Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notices (PMNs) 

P-11-411, P-11-412, P-11-413, and P-11-414 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 17
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

A-002 Post Focus Engineering Report for 

 PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

A-003 Post Focus Exposure Report for 

 PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

EPA SANITIZED Page 2 of 17
A-001 

Structure Activity Team (SAT) Report 

 for PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

EPA SANITIZED Page 3 of 17
SAT Report

PMN Number: P-11-0411

SAT Date: 6/10/2011

Print Date: 3/1/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2

 Persistence Bioaccum Toxicity Comments

2 1 1 Anion

1 2 1 Cation

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ; Anion rapid; Cation negl

Keywords:

 Keywords: LUNG, IRR, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-11-0411-13

FATE: Estimations for 

log Kow = -1.64 (M)

log Koc = 1.00 (E)

log Fish BCF = 0.50 (E)

log Fish BAF = -0.05 (E)

FATE: Estimations for 

log Kow = 7.07 (E)

log Koc = 4.41 (E)

log Fish BCF = 3.50 (E)

EPA SANITIZED Page 4 of 17
log Fish BAF = 2.13 (E)

PMN Substance: Solid 

S = Disp. (ICB)

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = Anion 0-25 via biodeg; Cation 90 via sorption and biodeg; 

 For P-11-0411: OECD 306 (SW, Closed Btl Biodeg): 44%/28d.

Time for complete ultimate aerobic biodeg = Anion wk-mo; Cation wk

Sorption to soils/sediments = Anion low; Cation v.strong

PBT Potential: Anion P2B1; Cation P1B2

*CEB FATE: Migration to ground water = Anion rapid; Cation negl

 Health:

 Health Summary: Absorption is nil through the skin, poor through the GI 

tract, and moderate through the lungs based on analogs. There is concern for lung effects if 

inhaled and irritation to all exposed tissues based on the properties of the PMN 

material Low moderate concern. 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 4.2

daphnid 48-h LC50 2.4

green algal 96-h EC50 2.4 < 0.5 invalid

fish _ chronic value 0.23

daphnid _ chronic 

value

0.17

algal _ chronic 

value

0.60

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

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

chemical class = MW 564; solid with unknown mp (P);; S 

= dispersible in water at 20 C (P); pH7; effective concentrations based on 100% active 

ingredients and mean measured concentrations of the amine; hardness <150.0 mg/L as CaCO3; 

and TOC <2.0 mg/L;

This PMN came with a study and the same study was provided for P11-0412, P11-0413, and 

P11-0414

Below are conclusions and attached document also shows details.

EPA SANITIZED Page 5 of 17
Ecotoxicity Study Review for 

(CASRN None)

PMN P11-0411/412/413/414

One ecotoxicity study was submitted with PMNs P11-0411, P11-0412, P11-0413, and P11-0414 

from : a 72-hour range-finding algal toxicity test. The study was 

conducted in March 2011 using the test material identified as PMN P11-0411 with MW = 

563.78. Water solubility of the PMN material was stated as “dispersible”. The studies were 

conducted by and were not performed under GLP conditions. No certificate of 

analysis or a signed quality assurance statement was provided. The study did not comply with 

OPPTS or OECD guidelines. 

1) The 72-hour algal toxicity test was conducted with the marine diatom (Skeletonema costatum) 

under static conditions. The initial inoculum was 10,000 cells /mL with each nominal 

concentration of 0, 0.1, 0.5, 1.0, 5.0, 10, 50 and 100 mg/L of the PMN test material. 

72-hour EC50 < 0.5 mg/L

The study is considered invalid. No information was provided on the following: measurements 

of the PMN material in solution, number of replicates, preparation methods for the test solutions, 

purity of the material tested, test conditions (photoperiod, observation intervals, etc.), water 

quality parameters or methodology for how the EC50 value was derived. 

ECOSAR (v. 1.1) was used to predict toxicity for the PMN material under the chemical category 

. 

The most appropriate and environmentally protective value used to determine the chronic 

concern concentration is the ECOSAR v. 1.1 ChV value for daphnia as 0.17 mg/L. This value is 

divided by an assessment (uncertainty) factor of 10 to yield 0.017 mg/L or 17 ìg/L or 17 ppb.

Chronic Concern Concentration = 17 ppb.

To calculate the acute concern concentration, the 48-hour EC50 value for daphnia of 2.4 mg/L is 

divided by an assessment factor of 5 to yield 480 ìg/L or 480 ppb. 

Acute Concern Concentration = 480 ppb.

Reviewer: S. Pollack

13th June 2011

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

17 study data were invalid

SARs

SAR Class new chemicals category: 

Ecotox Category 

Ecotox Factors Comments: 

EPA SANITIZED Page 6 of 17
 

 SAT Chair: Becky Jones

EPA SANITIZED Page 7 of 17
A-002 

Post Focus Engineering Report 

 for PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

EPA SANITIZED Page 8 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0411 0412, 0413, 0414

Post-Focus Draft Revision 2 1/19/2012

ENGINEER: El-Zoobi \ EV \ JD

PV (kg/yr): 

Revision Notes / Assessment Overview: =====>Rev. (2):

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS :

EPA SANITIZED Page 9 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

Consumer Use: 

SAT (concerns) (06/10/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

Migration to groundwater: Anion: rapid, Cation: negligible

PBT rating: P2B1T1 P2B1T1 (anion; P11-0411, 0412, and

0413); P1B1T1 (anion; P11-0414) /// P1B1T1 (cation; all

PMNs)

Health: 1-2 Dermal, Inhalation

Eco: 2 Water (All releases to water with a CC = 79 ppb

(P11-0412) and 17 ppb (all others))

OCCUPATIONAL EXPOSURE RATING: 1C

NOTES & KEY ASSUMPTIONS:

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

EPA SANITIZED Page 10 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

POLLUTION PREVENTION CONSIDERATIONS:

No Pollution Prevention information provided by the

submitter.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0411 0412, 0413, 0414

Manufacturing

Number of Sites/ Location: 

Days/yr: 

Basis:

Process Description: 

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.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis: 

EPA SANITIZED Page 11 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0411 0412, 0413, 0414

Use: 

Number of Sites/ Location: 

Days/yr: 

Basis:

Process Description: 

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.

EPA SANITIZED Page 12 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

INITIAL REVIEW ENGINEERING REPORT CBI: 

PMN: 11-0411 0412, 0413, 0414

Processing: 

Number of Sites/ Location: 

Days/yr: 

Basis:

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

EPA SANITIZED Page 13 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

EPA SANITIZED Page 14 of 17
file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

EPA SANITIZED Page 15 of 17
A-003 

Post Focus Exposure Report 

 for PMNs P-11-411, P-11-412, P-11-413, and P-11-414 

EPA SANITIZED Page 16 of 17
1/25/2011 Page 1 of 1 

 

POST FOCUS EXPOSURE REPORT 

Updated exposure report based on Test Data Review Engineering Report, Post-Focus Draft 

Revision 2, 1/19/2012 

Case Number: 

P110411C 

Assessor: 

Delpire 

ENVIRONMENTAL RELEASES 

Scenario#: Number of Release Sites: 

Release Activity: 

Release Description: WATER LANDFILL INCINER LAND/INCIN FUGITIVE 

Total Releases: 

 

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

Release Days/yr: 

 

Per Site Release: 

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

Remarks: EAB DROP: Release information for this compound does not meet criteria for preparation 

of an exposure assessment in the Exposure Assessment Branch=s (EAB) Initial Review 

Exposure Report (this report). Report is for P-11-0411, P-11-0412, P-11-0413, and P-11-

0414. 

EPA SANITIZED Page 17 of 17