## Support Documents for Significant New Use Rule (SNUR) on
Premanufacture Notice (PMN)

P-11-34

EPA Docket EPA-HQ-OPPT-2011-0942

## Index A-001 Structure Activity Team (SAT) Report for PMN P-11-34 A-002 Initial Review Engineering Report for PMN P-11-34 A-003 Initial Review Exposure Report for PMN P-11-34

## A-001 Structure Activity Team (SAT) Report

for PMN P-11-34

### SAT Report PMN Number: P-11-0034 SAT Date: 10/29/2010 Print Date: 8/31/2011

Related cases : Health related cases: Ecotox related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 2 2

Persistence Bioaccum Toxicity Comments 2 11

Exposure Based Review : Health: Ecotox: N o
Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: IRR/CORR-E,S,MM,L; SENS-S; AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-11-0034 FATE: Estimations for low weight with one equivalent of each monomer MW 352 C20H36 N 2O3 Liquid with MP < 25 C (E) log Kow = 2.69 (E) S > 10 g/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) log Koc = 4.16 (E) log Fish BCF = 1.44 (E)log Fish BAF = 1.52 (E) POTW removal (%) = 0-25 via biodeg Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = low PBT Potential: P2B1 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: N ot absorbed from the skin, p oor absorption from the GI tract and good absorption from the lung ( p che m ). Concern for irritation and possible corrosion to all tissues and dermal sensitization.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 7.3 p henol-amine SAR daphnid 48-h LC50 1.6 p henol-amine SAR green algal 96-h EC50 1.5 aliphatic amine SAR fish

_ chronic value 0.23 p henol-amine SAR daphnid

_ chronic value 0.21 p henol-amine SAR algal

_ chronic value 0.49 aliphatic amine SAR Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for aliphatic amines and p henol-amines; SAR chemical class = aliphatic amine, p henol-amine; MW 247 with 100% < 1000 and 90% < 500; log Kow = 2.69 (EPI, representative structure); liquid (M); S = 22.4 g/L (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 21 p henol-amine SAR

SARs aliphatic amines and p henol-amines SAR Class aliphatic amine, p henol-amine

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

## A-002
Initial Review Engineering Report

for PMN P-11-34INITIAL REVIEW ENGINEERING REPORT PMN: 11-0034 Post-Focus Draft Revision 1 7/27/2011

ENGINEER: Prothero \ JAS PV (kg/yr): 9,500 Import Only

SUBMITTER:

.
USE:

OTHER USES:

MSDS: Label:

CRSS : Chemical Name: Formaldehyde, polymer with .alpha. -(2-aminomethylethyl)-.omega. -(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)] and 4-(1,1-dimethylethyl)phenol S-H20: 22.4 g/L @ VP: 1.0E-6 torr @ MW: 247.00 90.00%<500 100.00%<1000 Physical State and Misc CRSS Info: Neat: Liquid Mfg: NK: Import Proc/Form: Solution: 50-55% PMN material, then Solution: 12.4% PMN material End Use: Destroyed. NAVG = 247 with 90% < 500 and 100% < 1000 by GPC. Submitted Data: None, all of the submitted properties are for formulated material. Estimated Data: BP = 428 °C (EPI); VP = 3.2E-7 torr (EPI); WS = 22.4 g/L(EPI); logP = 2.69 (EPI). The EPI estimations were performed on the component consisting of one equivalent of each feedstock and m=1, having a molecular weight of 353 g/mole and a molecular formula of C20 H36 O3. The amine FGEW cannot be calculated or estimated due to the unknown molecular weight of the amine containing prepolymer. The amine FGEW will be less than the NAVG molecular weight of 247.

Consumer Use: No

SAT (concerns) (10/29/2010): Related Cases and Related Cases and Misc SAT Info: Analogs: Migration to groundwater: Rapid PBT rating: P2B1T1 ' Health: 2 Dermal, Inhalation Eco: 2 Water (All releases to water with a CC = 21 ppb.)

OCCUPATIONAL EXPOSURE RATING: 1C

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER. Focus IRER Notes: PMN is import only -> MFG not assessed. Past cases (same submitter, same use), and (similar use) were referenced for consistency. Past case IRERs are generally consistent with this IRER, with the following main differences: some use applications were significantly different (e.g., automated, high-speed roll coating was possible in a past case) and this PMN has corrosive characteristics that reduce dermal exposure likelihood. // IRER Rev 1 Notes: Updated release media (no release to water) per July 2011 amendment (BITR110701756458091) and future enactment of SNUR for no release to water.

POLLUTION PREVENTION CONSIDERATIONS: None

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0034

Use: stems

Number of Sites/ Location:

Days/yr: Basis:Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

).

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

Inhalation:Dermal:

## A-003
Initial Review Exposure Report

for PMN P-11-347/27/2011 Page of POSTFOCUS EXPOSURE REPORT

Case Number: P110034 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).