Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-578 

EPA Docket EPA-HQ-OPPT-2011-0942 

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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 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-578

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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: No

Ecotox: No

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)

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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); pH7; 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 

(ppb)

2

SARs hydrazines

SAR Class hydrazide new chemicals category: hydrazines 

and related compounds

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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A-002 

Initial Review Engineering Report 

 for PMN P-11-578 

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8/31/2011 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 

Scenario1 

 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q104

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 Manufacturing (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. 

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: 

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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: 

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8/31/2011 Page 3 of 3 

INITIAL REVIEW EXPOSURE 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 

SLUDGE1 

AND DAYS OF 

RELEASE 

(kg/site/day)/(days)

MIGRATION 

DESCRIPTOR2

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 

LADDpot (mg/kg/day) 3.92E-04 30.00 75.00 71.80 1.40 

LADCpot (mg/L) 2.01E-02 30.00 75.00 NA NA 

REMARKS: 

 

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A-003 

Initial Review Exposure Report 

 for PMN P-11-578 

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INITIAL 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: No

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SAT (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: 76

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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

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:

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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/yr

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Landfill

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/yr

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Number of workers (all sites) with dermal exposure: 3

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