Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-532 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-532 

A-002 Initial Review Engineering Report for 

PMN P-09-532 

A-003 Initial Review Exposure Report for 

PMN P-09-532 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-09-532 

 

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SAT Report

PMN Number: P-09-0532

SAT Date: 8/11/2009

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3

 Persistence Bioaccum Toxicity Comments

 2 1 1

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health:

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-09-0532

FATE: 

Solid

log Kow = 5.32 (E); 

S = 0.092 mg/L at 25 EC (E)

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

BP > 400 EC (E)

H < 1.00E-8 (E)

log Koc = 4.48 (E)

log Fish BCF = 3.18 (E)

log Fish BAF = 1.09 (E) 

POTW removal (%) = 75-90 via sorption and possible partial biodeg

Time for complete ultimate aerobic biodeg $ mo

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Sorption to soils/sediments = strong

PBT Potential: P2B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes for the neat material, while for 

the material in solution, absorption is poor all routes, based on physical/chemical properties. No 

significant health concerns.

 Test Data: Submitted with :

Salmonella assay negative with and without activation;

Rat oral LD50 > 2000 mg/kg;

Rat dermal LD50 > 2000 mg/kg;

Minimal eye irritant in rabbits;

Not a dermal irritant in female rabbits;

Not a dermal sensitizer in female guinea pigs;

Repeated dose (gavage) tests in rats yielded no clinical signs of toxicity

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.43 or *

daphnid 48-h LC50 0.41 or *

green algal 96-h EC50 0.17

fish _ chronic value 0.009

daphnid chronic value 0.070

algal _ chronic value 0.030

Sewage Sludge 3-h EC50

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for ; SAR 

chemical class = ; MW 397; solid with unknown mp (P); log Kow = 5.32 (EPI); 

S = 0.092 mg/L at 20 C (P); pH7; effective concentrations based on 100% active ingredients 

and mean measured concentrations; DW hardness < 150.0 mg/L as CaCO3; and DW TOC <2.0 

mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1

SARs

SAR Class

Ecotox Factors Comments: 

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A-002 

Initial Review Engineering Report 

for PMN P-09-532 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0532

Focus Ready Draft 8/17/2009

ENGINEER: Macek \ DDH

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: No LABEL: No

Gen Eqpt: MSDS not included.

TLV/PEL: - not available.

 

 

 

Consumer Use:

SAT (concerns): (8/11/2009):

Migration to groundwater:

PBT rating: P2 B1 T1 .

Health: 1

Eco: 3, Water (All releases to surface water with a CC = 1 ppb)

OCCUPATIONAL EXPOSURE RATING: NR

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: 

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P-09-0532

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. Note that incineration and landfill are not required

Water or Incineration or Landfill

Output 2: 1.1E+0 kg/site-day over 301 day/yr 

Incineration

Output 2: 1.1E+0 kg/site-day over 301 day/yr 

RELEASE TOTAL

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P-09-0532

 

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. Note that incineration and landfill are not required

Water or Incineration or Landfill

Output 2: 2.6E-3 kg/site-day over 260 day/yr 

RELEASE TOTAL

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P-09-0532

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources 

to the same medium. 

Water or Incineration or Landfill

Output 2: 7.7E+0 kg/site-day over 44 day/yr 

RELEASE TOTAL

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A-003 

Initial Review Exposure Report 

for PMN P-09-532 

 

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8/14/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090532 Reviewer: Sherer 

 

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=1 

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, PDM --- --- --- --- 247.43 43 --- --- --- --- --- 

max Acute 

Eco, PDM --- --- --- --- 35.35 186 --- --- --- --- --- 

max Acute 

Eco, PDM --- --- --- --- 0.61 13 --- --- --- --- --- 

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 streamflow of 

the 7 consecutive days of lowest flow within a 10 year period. 

Remarks: 

Fate test recommendations?: (default is NA) 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090532 Assessor: Sherer 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: max Acute Eco, PDM 

 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY max 

Acute Eco, PDM 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): 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 8.48 15.38 24.36 29.61 

ALL 10 29.13 144.41 247.43 295.70 

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 7.98E-06 2.74E-05 mg/kg/day 5.16E-05 1.77E-04 mg/kg/day 

LADCpot 4.09E-04 1.40E-03 mg/L 0.62 2.12 mg/kg 

Acute 

ADRpot 1.29E-03 1.21E-02 mg/kg/day 2.30E-02 7.90E-02 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 1 RELEASE ACTIVITY: max Acute Eco, PDM 

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES

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 

1.00 12 43 High 

Remark: COC exceeded greater than 20 days per year.

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090532 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: max Acute Eco, PDM 

 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY max 

Acute Eco, PDM 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): 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 1.21 2.20 3.48 4.23 

ALL 10 4.16 20.63 35.35 42.24 

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 7.80E-06 2.68E-05 mg/kg/day 5.04E-05 1.73E-04 mg/kg/day 

LADCpot 4.00E-04 1.37E-03 mg/L 0.60 2.07 mg/kg 

Acute 

ADRpot 1.84E-04 1.72E-03 mg/kg/day 3.29E-03 1.13E-02 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY max Acute Eco, PDM 

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

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 

1.00 51 186 High 

Remark: COC exceeded greater than 20 days per year.

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090532 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: max Acute Eco, PDM 

 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY max 

Acute Eco, PDM 

SIC-CODE DESCRIPTION: POTW's (All facilities) 

SIC-CODE (S): 4952 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 5.18E-03 1.48E-02 2.43E-02 2.89E-02

ALL 10 11.11 1.94 1.06 0.96 5.85E-02 0.34 0.61 0.68 

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 2.88E-08 3.25E-07 mg/kg/day 1.86E-07 2.10E-06 mg/kg/day 

LADCpot 1.48E-06 1.67E-05 mg/L 2.23E-03 2.52E-02 mg/kg 

Acute 

ADRpot 1.23E-06 2.80E-05 mg/kg/day 1.40E-05 1.59E-04 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090532 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 RELEASE ACTIVITY max Acute Eco, PDM 

SIC CODE DESCRIPTION: POTW's (All facilities) 

ASSOCIATED SIC CODES: 4952 

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 

1.00 4 13 High 

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8/14/2009 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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