Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notices (PMN) 

P-07-537 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-07-537 

A-002 Initial Review Engineering Report for 

 PMN P-07-537 

A-003 Initial Review Exposure Report for 

 PMN P-07-537 

A-004 TSCA Section 5(e) Consent Order and 

Determinations Supporting Consent Order for 

PMN P-07-537 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-07-537 

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- "- - - - -

STRUCTURE ACTIVITY TEAM REPORT ver. 04198 - - - - -- -- -- -

ICa!,e #: P-07 -0537 

Date: 7/20/2007 Chair: 

Name: 

RN; Name: 

!Molecullar Fonnula; 

1------

I

L. Keifer 

Related Case Numbers Case Role Role 

Page of 

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STRUCTURE ACTIVITY TEAM REPORT 

CASE NUMBER: P07-0537 

RELATED CASES: 

CONCLUSIONS/DISCUSSIONS 

TYPE'OF CONCERN: 

LEVEL OF CONCERN: 

KEYWORDS: ACUTE NEURO 

AQUATOX 

SUMMARY OF ASSESSMENT 

HEALTH 

2-3 

07/20/07 

ECOTOX 

2 

HEALTH: Not expected to be absorbed through the skin as the neat 

material, absorbed through the skin if in solution (pchem), 

absorbed from the lung and GI tract (analog); the PMN substance 

is expected to release metabolically; 

Concern for acute toxicity and neurotoxicity based on submitted 

test data. 

*CEB HEALTH: Moderate high concern (Dermal, inhalation); 

'XB: Testing desired ' 

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ECOTOX: Predicted (p) and measured (M) toxicity values in mg/L 

(ppm) are: 

fish 96-h LC50 > 100.0 P 

daphnid48-hLC50 >100.0 P 

green algal 96-h EC50 c > 100.0 P 

fish chronic value > 10.0 P 

fish ChV7.0 P 

daphnid ChV > 10.0 P 

algal ChV > 10.0 P 

Predictions are based on SARs for ; SAR chemical 

class = ; MW148; 

effective concentrations based on 100% active ingredients and 

nominal concentrations; hardness <150.0 mg/L as CaC03; and TOC 

<2.0 mg/L; 

moderate concern for toxicity 

assesSment factor = 10.0 

concern concentration 0.700 mg/L (ppm) 

*CEB ECOTOX: All releases to water with CC XB: 

testing desired 

SAT Co-chair: Leonard Keifer 564-8916 

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......, 

, NCSAB SAT REPORT 

PMN: P-07-0537 ICAS RN: I 

.' Chemical Name: 

Analogs: . 

Production VOlume

Structure: 

! 

Use: 

Formula: . IEq Wt: 

Endpo[nt (mg/L) Est. Value Meas. Value Comments 

Fish 96-h > \00 

Daphnid 4S-h > joo 

Algal 96-h >(OO 

Fish ChV '/ fa 

Daphnid ChV :> Ii) . 

!Algal ChV "7 (0 . 

, 

BCF 

CHEMICAL CLASS: ISAR: 

ECOTOX CONCERN I HIM /5J /CONCERN Caf-JCENTRA TION > /,0 

DATE (Iv/f)! IASSESSOR: 

{ ( 

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~~~~.'~~----------------------------------------~'~ 

Ii, GTOX Report " , 

CAS No, 

Name of Analog 

I 

. ,.Siilmonella Assay: 

CHO: 

~-

Chromosomal Aberration CHL: 

--

V79: 

E. c().li Reverse Mutation: 

f§--'" 

.....,.""-~ . .;~:-- .. 

~ifMQuse Micronucleus Assay: 

Rc1ld: 

·07/03/07 

. with activation 

@ 

D 

0 

ffiJ 

Route: 

1'--__ -' 

RafHepatocytes Unscheduled DNA Synthesis: 

comments 

I. 

ECOTOX: 

OECD 

Completed 

without activation 

[ill 

0 

0 

[ffi 

o 

o 

10: Rec# 4 : 

Reviewer 

ked 

Positive Strains 

877 

, 

• :.5 

F.ate: •. ' 

~ _______________________ B_iO_d_e_g_m_d_a_b_i_'it_y_d_a_Q __ O_n_p_g_'_1~4_2_· ____ ~ ____ ~ __________ ~1· 1 

. 

~ 

::::;;:::::::::===;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::;;;;:::=;;;::~::=;;;:; , 

Wednesday, July 18, 2007 Page 1 

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~--~--~----------------------------~----------~~------------------~ 

t,Toxicology Report .. ": ~ 

jATOX 

.SfudyType 'Species 

IRATS . 

l."'.~.,,;,: T~. Substance Description 

~,.. ®.Qffiogeneous 

Test Conditions 

Rcvd: 

7/3/2007 

I 

OECD 

Completed 

S~ ~R~o~m~e~ ______ ~ 

~ LID_ER_M __ ---' 

10: Rec# 4 

Reviewer 

ked 

891 

Study#: 

891 

. 

Results 

Wednesday. July 11, 2007 Page 2 

t 

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<, 

~.Toxicofogy Report 

PJ.tN No. 

Pi()Y.,Q537 

CAS No. Rcvd: 

7/3/2007 

OECD 

Completed ID: Rec# 4 893 

slA 

'So 

"-: study Type 

Name of Analog 

t~st Substance Description . 

. :-1:e'St Conditions 

SeX 

I D 

Reviewer 

ked 

Sludy#: 

893 

. 

I 

Results -

.

, ' 

, 

~=====~.~ Wednesday, July 11, 2007 Page 4 

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~. '----:"--------------~---~--'--

-

.Toxicology Report 

iRATS 

. Study Type Species 

I$TOXRPDS 

<test $ubstance Description 

·Test-Conditions 

~cvd: 

71312007 

DECO 

Completed 

SeX Route 

~ IGAVG 

10: Ree# 4 

Reviewer 

ked 

895 

Study#: 

895 

.· 

I 

R¢$uHs 

.... -

' .

..... . 

......... .. ' .. 

Wednesday, July 11, 2007 Page 6 

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A-002 

Initial Review Engineering Report 

 for PMN P-07-537 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 07-0537

Focus Ready Draft 7/26/2007

ENGINEER: Arnold \ DGR

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS (07/19/2007):

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Consumer Use: No

SAT (concerns) (07/20/2007):

Migration to groundwater: Rapid

PBT rating: P2B1T1

Health: 2-3 Dermal, Inhalation, XB Testing (Testing desired)

Eco: 2 Water (All releases to water), XB Testing (Testing

desired)

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EXPOSURE-BASED REVIEW: 

 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 07-0537

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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. 

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Inhalation:

 

 

 

 

Dermal:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 07-0537

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

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medium. 

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

 

 

 

 

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MEMORANDUM of CBI TELEPHONE CONVERSATION

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A-003 

Initial Review Exposure Report 

 for PMN P-07-537 

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Page of

INITIAL REVIEW EXPOSURE REPORT

Case Number: P070537 Assessor:

ENVIRONMENTAL RELEASES

Scenario#: 1 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:

Consumer use expected? No, consumer use is not expected.

Parameter Exp Based Persistent Exceedance value

Drinking (Surface) Water Dose (mg/kg/day) Yes N/A

Fish Ingestion Dose (mg/kg/day) Yes N/A

Inhalation Dose (mg/kg/day) Yes N/A

Groundwater Dose (mg/kg/day) Yes N/A

Surface Water Release after treatment (kg/yr) Yes N/A

Total Release After Treatment (kg/yr) Yes N/A

Consumer Exposure Dose? No

FATE TESTING RECOMMENDATION: Porous Pot (OECD 303A)

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INITIAL REVIEW EXPOSURE REPORT Page of 

CASE NUMBER:P070537

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #:1 RELEASE

ACTIVITY:Manufacturing & Use

SIC-CODE DESCRIPTION

SIC-CODE (S) EXPOSED POPULATION:Adult

WASTE WATER

TREATMENT REMOVAL 

(%)

COC

(μg/L)

RELEASE

DAYS

PRE-TREATMENT

RELEASE 

(kg/day)

POST-TREATMENT

RELEASE 

(kg/day)

BCF

(L/kg)

20. 700.00 3.16

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic

MEAN 30Q5 7Q10 1Q10

Harmonic

MEAN 30Q5 7Q10 1Q10

ALL 50 311.58 116.44 75.70 61.91 426.21 1140.50 1754.29 2145.05

ALL 10 32.75 11.98 7.19 5.98 4054.96 1.11E+04 1.85E+04 2.22E+04

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking

Water Units Fish Ingestion Results

Fish

Ingestion

Units

Cancer

LADDpot mg/kg/day mg/kg/day

LADCpot mg/L mg/kg

Chronic Non-Cancer

ADDpot mg/kg/day mg/kg/day

ADCpot mg/L mg/kg

Acute

ADRpot mg/kg/day mg/kg/day

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INITIAL REVIEW EXPOSURE REPORT Page of

CASE NUMBER: P070537

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVITY: Manufacturing & Use

SIC CODE DESCRIPTION

ASSOCIATED SIC CODES: 

SIC CODE RESULTS

COC (μg/L) % yr exceeded Days/yr

exceeded

Release

days/year

Loading

(kg/site/day)

Waste Water

Treatment (%)

High/Avg

Analysis

700.00 20.00

REMARK

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INITIAL REVIEW EXPOSURE REPORT Page of

CASE NUMBER:P070537

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #:1 ACTIVITY

RELEASE DESCRIPTION:

EXPOSED POPULATION:Adult

NUMBER OF

SITES LANDFILL RELEASE

(kg/yr)

LANDFILLED SLUDGE

(kg/yr)

MIGRATION FACTOR1

DRINKING WATER

TREATMENT

 (%)

 

 Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

IR

 (L/day)

Cancer

LADDpot (mg/kg/day)

LADCpot (mg/L) 

Chronic Non-Cancer

ADDpot (mg/kg/day)

ADCpot (mg/L) 

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INITIAL REVIEW EXPOSURE REPORT Page of

CASE NUMBER:P070537

INHALATION EXPOSURE ESTIMATES FROM FUGITIVE RELEASES

SCENARIO #:1 RELEASE ACTIVITY

RELEASE DESCRIPTION:

METHOD OF CALCULATION

EXPOSED POPULATION:Adult

NUMBER OF

SITES % TREATMENT TYPE OF REMOVAL

PRE-TREAT RELEASE

(kg/yr)

POST-TREAT RELEASE

(kg/yr)

 

Exposure Units Results

ASSUMPTIONS

ED

(years)

AT

(years)

BW

(kg)

Inh. Rate

(m3

/hr)

Cancer

LADDpot (mg/kg/day)

LADCpot (mg/m3

) 

Chronic Non-Cancer

ADDpot (mg/kg/day)

ADCpot (mg/m3

) 

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A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-07-537 

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