Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-234 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-234 

A-002 Initial Review Engineering Report for 

PMN P-09-234 

A-003 Initial Review Exposure Report for 

PMN P-09-234 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-234 

 

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SAT Report

PMN Number: P-09-0234

SAT Date: 2/27/2009

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 2

 Persistence Bioaccum Toxicity Comments

 1 1 1

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Dermal, inhalation

Ecotox: All releases to water

Fate: ;

P2Rec Comments:

Comment: SAT had no comment

Keywords:

 Keywords: EYE; LUNG; IRR-E,S,MM; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-09-0234

FATE: Estimations for typical n=2 

Liquid with MP < 25 EC (E)

log Kow = 2.52 (E); 

S = Disp./349 mg/L at 25 EC (ICB/E)

VP < 1.0E-6 torr at 25 EC (E)

BP > 400 EC (E)

H < 1.00E-8 (E)

log Koc = 2.90 (E)

log Fish BCF = 1.33 (E) 

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POTW removal (%) = 50-90 via sorption

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = moderate - strong

PBT Potential: P1B1

*CEB FATE: Migration to ground water = slow - moderate

 Health:

 Health Summary: Absorption is poor from the skin, moderate from the GI 

tract, and good from the lung (analog). Concern for effects on the lung; irritation to 

eye, skin (chronic), mucous membranes and lung based on properties of the 

compounds. As a the PMN substance may anesthetize the eye allowing 

considerable damage before anything is noticed.

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 2.8

daphnid 48-h LC50 2.8

green algal 96-h EC50 2.8

fish _ chronic value 0.56

daphnid chronic value 0.56

algal _ chronic value 0.70

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for 

; SAR chemical class = 

 pH7; effective concentrations 

based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as 

CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

56

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-09-234 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0234

Focus Ready Draft 3/5/2009

ENGINEER: Prothero \ JAS

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

 

 

SAT (concerns): (2/27/2009):

Migration to groundwater: Slow to moderate

PBT rating: P1 B1 T1

Health: 2, Dermal, Inhalation

Eco: 2, Water (All releases to water with a CC = 56 ppb), 

OCCUPATIONAL EXPOSURE RATING: 1B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

POLLUTION PREVENTION CONSIDERATIONS:

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P2 REC:

 

 

 

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P-09-0234

.

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P-09-0234

 

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A-003 

Initial Review Exposure Report 

for PMN P-09-234 

 

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3/4/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090234 Reviewer: Sherer/Kwon 

 

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 

7Q10 

CC=56 

PDM 

Days 

Exceeded

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 

max Acute Eco --- --- --- --- 1.89E+04 --- --- --- --- --- --- 

 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. 

Remarks: 

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria 

Parameter 

Drinking (Surface) Water Dose (mg/kg/day) 

Fish Ingestion Dose (mg/kg/day) 

Inhalation Dose (mg/kg/day) 

Groundwater Dose (mg/kg/day) 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: 

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3/4/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090234 Assessor: Sherer/Kwon 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: max Acute Eco 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 

Per Site Release: 

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

Remarks: 

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3/4/2009 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090234 

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY max 

Acute Eco 

EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

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 50 125.56 44.02 26.80 22.53 159.29 454.34 746.27 887.71 

ALL 10 11.11 1.94 1.06 0.96 1800.18 1.03E+04 1.89E+04 2.08E+04

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 3.40E-06 3.85E-05 mg/kg/day 3.12E-07 3.53E-06 mg/kg/day 

LADCpot 1.75E-04 1.97E-03 mg/L 3.74E-03 4.22E-02 mg/kg 

Acute 

ADRpot 3.80E-02 0.86 mg/kg/day 6.12E-03 6.92E-02 mg/kg/day 

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3/4/2009 Page of 

LEGEND FOR NEW CHEMICALS EXPOSURE REPORT 

This new chemicals exposure report was prepared by the Exposure Assessment Branch (EAB) of the Economics, 

Exposure and Technology Division, Office of Pollution Prevention and Toxics, USEPA. 

The goals of these reports are to calculate conservative (protective) estimates of exposure endpoints for consumers, 

the general population, and the environment. 

For each exposure scenario to industrial releases, the following three endpoints are calculated: 

(1) maximum possible acute concentrations and doses 

(2) maximum possible chronic concentrations and doses 

(3) for water releases ≥ 20 days, the probability of exceedence of the aquatic concentration of concern 

These endpoints are identified by abbreviations on the Release Activity line, e.g., (1) max ADR, (2) max 

LADD, (3) max PDM. Depending on the release inputs, these endpoints may be calculated and presented on 

the same page or different pages. That is, a release activity ID of mfg; max ADR, max PDM, max LADD

indicates that all the exposure endpoints were calculated from common manufacturing release values; 

conversely, a release activity ID of mfg &proc; max ADR indicates that only the maximum acute exposure 

values were calculated for manufacturing and processing releases that occurred at the same site. 

For each consumer product use exposure scenario, whether exposure is to the user directly or to the general 

population/environment, the maximum exposure values are calculated and presented together. 

In addition to the exposure values above, EPA policy directs that exposure and release values be compared to 

criteria threshold values for Exposure-based and PBT Exposure-based cases. 

Exposure-based (YX) cases (those with ≥ 100,000 kg/yr production volume) 

Criteria are exceeded under the following conditions: 

 Presence in consumer product with likely exposure 

≥ 3E-3 mg/kg/d exposure via air, fish ingestion or drinking water 

≥ 10,000 kg/yr release to environment (post-treatment) 

≥ 1,000 kg/yr release to water (post-treatment) 

Persistent, Bioaccumulative, Toxic (PBT) chemicals of P2B2 rating or higher and production volume ≥ 20,000 kg/yr 

Criteria are exceeded as for YX cases, with the following differences: 

≥ 2,000 kg/yr release to environment (post-treatment) 

≥ 200 kg/yr release to water (post-treatment) 

Bolding rules in the Report: Values for endpoints above that are also health or eco concerns are bolded. 

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