Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-207 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-207 

A-002 Initial Review Engineering Report for 

PMN P-09-207 

A-003 Initial Review Exposure Report for 

PMN P-09-207 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-207 

 

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SAT Report

PMN Number: P-09-0207

SAT Date: 2/20/2009

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 3 Health: ; Eco: worst case 

 2 Health: ; Eco: as intended in PMN 

 Persistence Bioaccum Toxicity Comments

 1 1 1

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal, inhalation

Ecotox: All releases to water

Fate: ;

Keywords:

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

Summary of Assessment:

 Fate:

Fate Summary: FATE: 

Liquid with MP = 22 EC (M)

S = Disp.

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

BP > 400 EC (E)

H < 1.00E-8 (E)

POTW removal (%) = 90 via sorption and biodeg; OECD 301E: 96%/28d; OECD 209: 3-h 

EC50 = 98 mg/L.

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = moderate

PBT Potential: P1B1

*CEB FATE: Migration to ground water = negl due to biodeg

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 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 0.72 worst case

daphnid 48-h LC50 0.72 worst case

green algal 96-h EC50 0.72 worst case

fish _ chronic value 0.14 worst case

daphnid _ chronic value 0.14 worst case

algal _ chronic value 0.18 worst case

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;

This PMN came with ecotoxicity data. Attached spreadsheet shows details. Below are 

conclusions

Conclusion: The 96-hr LC50 acute fish test is considered invalid. There is no information 

providing details on the test concentration replication, whether the test was static or flow-thru, or 

whether the testing concentrations were nominal or measured. The nominal concentrations 

reported are not acceptable because the PMN substance is a moderately dispersible 

. Toxicity of the PMN substance is therefore based on ECOSAR predictions for the 

fish acute 96-hr LC50 test with a value of 0.720 mg/L. The COC is derived by dividing the acute 

value (0.720 mg/L) by an uncertainty (assessment) factor of 10, yielding a COC of 0.072 mg/L 

or 72 ppb. The PMN substance, P09-207 represents a moderate concern for ecotoxicity for the 

intended product based on ECOSAR predictions. However, there is a high concern 

for toxicity for worst case scenario that can be made under the given CAS name for 

. Under the PMN definition, shorter could be made and sold 

in commerce that would have higher toxicity to aquatic organisms than the substance tested in 

these assays. Consequently, the predicted values from ECOSAR will be used for assessing 

ecological hazard for the environment. The predicted concern concentration is 1 ppb.

Factors Values Comments

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Assessment Factor 10

Concentration of Concern 

(ppb)

14

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-09-207 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0207

Focus Ready Draft 2/26/2009

ENGINEER: Jon \ DDH

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: LABEL: 

Gen Eqpt: 

Respirator:

Health Effects:

TLV/PEL: - 

CRSS: (12:00:00 AM):

Chemical Name: 

 

 

 

Consumer Use:

SAT (concerns): (2/19/2009):

Related Cases and Misc SAT Info:

Eco rating of PMN as intended is: 2; Eco rating using worst case 5 EO units is 3.

Migration to groundwater: negl due to biodeg

PBT rating: P1 B1 T1

Health: 2, Dermal, Inhalation

Eco: 3, Water (All releases to water with a CC = 14 ppb)

OCCUPATIONAL EXPOSURE RATING: 1A

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NOTES & KEY ASSUMPTIONS:

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

 

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: No (0 criteria met)

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P-09-0207

Use: 

Number of Sites/Location: 

Basis: 

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

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P-09-0207

Manufacturing

Number of Sites/Location: 

Basis: 

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

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A-003 

Initial Review Exposure Report 

for PMN P-09-207 

 

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2/25/2009 Page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090207 Reviewer: Cinalli 

 

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=14 

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 --- --- --- --- 19.83 --- --- --- --- --- --- 

 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: 

Fate test recommendations?: 

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2/25/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090207 Assessor: Cinalli 

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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2/25/2009 Page of 

INITIAL EXPOSURE REVIEW REPORT 

 Chemical ID: P090207 

SCENARIO NUMBER:1 RELEASE ACTIVITY: max Acute Eco 

FACILITY NAME: 

FACILITY LOCATION: 

DISCHARGE TYPE: 

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 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) 5.96 13.66 19.83 24.54 NA 

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water 

Results 

Drinking Water 

Units 

Fish Ingestion 

Results 

Fish Ingestion 

Units 

Cancer 

LADDpot 7.63E-07 mg/kg/day 0.00 mg/kg/day 

LADCpot 3.92E-05 mg/L 0.00 mg/kg 

Acute 

ADRpot 1.14E-03 mg/kg/day 0.00 mg/kg/day 

Surface Water Comments: 

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2/25/2009 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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