Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-366 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-366 

A-002 Initial Review Engineering Report for 

PMN P-09-366 

A-003 Initial Review Exposure Report for 

PMN P-09-366 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-366 

 

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SAT Report

PMN Number: P-09-0366

SAT Date: 5/27/2009

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

 1 1 1

Exposure Based Review:

Health: No Exposure based testing (health):

Ecotox: Yes

Routes of exposure: Health: Inhalation and dermal

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: SENS-DERMAL, ONCO, LUNG, IRR, THYROID, 

UNCERT-DEVEL/NEURO, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-09-0366

FATE: Estimations for low weight MW 231 

Liquid with MP < 25 EC (E)

log Kow = 0.92 (E); 

S = Disp./>10 g/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 = 1.00 (E)

log Fish BCF = 0.50 (E) 

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POTW removal (%) = 90 via sorption and biodeg; OECD 303A(ASST): 92.2% (test unit 1),

 93.9% (test unit 2)/28d.

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = low - moderate

PBT Potential: P1B1

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

 Health:

 Health Summary: Absorption is poor through the skin, moderate through 

the GI tract, and good through the lungs based on analogs. There is concern for dermal 

sensitization by analogy to which was 

reported to be a dermal sensitizer in humans. There is a marginal concern for oncogenicity 

based on NTP reports where one analog was reported to be positive after 

dermal administration and the other analog was equivocal. There is concern for irritation and 

lung effects if inhaled based on the properties of the PMN material. There is uncertain 

concern for developmental neurotoxicity based on analogs thyroid gland hyperplasia 

in two year dermal study in mice . Low moderate concern. 

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.20 11.3

daphnid 48-h LC50 0.20 1.97

green algal 96-h EC50 0.20 3.84 (growth rate)

2.39 (yeild)

fish _ chronic value 0.040

daphnid _ chronic value 0.040

algal _ chronic value 0.050

Sewage Sludge 3-h EC50 _

Sewage Sludge Chronic Value

Ecotox Values Comments: Predictions are based on SAR-nearest analog method for 

compare , identical to one component of the PMN substance; SAR chemical 

class = MW 231; liquid with unknown mp (P); S = 

dispersible at 20 C, pH 7 (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;

This PMN was accompanied by acute fish, daphnia, and algal studies. Complete details of their 

evaluation are provided in the attached spreadsheet.

Conclusion: The results from all three tests are considered valid. The test substance is a complex 

mixture that forms an emulsion in water. Results from the analytical evaluation of the PMN

substance indicated in the chromatograms shows overall consistency in the test substance during

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exposures. All measured concentrations were within 83-93%, 84-95%, or 94-117% of nominal 

for algae, daphnia and bluegill respectively. Therefore measured concentrations are reported. 

Dissolution in the fish test resulted in turbidity of the test substance at 10 mg/L but this does not 

invalidate the test. The most sensitive species considered for these analyses is Daphnia magna 

therefore the CC is derived from the 48-hr EC50 value of 1.97 mg/L. This value is divided by a 

factor of 10 to simulate a chronic toxicity value and then again by an assessment (uncertainty) 

factor of 10 to derive a CC = 0.0197 mg/L or 20 μg/L (ppb). The PMN substance P09-0366 is of 

moderate concern for ecotoxicity.

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

20 Based on acute daphnia study. This 

supersedes ECOSAR predictions (4 

ppb).

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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A-002 

Initial Review Engineering Report 

for PMN P-09-366 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0366

Focus Ready Draft 6/4/2009

ENGINEER: Hall \ AH

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

 

 

 

Consumer Use:

SAT (concerns): (5/27/2009):

Migration to groundwater: Moderate to Rapid

PBT rating: P1 B1 T1

Health: 1-2, Dermal, Inhalation (No testing desired)

Eco: 3, Water (All releases to water with a CC = 20ppb), 

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS:

Generated by the 06/01/2009 version of ChemSTEER. 

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POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: 

 

 

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P-09-0366

Manufacturing 

Number of Sites/Location: 

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. 

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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P-09-0366

Use: 

Number of Sites/Location: 

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. 

RELEASE TOTAL

1

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-09-366 

 

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6/3/2009 Page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090366 Reviewer: 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 

7Q104 

CC=20 

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 --- --- --- --- 5175.60 58 --- --- --- --- --- 

 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: 

. 

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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6/3/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090366 Assessor: Kwon 

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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6/3/2009 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090366 

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 9.91 29.93 44.15 54.45 

ALL 10 553.69 2985.07 5175.60 6181.02 

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 1.25E-05 6.98E-04 mg/kg/day 1.69E-07 9.45E-06 mg/kg/day 

LADCpot 6.41E-04 3.58E-02 mg/L 2.02E-03 0.11 mg/kg 

Acute 

ADRpot 2.50E-03 0.25 mg/kg/day 5.63E-05 3.14E-03 mg/kg/day 

SIC Code Comments: 

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6/3/2009 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090366 

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 

20.00 16 58 High 

Remark: COC exceeded greater than 20 days/year. 

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6/3/2009 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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