## Support Documents for Significant New Use Rules (SNURs) on Premanufacture Notices (PMNs) P-09-193 and P-09-195

EPA Docket EPA-HQ-OPPT-2010-1075

## Index A-001 Structure Activity Team (SAT) Report s for PMNs P-09- 193 and P -09-195 A-002 Initial Review Engineering Reports for PMNs P-09- 193 and P -09-195 A-003 I nitial Review Exposure Reports for PMNs P-09- 193 and P -09-195

## A-001 Structure Activity Team (SAT) Reports for PMNs P-09-193 and P-09-195

### SAT Report PMN Number: P-09-0193 SAT Date: 3/13/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 2 3

Persistence Bioaccum Toxicity Comments 2 1 2 Exposure Based Review : Health: Ecotox: N o Routes of exposure : Health: Dermal, inhalation, drinking water Ecotox: All releases to water Fate: ; Keywords : Keywords: LIVER; KIDNEY; HEART; N EURO; ONCO; MUTA; DEVEL; IRR-E,MM,L,S; SENS-S,L; AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0193 FATE: Solid with MP = 88 EC (E) log Kow = -0.94 (E); S > 10 g/L at 25 EC (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) POTW removal (%) = 0-90 via possible partial biodeg Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = lowPBT Potential: P2B1 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: Absorbed all routes (analog/ p che m ); expected to be an alkylating agent. Concern for oncogenicity, mutagenicity, developmental toxicity, dermal and respiratory sensitization, and irritation to all tissues from the alkylating activity of the compound. Concern for liver, kidney, heart, and developmental (uncertain) toxicity; and neurotoxicity based on data for analogues submitted as rat developmental toxicity LOEL = 2000 mg/kg; , rat 90-day oral NOEL = 100 mg/kg, LOEL = 200 mg/kg, convulsions, liver, kidney, and heart toxicity
Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 1500 daphnid 48-h LC50 190 green algal 96-h EC50 32 fish

_ chronic value 46 daphnid chronic value 0.078 algal

_ chronic value 27 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions based on SARs for ; SAR chemical class = MW 338; log Kow= -0.94 (EPI); solid with unknown mp (P); S = 471 g/L at 25 C (P); p H7; hardness <150.0 mg/L as CaCO3; ECs based on 100% active ingredients and mean measured concentrations; and TOC <2.0 mg/L;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 8

SARs SAR Class
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

### SAT Report PMN Number: P-09-0195 SAT Date: 3/13/2009

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 1 2 Exposure Based Review : Health: Ecotox: N o Routes of exposure : Health: Dermal, inhalation, drinking water Ecotox: All releases to water Fate: ; Keywords : Keywords: LIVER; KIDNEY; HEART; N EURO; ONCO; MUTA; DEVEL; IRR-E,MM,L,S; SENS-S,L; AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0195 FATE: Solid with MP = 90 EC (E) log Kow = -1.12 (E); S > 10 g/L at 25 EC (E) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) log Koc = 2.81 (E) log Fish BCF = 0.50 (E) POTW removal (%) = 0-90 via possible partial biodeg Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = low - moderatePBT Potential: P2B1 *CEB FATE: Migration to ground water = moderate - rapid

Health : Health Summary: Expect poor absorption via all routes (analog/ p che m ); expected to be an alkylating agent. Concern for oncogenicity, mutagenicity, developmental toxicity, dermal and respiratory sensitization, and irritation to all tissues from the alkylating activity of the compound. Concern for liver, kidney, heart, and developmental (uncertain) toxicity; and neurotoxicity based on data for analogues submitted as rat developmental toxicity LOEL = 2000 mg/kg; , rat 90-day oral NOEL = 100 mg/kg, LOEL = 200 mg/kg, convulsions, liver, kidney, and heart toxicity
Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 6700 daphnid 48-h LC50 360 green algal 96-h EC50 56 fish

_ chronic value 89 daphnid chronic value 0.12 algal

_ chronic value 50 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions based on SARs for ; SAR chemical class = MW 509; log Kow= -1.12 (EPI); solid with unknown mp (P); S = 471 g/L at 25 C (P); p H7; hardness <150.0 mg/L as CaCO3; ECs based on 100% active ingredients and mean measured concentrations; and TOC <2.0 mg/L;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 12

SARs SAR Class
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

## A-002 Initial Review Engineering Reports

for PMNs P-09-193 and P-09-195INITIAL REVIEW ENGINEERING REPORT P-09-0193 Focus Ready Draft 3/19/2009

ENGINEER: Arnold \ DDH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE: Flame retardant monomer for polyurethane.

OTHER USES:

MSDS : Yes LABEL : N o Gen Eqpt: appropriate chemical resistant gloves/ safety glasses with side shields/ general ventilation or local exhaust Respirator: in opeations where the exposure limits can be exceeded, wear a NIOSH approved respirator/ if a respirator is worn, OSHA requires compliance with its respiratory protection program (29 CFR 1910.134) Health Effects: inhalation may cause irritation of the nose and throat, headache, nausea, and drowsiness/ skin contact may cause irritation with discomfort/ eye contact causes irriation and may injure cornea/ moderately toxic if ingested. TLV/PEL : - none established for PMN.

CRSS: Chemical Name: Phosphonic acid, [2-[bis(2-hydroxyethyl)amino ]ethyl]-, bis(2-chloroethyl) ester S-H2O: 471 g/L @ VP: 1.0E-6 torr @ MW: 338 0.0%<500 0.0%<1000 Physical State and Misc CRSS Info:

Consumer Use : N o SAT (concerns): (3/13/2009): Migration to groundwater: Rapid PBT rating: P 2 B 1 T 2 Health: 2, Dermal, Drinking Water, Inhalation Eco: 3, Water (All releases to water with a CC = 8 ppb)

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: N o (0 criteria met)P-09-0193

Manufacturing

Number of Sites/Location: 1
Basis: Process Description:



### ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:P-09-0193

Use:

Number of Sites/Location: 1 submitter site(s)
Basis: Process Description:



### ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:INITIAL REVIEW ENGINEERING REPORT P-09-0195 Focus Ready Draft 3/19/2009

ENGINEER: Arnold \ DDH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE: Flame retardant monomer for polyurethane.

OTHER USES:

MSDS: Yes LABEL : N o Gen Eqpt: appropriate chemical resistant gloves/ safety glasses with side shields/ general ventilation or local exhaust Respirator: in opeations where the exposure limits can be exceeded, wear a NIOSH approved respirator/ if a respirator is worn, OSHA requires compliance with its respiratory protection program (29 CFR 1910.134) Health Effects: inhalation may cause irritation of the nose and throat, headache, nausea, and drowsiness/ skin contact may cause irritation with discomfort/ eye contact causes irriation and may injure cornea/ moderately toxic if ingested. TLV/PEL : - none established for PMN.

CRSS: (12:00:00 AM): Chemical Name:

S-H2O: 58 g/L @ VP: 1.0E-6 torr @ MW: 509 0.0%<500 0.0%<1000 Physical State and Misc CRSS Info:

Consumer Use : N o SAT (concerns): (3/13/2009): Migration to groundwater: Moderate to Rapid PBT rating: P 2 B 1 T 2 Health: 2, Dermal, Drinking Water, Inhalation Eco: 2, Water (All releases to water with a CC = 12 ppb)

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE -BASED REVIEW: N o (0 criteria met)P-09-0195

Manufacturing

Number of Sites/Location: 1
Basis: Process Description:



### ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:P-09-0195

Use:

Number of Sites/Location: 1
Basis: Process Description:



### ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

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

## A-003 Initial Review Exposure Reports for PMNs P-09-193 and P-09-195Date 3/18/09 Page of
INITIAL REVIEW EXPOSURE REPORT Summary Page

Chemical ID: P090193 Reviewer: Cinalli

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 No NA Ground water (landfill) No NA Consumer Use: DtD 2 No NA Inhalation Air: incineration (stack) No NA Air: fugitive No NA Consumer Use: CEM 3 No NA Dermal Consumer Use: CEM No NA Eco Surface water: ADR conc and/or PDM 4 No NA

Consumer Use: DtD No NA

1 Assessment cycles are endpoint concentrations and dose calculations within the NCEM2 model. 2 Down-the-Drain 3 Consumer Exposure Model 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.

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).Date 3/18/09 Page of
INITIAL REVIEW EXPOSURE REPORT Summary Page

Chemical ID: P090195 Reviewer: Cinalli

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 No NA X Ground water (landfill) No NA X Consumer Use: DtD 2 No NA Inhalation Air: incineration (stack) No NA Air: fugitive No NA X Consumer Use: CEM 3 No NA Dermal Consumer Use: CEM No NA Eco Surface water: ADR conc and/or PDM 4 No NA X

Consumer Use: DtD No NA

1 Assessment cycles are endpoint concentrations and dose calculations within the NCEM2 model. 2 Down-the-Drain 3 Consumer Exposure Model 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.

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).