown site(s) Days/yr: 200 Basis: P-02-25: 10 PROC sites for 50,000 kg/yr PV (5,000 kg/site-yr), 250 use days/yr. For this case, NS = (4,500 kg/yr PV) / (5,000 kg/site-yr) = 0.8 sites. For 1 site, scale day/yr to 200.
Process Description: Unload PMN (100% powder) from containers (5 to 20 kg bags or 0.25 to 5 kg bottles) -> mix with other additives and binders or use at 100% pure -> on-site use (e.g., coated onto parts, wires, O-rings, etc. for industrial and commercial uses by dip or brush application -> dried (physical form and concentration per submission/MSDS, process per past case ) OR package brazing material (solid, paste, or liquid) for use at customer sites

### 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: 1.1E-1 kg/site-day over 200 days/yr from 1 site or 2.2E+1 kg/yr to: Air, water, incineration or land (Dust Model) from: Unloading Solid Raw Material from Transport Containers basis: User-Defined Loss Rate Model. PMN is a neat solid. CEB assumes there is potential for dust release during transfer of imported PMN. The 2006 Dust Model estiamtes 0. 5% release to air, water, incineration or land.

Water or Incineration or Landfill Output 2: 2.2E-1 kg/site-day over 200 days/yr from 1 site or 4.5E+1 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. Media of release not known. Past case P02-0025 estimated 1% release to water, incineration or land.

Water or Incineration or Landfill Conservative: 4.5E-1 kg/site-day over 200 days/yr from 1 site or 9.0E+1 kg/yr to: uncertain from: Equipment Cleaning Losses of Liquids from Multiple Vessels basis: EPA/OPPT Multiple Process Vessel Residual Model, CEB standard 2% residual. Media of release not known. Past case P02-0025 estimated 2% release to water, incineration or land.

RELEASE TOTAL 1.6E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 9 Basis:

Inhalation:
Exposure to Particulate (Class I) Typical: 1.1E+0 mg/day over 200 days/yr Worst Case: 3.6E+0 mg/day over 200 days/yr Number of workers (all sites) with inhalation exposure: 9 Basis: Unloading Solid Raw Material from Transport

### Containers; EPA Small Volume Handling Model, less than 54 kg of PMN handled per site-day. Std. model used to estimate exposure. Note past case P02-0025 referenced "CEB Dye weighers data" and estimated 2.1 mg/day (typical) to 7.2 mg/day (worst-case). 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: Not required, per SAT.

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0546
Use: Brazing of parts/component manufacture

Number of Sites/ Location: 2 unknown site(s) Days/yr: 250 Basis: P-02-0025: 10 - 15 customer sites, 250 day/yr use for 9 formulators (1 - 1.5 customers/ formulator). For this case, assume 2 customers.
Process Description: (From Foster, 2001): (OEM facilities) - The metal coated parts to be braized (e.g., aluminum heat exchangers), are loaded onto a conveyor and first enter vented metal enclosures beginning with a thermal degreaser/washer, then to the fluxer application (application of braizing coating), then into a dryer to remove moisture followed by the braising furnace and primary and secondary cooling chambers. The metal parts are coated with the flux, heated to temperatures of 435 to 480 deg. C at which the flux melts to form the bond between the parts.

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY PMN chemical is fused onto the metal parts as a result of the braising operation. Aside from residual in packaging, process releases not expected, per past case P02-0025.

Incineration or Landfill Conservative: 9.0E-2 kg/site-day over 250 days/yr from 2 sites

### or 4.5E+1 kg/yr to: industrial waste disposal (water not expected for this process) 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.

RELEASE TOTAL 4.5E+1 kg/yr - all sites

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

Inhalation: Expected to be negligible. // Inhalation exposure is not expected from the braising operation. The intended use of the PMN chemical is to form the bond between metal parts so the great majority will end up on the parts. Vapors from the furnace and primary and secondary cooling chambers are not expected to be open to the workplace environment (as per Foster, 2001)
Exposure to Particulate (Class I) Typical: 4.3E-1 mg/day over 250 days/yr Worst Case: 1.4E+0 mg/day over 250 days/yr 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. Assume 3 workers/ site max exposed during this activity. 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: Not required, per SAT.

CBI:file:///J|/SNURS/SNUR%20SANITIZATION/AUG%202011/P-11-0546/p110546.eng.txt[9/12/2011 9:53:44 AM] 

### MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Ariel Hou Organization: ERG for CEB

CALL TO:
Organization:

Date: 08/10/2011

Time: 2:30PM

Phone:

PMN: 11-0546

Submitter was not available at time of call. Voicemail left at 2:30pm.

# A-003 Initial Review Exposure Report

for PMN P-11-5468/12/11 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-11-0546 Reviewer: Sherer/SS

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 7Q10 4
CC = 110 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

PROC: Max ADR:
max acute eco 4.90E-03 --- --- --- 1.01E+02 --- --- --- --- --- ---

PROC: PDM1 --- --- --- --- 1.01E+02 27 --- --- --- --- --- PROC: Max LADD --- 8.42E-05 --- --- --- --- 9.19E-05 --- --- --- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manuf acturing (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 (A DR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution Model (PDM). Th ere 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 7Q 10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:8/12/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0546 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: 1. Release Activity: PROC: Max ADR
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 156.00 0.00 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 200.00 0.00/0.00 N/A N/A

Per Site Release: 0.78 0.00/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/12/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0546

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 Number of Site s: 1 RELEASE ACTIVITY:PROC: Max ADR SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

0.00 200. 0.78 0.78 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 2.71 6.30 9.98 11.81

ALL 10 39.60 13.29 7.76 7.57 19.70 58.69 100.52 103.04

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 1.16E-05 8.42E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 5.94E-04 4.32E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 5.26E-04 4.90E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:8/12/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0546 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: 1. Release Activity: PROC: PDM1
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 156.00 0.00 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 200.00 0.00/0.00 N/A N/A

Per Site Release: 0.78 0.00/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/12/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0546

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 Number of Site s: 1 RELEASE ACTIVITY:PROC: PDM1 SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

0.00 200. 0.78 0.78 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 2.71 6.30 9.98 11.81

ALL 10 39.60 13.29 7.76 7.57 19.70 58.69 100.52 103.04

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 1.16E-05 8.42E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 5.94E-04 4.32E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 5.26E-04 4.90E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:8/12/11 page of

IN ITI AL REVIEW EX POSURE REPORT

Chemical ID: P-11-0546

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: PROC: PDM1 SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)

ASSOCIATED SIC CODES: Subset of 4952

SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis

110.00 7 27 200.00 0.78 0.00 High8/12/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0546 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: 1. Release Activity: PROC: Max LADD
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 156.00 156.00 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 1.00 1.00/0.00 N/A N/A

Per Site Release: 156.00 156.00/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/12/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0546

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 Number of Site s: 1 RELEASE ACTIVITY:PROC: Max LADD SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

0.00 1. 156. 156.00 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A

ALL 10 39.60 13.29 7.76 7.57 N/A N/A N/A N/A

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 1.16E-05 8.42E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 5.94E-04 4.32E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments:8/12/11 page of

IN ITI AL REVIEW EX POSURE REPORT Chemical ID: P-11-0546

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 3 ACTIVITY: PROC: Max LADD

RELEASE DESCRIPTION:

EXPOSED POPULATION: Adult

NUMBER OF SITES NON-SLUDGE LANDFILL RELEASE AND DAYS OF RELEASE (kg/site/day)/(days) LANDFILLED SLUDGE 1
AND DAYS OF RELEASE (kg/site/day)/(days) MIGRATION DESCRIPTOR 2 ADSORPTION TO WASTEWATER SLUDGE (%) DRINKING WATER TREATMENT (%)

1. 156.00/1.00 0.00/0.00 Rapid 0.00 0.00

1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the surface water pre-treatment release.

2 Migration Descriptor Log Koc Groundwater Concentration (GWC) (mg/L per kg release) Negligible no migration None Negligible to slow > 4.5 3.21E-6 Slow <4.5 to 3.5 2.67E-5 Moderate <3.5 to 2.5 5.95E-5 Rapid <2.5 7.55E-5

ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (L/day)
Cancer
LADD pot (mg/kg/day) 9.19E-05 30.00 75.00 71.80 1.40
LADC pot (mg/L) 4.71E-03 30.00 75.00 NA NA

REMARKS: