## 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

## 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

## A-001 Structure Activity Team (SAT) Report for PMNs P-11-411, P-11-412, P-11-413, and P-11-414

### 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: N o Ecotox: N o 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)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, p oor 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); p H7; 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.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. N o 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. N o information was provided on the following: measurements of the PMN material in solution, number of replicates, p reparation methods for the test solutions, p urity of the material tested, test conditions ( p hotoperiod, 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 p pb. Chronic Concern Concentration = 17 p pb. 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 p pb. Acute Concern Concentration = 480 p pb. Reviewer: S. Pollack

13th June 2011
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 17 study data were invalid

SARs SAR Class new chemicals category:
Ecotox Category
Ecotox Factors Comments:SAT Chair: Becky Jones

## A-002 Post Focus Engineering Report for PMNs P-11-411, P-11-412, P-11-413, and P-11-414file:///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 :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.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: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.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 SUMMARYfile:///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:file:///J|/INITENG/P11%20cases/p110411c.en2.txt[3/1/2012 8:42:48 AM]

## A-003 Post Focus Exposure Report for PMNs P-11-411, P-11-412, P-11-413, and P-11-4141/25/2011 Page 1 of 1
POST FOCUS EXPOSURE REPORT
Updated exposure report based on Test Data Re view 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.