## Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-578

EPA Docket EPA-HQ-OPPT-2011-0942

## Index A-001 Structure Activity Team (SAT) Report for PMN P-11-578 A-002 Initial Review Engineering Report for PMN P-11-578 A-003 Initial Review Exposure Report for PMN P-11-578

## A-001 Structure Activity Team (SAT) Report
for PMN P-11-578

### SAT Report PMN Number: P-11-0578 SAT Date: 8/23/2011 Print Date: 10/3/2011

Related cases : Health related cases:

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1-2 3

Persistence Bioaccum Toxicity Comments 1 12

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: SENS-DERMAL, UNCERT-SENS-RESPIRATORY, MUTA, ONCO, DEVEL, AQUATOX-A,C Summary of Assessment :
Fate : Fate Summary: P-11-0578 FATE: Solid with MP = 120-127 C (M) log Kow = 2.28 (E); S = 202 mg/L at 25 C (E) VP = 9.0E-6 torr at 25 C (E) BP = Dec. > 299 C (M) H < 1.00E-8 (E) log Koc = 1.40 (E) log Fish BCF = 1.17 (E)log Fish BAF = 1.28 (E) POTW removal (%) = 90 via biodeg Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = low PBT Potential: P1B1 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: Absorption is nil through the skin as the neat material, moderate through the skin when in solution, and moderate through the lungs and GI tract based on physical/chemical properties. The hydrazide can react with keto groups in the body to form hydazones. There is concern for mutagenicity, oncogenicity, and developmental toxicity for the hydrazide. There is also concern for dermal sensitization and uncertain concern for respiratory sensitization based on the reactivity of the hydrazide. Low moderate concern.
Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 1.4 daphnid 48-h LC50 2.6 green algal 96-h EC50 0.073 fish

_ chronic value 0.067 daphnid

_ chronic value 0.095 algal

_ chronic value 0.018 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for hydrazines; SAR chemical class = hydrazide; MW 192; log Kow = 2.28 (EPI); solid with mp = 127 C (M); S = 0.2 g/L at 25 C (P); p H7; effective concentrations based on 100% active ingredients and nominal 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) 2

SARs hydrazines SAR Class hydrazide new chemicals category: hydrazines and related compounds
Ecotox Factors Comments:
SAT Chair: Becky Jones

## A-002 Initial Review Engineering Report
for PMN P-11-5788/31/2011 Page 1 of 3

INITIAL REVIEW EXPOSURE REPORT (IRExR) Chemical ID: P-11-0578 Reviewer: Wong/BC

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

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Drinking Water Fish Ingestion ADR LADD ADR LADD 7Q10 4 CC =

2 PDM Days Exceede d LADD ADR LADD ADR LADD

Release activity(ies) 2
; exposure calculation(s) 3 mg/kg/day mg/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

MFG:USE: Max LADD --- --- --- --- --- --- 3.92E-04 --- --- --- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufact uring (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one expo sure 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. 4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:8/31/2011 Page 2 of 3

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0578 Assessor: Wong/BC
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: 1. Release Activity: MFG:USE: Max LADD Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/A 666.20 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: N/A 1.00/0.00 N/A N/A
Per Site Release: N/A 666.20/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:8/31/2011 Page 3 of 3

INITIAL REVIEW EX POSURE REPORT Chemical ID: P-11-0578

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 1 ACTIVITY: MFG:USE: Max LADD
RELEASE DESCRIPTION:
EXPOSED POPULATION: Adult

NUMBER OF SITES NON-SLUDGE LANDFILL RELEASE AND DAYS OF RELEASE (kg/site/day)/(days) LANDFILLED SLUDGE 1 AND DAYS OF RELEASE (kg/site/day)/(days) MIGRATION DESCRIPTOR 2 ADSORPTION TO WASTEWATER SLUDGE (%) DRINKING WATER TREATMENT (%)

1. 666.20/1.00 0.00/0.00 Rapid 0.00 0.00

1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the surface water pre-treatment release.

2 Migration Descriptor Log Koc Groundwater Concentration (GWC) (mg/L per kg release) Negligible no migration None Negligible to slow > 4.5 3.21E-6 Slow <4.5 to 3.5 2.67E-5 Moderate <3.5 to 2.5 5.95E-5 Rapid <2.5 7.55E-5

ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (L/day) Cancer LADD pot (mg/kg/day) 3.92E-04 30.00 75.00 71.80 1.40 LADC pot (mg/L) 2.01E-02 30.00 75.00 NA NA

REMARKS:

## A-003 Initial Review Exposure Report
for PMN P-11-578INITIAL REVIEW ENGINEERING REPORT CBI: PMN: 11-0578 Focus Ready Draft 9/1/2011
ENGINEER: Austin \ AH PV (kg/yr): 28,000

SUBMITTER: Eastman Kodak Co USE: Chemical intermediate for a coupler for imaging products.

OTHER USES: Analogs L-00-0239 and L-01-0065 are additives used in electroplating solution.

MSDS: Yes Label: No Gen Eqpt: Process enclosures, local exhaust ventilation, or other engineering controls; safety glasses with side shields (or goggles), impervious gloves and protective clothing Respirator: NIOSH-approved with an APF of 10 Health Effects: Harmful if inhaled, absorbed through the skin, or swallowed. May cause transient irritation to the eyes. TLV/PEL: No information provided.

CRSS : Chemical Name: Benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide S-H20: 0.2 g/L @ VP: 9.0E-6 torr @ MW: 192.00 %<500 %<1000 Physical State and Misc CRSS Info: Neat: Solid Mfg: Solid Proc/Form: NA End Use: Destroyed. Submitted data: solid; MP = 120-127 °C (DSC); decomposes > 299 °C (DSC); agglomerate mean particle size = 84.58 μm, range = 1.79 to 517.2 μm; primary mean particle size = 1. 615 μm, range = 0.15-5.87 μm; 13C NMR, 1H NMR, and IR spectra provided. Literature data (STN eprop): MP = 121-123 °C, 117-118 °C. EPI estimated data (input MP = 120 °C): VP = 8.76E-6 torr; WS = 0.202 g/L; log P = 2.28. ACD Labs estimated data (STN pprop): WS = 0.92 g/L; log P = 2.001.

Consumer Use: NoSAT (concerns) (08/23/2011): Migration to groundwater: Rapid PBT rating: P1B1T2 Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 2ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3A

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

POLLUTION PREVENTION CONSIDERATIONS: No Pollution Prevention information provided by the submitter.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0578 Manufacturing

Number of Sites/ Location: 1 Eastman Business Park Rochester NY 14652 Days/yr: 76ENVIRONMENTAL 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.

Incineration Output 2: 2.9E+1 kg/site-day over 76 days/yr from 1 site or 2.2E+3 kg/yr

Incineration or Landfill Output 2: 1.8E+0 kg/site-day over 76 days/yr from 1 site or 1.4E+2 kg/yr

Landfill Output 2: 1.5E+0 kg/site-day over 76 days/yr from 1 site or 1.1E+2 kg/yr

RELEASE TOTAL 2.5E+3 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 5 Basis:Inhalation: Exposure to Particulate (Class I) Upper Bound: 1.5E+2 mg/day over 76 days/yr Number of workers (all sites) with inhalation exposure: 5

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? Yes OR b) Hazard Rating for health of 2 or greater? 1-2 No Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal: Exposure to Solid at 100.00% concentration High End: 3.1E+3 mg/day over 76 days/yr Number of workers (all sites) with dermal exposure: 5

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0578

Use:

Number of Sites/ Location: 1 Eastman Business Park Rochester NY 14652 Days/yr: 154 Basis:

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.

Incineration or Landfill Output 2: 1.0E+0 kg/site-day over 134 days/yr from 1 site or 1.4E+2 kg/yrLandfill Output 2: 2.1E+0 kg/site-day over 134 days/yr from 1 site or 2.8E+2 kg/yr

RELEASE TOTAL 4.2E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 3 Basis:

Inhalation: Exposure to Particulate (Class I) Upper Bound: 1.5E+2 mg/day over 154 days/yr Number of workers (all sites) with inhalation exposure: 3

Dermal: Exposure to Solid at 100.00% concentration High End: 3.1E+3 mg/day over 154 days/yrNumber of workers (all sites) with dermal exposure: 3