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

P-11-577

EPA Docket EPA-HQ-OPPT-2011-0942

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-577 A-002 Initial Review Engineering Report for PMN P-11-577 A-003 Initial Review Exposure Report for PMN P-11-577

# A-001 Structure Activity Team (SAT) Report

for PMN P-11-577

## SAT Report PMN Number: P-11-0577 SAT Date: 8/23/2011 Print Date: 8/31/2011

Related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 3

Persistence Bioaccum Toxicity Comments 1 12

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: REPRO, LIVER, SENS-DERMAL, IRR, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-11-0577 FATE: Liquid with MP < 25 C (E) log Kow = 1.72 (E); S = 5.63 g/L at 25 C (E) VP = 0.53 torr at 25 C (E, N OMO5) BP = 192 C ( N OMO5) based on 76-80 C @ 10 mm (M) H = 1.46E-5 (E) log Koc = 1.47 (E) log Fish BCF = 0.80 E)

### log Fish BAF = 0.402 (E) POTW removal (%) = 90 via biodeg Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = low Volatilization half-life from a standard river = 50 hrs Volatilization half-life from a standard lake = 27 da Atmospheric Oxidation Half-life = 2.4 hr via OH radical PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is good all routes based on analogs. Expect ester hydrolysis and disulfide formation through the mercaptan. The PMN compound may be an irritant. There is concern for dermal sensitization based on potential binding to proteins and concern for liver effects and possible reproductive effects by analogy to methyl thioglycolate. Methyl thioglycolate was tested in a 2-week oral study in rats with deaths at 300 mg/kg and p ossible liver effects at 100 mg/kg ( N OEL = 10 mg/kg) (8e-10578) and possible reproductive effects at 300 mg/kg. Testicular atrophy, degenerated spermatids or atrophied seminiferous epithelium in the testes was noted at 300 mg/kg. Moderate concern.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 8.5 all values are from the thiol SARs daphnid 48-h LC50 1.0 green algal 96-h EC50 0.58 fish

_ chronic value 1.0 daphnid

_ chronic value 0.096 algal

_ chronic value 0.22 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for esters and thiols; SAR chemical class = ester, thiol; MW 148; log Kow = 1.72 (EPI); liquid with mp = unknown (P); S = 5.63 g/L at 25 C (P); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

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

SARs esters and thiols SAR Class ester, thiol new chemicals category: thiols

### Ecotox Factors Comments:

SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report

for PMN P-11-577

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0577 Focus Ready Draft 8/29/2011

ENGINEER: El-Zoobi \ JAS PV (kg/yr): 10 Import Only

SUBMITTER: International Flavors & Fragrances Inc.
USE: Fragrance ingredient for use in soaps, detergents, cleaners and cosmetics. LM-04-8 (same submitter), all analogs, STN CA 135:343645, and 135:343645 are for the same use. The substance has a green, mango, fruity odor.

OTHER USES: No other uses found.

MSDS: Yes Label: No
Gen Eqpt: Use tight-fitting goggles, face shield or safety glasses with side sheilds if eye contact mich occur. Use chemical-resistant gloves. Use local exhaust ventilliation. Respirator: No respiratory protection is required during normal operations in a workplace where engineering controls such as adequate ventilation, etc. are sufficient. If engineering controls and safe work practices are not sufficient, an approved, properly fitted respirator with organic vapor cartridges or canisters and particulate filters should be used. Health Effects: Combustible liquid. Toxic by inhalation, ingestion, skin absorption. Severe skin, eye and respiratory irritant. TLV/PEL: none established.

CRSS : Chemical Name: Butanoic acid, 3-mercapto-, ethyl ester S-H20: 5.63 g/L @ VP: 5.3E-1 torr @ MW: 148.00 %<500 %<1000 Physical State and Misc CRSS Info: Neat: Liquid Mfg: Liquid Proc/Form: Solution: 0.01% in dipropylene glycol; then Solution: 12 ppm in fragrance oil blend End Use: Solution or Solid: 0.6 ppm PMN substance in consumer product. Submitted Data: Liquid; flash point = 74°C. Measured Data from Same as L-01-12: BP = 76-80°C@10 torr; flash point = 74°C. Literature Data (STN eProp): BP = 95-100°C@50 torr. Estimated Data (NOMO5 with 76°C@10 torr): BP = 191.5°C; VP = 0.53. Estimated Data (EPI with MP = 20°C): WS = 5.631 g/L; log

### P = 1.72; BP = 188.04°C; VP = 0.652 torr. Estimated Data (STN/ACD Labs): WS = 3.6 g/L; log P = 1.726; BP = 189.5°C; VP = 0.567 torr.

Consumer Use: Yes

SAT (concerns) (08/23/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Same as LM04-8 = L01-12 = L00-396; Analogs: P10-56, P02-248. // Human Health Related Cases: L00-396/L01-0012 Migration to groundwater: Negligible PBT rating: P1B1T2 . Health: 2 Dermal, Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 10 ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3D

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER. The PMN is imported; therefore no releases or exposures from manufacturing were assessed. /// Past cases referenced for consistency are: P10-0355, P06-0789, P06-0645, and L05-0321 (all same submitter, same use). All were import only, therefore they did not assess domestic manufacturing. For all past cases, the final product is used 100% in a cusomer product, therefore, after the incorporation of the PMN into the final product, no further assessments were made (consistent with this IRER). /// All past cases assessed inhalation exposures to particulate during the Use operation (consistent with this IRER as the submission states products may be solid or liquid). All past cases assessed all cleaning residues to water (consistent with this IRER per the submission). Past cases P10-0355, P06-0645 and L04-0321 assess dermal exposures to solids and liquids (consistent with this IRER as the submission states products may be solid or liquid). /// The CEB Generic Scenario for manufacture and processing of fragrances was referenced.

POLLUTION PREVENTION CONSIDERATIONS: P2 claims: On Site Treatment: all industrial wastewaters that exit the compounding facility (Hazlet, NJ) are pretreated via a permitted, Sequencing Batch Reactor (SBR), waste activated sludge facility and then discharged to the local POTW. Off Site Treatment: the wastewater enters the POTW (Bayshore Regional Sewerage Authority (BRSA), NPDES# NJ0024708), a 16 million gallon per day (MGD) capacity treatment facility. The typical daily flow through the BRSA facility is 8-10 MGD. The treated effluent from the POTW is combined with the wastewaters from other municipalities. This total flow is then managed and discharged through the Monmouth County Bayshore Outfall Authority into the Atlantic Ocean,

### approximately 2,000 feet offshore.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0577
Processing: Formulation of Fragrance Oil

Number of Sites/ Location: 2 International Flavors & Fragrances Inc. Union Beach NJ 07735 International Flavors & Fragrances Inc Hazlet NJ 07730 Days/yr: 10 Basis: Submission states: 2 sites, 1 kg/bt, 10 bt/yr, 48 hr/bt. PMN blended from 100% down to a maximum level of 0. 01%. CS indicates 5 bt/site-yr.
Process Description: PMN material imported (100 %, liquid) and loaded into mixing vessel -> Combined with other fragrance ingredients -> Finished fragrance oil (<0. 01%, liquid) (per 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.

Water Conservative: 1.0E-2 kg/site-day over 5 days/yr from 2 sites to: On-site WWTP then discharged to POTW (Bayshore Regional Sewerage Authority; NJ0024708) (per submission) from: Equipment Cleaning Losses of Liquids from a Single Vessel basis: EPA/OPPT Single Vessel Residual Model, CEB standard 1% residual. Submission estimates trace amounts from equipment cleaning sent to on-site wastewater treatment plant and discharged to POTW - Bayshore Regional Sewerage Authority; NJ0024708.

Air Typical: 3.6E-6 kg/site-day over 5 days/yr from 2 sites Worst Case: 7.1E-6 kg/site-day over 5 days/yr from 2 sites to: Fugitive air from: Unloading Liquid Raw Material from Drums basis: EPA/OAQPS AP-42 Loading Model. Submission does not estimate air releases during the compounding process.

Air Typical: 3.6E-2 kg/site-day over 5 days/yr from 2 sites Worst Case: 7.1E-2 kg/site-day over 5 days/yr from 2 sites to: Fugitive air from: Loading Liquid Product into Drums

### basis: EPA/OAQPS AP-42 Loading Model. Submission does not estimate air releases during the compounding process.

RELEASE TOTAL 8.1E-1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 92 Basis:

Inhalation:
Exposure to Vapor (Class II) Typical: 1.7E-3 mg/day over 5 days/yr Worst Case: 1.0E-1 mg/day over 5 days/yr Number of workers (all sites) with inhalation exposure: 46 Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT Mass Balance Model. NOTE: The respirator class is: II. Gas/vapor (all substances in the gas form).

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? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)
Exposure to Vapor (Class II) Typical: 1.7E+1 mg/day over 5 days/yr Worst Case: 1.0E+3 mg/day over 5 days/yr Number of workers (all sites) with inhalation exposure: 46 Basis: Loading Liquid Product into Drums; EPA/OPPT Mass Balance Model. NOTE: The respirator class is: II. Gas/vapor (all substances in the gas form).

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? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal:
Exposure to Liquid at 100.00% concentration High End: 1.8E+3 mg/day over 5 days/yr Number of workers (all sites) with dermal exposure: 46

### Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.
Exposure to Liquid at 0.01% concentration High End: 1.8E-1 mg/day over 5 days/yr Number of workers (all sites) with dermal exposure: 46 Basis: Loading Liquid Product into Drums; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0577

Use: Formulation of Consumer Products

Number of Sites/ Location: 25 unknown customer sites Days/yr: 49 Basis: Submission states 25 customers but customers may have more than one site. Fragrance oil wll be used at 5% concentation in the consumer produtcts. PMN concentration in final product = 0.0001 x 0.05 = 0.000005. CEB assumes 25 sites and estimates number of days/site-yr based on CEB GS (2009) which estimates an average of 82 kg/site-day of fragrance oil processed per day. At 0.01% concentration, the daily use rate of the PMN chemical is 0.0082 kg/site-day. Days/site-yr = 1,000/0.82/25 = 49.
Process Description: Fragrance oil unload from drums (<0. 01%, liquid) into mixing tank -> Mixed with other chemicals -> Finished household consumer products (0. 000005% PMN) per 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.

Water High End: 6.2E-4 kg/site-day over 19 days/yr from 25 sites to: uncertain from: Cleaning Liquid Residuals from Drums Used to Transport the Raw Material basis: EPA/OPPT Drum Residual Model, CEB standard 3% residual. Submission does not account for container cleaning, but indicates that they anticipate that all water from washing storage vessels, equipment, and lines would be discharged to POTW. CEB assumes release to POTW. Note SAT concern for water.

Water Conservative: 1.6E-4 kg/site-day over 49 days/yr from 25 sites to: POTW (per submission) from: Equipment Cleaning Losses of Liquids from a Single,

### Small Vessel basis: EPA/OPPT Multiple Process Vessel Residual Model, CEB standard 2% residual. anticipate that all water from washing storage vessels, equipment, and lines would be discharged to POTW. Note SAT concern for water.

Water or Air or Incineration or Landfill Output 2: 5.6E-5 kg/site-day over 49 days/yr from 25 sites or 6.8E-2 kg/yr to: Uncertain from: Dust Waste Generated from Conveying, Mixing, and Packaging Powdered Commercial and Consumer Products basis: User-Defined Loss Rate Model. Per CEB GS (2009), Loss fraction of 0.68%. media of release uncertain - water, incineration, air, or land

Air Typical: 2.9E-6 kg/site-day over 49 days/yr from 25 sites Worst Case: 5.8E-6 kg/site-day over 49 days/yr from 25 sites to: Fugitive air from: Unloading Liquid Raw Material from Drums basis: EPA/OAQPS AP-42 Loading Model.

Air Typical: 2.9E-5 kg/site-day over 49 days/yr from 25 sites Worst Case: 5.8E-5 kg/site-day over 49 days/yr from 25 sites to: Fugitive air from: Loading Liquid Product into Small Containers basis: EPA/OAQPS AP-42 Loading Model.

RELEASE TOTAL 6.4E-1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 725 Basis: Submission states that consumer products may be solid or liquid. Therefore, solid exposures (inhalation and dermal were assessed). Submission estimates up to 50 total workers potentially exposed. CEB Generic Scenario (2009) estimates 29 workers per site and conservatively estimates that up to 29 workers are potentially exposed for each worker activity.

Inhalation:
Exposure to Vapor (Class II) Typical: 1.4E-3 mg/day over 49 days/yr Worst Case: 8.4E-2 mg/day over 49 days/yr Number of workers (all sites) with inhalation exposure: Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT Mass Balance Model.

### NOTE: The respirator class is: II. Gas/vapor (all substances in the gas form).

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? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)
Exposure to Vapor (Class II) Typical: 1.4E-2 mg/day over 49 days/yr Worst Case: 8.4E-1 mg/day over 49 days/yr Number of workers (all sites) with inhalation exposure: Basis: Loading Liquid Product into Small Containers; EPA/OPPT Mass Balance Model. NOTE: The respirator class is: II. Gas/vapor (all substances in the gas form).

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? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)
Exposure to Particulate (Class I) Upper Bound: 2.5E-4 mg/day over 49 days/yr Number of workers (all sites) with inhalation exposure: Basis: Loading Solid Product into Transport Containers; OSHA Respirable 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? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal:
Exposure to Liquid at 0.01% concentration High End: 1.8E-1 mg/day over 49 days/yr Number of workers (all sites) with dermal exposure: 725 Basis: Unloading Liquid Raw Material from Drums; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.

### Exposure to Liquid at 0.00% concentration High End: 8.8E-3 mg/day over 49 days/yr Number of workers (all sites) with dermal exposure: 725 Basis: Loading Liquid Product into Small Containers; EPA/OPPT 2-Hand Dermal Contact with Liquids Model.
Exposure to Solid at 0.00% concentration High End: 1.6E-2 mg/day over 49 days/yr Number of workers (all sites) with dermal exposure: 725 Basis: Loading Solid Product into Transport Containers; EPA/OPPT Direct 2-Hand Dermal Contact with Solids Model.

# A-003 Initial Review Exposure Report

for PMN P-11-5778/26/11 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-11-0577 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 = 10 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 --- --- 1.83E-08 --- 1.61E-03 --- --- --- --- --- ---

PROC: Max LADD --- --- --- 1.71E-12 --- --- --- --- --- --- --- USE: Max ADR:
max acute eco 2.96E-07 --- 2.00E-08 --- 8.05E-03 --- --- --- --- --- ---

USE: PDM1 --- --- --- --- 2.08E-03 0 --- --- --- --- --- USE: Max LADD --- 1.01E-09 --- 2.73E-11 --- --- --- --- --- --- ---

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:8/26/11 page of



### Results Table: Consumer Exposure Results Summary

Water (DtD) Dermal Inhalation
Drinking Water Fish Ingestion

ADR LADD ADR LADD 7Q10 PDM Days Exceed

ed ADR LADD ADR LADD

Scenario mg/kg/day mg/kg/day mg/kg/da y mg/kg/day μg/l # Days mg/ kg/day mg/kg/day mg/kg/day mg/kg/day
CEM 2

, General Purpose --- --- --- --- --- --- 5.44E-06 3.40E-06 1.82E-04 5.07E-05

CEM 2

, Laundry detergen
t --- --- --- --- --- ---

1.73E-06 1.87E-07 2.39E-04 3.98E-05

CEM 2

, Bar
soap --- --- --- --- --- --- 2.92E-05 2.63E-05 --- ---

1 Down-the-Drain Module within NCEM2 model. 2 Consumer Exposure Module within NCEM2 model.8/26/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0577 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

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

Total Releases: 0.10 N/A N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 5.00 0.00/0.00 N/A N/A

Per Site Release: 1.00 E-02 N/A/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/26/11 page of

IN ITI AL REVIEW EX POSURE REPORT

CHEMICAL ID: P-11-0577

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS
SCENARIO #: 1 RELEASE ACTIVITY: PROC: Max ADR
FACILITY NAME: BAYS HORE REGIONAL SA
FACILITY LOCATION: UNION BEACH NJ 07735
RECEIVING WATER NAME: ATLANTIC OCEAN
REACH NUMBER: 02030104014 FACILITY ON REACH: Unk DISCHARGE TYPE: Direct
NPDES PERMIT #: NJ0024708 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

90. 5. 25.92 0.01 1.00E-03 6.30

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 23.90 1.61E-03 CHRONIC SCENARIO 65.00 5.94E-04

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 1.71E-12 30.00 75.00 71.80 6.00

LADC pot (mg/kg) 2.05E-08 30.00 75.00 NA NA Acute ADR pot (mg/kg/day) 1.83E-08 NA 1 day 71.80 129.00 Lakes Comments:8/26/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0577 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

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

Total Releases: 0.10 N/A N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

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

Per Site Release: 5.00 E-02 N/A/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/26/11 page of

IN ITI AL REVIEW EX POSURE REPORT

CHEMICAL ID: P-11-0577

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS
SCENARIO #: 2 RELEASE ACTIVITY: PROC: Max LADD
FACILITY NAME: BAYS HORE REGIONAL SA
FACILITY LOCATION: UNION BEACH NJ 07735
RECEIVING WATER NAME: ATLANTIC OCEAN
REACH NUMBER: 02030104014 FACILITY ON REACH: Unk DISCHARGE TYPE: Direct
NPDES PERMIT #: NJ0024708 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

90. 1. 25.92 0.05 5.00E-03 6.30

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 23.90 8.07E-03 CHRONIC SCENARIO 65.00 2.97E-03

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 1.71E-12 30.00 75.00 71.80 6.00

LADC pot (mg/kg) 2.05E-08 30.00 75.00 NA NA Acute ADR pot (mg/kg/day) N/A NA 1 day 71.80 129.00 Lakes Comments:8/26/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0577 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: 25. Release Activity: USE: Max ADR
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 0.40 N/A N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 19.00 0.00/0.00 N/A N/A

Per Site Release: 8.36 E-04 N/A/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/26/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0577

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

SCENARIO #: 3 Number of Sites: 25 RELEASE ACTIVITY:USE: Max ADR
SIC-CODE DESCRIPTION: Soaps, Detergent, etc. Manufacture SIC-CODE (S): 2841-2844 EXPOSED POPULATION: Adult

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

90.00 19. 0.00084 8.36E-05 0.00 6.30

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 50 413.73 144.88 85.50 75.59 2.02E-04 5.77E-04 9.78E-04 1.11E-03

ALL 10 47.35 23.64 10.39 11.73 1.77E-03 3.54E-03 8.05E-03 7.13E-03

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 8.20E-11 7.17E-10 mg/kg/day 2.22E-12 1.94E-11 mg/kg/day

LADC pot 4.21E-09 3.68E-08 mg/L 2.65E-08 2.32E-07 mg/kg

Acute

ADR pot 4.82E-08 2.96E-07 mg/kg/day 2.29E-09 2.00E-08 mg/kg/day

SIC Code Comments:8/26/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0577 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:4 Number of Release Sites: 25. Release Activity: USE: PDM1
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 0.26 N/A N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 49.00 0.00/0.00 N/A N/A

Per Site Release: 2.16 E-04 N/A/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/26/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0577

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

SCENARIO #: 4 Number of Site s: 25 RELEASE ACTIVITY:USE: PDM1
SIC-CODE DESCRIPTION: Soaps, Detergent, etc. Manufacture SIC-CODE (S): 2841-2844 EXPOSED POPULATION: Adult

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

90.00 49. 0.00022 2.16E-05 0.00 6.30

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 50 413.73 144.88 85.50 75.59 5.22E-05 1.49E-04 2.53E-04 2.86E-04

ALL 10 47.35 23.64 10.39 11.73 4.56E-04 9.14E-04 2.08E-03 1.84E-03

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 5.47E-11 4.78E-10 mg/kg/day 1.48E-12 1.29E-11 mg/kg/day

LADC pot 2.80E-09 2.45E-08 mg/L 1.77E-08 1.54E-07 mg/kg

Acute

ADR pot 1.25E-08 7.64E-08 mg/kg/day 5.91E-10 5.16E-09 mg/kg/day

SIC Code Comments:8/26/11 page of

IN ITI AL REVIEW EX POSURE REPORT

Chemical ID: P-11-0577

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4 RELEASE ACTIVITY: USE: PDM1 SIC CODE DESCRIPTION: Soaps, Detergent, etc. Manufacture

ASSOCIATED SIC CODES: 2841-2844

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

10.00 0 0 49.00 2.16E-04 90.00 High8/26/11 page of

IN ITIA L REVIEW EXPOSURE REPORT

Chemical ID: P-11-0577 Assessor: Sherer/SS

ENVIRONMENTAL RELEASES

Scenario#:5 Number of Release Sites: 25. Release Activity: USE: Max LADD
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 0.56 N/A N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

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

Per Site Release: 2.24 E-02 N/A/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/26/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0577

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

SCENARIO #: 5 Number of Sites: 25 RELEASE ACTIVITY:USE: Max LADD
SIC-CODE DESCRIPTION: Soaps, Detergent, etc. Manufacture SIC-CODE (S): 2841-2844 EXPOSED POPULATION: Adult

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

90.00 1. 0.0224 2.24E-03 0.00 6.30

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 50 413.73 144.88 85.50 75.59 N/A N/A N/A N/A

ALL 10 47.35 23.64 10.39 11.73 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-10 1.01E-09 mg/kg/day 3.12E-12 2.73E-11 mg/kg/day

LADC pot 5.93E-09 5.18E-08 mg/L 3.74E-08 3.27E-07 mg/kg

Acute

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

SIC Code Comments:8/26/11 page of

CEM Inputs ID Number: P-11-0577,1

Product: unknown Chemical Name: P-11-0577
Scenario: General Purpose Cleaner Population: Adult Molecular Weight (g/mole): 148 Vapor Pressure (torr) 0.53 Consumer Product Weight Fraction - Central Tendency (unitless): 1e-05 Consumer Product Weight Fraction - HighEnd (unitless): 1e-05

Inhalation Inputs Frequency of Use (chronic) (events/yr): 300 Exposure Duration (chronic) (years): 57 Frequency of Use (acute) (events/day): 1 Exposure Duration (acute) (days): 1 Mass of Product Used per Event - Central Tendency (g): 61.5 Mass of Product Used per Event - High-End (g): 123

Inhalation Rate During Use (m 3 /hr): 1.1 Duration of Event - Central Tendency (hours/event): 0.667

Inhalation Rate After Use (m 3 /hr): 0.55 Duration of Event - High-End (hours/event): 1.42

Zone 1 Volume (m 3 ): 20 Whole House Volume (m 3 ): 369 Air Exchange Rate (air exchanges/hr): 0.45 Body Weight (kg): 71.8

Activity Patterns (Note: 1=Bedroom 2= Kitchen 3=Bathroom 4=Living Room 5=Utility Room 6=Car 7=Out)

User: 1 1 1 1 1 1 1 2 2 1 5 4 2 4 6 7 4 2 2 7 4 4 4 1

Non-User: 1 1 1 1 1 1 1 1 3 2 4 4 2 4 7 7 4 2 2 7 4 4 4 1

Hour: 0 6 12 18

Start Time: 7 Room of Use: 2. Kitchen
Dermal Inputs Frequency of Use (chronic) (events/yr): 300 SA/BW (cm2/kg): 15.6 Frequency of Use (acute) (events/day): 1 Exposure Duration (chronic) (years): 57

Amount Retained / Absorbed to Skin (g/cm2-event): 3.49e-05 Exposure Duration (acute) (days): 1

Averaging Time (chronic) (days): 2.74e+04 Averaging Time (acute) (days) : 18/26/11 page of

CEM Inhalation Exposure Estimates
ID Number: P-11-0577,1
Scenario: General Purpose Cleaner Population: Adult
Exposure Duration (years) chronic: 57 Exposure Duration (days) acute: 1

Exposure Units Result AT (days)

Chronic Cancer

LADD pot (mg/kg-day) 5.07e-05 2.74e+04

LADC pot (mg/m 3 ) 2.11e-04 2.74e+04

Acute

ADR pot (mg/kg-day) 1.82e-04 1
Cp pot (mg/m 3 ) 7.47e-03 NA

LADD - Lifetime Average Daily Dose (mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m 3 )

ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m 3 )

Note: 75 years = 2.738e+04 days pot - potential dose

Note: The general Agency guidance for assessing short-term, infre quent events (for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acu te exposures rather than as chronic exposure. (Methods for E xposure-Response Analysis for Acute Inha lation Exposure to Chemicals (External Review Draft). EPA/600/R-98/051. April 1998)8/26/11 page of

CEM Dermal Exposure Estimates
ID Number: P-11-0577,1
Scenario: General Purpose Cleaner Population: Adult
Exposure Duration (chronic) (years): 57 Exposure Duration (acute) (days): 1

Exposure Units Result AT (days)

Chronic Cancer

LADD pot (mg/kg-day) 3.40e-06 2.74e+04

Acute

ADR pot (mg/kg-day) 5.44e-06 1

LADD - Lifetime Average Daily Dose (mg/kg-day) ADR - Acute Dose Rate (mg/kg-day)8/26/11 page of

CEM Inputs ID Number: P-11-0577,2

Product: unknown Chemical Name: P-11-0577
Scenario: Laundry Detergent Population: Adult Molecular Weight (g/mole): 148 Vapor Pressure (torr) 0.53 Consumer Product Weight Fraction - Central Tendency (unitless): 1e-05 Consumer Product Weight Fraction - HighEnd (unitless): 1e-05

Inhalation Inputs Frequency of Use (chronic) (events/yr): 312 Exposure Duration (chronic) (years): 57 Frequency of Use (acute) (events/day): 1 Exposure Duration (acute) (days): 1 Mass of Product Used per Event - Central Tendency (g): 200 Mass of Product Used per Event - High-End (g): 400

Inhalation Rate During Use (m 3 /hr): 1.1 Duration of Event - Central Tendency (hours/event): 0.333

Inhalation Rate After Use (m 3 /hr): 0.55 Duration of Event - High-End (hours/event): 0.667

Zone 1 Volume (m 3 ): 20 Whole House Volume (m 3 ): 369 Air Exchange Rate (air exchanges/hr): 0.45 Body Weight (kg): 71.8

Activity Patterns (Note: 1=Bedroom 2= Kitchen 3=Bathroom 4=Living Room 5=Utility Room 6=Car 7=Out)

User: 1 1 1 1 1 1 1 2 3 5 5 4 2 4 6 7 4 2 2 7 4 4 4 1

Non-User: 1 1 1 1 1 1 1 1 3 2 4 4 2 4 7 7 4 2 2 7 4 4 4 1

Hour: 0 6 12 18

Start Time: 9 Room of Use: 5. Utility Room
Dermal Inputs Frequency of Use (chronic) (events/yr): 52 SA/BW (cm2/kg): 15.6 Frequency of Use (acute) (events/day): 1 Exposure Duration (chronic) (years): 57

Amount Retained / Absorbed to Skin (g/cm2-event): 1.11e-05 Exposure Duration (acute) (days): 1

Averaging Time (chronic) (days): 2.74e+04 Averaging Time (acute) (days) : 18/26/11 page of

CEM Inhalation Exposure Estimates
ID Number: P-11-0577,2
Scenario: Laundry Detergent (Machine Washing) Population: Adult
Exposure Duration (years) chronic: 57 Exposure Duration (days) acute: 1

Exposure Units Result AT (days)

Chronic Cancer

LADD pot (mg/kg-day) 3.98e-05 2.74e+04

LADC pot (mg/m 3 ) 1.24e-04 2.74e+04

Acute

ADR pot (mg/kg-day) 2.39e-04 1
Cp pot (mg/m 3 ) 1.96e-02 NA

LADD - Lifetime Average Daily Dose (mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m 3 )

ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m 3 )

Note: 75 years = 2.738e+04 days pot - potential dose

Note: The general Agency guidance for assessing short-term, infre quent events (for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acu te exposures rather than as chronic exposure. (Methods for E xposure-Response Analysis for Acute Inha lation Exposure to Chemicals (External Review Draft). EPA/600/R-98/051. April 1998)8/26/11 page of

CEM Dermal Exposure Estimates
ID Number: P-11-0577,2
Scenario: Laundry Detergent (Hand Washing) Population: Adult

Exposure Duration (chronic) (years): 57 Exposure Duration (acute) (days): 1

Exposure Units Result AT (days)

Chronic Cancer

LADD pot (mg/kg-day) 1.87e-07 2.74e+04

Acute

ADR pot (mg/kg-day) 1.73e-06 1

LADD - Lifetime Average Daily Dose (mg/kg-day) ADR - Acute Dose Rate (mg/kg-day)8/26/11 page of

CEM Inputs ID Number: P-11-0577,3

Product: unknown Chemical Name: P-11-0577
Scenario: Bar Soap Population: Adult Molecular Weight (g/mole): 148 Consumer Product Weight Fraction - Central Tendency (unitless): 1e-05 Consumer Product Weight Fraction - High-End (unitless): 1e-05

Inhalation Inputs
There are no Inhalation inputs for this scenario.
Activity Patterns There are no Activity Patterns for this scenario.
Dermal Inputs Frequency of Use - body (chronic) (events/yr): 329 SA/BW - body (cm2/kg): 286

Frequency of Use - body (acute) (events/day): 1 SA/BW - Hands (cm2/kg): 15.6

Frequency of Use - Hands (chronic) (events/yr): 730 Exposure Duration (years) chronic: 74

Frequency of Use - Hands (acute) (events/day): 2 Exposure Duration (days) acute: 1

Amount Retained/Absorbed to Skin (g/cm2-event): 9.22e-06

Averaging Time (chronic) (days): 2.74e+04 Averaging Time (acute) (days) : 18/26/11 page of

CEM Dermal Exposure Estimates
ID Number: P-11-0577,3
Scenario: Bar Soap Population: Adult
Exposure Duration (years) chronic: 74 Exposure Duration (days) acute: 1

Exposure Units Result AT (days)

Chronic Cancer

LADD pot (mg/kg-day) 2.63e-05 2.74e+04

Acute

ADR pot (mg/kg-day) 2.92e-05 1

LADD - Lifetime Average Daily Dose (mg/kg-day) ADR - Acute Dose Rate (mg/kg-day)

Note: 75 years = 2.738e+04 days pot - potential dose

Note: The general Agency guidance for assessing short-term, infrequent events (for most chemicals, an exposure of less than 24 hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than as chronic exposure. (Methods for Exposure-Response Analysis for Acute Inhalation Exposure to Chemicals (External Review Draft). EPA/600/R-98/051. April 1998)