# Supporting Documents for Significant New Use Notice (SNUN) S-08-07 for SNUR at 40 CFR 721.5185

EPA Docket: EPA-HQ-OPPT-2009-0669

September 2008

# Index:

A-1 Significant New Use Notice (SNUN) S-08-07 for SNUR at 40 CFR 721.5185

B-1 Structure Activity Team (SAT) Report for S-08-07

B-2 Initial Review Engineering Report (IRER) for S-08-07 Post Focus Version

B-3 Initial Review Exposure Report (IRExR) for S-08-07 Post-Focus Draft

B-4 Final Risk Assessment for S-08-07

# A-1 Significant New Use Notice (SNUN) S-08-07 for SNUR at 40 CFR 721.5185

# Significant New Use Notice (SNUN) S-08-07 for SNUR at 40 CFR 721.5185

EPA Docket: EPA-HQ-OPPT-2009-0669

June 27, 2008

# B-1 Structure Activity Team (SAT) Report for S-08-07

### STRUCTURE ACTIVITY TEAM REPORT 07/11/08

CASE NUMBER: S08-0007

RELATED CASES:

CONCLUSIONS/DISCUSSIONS

TYPE OF CONCERN: HEALTH ECOTOX

LEVEL OF CONCERN: 2-3 2

KEYWORDS: NEURO DEVEL IRR-E MUTA ONCO LIVER KIDNEY SENS AQUATOX (A,C)

SUMMARY OF ASSESSMENT

FATE: Liquid with MP = -35 ̊ C (M) log Kow = -0.52 (E); S > 10 g/L at 25 ̊ C (E)
VP = 4.1E-2 torr at 25 ̊ C (NOMO5)
BP = 240 ̊ C (M) H < 1.00E-8 (E) log Koc = 1.00 (E) log Fish BCF = 0.50 (E) POTW removal (%) = 0-50 via stripping, and biodeg Time for complete ultimate aerobic biodeg = wk to mo Sorption to soils/sediments = low PBT Potential: P1B1T2 *CEB FATE: Migration to ground water = rapid

HEALTH: Absorption good all routes based on analogs and test data submitted for ; the portion can under Michael addition;

submitted test data from were: rat acute oral LD50 = 588 mg/kg with possible neurotoxic signs, such as, clonic convulsions, body tremors, and decreased respiratory rate; rat acute dermal LD50 = 1.26 g/kg with liver effects; rat acute inhalation LC50 = 0.9 mg/L, LC100 = 1.79 mg/L; lung congestion in rats that died; moderate eye irritation in rabbits; slight skin irritation in rabbits; Ames test was negative; chromosome aberration test in human cells in culture was positive; mouse micronucleus ( ip ) test was negative; moderate (60%) skin sensitization in guinea pigs (M&K); and

### rat 28-d subchronic (oral-gavage) NOAEL = 15 mg/kg/d, LOEL = 50 mg/kg/d with effects to the liver with blood chemistry changes which was significantly lowered total protein indicating perturbed hepatic functions; microscopic examinations indicated hepatotoxicity;

submitted test data from were: rat acute oral LD50 = 520 mg/kg;

test data for analogs: mouse lymphoma forward mutation test was positive ( ); chromosome aberration test with CHO cells was positive ( ); positive eye irritation and 3 of 6 rabbits died when chemical was applied to the skin ( ); rat acute dermal LD50 = 540 •L/kg ( ); rat 13-wk dermal toxicity test showed lethality at 500 mg/kg/d, kidney toxicity at 75 mg/kg/d, and NOEL = 10 mg/kg/d ( );

concerns for acute toxicity, neurotoxicity, eye irritation, mutagenicity, skin sensitization, and liver toxicity based on submitted test data from ; concern for neurotoxicity, developmental toxicity, and oncogenicity and uncertain concern for immunotoxicity based

on

. *CEB HEALTH: Moderate high concern (Dermal, inhalation, drinking water)

ECOTOX: Predicted (P) and measured (M) toxicity values in mg/L (ppm) are: fish 96-h LC50 = 180.0 P fish 96-h EC29 = 222.0 M SR24,M daphnid 48-h LC50 = 170.0 P daphnid 48-h LC50 = 120.0 M S,M green algal 96-h EC50 > 100.0 P green algal 72-h EC50 > 120.0 M S,M fish ACR >= 20.0 fish chronic value = 10.0 P daphnid ACR >= 18.0 daphnid ChV = 7.0 P algal ChV > 10.0 P algal ChV > 120.0 M S,M Predictions are based on SARs for ; SAR chemical class = ; log K

ow 

### = -0.54 (CLOGP); ; pH7; 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L; moderate concern for chronic toxicity; assessment factor = 10.0 concern concentration = 0.700 *CEB ECOTOX: All releases to surface water with CC = 700 ppb

### SAT Co-chair: Leonard Keifer 564-8916

# B-2 Initial Review Engineering Report (IRER) for S-08-07 Post Focus Versions080007.en1 INITIAL REVIEW ENGINEERING REPORT CBI: Other New Chem:08-0007 Post-Focus Draft Revision 1 9/18/2008
ENGINEER: Macek \ DDH\CLM PV (kg/yr):
Revision Notes / Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: Label: No
TLV/PEL: None provided

CRSS (07/10/2008):

Consumer Use: No
SAT (concerns) (07/11/2008): Migration to groundwater: Rapid PBT rating: P1B1T2 Health: 2-3 Dermal, Drinking Water, Inhalation Eco: 2 Water (All releases to water with a CC = 700 ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3B
Page 1s080007.en1 NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT CBI: Other New Chem:08-0007

Number of Sites/ Location:
Days/yr: Basis:
Page 2s080007.en1
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:

Page 3s080007.en1 Inhalation:

Dermal:

INITIAL REVIEW ENGINEERING REPORT CBI: Other New Chem:08-0007s080007.en1

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

Inhalation:

Page 5s080007.en1

6s080007.en1 Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

7s080007.en1

Page 8s080007.en1

Page 9s080007.en1

Page 10s080007.en1



CBI: Yes
MEMORANDUM of CBI TELEPHONE CONVERSATION
CALL BY: Daryl Hudson Organization: ERG for CEB

CALL TO: Organization:
Date: 07/14/2008

Time: 10:00 AM

Phone:
Concerning what TSCA CBI?

Other New Chem: 08-0007

Page 11

# B-3 Initial Review Exposure Report (IRExR) for S-08-07 Post-Focus DraftINITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: S080007 Reviewer: Sherer

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Water Concentration* Fugitive Air Drinking Water Fish Ingestion

ADR LADD ADR LADD 7Q10 CC=? PDM Days Exceeded LADD Acute Chronic ADR LADD Release activity(ies) 2 ; exposure calculation(s) 3 mg/kg/day mg/kg/day mg/kg/day mg/kg/day μ g/l # Days mg/kg/day μg/day μg/day mg/kg/day mg/kg/day

--- --- --- --- --- --- --- 5.30E-03 1 .40E-03 --- ---

--- --- --- --- --- --- --- 4 .08E-03 1 .08E-03 --- ---

--- --- --- --- --- --- --- 3 .08E-03 8.12E-04 --- ---
4.46E-07 1.52E-09
--- --- 8.57E-03 1 --- --- --- --- ---

1 Exposure scenario titles consist of release activ ity followed by exposure calculation abbreviation.
2 Release activities are from engineering report's Manufactur ing (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?: (default is NA)INITIAL REV IEW EXPOSU RE REPORT (IRExR)

Summary Table: Endpoints assessed

Endpoints-Assessed Table Reasons for not assessing releases

Endpoints/Assessment Cycles 1 Releases Assessed in NCEM2? No XB Testing Required No Hazard Concern No Releases Release Below Acute Threshold 5 Release Below Chronic Threshold 5 Other

Ingestion Surface water Y Ground water (landfill) N Consumer Use: DtD 2 N Inhalation Air: incineration (stack) N Air: fugitive N Consumer Use: CEM 3 N Dermal Consumer Use: CEM N Eco Surface water: ADR conc and/or PDM 4 Y

Consumer Use: DtD N

1 Assessment cycles are endpoint concentrations and dose calculations within the NCEM2 model.
2 Down-the-Drain Module
3 Consumer Exposure Module
4 Probabilistic Dilution Model
5 The threshold values for assessing endpoints are 1 mg/day for acute doses and 1 mg/year for chronic doses.

Remarks:INITIAL REVIEW EXPOSURE REPORT

Chem ical ID: S080007 Assessor: Sherer

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites:
Release Activity:

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:INITIAL REVI EW EX POSURE REPORT

CHEMICAL ID: S080007

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS

SCENARIO #: 1 RELEASE ACTIVITY:
FACILITY NAME:
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 5.30E-03 CHRONIC SCENARIO 1.40E-03

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 0.00 30.00 75.00 71.80 6.00 LADC pot (mg/kg) 0.00 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 0.00 NA 1 day 71.80 129.00INITIAL REVIEW EXPOSURE REPORT

Chem ical ID: S080007 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites:
Release Activity:

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:INITIAL REVI EW EX POSURE REPORT

CHEMICAL ID: S080007

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS

SCENARIO #: 2 RELEASE ACTIVITY:
FACILITY NAME:
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 4.08E-03 CHRONIC SCENARIO 1.08E-03

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 0.00 30.00 75.00 71.80 6.00 LADC pot (mg/kg) 0.00 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 0.00 NA 1 day 71.80 129.00INITIAL REVIEW EXPOSURE REPORT

Chem ical ID: S080007 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites:
Release Activity:

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:INITIAL REVI EW EX POSURE REPORT

CHEMICAL ID: S080007

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS

SCENARIO #: 3 RELEASE ACTIVITY:
FACILITY NAME:
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 3.08E-03 CHRONIC SCENARIO 8.12E-04

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 0.00 30.00 75.00 71.80 6.00 LADC pot (mg/kg) 0.00 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 0.00 NA 1 day 71.80 129.00INITIAL REVIEW EXPOSURE REPORT

Chem ical ID: S080007 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:4 Number of Release Sites:
Release Activity:

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:INITIAL EXP OSURE REVIEW REPORT

Chemical ID: S080007 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:4 RELEASE ACTI VITY:

FACILITY NAME:

FACILITY LOCATION:

RECEIVING WATER NAME:

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct

NPDES PERMIT #: 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 ( μ g/L) 3.55E-03 5.34E-03 8.57E-03 8.57E-03 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units

Cancer

LADD pot 1.52E-09 mg/kg/day 0.00 mg/kg/day

LADC pot 7.78E-08 mg/L 0.00 mg/kg

Acute

ADR pot 4.46E-07 mg/kg/day 0.00 mg/kg/dayINITIAL REVI EW EX POSURE REPORT Chemical ID: S080007

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER: 4 RELEASE ACTI VITY:

FACILITY NAME:

FACILITY LOCATION:

RECEIVING STREAM NAME:

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct

NPDES PERMIT NUMBER: GAGING STATION ID:

GAGING STATION
PERIOD OF RECORD: GAGING STATION
NUMBER OF OBSERVATIONS: NUMBER OF STATIONS ON REACH:

50 %ile FLOW (MLD): N/A 10 %ile FLOW (MLD): N/A EFFLUENT FLOW (MLD)

RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Pre-treatment Loading (kg/site/day) Waste Water Treatment (%)

700.00 0 1

## LEGEND FOR NEW CHEMICAL S EXPOSURE REPORT

This new chemicals exposure report wa s 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 calcula te 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 abbreviati ons on the Release Activity line, e.g., (1) max ADR , (2) max LADD , (3) max PDM . Depending on the release inputs, these e ndpoints 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 cal culated 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 proce ssing 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 dir ects 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) chemical s of P2B2 rating or hi gher 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 th at are also health or eco concerns are bolded.

# B-4 Final Risk Assessment for S-08-07

### Briefing Paper Case Number: S08-0007 Limited Standard Review

PART I: BACKGROUND DATA

Program Manager: Tracey Pennington

CCD Disposition Date: October 2, 2008

Day 90: October 8, 2008

A. Submitter:

B. Chemical Identity:

2-Propen-1-one, 1-(4-morpholin yl)- CASRN: 5117-12-4

C. Physical Form:

F. Molecular Weigh t:

G. Volume:

H. Use:

I. Test Data Submitted with PMN:

J. MSDS: Yes,

K. SAT Ratings: Human Health: 2- 3 Environment: 2 PBT: P1B1T2

L. Focus Results: At Focus on 07/28/08, S 08-0007 was placed into limited standard review to validate its consistency with the PMN because that is the end product of this substance. Potential risks to human health were low based on adequate respiratory protection. The Inhalation Monitoring Crite ria for the Pilot Program were met for inhalation exposures from use. No Inhala tion Monitoring was reque sted. Potential risks to the environment were low based on EPA believes that the new use is the residual content in the , so it is not "completely reacted and cured".

PART II: NEW INFORMATION

After discussing the case further with the submitter, S08-0007 was submitted pursuant to 40 CFR 721.5185 for the significant new use of releases to water of the chemical substance. Further, the

### substance is not being completely reacted a nd cured as there is a 0.04% residual in the accompanying PMN submission

The SNUR as currently written stipulates:

 Protection in the workplace: §721.63 (a)(1), (a)(2 )(i), (a)(2)(iv), (a)( 3)(i), (a)(3)(ii), (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)( xii), (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), (a)(6)(v), (b) (concentration se t at 0.1 percent), and (c).

 Hazard Communication: §721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)( 1)(v), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)( i), (g)(3)(ii), (g)(4)(i), and (g)(5).

 Industrial, commercial, and c onsumer activities: §721.80 (a), (c ), (f), (p): First trigger (1year), second (1,500,000), and third (2,000,000) or 1 year whichever is greater then 7,750,000 or 5 years after the commencement of commercial manufacture, whichever comes later and §721.80(y)(1).

 Disposal: §721.85 (a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). Disposal by landfill must go to a RCRA hazardous waste landfill.

 Release to water: §721.90 (a )(i), (b)(1), and (c)(1).

Based on a modification to the Consent Order in May 2006, the SNUR needed to be modified to reflect:

 Removal of Disposal: §721.85 (a )(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). Disposal by landfill must go to a RCRA hazardous waste landfill.

 Removal of Release to water: §721.90 (a)(i), (b)( 1), and (c)(1).

The following is a summary of the additional information submitted for review:

 Further clarification of residual handling pr actices from

 Submission of an MSDS

Based upon this information, revised engineering and exposure reports were placed

### PART III. RECOMMENDATION AND RATIONALE

Based on the new information provided and the prev ious need to modify the existing SNUR to
comp ly with the modified Consent Order, th e program manager recommends allowing the “significant new use” of rele ases to water. Further, the existing SNUR at 40 CFR 721.5185 should be modified to reflect this change.