Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-577 

EPA Docket EPA-HQ-OPPT-2011-0942 

EPA SANITIZED Page 1 of 37
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 

EPA SANITIZED Page 2 of 37
A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-577 

EPA SANITIZED Page 3 of 37
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: No

Ecotox: No

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, NOMO5)

BP = 192 C (NOMO5) based on 76-80 C @ 10 mm (M)

H = 1.46E-5 (E)

log Koc = 1.47 (E)

log Fish BCF = 0.80 E)

EPA SANITIZED Page 4 of 37
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 

possible liver effects at 100 mg/kg (NOEL = 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); pH7; 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 

(ppb)

10 thiol SAR

SARs esters and thiols

SAR Class ester, thiol new chemicals category: thiols

EPA SANITIZED Page 5 of 37
Ecotox Factors Comments: 

 SAT Chair: Becky Jones

EPA SANITIZED Page 6 of 37
A-002 

Initial Review Engineering Report 

 for PMN P-11-577 

EPA SANITIZED Page 7 of 37
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

EPA SANITIZED Page 8 of 37
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,

EPA SANITIZED Page 9 of 37
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

EPA SANITIZED Page 10 of 37
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

EPA SANITIZED Page 11 of 37
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,

EPA SANITIZED Page 12 of 37
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.

EPA SANITIZED Page 13 of 37
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.

EPA SANITIZED Page 14 of 37
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.

EPA SANITIZED Page 15 of 37
A-003 

Initial Review Exposure Report 

for PMN P-11-577 

EPA SANITIZED Page 16 of 37
8/26/11 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 Scenario1 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q104 

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 Manufacturing (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 (ADR), Lifetime Average Daily Dose (LADD), and 

Probabilistic Dilution Model (PDM). There 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 7Q10 streamflow, which is defined as the average daily 

streamflow of the seven consecutive days of lowest flow within a ten year period. 

Remarks: 

EPA SANITIZED Page 17 of 37
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/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day 

CEM2, 

General 

Purpose 

--- --- --- --- --- --- 

5.44E-06 3.40E-06 1.82E-04 5.07E-05 

CEM2, 

Laundry 

detergen

t 

--- --- --- --- --- --- 

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

CEM2, 

Bar 

soap 

--- --- --- --- --- --- 

2.92E-05 2.63E-05 --- --- 

1 Down-the-Drain Module within NCEM2 model. 

2 Consumer Exposure Module within NCEM2 model.

EPA SANITIZED Page 18 of 37
8/26/11 page of 

 INITIAL 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: 1.00E-02 N/A/0.00 N/A N/A 

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 19 of 37
8/26/11 page of 

INITIAL REVIEW EXPOSURE 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: BAYSHORE 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 

LADDpot (mg/kg/day) 1.71E-12 30.00 75.00 71.80 6.00 

LADCpot (mg/kg) 2.05E-08 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.83E-08 NA 1 day 71.80 129.00 

Lakes Comments: 

EPA SANITIZED Page 20 of 37
8/26/11 page of 

 INITIAL 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: 5.00E-02 N/A/0.00 N/A N/A 

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 21 of 37
8/26/11 page of 

INITIAL REVIEW EXPOSURE 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: BAYSHORE 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 

LADDpot (mg/kg/day) 1.71E-12 30.00 75.00 71.80 6.00 

LADCpot (mg/kg) 2.05E-08 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A NA 1 day 71.80 129.00 

Lakes Comments: 

EPA SANITIZED Page 22 of 37
8/26/11 page of 

 INITIAL 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: 8.36E-04 N/A/0.00 N/A N/A 

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 23 of 37
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INITIAL REVIEW EXPOSURE 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. (μg/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 INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

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

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

Acute 

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

SIC Code Comments: 

EPA SANITIZED Page 24 of 37
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 INITIAL 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: 2.16E-04 N/A/0.00 N/A N/A 

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 25 of 37
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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0577 

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

SCENARIO #: 4 Number of Sites: 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. (μg/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 INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

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

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

Acute 

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

SIC Code Comments: 

EPA SANITIZED Page 26 of 37
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INITIAL REVIEW EXPOSURE 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 (μg/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 High 

EPA SANITIZED Page 27 of 37
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 INITIAL 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: 2.24E-02 N/A/0.00 N/A N/A 

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 28 of 37
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INITIAL REVIEW EXPOSURE 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. (μg/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 INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 1.16E-10 1.01E-09 mg/kg/day 3.12E-12 2.73E-11 mg/kg/day 

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

Acute 

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 29 of 37
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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 (m3/hr): 1.1 Duration of Event - Central Tendency 

(hours/event): 

0.667 

Inhalation Rate After Use (m3/hr): 0.55 Duration of Event - High-End 

(hours/event): 

1.42 

Zone 1 Volume (m3): 20 Whole House Volume (m3): 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) : 1 

 

EPA SANITIZED Page 30 of 37
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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 

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

 LADCpot (mg/m3) 2.11e-04 2.74e+04 

 Acute 

 ADRpot (mg/kg-day) 1.82e-04 1 

 Cppot (mg/m3) 7.47e-03 NA 

 LADD - Lifetime Average Daily Dose (mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m3) 

 ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m3) 

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)

EPA SANITIZED Page 31 of 37
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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 

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

Acute 

 ADRpot (mg/kg-day) 5.44e-06 1 

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

 ADR - Acute Dose Rate (mg/kg-day) 

EPA SANITIZED Page 32 of 37
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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 (m3/hr): 1.1 Duration of Event - Central Tendency 

(hours/event): 

0.333 

Inhalation Rate After Use (m3/hr): 0.55 Duration of Event - High-End 

(hours/event): 

0.667 

Zone 1 Volume (m3): 20 Whole House Volume (m3): 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) : 1 

 

EPA SANITIZED Page 33 of 37
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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 

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

 LADCpot (mg/m3) 1.24e-04 2.74e+04 

 Acute 

 ADRpot (mg/kg-day) 2.39e-04 1 

 Cppot (mg/m3) 1.96e-02 NA 

 LADD - Lifetime Average Daily Dose (mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m3) 

 ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m3) 

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)

EPA SANITIZED Page 34 of 37
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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 

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

Acute 

 ADRpot (mg/kg-day) 1.73e-06 1 

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

 ADR - Acute Dose Rate (mg/kg-day) 

EPA SANITIZED Page 35 of 37
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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) : 1 

EPA SANITIZED Page 36 of 37
8/26/11 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 

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

Acute 

 ADRpot (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) 

EPA SANITIZED Page 37 of 37