PMN Page 1 Page 1 of 1,1 0' U.S. ENVIRONMENTAL PROTECTION AGENCY 

## PREMANUFACTURE 

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# Company Sanitized D.C. 20460 

### GENERAL INSTRUCTIONS You must provide all information requested in this form to the extentthat it is known to or reasonably ascertainable by you. Make reasonable estimates ifyou do not have actual data. • Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603). Ifa user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, your user fee ID number must also appear on your corresponding fee remittance, which is sent to EPA, Washington Financial Management Center (3303), P.O. 360399M, Pittsburgh, PA 15251-6399, Attn. TSCA User fee.
Part I - GENERAL INFORMATION You must provide the currently COlTecl Chemical Abstracts (CA) Name ofthe new chemical substance, even ifyou claim the identity as confidential. You may authorize another person to submit chemical identity information for you, but your submission will notbe complete and the review will not begin until EPA receives this information. A letter in support ofyour submission should reference your TS user fee identification number. You must submit an original and two copies ofthis notice including all test data. Ifyou claimed any information as confidential, a single sanitized copy must also be submitted. Part 11- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE Ifthere are several manufacture, processing, or use operations to be described in Part II, sections Aand Bofthis notice, reproduce the sections as needed.

Part 111-LIST OF ATTACHMENTS Attach additional sheets ifthere is not enough space to answer a question fully. Label each continuation sheet with the corresponding section heading. In Part Ill. list these attachments, any test data or other data and any optional information included inthe notice.
OPTIONAL INFORMATION You may include any information that you want EPA to consider in evaluating the new substance. On page 11 ofthis form, space hasbeen provided for you to describe pollution prevention and recycling information you may have regarding the new substance. So-<:alled "binding" boxes are included throughout this form for you to indicate your willingness to be bound to certain statements you make in this section. such as use, production volume, protective equipment
... This option is intended to reduce delays that routinely accompany the development ofconsent orders or Significant New Use Rules. Except in the case ofexemption applications (such as TMEA, L VE, LOREX) where certain infotrnation provided in such notification is binding on the submitter when the Agency approves the exemption application, checking a binding box in this notice**~** by itselfprohibit the submitter from later deviating from the information (exceptchemical identity) reported in the form. CONFIDENTIALITY CLAIMS You may claim any information in this notice as confidential. To assen aclaim on the form, mark (X) the confidential box next to the information thatyou claim as confidential. To assert a claim in an**attachmen~** circle or bracketthe infonnation you claim as confidential. Ifyou claim infonnation in the notices as confidential you must also provide a sanitized version ofthe notice (including attachments). Foradditional instructions on claiming information as confidential, read the Instructions ManuaL Mark (x) ifany information in this notice is claimed as confidential TEST DATA AND OTHER DATA You are required to submit all test data in your possession or control and to provide a description ofall other data known to or reasonably ascertainable by you, ifthese data are related to the health and environmental effects on the manufacture, processing, distribution in commerce, use, ordisposal ofthe new chemical substance. Standard literature citations may be submitted for data in the open scientific literature. Complete test data (written in English), not summaries ofdata. must be submitted ifthey do not appear in the open literature. You should clearly identify whether test data is onthe substance or on art analog. Also, the chemical composition ofthe tested material should becharacterized. Following are examples oftest data and other data. Data should be submitted according to the requirements of§720.50 ofthe Premanufacture Notification Rule (40 CFR Part 720).
r--.: Test Data (Check Below any included in this notice)**~r** ('".:;:) Environmental fate data Yes Other data (,,"::,,­ ",... Health effects data Yes Risk assessments

## ;Q 

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Environmental effects data 

## 0 Yes Structure/activity relia.ticmslup',r:l**~** PhysicallChemlcai Properties' 

## 0 Y es Test data not in**~t ssesslo~**  or control ofthe' itter 

## B AphYSIcal and chemIcal properties woTksheet IS located on the last page

## ~iS form. TYPE OF NOTICE (Check Only One) 

# - o PMN (Premanufacture Notice) 

# o lNTERMEDlATE PMN (submitted in sequence with final product PMN) 

# o SNUN (Significant New Use Notice) 

# D TMEA (Test Marketing Exemption Application) 

# o LVE (Low Volume Exemption) @40 CFR 723.50(0)(1) 

# D LOREX (Low Release/Low Exposure Exemption) @40 CFR 723.50(c)(2) L VE Modification LOREX Modification 

# o o IS THIS ACONSOLIDATED PMN? Yes 

# o

EPA FORM 7710-25 (Rev. 5-95) Replaces previous editions ofEPA Form 7710-25. 

# 181PMN Page 2 ; Page 2 of 1,101 Public reporting burden for this collection ofinformation is estimated to average 110 hours perresponse, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect ofthis collection ofinformation, including suggestions for reducing this burden, to Director, Collection Strategies Division (2822), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., N.W., Washington, D.C. 20460; and to the Office ofManagement and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503. 

### CERTIFICATION

-- A Printed copy of this signature page, with original Signature, must be submitted I certifY that to the best ofmy knowledge and belief: 1. The company named in Part I, section A, subsection 1 a ofthis notice fonn intends to manufacture or import for a commercial purpose, otherthan in small quantities solely for research and development, the substance identified in Part I, Section B. 2. All infonnation provided in this notice is complete and truthful as ofthe date ofsubmission. 3. I am submitting with this notice all test data in my possession or control and a description ofall other dataknown to or reasonably ascertainable by me as required by §720.50 ofthe PremanufactureNotification Rule.
Additional Certification Statements: Ifyou are submitting a PMN, Intennediate PMN, Consolidated PMN, or SNUN, checkthe following user fee certification statementthat applies: 

## [!] The Company named in Part I, Section A has remitted the fee of$2500 specified in 40 CFR 700.45(b), or 

# o The Company named in Part I, Section A has remitted the fee of$1000 for an Intennediate PMN (defined@40 CFR 700.43) in accordance with 40 CFR 700.45(b), or 

# o The Company named in Part J Section A is a small business concern under40 CFR 700.43 and has remitted a fee of$100 in accordance with 40 CFR 700.45(b). Ifyou are submitting a low volume exemption (LVE) application in accordance with 40 CFR 723.50(c)(J) or a Low release and lowexposure exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), checkthe following certification statements: 

# o The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial purposes, other than in small quantities solely for research and development, under thetenns of40 CFR723.50. 

# o The manufacturer is familiar with the tenns ofthis section and will comply with those tenns; and 

# o The new chemical substance for which the notice is submitted meets all applicable exemption conditions. 

# o Ifthis application is for an LVE in accordance with 40 CFR 723.50(c)(J), the manufacturer intends to commence manufacture ofthe exempted substance for commercial purposes within I year ofthe date ofthe expiration ofthe 30 day review period. The accuracy ofthe statements you make in this notice should renect your best prediction ofthe anticipated facts regarding the chemical substance described herein. Any knowinl!ud willful misinterpretation is subject to criminal penalty pursuant to 18 USC 1001. Signatun: and title ofAuthorized Official (Original Signature Required) Date
Signatun: ofagent • (ifapplicable) Date Confidential 

# D

EPA FORM 7710·25 (Rev. 5·95) Page 2; Page 3 of 1.10'

la. Person Submitting Notice (in U.S.) Company Mailing address (number and street)
Postal Code City, State
b. Agent(if Name ofauthorized official applicable)

Mailing address (number and street) City, State Postal Code Telephone (include area code)

c.

## IfYOu~eSubmi~;·n~g~~Krti~;;P;tQr;~~~~~~~~~~~bo~X:.::::::::::::::::::::::::::::::::::::::::::=i~~ Joint Submitter (if Position applicable) Company

Postal Telephone (include country or area code) 2. Technical Contact (in U.S.) Name ofauthorized official Dr. Richard Jourdenais Company Technology Sciences Group Inc. Position Director, Chemicals Division

3. Ifyou have had a prenotice communication (PC) concerning this notice and EPA assigned a PC Number 10 Ihe notice. enlerth**:::::e.::n=um::be=r.~** ___**-+~** 4. Ifyou previously submined an exemption application for the chemical substance covered by this notice. enter the exemption number assigned by EPA. Ifyou previously submitted a PMN for this substance enler the PMN number EPA withdrawn or**~** 5. Ifyou have submined a notice ofBona fide inlenllo manufacture or import for the chemical substance covered by this notice. enter the notice number assigned by EPA.**~** 

# D Manufacture I. 6. Type ofNotice

-**M~k** (X) Only 

# D Binding Option Mark Mailinl! address (number and street) 1150 18th Street NW Suite 1000 Postal Code Telephone (include area code) Washington, DC 20036 202-828-8992

12.**~** Import Only**M~k(X)** ifnone Mark (X) ifnone Mark (X) ifnone 1 

# D 13. Both 

# D Binding Option 

# , I**M~k**
EPA FORM 7710-25 (Rev. 5-95) Page 3PMN Page 4 ; Page 4 of 1,101 Part I -- GENERAL INFORMATION -- Continued Section B
-- CHEMICAL IDENTITY INFORMATION: 

# I You must provide a currently correct Chemical Abstracts (CA) Mme ofthe substance based on the nintb Collective Index (9CI) ofCA nomenclature rules and conventions. Mark (X)the "Confidential" box nextto any item you claim as confidential Complete either item I (Class I or2 substances) or 2 (Polymers) as appropriate. Complete all other items. Ifanother person will submit chemical identity infonnation for you (foreither Item 1or 2), mark (X)the box atthe right. 

# 0 Identify the name, company, and address ofthat person in a continuation sheet. .. I. Class I or 2 chemical substances (fordefinitions ofclass I and class 2 substances, see the Instructions Manual) a. Class ofsubstance

- Mark (X) I 

# 0 Class I or 2 

# 0 Class 2 b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistentwith TSCA Inventory listings for similar substances. For Class I substances a CA Index Name must beprovided. For Class 2 substances either a CA Index Name orCA Preferred Name must be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions).

c.

d.

e. Please identify which method you used to develop or obtain the specified chemical identity infonnation reported in this notice: (check one). 

### r-;l Method I (CAS Inventory Expert Service a copy ofthe Identification 

# D Method 2 (Other Source) 

### L.:.J report obtained from the CAS Inventory Expert Services must be submitted as an attachment to this notice) Molecular fonnula CBI CAS Registry Number (ifa number already exists for the substance) For a class 1substance, provide a complete and correct chemical structure diagram. For a class 2 substance, provide a correct representative or partial chemical structure diagram, as complete as can be known, ifone can be reasonably ascertained. Please see the E-PMN Instruction Manual for discussion of"native fonnat" diagram software which can be helpful in reviewing your substance.**~** Mark (X)this box ifyou attach a continuation sheet. Confidential

EPA FORM 7710-25 (Rev. 5-95) Page 4PMN Page 4a ; Page 5 of 1,101 Fora class 2 substance· (I)List the immediate precursor substances with their respective CAS Registry Numbers. (2) Describe the nature ofthe reaction or process. (3) Indicate the range ofcomposition and the typical composition (where appropriate).

e. (1) List the immediate precursor substances with their respective CAS Registry Numbers. ConfiName (CAS #) dential 

# D

e. (2) Describe the nature ofthe reaction or process. 

# D

e. (3) Indicate the range ofcomposition and the typical comJlOsition (where appropriate). 

# D

lU Mark (X) this box ifyou attach acontinuation sheet. EPA FORM 7710·25 (Rev. 5·95) Page 4aPMN Page 5 ; Page 6 of 1,10 PartI
-- G.ENERAL INFORMAnON
-- Continued Section B - CHEMICAL IDEJ't.TITY INFORMATION
- Continued 2. Polymers (For a definition ofpolymer, see the Instructions Manual.) Confidential a. Indicate the number-average weight ofthe lowest molecular weight composition ofthe polymer you intend to manufacture. 

# D Indicate maximum weight percent oflow molecular weight species (not including residual monomers, reactants, or solvents) below 500 and below I 000 absolute molecular weight ofthat composition. Describe the methods ofmeasurement orthe basis for your estimates: GPCU Other 

### U: (SpecifY below) (i) lowest number average molecularweight: 

# I I (ii) maximum weight %below 500 molecular weight: (iii) maximum weight %below 1000 molecular weight: 

# 0 Mark (X) this box ifyou attach a continuation sheet. b. You must make separate confidentiality claims for monomerorother reactant identity, composition information, and residual information. Mark (X) the "Confidential" box next to any item you claim as confidential (1) 

### - Provide the specific chemical name and CAS Registry Number (ifa numberexists) ofeach monomer or otherreactant used in the manufacture of the polymer. (2) Mark (X) this column ifentry in column (I) is confidential. (3) 

### - Indicate the typical weight percent ofeach monomer or other reactant in the polymer. (4) 

## - Choose "yes" from drop down menu ifyou want a monomer or other reactant used at two weight percent or less to be listed as part ofthe polymer description on the TSCA Chemical Substance Inventory. (5) 

### - Mark (X) this column ifentries in columns (3) and (4) are confidentiaL (6) Indicate the maximum weight percent ofeach monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. (7) 

## - Mark (X) this column ifentry in column (6) is confidential. Monomer or other reactant and CAS Registry Number Confi­**~lncludein** Confi­ 

# M"dm=: Confidential . identity dential residual dential (I) (2) 3 (4) (5) (6) (7) 

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# ---­ D Mark (X) this box ifyou attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 5PMN Page Sa; Page 7 of 1.10 c, Please identifY which method you used to develop orobtain the specified chemical identityC:rnnation reported in this notice (check one), COl 

# D Method I (CAS Inventory Expert Service· a copy ofthe identification report Method 2 (other source) obtained from CAS Inventory Expert Service must be submitted as an attachment to this notice) 

# D d, The currently correct Chemical Abstracts (CA) name for the polymer that is consistentwith TSCA Inventory listings for similar polymers, 

# D

CAS Registry Number (ifa number already exists for the substance)
e, Provide a correct representative or partial chemical structure diagram, as complete as can be known, ifone can be reasonably ascertained" Please see the E·PMN Instruction Manual for discussion of"native format" diagram software which can be helpful in reviewing your substance,



# o Mark (X) this box ifyouattach a continuation sheet

EPA FORM 7710·25 (Rev 5·95) Page SaPMN Page 6; Page 8 of 1,10
Impurities (a) IdentifY each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide the CAS Registry Number ifavailable. Ifthere are unidentified impurities, enter "unidentlfied. rt Estimate the maximum % of
. . . . estimate their total %. Impurity and CAS Registxy Number Maximum Confipercent dential % 

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# D
Confidential 

# 0 o Mark (X)this box ifyou attach acontinuation sheet. 5. Trade identification

- List trade names forthe new chemical substance identified in subsection I or 2. KarenzMr®PEl,PEl-VM,PEMB,PEMB and PE3MB, KarenzMT(PEMB and PE3MBl 

# o Mark (X) this box ifyou attach a continuation sheet. 6. you you must name your substance that reveals the specific chemical identity ofthe new chemical substance to the maximum extent possible. Referto the TSCA Chemical Substance Inventoxy, 1985 Edition. Appendix B for guidance on developing generic names. Ppll.ythiol

manufacture, processing, use, or disposal ofthe new chemical substance. Provide the CAS Registxy CAS

EPA FORM 7710-25 (Rev. 5-95) Page 6 Number ConfidentialPMN Page 7 ; Page 9 of 1,101 

### PartI
-- GENERAL INFORMATION
-- Continued Section C
-- PRODUCTION, IMPORT, AND USE INFORMATION: Mark (X) the "Confidential" box next to any item you claim as confidential. 1. Production volume

­ Estimate the maximum production volume during the first 12 monthsofproduction. Also estimate the maximum production volume for any consecutive 12-monthperiod during the first three years ofproduction. Estimates should be on 100% new chemical substance basis. For a LowVolume Exemption application, ifyou choose to haveyour notice reviewed at a lowerproduction volume than 10,000 kg/yr, specify the volume and mark (x) in the binding box. Ifgranted, you are bound to this volume Maximum

# fi,,, 12-month prod","on (kg/y<) Maximum 12-month production (kg/y<) 

# :Ij::''''''' (100% new chemical substance basis) (100% new chemical substance basis) dentlal Ma!;) 

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2. Use Infonnation

- You must make separate confidentiality claims for the description ofthe category ofuse, the percent ofproduction volume devoted to each category, the formulation of the new substance, and other use information. Mark (X) the "Confidential" Box nextto any item you claim as confidential. a. (J)--Describe each intended category ofuse ofthe new chemical substance by function and application. (2) --Mark (X) this column ifentry column (1) is**~onfidential** business information (CBI). (3) --Indicate your willingness to have the information provided in column (I)binding. (4) --Estimate the percent oftotal production for the first three years devoted to each category ofuse. (5) --Mark (X) this column ifentry in column (4) is confidential business information (CBI). (6)-­**~stimate** the percent ofthe new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites under yourcontrol associated with each category ofuse. (7)--Mark (X) this column ifentry in column (6) is confidential business information (CBI). (8) -Indicate % of product volume expected for the listed "use" sectors, Mark more than one box ifappropriate. Mark (X) to indicate your willingness to have the use type provided in (8) binding. (9) --Mark (X) this column ifentry(ies) in column (8) is (are) confidential business information (CBI) Category ofuse (1) (by function and application i.e. a CBI Binding Prod- CBI °/0 in CBI % ofsubstance expected per use CBI dispersive dye for finishing polyester fibers) Option uction Fonnu (8) MiIrk % latian (x) (2) (3) (4) (5) (6) (7) Cons- Indus- Com- Binding (9) .mer trial mercial OptiM 

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'--­ • Ifyou have identified a "consumer» use, please provide on acontinuation sheet adetailed description ofthe use(s) ofthis chemical substance in consumerproducts.

In addition include estimates ofthe concentration ofthe new chemical substance as expected in consumer products and describe the chemical reactions by which this 

## I

# d bstance loses its identity in the consumerproduct. Mark (X) this box ifyou attach a continuation sheet. b. Generic use Ifyou claim any category ofuse description in subsection 2a as confidential, enter a generic description ofthat category. Read the Instruction description Manual for examples ofgeneric use descriptions. Monome:r:for industrial paints, coatings, ink and adhesives 

# ID Mark (X) this box ifyou attach a continuation sheet. 3. Hazard Information

- Include in the notice a copy ofreasonable facsimile ofany hazard warning statement, label, material safety data sheet, or other Binding

information which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for Option the safe handing, transport, use, or disposal ofthe new substance. List in part III hazard information you include. Mark (x)

## ~ Mark (X) this box ifyou attach hazard information. 

# I I EPA FORM 7710-25 (Rev. 5-95) Page 7PMN Page 8 ; Page 10 of 1, 1C Section A
-- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER box next to any item you Complete section A for each type ofmanufacture, processing, or operation involving the new chemical substance at industrial sites you control. Importers do not have to complete this section for operali0l1s outside the U.S.; however, you may still have reporting requirements if there are further industrial or use' must describe these See instructions manual l. ofthe site at which the will occur.
Site address (number and street)

Ifthe same operation will occur at more than one site, enter the number ofsites. IdentifY the additional sites on a continuation sheet, and ifany ofthe sites have significantly different production rates oroperations, include all the infonnation requested in this section for those sites as attachments.

J, Batch
2. Continuous Mil.X,mIUm kg/day (100%new chemical substance) Use BatchesJyear Days/year Confidential 

# D

d. Process description Mark (X) to indicate your willingness to have your process description binding, (1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specifY- e,g, 5 gallon pails, 55 drum, rail car, tank truck, etc,). (2) Provide the identity, the approximate weight (by kg/day or kglbatch on a 100% new chemical substance basis), and entry pointofall starting materials and feedstocks (including reactants, solvents, catalysts, etc,), and ofall products, recycle streams, and wastes, Include cleaning chemicals (note frequency ifnot used daily or per batch,), (3) IdentifY by number the points ofrelease, including small or intem1ittent releases, to the environment ofthe new chemical substance, Ifreleasing to two media at the same step, assign a second release number for the second medium,

attach a continuation sheet EPA FORM 7710-25 (Rev, 5-95) Page 8PMN Page 8a ; Page 11 of 1,10 Confidential 

# D

EPA FORM 7710-25 (Rev. 5-95) Page SaPMN Page 9 ; Page 12 of 1,1 C



# D D D Part II-w HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE wW Continued Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER
- Continued 2. Occupational Exposure
- You must make separate confidentiality claims for the description ofworker activity, physical form ofthe new chemical substance, number of works exposed, and duration ofactivity. Mark (X) the "Confidentialn box next to any item you claim as confidential (I) -- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which \MJrkers may be exposed to the substance. (2)
-- Mark (X) this column ifentry in column (I)is confidential business information (CBI). (3)
-- Describe any protective equipment and engineering controls used to protect workers. (4) and (6) Indicate your willingness to have the information provided in column (3) or (5) binding. (5)
-- Indicate the physical formes) ofthe new chemical substance (e.g., solid: crystal, granule, powder, or dust) and % new chemical substance (ifpart ofa mixture) at the time ofexposure. (7)
-- Mark (X) this column ifentry in column (5) is confidential business information (CBI). (8)
-- Estimate the maximum number of\MJrkers involved in each activity for all sites combmed. (9)
-- Mark (X) this column ifentry in column (8) is confidential business information (CBI). (10) and (11)
- Estimate the maximum dWlltion ofthe activity for any worker in hours per day and days peryear. (12)
-- Mark (X)this column ifentries in columns (10) and (II) are confidential business information (CBI). Worker activity (i.e., bag dumping, filling drums) (I) CBI
(2) Protective Equipmenti Engineering Controls (3) Binding Option Mark (x)

(4) Physical forms(s) and % new substance

(5) Bindmg Option Mark (x)

(6) CBI
(7) # of Workers Exposed

(8) CBI
(9) Maximum duration CBI
(12) Hrs/day

(10) Days/yr (ll)

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# 1 Mark (X)this box ifyou attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) 9PMN Page 9a; Page 13 of 1,10 3. Environmental Release and Disposal

-- You must make separate confidentiality claims for the release number and the amount ofthe new chern ICal substance released and other release and disposal information. Mark (X) the "Confidential" box next to each item you claim as confidential. (I) -- Enter the number ofeach release point identified in the process description, part II, section A, subsection Id(3). (2)
-- Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology (in kg/day orkglbatch). (3)
-- Mark (X) this column ifentries in columns (1) and (2) are confidential business information (CBI). (4)
-- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site oroff-site land or incineration, P01W, or other (specify» to which the new substance will be released from that release point. (5)
-- a. Describe control technology, ifany, and control efficiency that wiII be used to limit the release ofthe new substance to the environment. For releases disposed ofon land, characterize the disposal method and state whether it is approved for disposal ofRCRA hazardous waste. On acontinuation sheet, for each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate the amount released to the environment aftercontrol technology (in kg/day). (6)
-- Mark (X) this column ifentries in columns (4) and (5) are confidential business information (CBI). (7)
-- Identify the destination(s) ofreleases to water, Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers ofthe P01W(Publicly Owned Treatment Works). Mark (X) ifthe P01Wname or NPDES # is confidential business information (CBI). Release Amount ofnew CBI Medium of Control technology and efficiency (you may wish to optionally attach CBI Number substance released release efficiency data)

(1 ) (2a) (2b) e.g. sLack.if Binding (4) Mark (3) (5a) (Xl (5b) (6) 

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# D D Mark (X) this box ifyou attach a continuation sheet.
EPA FORM 7710-25 (Rev. 5-95) Page 9aPMN Page 10; Page 14 of 1,10 Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section B-- INDUSTRIAL SITES CONTROLLED BY OTHERS Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Importers do not have to complete this section for operations outside the U.s.; however, you mustreport any processing or use activities after import. See the Instructions Manual. Complete a separate section B for each type af pracessing, ar lISe aperatian irrvalving the new chemicalsubstance. Ifthe same operation is performed atmore than one site describe the typical operation common tothese sites. IdentitY additional sites on a continuation sheet. 1(a). Operation Description

-- To claim infonnation in this section as confidential, circle or bracket the specific infonnation that you claim as confidential. (I)
-- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify

- e,g, 5 gallon pails, 55 gallon drums, rail • cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2)
-- Either in the diagram or in the text field l(b)below, providethe
. identity, the approximate weight (by kg/day or kglbatch, on an 100"10 new chemical substance basis), and entry pointofall feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnot used daily or per batch). (3)
-- Either in the diagram orin the text field I(b) below, identify by number the points ofrelease, including small or intermittent releases. to the environment ofthe new chemical substance. (4) Please enter the # ofsites (remember to identify the locations ofthese sites on a continuation sheet); eBI # ofsites

I(b). (Optional) This space is for a text description to clarify the diagram above.



### [X] Mark (X)this box ifyou attach a continuation sheet. EPA FORM 7710-25 {Rev. 5-95) Page 10PMN Page 10a ; Page 15 of 1,10 2. Worker [xposure/Environmental Release (I)
-- From the diagram above, provide the letter for each worker activity, Complete 2-8 for each worker activity described, (2) _. Estimate the number ofworkers exposed for all sites combined, (4)
-- Estimate the typical duration ofexposure per worker in (a) hours perday and (b) days per year, (6)
-- Describe physical form ofexposure and % new chemical substance (ifin mixture), and any protective equipment and engineering controls, ifany, used to protect workers, (7)
-- Estimate the percent ofthe new substance as formulated when packaged or used as a final product (9) - From the process diagram above, enter the number ofeach release point Complete 9-13 for each release point identified, (10)
-- Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kglbatch), (12)
-- Describe media ofrelease i.e, stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, POTW, or other (specifY) and control technology, ifany, that will be used to limit the release ofthe new substance to the environment (14)
-- IdentifY byproducts which may result from the operation,

_ (3). (5). (8 , (11), 13) and (15)
-- Mark (X)this column ifany ofthe proceeding entries are confidential business information (CB!), Lett." #of CBI Duration Of CBt Protective Equip.lEngineering ControlslPhysical Form and! % new substance 0/0 in CBt

of Workers Exposure Fonn­ 

# (Cti. Exposed ulation Vlly • (I) (2) (3) (4a) (4b) (5) _(6) (7) (8) 

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# 0 I!l Mark (X)this box ifyou attach a continuation sheet, 

### OPTIONAL POLLUTION PREVENTION INFORMATION To claim information in the following section as confidential circle orbracket the specific information that you claim as confidential. In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal ofthe PMN substance. Please include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new chemical substance. Source reduction includes the reduction in the amount ortoxicity ofchemical wastes by technological modification, process and procedure modification, product reformulation, raw materials substitution, and!or inventory control. Recycling refers to the reclamation ofuseful chemical components from wastes that would otherwisebe treated or released as air emissions orwater discharges, or land disposal. Descriptions ofpollution prevention, source reduction and recycling should emphasize potential risk reduction subsequentto compliance with existing regulatory requirements and can be either quantitative or qualitative. The EPA is interested in the information to assess overall net reductions in toxicity or environmental releases and exposures, notthe shifting ofrisks to other environmental media or nonenvironmental areas (e.g., occupational or consumer exposure). In addition, information on the relative cost orperformance characteristics of the PMN substance to potential alternatives may be provided. All information provided in this section will be taken into consideration during the review ofthis substance. See PMN Instructions Manual and Pollution Prevention Guidance manual for I'tuidance and examples.

EPA FORM 7710-25 {Rev, 5-95) Page lOaPMN Page 11 : Page 16 of 1.10' Optional Pollution Prevention Information (Continued) Describe the expected net benefits, such as (I) an overall reduction in risk to human health or the environment; (2) a reduction in the volume manufactured; (3) a reduction in the generation ofwaste materials through recycling, source reduction or other means; (4) a reduction in potential toxicity orhuman exposure andlor environmental release; (5) an increase in product performance, a decrease in the cost ofproduction andlor improved operation efficiency ofthe new chemical substance in comparison to existing chemical substances used in similar application; or (6) the extent to which the new chemical substance rna be a substitute for an existin substance that oses a reater overall risk to human health or the environment. COl 

# D

ou attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 11PMN Page 12 ; Page 17 of 1,10



# J Part III -- LIST OF ATTACHMENTS Attach continuation sheets for sections ofthe fonn andtest data and other data (including physical/chemical properties and structure/activity infonnation), and optional infonnation afterthis page. Clearly identify the attachment and the section ofthe fonn to which it relates, ifappropriate. Number consecutively the pages ofany paper attachments. In the column below, enterthe inclusive page numbers ofeach attachment. Electronic attachments can be identified by filename. Mark (X) the "Confidential" box next to any attachment name you claim as confidential. Read the Instructions Manual for guidance on how to claim any infonnation in an attachment as confidential. You must include with the sanitized copy ofthe notice fonn a sanitized version ofany attachment in which you claim infonnation as confidential. # Attachment name Attachment Filename Attachment page number(s) Confidential

# ~

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# o Mark (X) this box ifyou attach a continuation sheet. Enterthe attachment name andnumber. EPA FORM 7710-25 (Rev. 5-95) Page 12 IPMN Page 13 ; Page 18 of 1,10 PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET To assist EPA's review ofphysical and chemical properties data, please complete the following worksheet for data you provide and include it in the notice, IdentifY the property measured, the page ofthe notice on which the property appears, the value ofthe property, the units in which the property is measured (as necessary), and whether or not the property is claimed as confidentiaL Ifthe attachments are electronic, give the attachment number(found on page 12) at (b), The physical state ofthe neat substance should be provided, These measured properties should be for the neat (100"10 pure) chemical substance, Properties that are measured fur mixtures or formulations should be so noted (% PMN substance in

### --->, You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplifY review and ensure that confidential information is properly protected, You should submit this worksheet as a supplementto your submission oftest data. This worksheet is not a substitute for submission oftestdata, Property Mark (X Page Value Measured 0 Conl\­ iC number Estimate dentisl (a) provided (b) (c) Mark (X) (M or E) (d) Physical state ofneat substance 

# 0 

# D (s) 

# 0(1) D(g) 

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# lZJ [Xl @ Temperature 

### °C Torr Density/relative density 

# i[Z] glcm3 

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# 0 @ Temperature 

### °C 

## [Xl

Solvent giL Solubility in water@ Temperature 

### °C 

# lZ] 0% gIL 

## [Xl Meltingtemperature 

# lZJ °C 

## [Xl Boiling / sublimation temperature@ torr pressure 

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# lZJ [Xl
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# 0 0 Particle size distribution 

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# lZJ [Xl**H~'s** Law constant 

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# 0 D 

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# lZJ [Xl Explodability 

# [ZJ [Xl Adsorption I coefficient 

# lZJ [Xli Other

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# [ZJ !Xl D Mark (X) this be.ifyou atlach a continuation sheet Enter Iha atlachment nama and number, ATTACHMENT PAGE 13

# . 

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.......................................................................

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### 14

# Inventory

# Expe'!§ervice
A division oftheAmeritan Chemical Society Phone: 800·631·1884, 614447-3870 Fax: 6t4-441·3747 E-mal: answers@cas.org Web:**www.cas.orglproducts~dientl**

INVENTORY EXPERT SERVICE REPORT



### .....

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Please print the above CA Index Nama on the appropriate page of your PHN. 

# o If this box is checked, CAS haa made correction(a) marked in red to your :rES order. Please make the same corraction(s) to your PMR before submitting it to the &PA.

CAS 2510 Olellt.1ngy River Road P.O,8ox 3343 Columbus. Ohio ;3210-0334 USA

### 15

# InventoryExpert

# Service'
A division oftheAmerican Chemical Society Phone: 800·631-1BB4. 611·447-3870 Faldl4-447-3747 E.mail: answers@cas.org Web: WoNW.cas.orgfproduasTdienti**INVF~TORY** EXPERT SERVICE REPORT

Plea.e print the above CA Index Name on the appropriate page of your PUN. 

# o If this box i. checked., CAS has maCle correction(s) marked. il1 red. to your IES order. Please make the same correction(s) to your PMH before submitting it to the EPA.

CAS 254Q Oleotan8Y Ri
....., Road P.O, Box 33-43 Columbus. Ohio**43210-033~** USA 

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# I....................................................................................................................

# ~~ ......._PAGE 1 OF 90 PAGES



### Mixture of PEMB and PE3MB: DETERMINATION OF PHYSICO-CHEMICAL PROPERTIES PROJECT NUMBER: 014510193

AUTHORS: R E Butler AJ Woolley D FWhite

STUDY SPONSOR: TEST FACILITY: Showa Denko K.K. Harlan Laboratories Ltd 13-9, Shiba Daimon 1-Chome Shardlow Business Park Minato-ku Shardlow TOKYO 105-8518 Derbyshire JAPAN DE722GD UK Telephone: +44 (0) 1332 792896 Facsimile: +44 (0) 1332799018



### 27PROJECT NUMBER: 014510193 PAGE 2 

### QUALITY ASSURANCE REPORT This study type is classed as short-term. Inspection of the routine and repetitive procedures that constitute the study is carried out as a continuous process designed to encompass the major phases at or about the time this study was in progress. In addition, inspection of general facilities not specifically related to this study are done monthly or annually in accordance with QA 

### Standard Procedure. This report has been audited by the Quality Assurance Unit, and is considered to be an accurate account ofthe data generated and ofthe procedures followed. In each case, the outcome of QA 

### evaluation is reported to the Study Director and Management on the day of evaluation. Audits of study documentation, and process inspections appropriate to the type and schedule ofthis study were as follows: 

### § 19 November 2008 Protocol Compliance Audit 09 March 2009 Freezing Temperature 07,28 January 2009 Boiling Temperature 07 January 2009 Relative Density 06 April 2009 Vapour Pressure 07 April 2009 Surface Tension 02,03 March 2009 Water Solubility 16 January 2009 Partition Coefficient 15 January 2009 Flash Point 05 January 2009 Auto-Ignition Temperature (Liquids and Gases) 09 January 2009 Adsorption Coefficient 03 April 2009 Fat Solubility 

### § 18 May 2009 Draft Report Audit 

### § Date ofQA 

### Signature Final Report Audit 

### § Evaluation specific to this study



## . 05 JUN 2009 

# ...**~:)j** 

# ..**~~~** 

# .................... DATE
................................................. Forthe Quality Assurance Unit*

'"Authorised QA Signatures: Manager, Quality Assurance: J G Riley sSe (Hons) MRQA Deputy Head of Department JM Crowther MISeT MRQA Senior Audit Staff: G Wren ONC MRQA


### 28PROJECT NUMBER: 0145/0193 PAGE 3 

### GLP COMPLIANCE STATEMENT With the exception of the explosive properties and oxidising properties calculations, the work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (51 1999/3106 

### as amended by 512004/0994»). These Regulations are in accordance with GLP standards published as OECD Principles on Good Laboratory Practice (revised 1997. ENV/MC/CHEM(98)17); and are in accordance with, and implement. the reqUirements of Directives 

### 2004/9/EC and 2004/10/EC. This report fully and accurately reflects the procedures used and data generated
.



## . -**~** 

## JUN 2009



# ............. ................................. DATE
................................................. R E Butler GRSC STUDY DIRECTOR

This report may be presented in finai form as a digital (pelf) doClKllent. Such documents are prepared by scanning the paper original.

and are considered ofequivalent integrity and authenticity toversions produced by optical photocopy. However. in allcases the hand-signed paper Original, held In secure archlves, Is the definitive document.


### 29PROJECT NUMBER: 0145/0193 PAGE 4 

### CONTENTS QUALITY ASSURANCE REPORT 

## 2 GLP COMPLIANCE STATEMENT 

## 3 CONTENTS 

## 4 SUMMARY 

## 7 1. INTRODUCTION 

### 9 

## 2. TEST MATERIAL 

### 9 

### 2.1 Test Material Description, Identification and Storage Conditions 

### 9 2.2 Chemical Structure 

### 9 

## 3. ARCHIVES 

## 10 4. MELTING/FREEZING TEMPERATURE 

## 11 4.1 Method 

### 11 4.2 Procedure 

### 11 4.3 Calculation 

### 11 4.4 Results 

### 12 4.5 Conclusion 

### 15 

## 5. BOILING TEMPERATURE 

## 16 5.1 Method 

### 16 5.2 Procedure 

### 16 5.3 Calculation 

### 17 5.4 Results 

### 18 5.5 Discussion 

### 20 5.6 Conclusion 

### 20 

## 6. RELATIVE DENSITY 

## 21 6.1 Method 

### 21 6.2 Procedure 

### 21 6.3 Calculations 

### 21 6.4 Results 

### 22 6.5 Conclusion 

### 22 

## 7. VAPOUR PRESSURE 

## 23 7.1 Method 

### 23 7.2 Procedure 

### 23 7.3 Calculation 

### 25 7.4 Results 

### 26 7.5 Conclusion 

### 40 8. SURFACE TENSION 

## 41 8.1 Method 

### 41 8.2 Procedure 

### 41 8.3 Calculation 

### 46 8.4 Results 

### 47 8.5 Validation 

### 49 8.6 Discussion 

### 49 8.7 Conclusion 

### 49

30PROJECT NUMBER: 014510193 PAGE 5


### 9. WATER SOLUBILITY 

### 60 9.1 Method 

### 50 9.2 Procedure 

### 50 9.3 Calculation 

### 54 9.4 Results 

### 55 9.5 Validation 

### 57 9.6 Discussion 

### 57 9.7 Conclusion 

### 58 10. PARTITION COEFFICIENT 

### 69 10.1 Method 

### 59 10.2 Procedure 

### 59 10.3 Calculation 

### 63 10.4 Results 

### 64 

### 10.5 Discussion 

### 66 10.6 Conclusion 

### 66 11. FLASH POINT 

### 67 11.1 Method 

### 67 11.2 Procedure 

### 67 11.3 Calculation 

### 67 11.4 Results 

### 68 11.5 Conclusion 

### 70 11.6 Reference 

### 70 12. EXPLOSIVE PROPERTIES 

### 71 12.1 Method 

### 71 12.2 Procedure 

### 71 12.3 Results 

### 72 12.4 Conclusion 

### 72 13. AUTO-IGNITION TEMPERATURE (LIQUIDS AND GASES) 

### 73 13.1 Method 

### 73 13.2 Procedure 

### 73 13.3 Results 

### 73 13.4 Conclusion 

### 75 13.5 Reference 

### 75 14. OXIDISING PROPERTIES (LIQUIDS) 

### 76 14.1 Method 

### 76 14.2 Procedure 

### 76 14.3 Results 

### 76 14.4 Conclusion 

### 76

31PROJECT NUMBER: 014510193 PAGES


### 15. ADSORPTION COEFFICIENT 

### 77 15.1 Method 

### 77 15.2 Procedure 

### 77 15.3 Calculation 

### 81 15.4 Results 

### 82 15.5 Discussion 84 

### 15.6 Conclusion 

### 85 16. FAT SOLUBILITY 

### 86 16.1 Method 

### 86 16.2 Procedure 

### 86 16.3 Results 

### 87 16.4 Discussion 

### 88 16.5 Conclusion 

### 88 Appendix 1 Coconut Oil Certificate ofAnalysis 

### 89 Appendix 2 Statement of

### GLP Compliance in accordance 

### with Directive 

### 2D0419IEC 90

32PROJECT NUMBER: 014510193 PAGE 7 

### Mixture of PEMB and PE3MB: DETERMINATION OF PHYSICO-CHEMICAL PROPERTIES

SUMMARY



## ..-.-

## ...

# -.--..

# - .....

## --..--. 

# . . Melting/Freezing Temperature. 

# l**~** 

# l using 854633: Method for the Determination of Crystallizing pofriC·MethOd··Af·Melting/Freezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 102 of the OECD Guidelines for Testing ofChemicals, 27 July 1995
.



# ...**~~iJ!!!fl** 

# .**.T.~PP.'!~~~!8** The test material was found to boil with decomposition

## C~~~~~l : :by differential scanning calorimetry, using ASTM E537-86, Method 

# . . ···JX2··Boliiiig·Teimperature of Commission Regulation (EC) No 440/2008 of 30 May 2008

and Method 103 ofthe OECD Guidelines for Testing of Chemicals, 27 July 1995
.

........ 00_ ........ _ .... __ ....... - .... --- .. - .......... -. 

# . . Relative**Denslty~** 

### lusing the pycnometer method, Method A3 Relative Density

### of"Corrimrssion'~eguiafion (EC) No 440/2008 

### of 30 May 2008 and Method 109 ofthe OECD Guidelines for Testing of Chemicals, 27 July 1995
.

........._

### ........

### -..

### -....

### -

### ..................... ,.,..........., 

# . . VapourPressure. 

### 1**~sing** 

### a vapour pressure balance, Method A4 Vapour Pressure

### orCoiiimlssioii··Regulati~n (EC) No 440/2008 

### of 30 May 2008 and Method 104 ofthe OECD Guidelines for Testing ofChemicals, 23 March 2006.

,....... _

### .........................................................................-_

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..... __ .......**~** ...........................**_~** .... _ .............__ .... _.J



### Surface Tension of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 115 of the OECD Guidelines for Testing of Chemicals, 27 July 1995. The test material is considered not to be a surface-active material. 

### Water Solubility. The water solubility the test material has been determined using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 44012008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27



# ....**~.~~¥.~. ~.~~:**  

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# .................................................

33PROJECT NUMBER: 014510193 PAGES 

### Partition Coefficient The partition coefficient of the test material has been determined using the HPLC method, Method A8 Partition Coefficient of Commission Regulation (EC) No 

### 440/2008 of 30 May 2008 and Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. The results are shown in the**followi~.Q.~?'!~.:** 

### .............................., 

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.........**--~-..................** 

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..............................__ ... '" .e••• •i.'



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# . : ................_ .............................................................................. _ ................................ _ ...................................................... "' ..: ......... ::: "' ......:_ .. : .. ,. .... .1 

## '··i=iiis-';·PCiiiit.··The test material has been determined to have a flash point of: : 1 ...... _ .... _ ...... _ ........**~** 

### using a closed cup equilibrium method, Method A9 of Commission Regulation (EC) No 

### 440/2008 of30 May 2008 

### Explosive Properties. Based on the chemical structures ofthe components of the test material, the test material has been predicted to be····················] using Method A14 Explosive Properties ofCommission Regulation (EC) 

# No44oiioos'C;i30 May 2008. 

### Auto-Ignition Temperature (Liquids and Gases). The test material has been

............

### -..................., 

### determined to have an auto-ignition temperature of: :using Method A15 of**~** .. "'- .......... - ... - ......1 

### Commission Regulation (EC) No 

### 440/2008 of30 May 2008. 

### Oxidising Properties. Based on the chemical structures of the components of the test material, the test material has been predicted to be:···················1using Method A21 !.. -_........ - ...- .......... -_.1 

### Oxidising Properties (Liquids) of Commission Regulation (EC) No 44012008 of 30 May 2008. 

### Adsorption Coefficient The adsorption coefficient was determined using the HPLC screening method, Method C19 Adsorption Coefficient of Council Regulation (EC) No 

### 440/2008 of 30 May 2008 and Method 121 of the OECD Guidelines for Testing of Chemicals, 22 January 2001. The results are shown in the following table:



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...................... _

...**~._:.** using a procedure based on Method 116 of



### ............................... _

### ....................... the OECD Guidelines for Testing of Chemicals, 12 May 1981.

34PROJECT NUMBER: 0145/0193 PAGE 9 

### Mixture of PEMB and PE3MB: DETERMINATION OF PHYSICO-CHEMICAl PROPERTIES 1. INTRODUCTION The**physico~chemical** 

### properties ofthe test material have been determined. Methods employed complied with those specified in Commission Regulation (EC) No 

### 440/2008 of 30 May 2008, Part

### A: Methods forthe determination ofphysico-chemical properties and Part C: Methods for the determination 

### of ecotoxicity and the current OECD Guidelines for Testing 

### of Chemicals. Testing was conducted between 07 January 2009 and 17April 2009. 

### 2. TEST MATERIAL 2.1 Test Material Description, Identification and Storage Conditions Sponsor's identification Mixture of PEMB and PE3MB

, , 

## -....

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## ....

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### Description , , 

# · , , 

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### : 

# . Batch number
1
...... -_ .. "'._
.... - ................ - .......... -_ ........ .. 

### Date received 15 December 2008 Storage conditions room temperature in the dark The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility ofthe Sponsor. 

### 2.2 Chemical Structure The Sponsor provided the following chemical structure for the test material.

ComponentA Component B

35PROJECT NUMBER: 014510193 PAGE 10 

### 3. ARCHIVES Unless instructed otherwise by the Sponsor, all original data and the final report will be retained in the Harlan Laboratories Ltd, Shardlow, UK archives for five years, after which instructions will 

### be sought as to further retention or disposal.



### 36PROJECT NUMBER: 0145/0193 PAGE 11 

### 4. MELTlNGIFREEZING TEMPERATURE 4.1 Method The determination was carried out using B84633: Method for the Determination of Crystallizing Point, Method A1 MeltinglFreezing Temperature of Commission Regulation (EC) No 440/2008 of 30 May 2008 and in accordance with Method 102 of the OECD Guidelines for Testing ofChemicals, 27 July 

### 1995. 4.2 Procedure An aliquot oftest material was placed into a test tube containing a thermometer. A wire loop with which the sample could 

### be agitated was placed inside the tube to ensure sample homogeneity during cooling. The testtube was surrounded by a glass jacket and then placed into a large beaker containing a dry ice/acetone mixture. The temperature and observations ofthe test material were recorded approximately every 30 seconds. The dry ice/acetone bath was maintained until the temperature had reached apprOximately -20°C or until the test material solidified. The determination was carried out in duplicate. Graphs oftemperature (K) versus time (seconds) were constructed to obtain the freezing temperature (Figure 4.1 and Figure 4.2). 

### 4.3 Calculation Measured temperatures were converted from °C to K using Equation 4.1. 

### Equation 4.1 

### T 

# =t+273.15 where: 

### T 

### = temperature (K) 

### t 

## = temperature 

### (0C)



### 37PROJECT NUMBER: 0145/0193 PAGE 12 

### 4.4 Results Cooling data for Determinations 1 and 2 are shown in the following tables: •...•....••__ .••.........•.

_..••...•....•....•....••....•..........•.............••...••..

__

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### --

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### 38PROJECT NUMBER: 0145/0193 PAGE 13

....... _-- '*'
.. - ................__ .. "'
......... _ .... __ .......... _ ................_ ...... __ ...............................................- •• -_ ...... - ........ - .......................... "'
........ .., .. - ................ - ............... . 

# . .

39PROJECT NUMBER: 014510193 PAGE 14 

### Graphs oftemperature (K) versus time (seconds) for Determinations 1 and 2 are shown in Figure 4.1 and Figure 4.2 respectively.



### 40PROJECT NUMBER: 014510193 PAGE 15**~**

## ...

## -... -.-

## ..**~**

### ........

## -.-....

## ---... -- .........**-.-.~---** 

## ...

## -....

## -.- ............

# --..

## --....

## -....

## -......**-~.--** 

## ..

## -....

## -..

## - ......**~.** , ' , ' 

# .**~.** __ •• _ •••• ___ •• _ •••• _ •• _. __ •• __ ••• __ •• __ ••• _ •••• _ •• __ ••• __ ••• __ •• __ •• _______ •• _. __ ••• __ •• ___ •• __ ._ •• _ ••• __ •• _----_._. ___ 1



### 41PROJECT NUMBER: 014510193 PAGE 16 

### 5. BOILING TEMPERATURE 5.1 Method The determination was carried out by differential scanning calorimetry (DSC) using the procedure specified in ASTM E537-86. Method A2 Boiling Temperature of Commission Regulation (EC) No 44012008 of 30 May 2008 and in accordance with Method 103 ofthe OECD Guidelines forTesting ofChemicals, 27 July 1995. 

### 5.2 Procedure 5.2.1 Calibration The temperature accuracy of the differential scanning calorimeter was assessed using an indium reference standard (purity*99.999%). The melting temperature was determined to be 156.4°C and within the defined tolerance (156.6 ± 

### 0.5°C). The instrument was therefore considered acceptable for use. 

### 5.2.2 Sample Aliquots (see following table) oftest material were placed in pierced aluminium crucibles. 

### Table 5.1 Determination Mass Taken (g) 1 O.OOSO 2 0.0053

* Value quoted by supplier



### 42PROJECT NUMBER: 0145/0193 PAGE 17 

### 5.2.3 Analysis The instrument parameters were as follows: Calorimeter Mettler Toledo DSC822e ThermoHaake Cooler EK45/MT Temperature program initial: 25.0oC rate: 20.00C/min final: 400.0oC Atmosphere Determination 1 - air (static) Determination 2 - nitrogen 

### 5.3 Calculation Measured temperatures were converted from °C to K using Equation 

### 5.1. Equation 

### 5.1 T", t+273.15 where: 

## T = temperature (K) 

### t 

# = temperature (OC)



### 43PROJECT NUMBER: 0145/0193 PAGE 18 

### 5.4 Results 

### Thermograms and thermographic data for Determinations 1 and 2 are shown in Figures 5.1 and Figure 5.2 and in the following tables respectively.

___ ••• w __ •• ___ • ______ •• _________**.~.** __________**.~** __ • _________ •• _________________ •• ___ ••• ___________________w_ . ..________________, , , 

# · · ,

, , , , , , , , 

# ·

, 

# · , 

# · · · · · ·

· , , ,



### 44PROJECT NUMBER: 0145/0193 PAGE 19



# .**---~ I.~**  ___ •• - •••••**~** ••• ••••• -.---_ ••••••• _ •• _ ••• ______ • ••• _ ••••••• ___ ._ ••• __ •• __ •••••••• ___ • __ ••• ___ • ______ •• _ ••**~** __ 6
__ ._._. ____ •• _1

45PROJECT NUMBER: 0145/0193 PAGE 20 

### 5.5 Discussion

, ,**~ _~**  ••.•_. __ _____ ___ .••... ____••••.

_.•. ________ •••••.•.____ ••

_...•.... ____•••.

_ •..._______•..••______ ••..

_.. . ____.t..._* •••••• J

46PROJECT NUMBER: 014510193 PAGE 21 

### 6. RELATIVE DENSITY 6.1 Method The determination was carried out using the pycnometer method, Method A3 Relative Density of Commission Regulation (EC) No 

### 44012008 of

### 30 May

### 2008 and in accordance with Method 

### 109 ofthe OECD Guidelines forTesting of Chemicals, 

### 27 July 

### 1995. 6.2 Procedure 6.2.1 Sample 

### A glass pycnometer of 

### 25 ml nominal capacity was cleaned and dried to a constant weight. Distilled water and test material were equilibrated at 

### 20.0 ± 0.5°C. 

### A calibration was carried out by determining the mass ofdistilled water required to fill the pycnometer. The pycnometer was then emptied and dried to constant weight. The mass of test material required to fill the pycnometer was then determined. 

### 6.3 Calculations The relative density was calculated using Equation 

### 6.1 and Equation 

### 6.2. Equation 6.1 Density(kg/m 3 ) 

# =-...:d(,--c-_a-:...) (b-a) where: a 

# = mass of pycnometer (g) b 

### = mass of pycnometer filled with water (g) c 

# = mass ofpycnometerfilled with test material (g) d 

# = density ofwater attest temperature (kg/m1

47PROJECT NUMBER: 014510183 PAGE 22 

### Equation 6.2 Relative density

# = P PH :P. 4·C 

### where: P 

# = density 

### oftest material 

### (kg/m3) 

### density 

### ofwater at 4°C (999.97 

### kg/m3) 

### 6.4 Results**I-~·-----~-·~~-~-------···-----------~------------------------------.--------------------.-.------------** 

### ..**-----------.-~-.------:** 

# · 

# . · 

# · 

# . . · . 

# · . · . · . · . 

# · · · · · · ·

48PROJECT NUMBER: 014510193 PAGE 23 

### 7. VAPOUR PRESSURE 

### 7.1 Method The vapour pressure was detennined using a vapour pressure balance with measurements being made at several temperatures and linear regression analysis used to calculate the vapour pressure at 25°C. Testing was conducted using Method A4 Vapour Pressure of Commission Regulation (EC) No 

### 440/2008 of 30 May 3008 and in accordance with Method 104 specified in the OECD Guidelines for Testing ofChemicals, 23 March 2006. 

### 7.2 Procedure The vapour pressure was detennined using a vapour pressure balance. The temperature of the sample was controlled electronically. The mass and temperature readings were recorded automatically into a computer file. A diagram of the**cross~section** 

### ofthe vapour pressure balance is represented in Figure 7.1. After evacuating the system, opening the shutter above the sample oven causes the escaping vapour jet to be directed at the scale pan. The difference in mass readings with the orifice covered and uncovered is proportional tothe vapour pressure atthe given oven temperature. A sequence of runs was started after a sample oftest material had been under vacuum for approximately 44 

### '!4 hours. Temperature and pressure readings were taken between 160 and 170°C with a one hourdwell at 1600C between runs.

49PROJECT NUMBER: 014510193 PAGE 24 

### Figure 7.1 Schematic Diagram ofthe Apparatus Used

2 

### 4 5

1 Microbalance 2 Oven 3 Glass viewing panel 4 Balance pan .5 Shutterwith orifice

6 Test sample

50PROJECT NUMBER: 014510193 PAGE 25 

### 7.3 Calculation The vapour pressure is related to the observed mass difference by Equation 7.1. 

### Equation 7.1 Vp 

## =om.g A where: Vp 

### = vapour pressure (Pa) 

## om = mass difference (kg) 

### g 

# = acceleration due to gravity (9.813 m S-2) 

### A 

## = area ofthe orifice (7

### .06858x1 0-6m

### 2) Vapour pressure is related to temperature by Equation 7.2. 

### Equation 7.2 slope
. Log1o 

### [Vp (Pa)]

# = + Intercept temperature (K) A plot of LOgl0 Vp (Pa) versus reciprocal temperature (11T(K» therefore gives a straight line graph. The vapour pressure of the sample was measured over a range 

### of temperatures to enable extrapolation to 298.15 K.

51PROJECT NUMBER: 014510193 PAGE2S 

### 7.4 Results



### 52PROJECT NUMBER: 014510193 PAGE 27**~---~ ~.** **---_._--** ...........

### ---.--

## ..

## -....... ----.--.--

## ...

## -.- .... ............

### _---- .........._---- .........._---._.._._._----. 

# . .

53PROJECT NUMBER: 014510183 PAGE 28 

### ;--.- .........

### -...

### --- ..

### -..

## -.-- .....

### -

## .. ......

# --.. ................. _- ......................... -----_

## ..

# ----..---- ..**--.--.----.~ --.~---**  _ 

# .

: 

# .

... ---------

## .... -----------

## ...

## -------.. ---------- 

### .... -_.----------_.------_._._-

## .... ---------------_.------------------------._---,



### 54____ PROJECT NUMBER: 014510193 PAGE 29



## ... --.------- 

## .......-..

### -

## .. -.---------- 

## .......**------~-- ---.-_._**  ...__...._-_ .......••••.

### _-_......•••• -_ ...

### _---

## ..

## -.- ..

## -...**------~**

# .

, M
__ •••• _. ______ • ___ ••• ___ ._ •••••••••• ___ •• ____________**._._._.~** _______ ••• ____ ._ •• ___ •••• ________ • ___ •••• __ ••• __ .* ._.___ .__ ,



### 55PROJECT NUMBER: 014510193 PAGE 30 

### ,-_.

__

### .__

### ....... _---_....................

### -..

### -.............

### -........... _--- 

### ......

## -------- ......_- .........

## ----- .....

# -..

## --.----..**-.~** 

# . . : 

# .

' ••• __ •• ----- •••••••• -- •• __ ••• _-------_ ••• _-_ •• _-----._ ••• a ______ ••••••• _ ••• __ ._. __ ._._. _____ • __ • __ • ___ • ____ ._ •• _ •• __**.~** ___________ •



### 56PROJECT NUMBER: 014510193 PAGE 31**~-** 

## .. -..

### -- ....

### -.-------.--

### .......**-.~** 

## ..**~-.-----.------.--** 

### ...

### -

## ....**------.-----.-~--** 

## .. -------.--.- .. ------------ ......

### ----. 

# . :



### 57PROJECT NUMBER: 0145/0193 PAGE 32**~.-** 

## ...**~.-~**

## .... --.---------.--.-

## ....

## ----.- .. -.--.-.--.- ..._----_._._------_ ..**-------------------------------- -----.--------------~**  

# . .

58PROJECT NUMBER: 014510193 PAGE 33



### 59PROJECT NUMBER: 014510193 PAGE 34



### 60PROJECT NUMBER: 014510193 PAGE 35

,... __ ....•..........

### _--_ ..---------_.--------_..**_---- -------.~**  

### ..**-------------.---------------------------~.-~.-------------:** 

# . .

.**---------------------------.----------.-~-.----------- ------------------------------~----.-.--.----.-------------.---**  

## ...**-~**

61PROJECT NUMBER: 0145/0193 PAGE 36

62PROJECT NUMBER: 014510193 PAGE 37



### 63PROJECT NUMBER: 014510193 PAGE 38

__________._.____ ••._______ •_________________ ._.______ •______**~_k**__________________ w _________**._~** ___ • __ •••• ____________________ w ___**~** ___ 1 

# . 

# . : 

# . 

# .

64PROJECT NUMBER: 014510193 PAGE 39**---~ --~**  

# .. .....

## -.-.- .••...••...••..**~**

## ... -

## .... -

## ....---- 

## .......---

## ...

## -...**-.~** 

## ... .......

## -..

## -.. -

### ........

## -........-- ............**~** , ,



# . .___..____... ..__... __..... ____.__.____.________.__._.__ ____...____________.___**.~**

### _______._______.____. _**~ _~_._.** ***~** 

### ____ w __**._~**



### 65PROJECT NUMBER: 014510193 PAGE 40 

### A summary ofthe results is shown in the following table: 

### :- ........... __........._-_

## ... _

## .......
_

## ......
_

## ..__

## ... ---_

## .. _--._._--

## ..

## _.---.. _---._.---_._--- 

## ...

## -.. _._--_._.---.---.--.- 

### ..

## -..**--.~** , ,**~--.-.----** 

### ...

## --.-- ...

## ---- ..

## -..----.-----.-.-.--------.-----_._---------- 

### ..

### --

## .._-------------

## ..

## ------- ..._----------_._---------.:



### 66PROJECT NUMBER: 014510193 PAGE 41 

### 8. SURFACE TENSION 8.1 Method The determination was carried out using a White Electrical Institute interfacial tension balance and a procedure based on the 

### ISO 304 ring method. With the exception ofthe following deviation, the experimental procedure used complied with that specified in Method AS Surface Tension of Commission Regulation (EC) No 

### 440/2008 of 30 May 2008 and in accordance with Method 115 of the OECD Guidelines for the Testing of Chemicals, 27 July 1995. 1) The surface tension result was not corrected using the Harkins-Jordan correction table as the correction is not applicable to the apparatus used. Once calibrated, the balance and ring assembly used in this test give a direct reading for surface tension that is within the required accuracy 

### (± 0.5 

### mN/m); this is as a result ofthe reduced ring dimensions. This deviation has been considered not to have affected the integrity ofthe study. 

### 8.2 Procedure 8.2.1 Cleaning ofapparatus The platinum ring and all glassware were cleaned with acetone, tap water, chromic acid, tap water and finally glass double-distilled water. The platinum ring was dried over a methanol flame and cleaned between each surface tension measurement. 

### 8.2.2 Preparation ofsample solution Table 8.1 Sample Preparation Time (mins) An aliquot (0.1007 g) of test material was diluted to 100 ml with glass double-distilled 

### oto 10 water. The sample solution was shaken at approximately 30°C for 96 hours at approximately 15 to 5775 200 rpm. The sample solution was equilibrated at20°C for 24 hours. 5775 to 7215 The sample solution was centrifuged at 13500 rpm for 20 minutes. 7220 to 7240 The sample was sampled using a pipette. 7240 to 7245 The supernatant was diluted to 90% of its former concentration with glass double­ 7245 to 7250 distilled water. The sample solution was transferred to the measuring vessel. 7255

67PROJECT NUMBER: 0145/0193 PAGE 42 

### 8.2.3 Surface tension readings The surface tension of the sample solution was measured at intervals until a constant reading was obtained. The elapsed time from transferral to the measuring vessel to obtaining each surface tension reading was recorded. A calibration reading ofglass double-distilled waterwas taken with each sample reading. Readings were taken ofthe minimum force required to detach the ring from the surface ofthe liquid. Temperature readings were taken directly after each sample and calibration reading. 

### 8.2.4 Analysis ofsample solution The concentration of test material in the sample solution was determined by high performance liquid chromatography (HPLC). 

### Samples Duplicate aliquots (A and B) of the sample solution were diluted by a factor of 2 using acetonitrile. 

### Standards Duplicate standard solutions of test material were prepared in acetonitrile:water (1:1 v/v) at two nominal concentrations of 1 

### mg/l and 100 

### mg/l. 

### Matrixblank Acetonitrile:water (1:1 v/v).



### 68PROJECT NUMBER: 014510193 PAGE 43 

### Analysis The standard and sample solutions were analysed by HPLC using the following conditions: HPLC System Agilent Technologies 1100, incorporating autosampler and workstation Column Prodigy 00S3 

### 100A 51J (250 x 

### 4.6 mm id) Column temperature 40°C Mobile phase acetonitrile:water containing 

### 0.1 % phosphoric acid 

### (75:25 vlv) Flow-rate 

### 1.0 mllmin UV detectorwavelength 200nm Injection volume 

### 100 IJI Retention time Component A:


### - 4.7 mins Component B:



### - 8.7 mins



### 69PROJECT NUMBER: 014510193 PAGE 44 

### Typical Chromatography Standard 108 

### mgn VW01 A. WavelenlJlh=2OO nm (PFT853101+o1401,D) mAU

600
500
400
300
200
100

o

## ~ - \,



### Standard 1.01 

### mgn VW01 A. Wawlengt/l=aog nm (PFTIl531013-1301.D) mAU

7.5

5 

# ! I**~** "! 2.5 

## ... 

# lJv

0

# ~L -2.5

-6 -7.5 -10 0 2 4 10 

### 12 14



### 70PROJECT NUMBER: 014510193 PAGE 45

___.___**R_~**__ _______________ ... _____ _____ _____ ...______ .._____ ._..___________ ..______________ ..____ .______._____

# .**~ ~.~_.** **~. R_._~** **~~**



### 71PROJECT NUMBER: 014510193 PAGE 46 

### 8.3 Calculation 8.3.1 Sample solution concentration The mean peak area of both standards for each concentration was corrected to the nominal concentration of 1 mg/l and 100 mgll and the mean values taken. The sample solution concentration 

### (gil) was calculated using Equation 8.1. 

### Equation 8.1 

### P 1 P 

## C**~~xC** 

## xDx---x--

IIpI 

### P ltd 

### 1000 100 $til 

### where: Cspl 

# = sample concentration (g/l) Pspl 

# = mean peak area of sample solution Pstd 

### = mean peak area of standard solution I 

### corrected to nominal standard concentration Cstd 

# = nominal standard concentration (1 mg/l or 100 mg/l) 

### D 

# = sample dilution factor (2) P 

## = purity of component (A

### = 14.3 

### %, B

# = 83.0 

### %) 8.3.2 Calibration factor (;) The calibration factor 

### (tJ). by which the measured surface tension of the sample solution is multiplied, was determined using Equation 8.2. 

### Equation 8.2

where: 

### ¢ 

# = calibration factor 

## V

L 

## = literature value forsurface tension ofwater attest temperature 

### (mN/m) 

## V

M 

## = measured value for surface tension ofwater at test temperature 

### (mN/m)

72PROJECT NUMBER: 0145/0193 PAGE 47 

### 8.4 Results 8.4.1 Sample solution concentration The mean peak areas relating to the standard and sample solutions are shown in the following table: i--·········
__··-_·-_································· .............. --.----.------- ...•...... -..---- ... .



## ..... -_

## .... __........... _--_

### .. --_

## ........ ------_.......... __.........•••...... _--_

## .... _--_

## ... _---_

## .._-­

73PROJECT NUMBER: 014510193 PAGE 48 

### 8.4.2 Calibration factor (f6) The readings, temperatures and the corresponding calibration factors for glass doubledistilled water are shown in the following table:**I--·······---·--~····-·-·-·-······--····-·---··--·····** ...-.--- .......... --- ..... --------- ..... ---.--- ....... -----------------._..-: 

# . . . : 

# · 

# · · ·

74PROJECT NUMBER: 0145/0193

_________________________________________________________________________________________________________________________ .w

__ PAGE 49



### 75PROJECT NUMBER: 014510193 PAGE 50 

### 9. WATER SOLUBILITY 9.1 Method The determination was carried out using the flask method, Method A6 Water Solubility of Commission Regulation (EC) No 44012008 of 30 May 2008 and in accordance with Method 105 ofthe OECD Guidelines for Testing ofChemicals, 27 July 1995. 

### 9.2 Procedure 9.2.1 Preliminary

## test An aliquot (1.01 g) of test material was diluted to 1000 ml with glass double-distilled water. After shaking at 30°C for**6~** 

### hours and standing at 20°C for 19 hours, the solution was centrifuged at 13500 rpm for 20 minutes and analysed. 

### 9.2.2 Definitive test Based on the preliminary result. mixtures (see following table) oftest material and glass double-distilled water were added to six separate flasks. 

### Table 9.1 Sample Number Mass ofTest Material (g) Volume ofWater (ml) 1 1.00 1000 2 1.00 1000 3 1.00 1000 4 1.01 1000 5 1.01 1000 6 1.01 1000 

### After addition of glass double-distilled water to the flasks, they were shaken at approximately 30°C and, after standing at 20°C for a period of24 hours, the contents of the 'flasks were centrifuged at 13500 rpm for 20 minutes. The pH ofeach solution was measured. 

### 9.2.3 Analysis ofsample solution The concentration of test material in the sample solutions was determined by high performance liquid chromatography (HPLC).



### 76PROJECT NUMBER: 014510193 PAGE 51 

### Samples 

### Duplicate aliquots (A and B) of the sample solution were diluted by a factor of 2 using acetonitrile. Standards 

### Duplicate standard solutions oftest material were prepared in acetonitrile:water 

### (1:1 v/v) 

### attwo nominal concentrations of

### 5 mgll and 

### 50 mgt!. Matrixblank 

### Acetonitrile:water (1:1 v/v). 

### Analysis 

### The standard and sample solutions were analysed by HPLC using the following conditions: HPLC System Agilent Technologies 

### 1100. incorporating autosampler and workstation Column Prodigy 

### SJ,J 00S3 

### (250 x 4.6 mm id) Column temperature 40°C Mobile phase acetonitrile:water containing 0.1

### % phosphoric acid 

### (75:25 vtv) Flow-rate 1.0 mllmin UV

### detectorwavelength 200nm Injection volume 100 

### J,JI Retention time Component A: -4.6mins Component B: -8.5 mins

77

# -- PROJECT NUMBER: 014510193 PAGE 52 

### Typical Chromatography Standard 65.5 mg/l
VWD1 A. Wal/lllength=200nm (pm42IOO7..Q701.D) N mAU**~o**

300 250 20D 150 lDO 50 0 :2 4 ;, 

## -r**.~** 

### .'., 14 

### -,

Standard 6.55 mg/I**~** \.

mAU 4D

30
2D

10

0 VWD1 A. WavelenI!Jl.h"200nm (pm421OO9..Q901.D)**~**

# rU~"!

?**~** fJ

;, i \..
10**1~**



### 78 14I PROJECT NUMBER: 014510193 PAGE 53**-.-~** 

### ...

### -- .....

### --- ..**~--** 

## ..**~~-----------.--** 

### ..**---.---.--------.~.----------** 

## ...**--------------~---------------------~.----.~----------~-~** ,



### Matrix Blank
VWD1 A, WIMIIeng1h-200nm (PFT7421011-1101.D) mAU 10 7.5

5 2.5

0 

# -

# ~~ -2.5

-5 2 4 R it 

### <? 

# ." 14



### 79 -7.5PROJECT NUMBER: 014510193 PAGE 54 

### 9.3 Calculation The mean peak area of both standards for each concentration was corrected to the nominal concentrations of 5 

### mg/land 50 mgll and the mean values taken. The sample solution concentration (gil) was calculated using Equation 9.1. Equation 

### 9.1 PaPI C D 1 

### P C 

### =-x x x--xspl 

### P SId sid 

### 1000 100 where: Cspl 

# = sample concentration (gil) 

### Pspl 

# = mean peak area ofsample solution Pstd 

# = mean peak area ofstandard solution, corrected to nominal standard concentration Cstd 

# = nominal standard concentration (5 mgll or 50 

### mg/l) 

### 0 

# = sample dilution factor (2) 

### P 

### = purity of component (A

# =14.3 

### %, B

# = 83.0 

### %)

80PROJECT NUMBER: 014510193 PAGE 55 

### 9.4 Results



# , ....**:~:** 

# 1 ......**~~!!~.i.t:J~!Y. .~~t**  

# ....................................................................................--:
, 

# .

81PROJECT NUMBER: 014510193 PAGE 56
--_

### ..... -_

### ...... ---_

### .. --_

### ..

### -...... _---_._---_

### ..**-------.---.---.-.~.-** 

### .....**-----------~ .~.-**  

## .....--------------.-

## ..---

## ..**--~----.---------** 

### :

* Standard and sample mean peak areas have been corrected for the mean peak area ofthe matrix blank. 

## t Data not used included in the mean concentration


### 82PROJECT NUMBER: 014510193 PAGE 57 

### The mean concentrations (g/l) of Components A and B in the 96, 120 and 144 hour sample solutions are shown in the following table:



# ...................................,......................r iI

## ble.9,6........................."................................



## ....'9:5"""" Vaifiicition.....··..........................................................................................



# .--.- ...-.-.--.--.- 

### .. ..

### -... ••...••..__....-_ .•.....••.__......_-_ ......

### _---_ ..._-------_._------_._..

### _.**---.-.-.-.-.-.~--.--.----.** 

# · · · · , 

# ·



# · , 

# · 

# · · 

# · · · · · · , 

# · ·

83PROJECT NUMBER: 014510193 PAGE 58**.~~.** __ • __ • __**~** •• __ •• _M •••• __ • ___ •• _____ • ________ W •• ____ ---- •• ---- ••**---.---~---------.--.---.---.-~-.---.-~--.--.--.-------** ••**-----~** 

# .



# .**~** _____**~** _______**~** _______**~.** _______ • _______ • _________ • ____ _ w _______ • ______ M
___________________ • _______ • _________ ---- ••**-----.--------~**



### 84PROJECT NUMBER: 014510193 PAGE 59 

### 10. PARTITION COEFFICIENT 10.1 Method The determination was carried out using the HPLC Method, Method A8 Partition Coefficient of Commission Regulation (EC) No 

### 440/2008 of 30 May 2008 and in accordance with Method 117 ofthe OECD Guidelines for Testing of Chemicals, 13 April 2004. 

### 10.2 Procedure 10.2.1 Preliminary estimate A preliminary assessment of the partition coefficient was made based on the approximate solubilities ofthe test material in n-octanol and water. This was carried out by visual assessment. 

### 10.2.2 Definitive test 

### Preparation 

### ofsample solution Test material (0.1093 g) was diluted to 100 ml with acetonitrile. 

### Preparation 

### ofdead time solution The dead time was determined by measuring the retention time of thiourea (purity* >99%,21 mg/l 

### solution in mobile phase). 

### Preparation 

### ofreference standardsolution A solution of reference standards (see following table) was prepared in acetonitrile. 

### Table 

### 10.1 Standard Purity (%)* Concentration (mgll) 2-Butanone 99+ 5.13 x 103 Benzene 

### 99.98 5.02 x 103 Toluene 99 3.33 x 103 Naphthalene ;;:99 

### 424 Phenanthrene 

### ;;:97 27.0 Triphenylamine 

### 98 219

.. Value quoted by supplier



### 85PROJECT NUMBER: 014810193 PAGE 60 

### Determination 

### ofretention 

### time The sample, dead time and reference standard solutions were injected in duplicate using the following HPLC parameters: HPLC System Column Column temperature Mobile phase pH of mobile phase Flow-rate Injection volume UV detectorwavelength


### Construction 

### ofcalibration curve Agilent Technologies 1100, incorporating workstation Prodigy ODS 3 100A 5jJm (250 x 

### 4.6 mm id) 400(; acetonitrile:water (75:25 v/v) 

### 6.B 1.0 mllmin 20 JJI dead time and reference standards: 240 nm sample: 220 nm

A calibration curve was constructed from the retention time data of the dead time and reference standard solutions (Figure 10.1). The capacity factors (k) for the reference standards were calculated using Equation 10.2. Log 1

### o Pow values of the reference standards are those quoted in Method 117 of the OECD Guidelines for Testing of Chemicals, 13 April 2004. 

### Partition coefficient

### ofsample The capacity factor was calculated using Equation 10.2 and the 

### 10910 PC1W 

### value determined using Equation 10.3 with reference to the calibration curve (Figure 10.1).



### 86PROJECT NUMBER: 014510193 PAGE 61 

### Typical Chromatography Dead Time
\/wDi A, WaveJengtlr-240 nm (PFT188\O01"()102.D) mAU

## ~

1000
800
600
400
200 

## I

## 0~~~~~==~~~=r~==~~~~~~==~~~~~1 4 sJ

mAU

GOD
500
400 31)0
200 100

0 

### Reference Standards

\/w01 A, wavetangth,.240 nm (PFT18S\004..()401.D)


## ... 

## i 

# - '" 

# I .. :d 

# !**~** i 

### , i1i 

### '" 

## I**~**


### \.

10 1'5 20

87PROJECT NUMBER: 014510193 PAGE 62



### 88PROJECT NUMBER: 014510193 PAGE 63 

### 10.3 Calculation
10.3.1 Capacity factor The capacity factor was determined using Equation 10.2. 

### Equation 10.2

where:

# = capacity factor 

### = retention time (min) 

### = dead time (min) 

### 10.3.2 Partition Coefficient The partition coefficient was calculated using Equation 10.3. 

### Equation 10.3 

### P Log 10 

### k-A l 

### Og'0 ow 

## = B where: 

### Pow 

# = partition coefficient 

### k 

# = capacity factor 

### A 

# = intercept ofthe calibration curve (Figure 10.1) 

### B 

### = slope ofthe calibration curve (Figure 10.1)



### 89PROJECT NUMBER: 014510193 PAGE 64 

### 10.4 Results 10.4.1 Preliminary estimate 

## .----.--.....**-----~** 

## ....

## ----...

## ---.- .....

## -.-......

## -.----_. __

### ........ -_

## .. ----_

### ....... -----_...........

## -.....................

## :


# . .

10.4.2 Definitive test Calibration The retention times of the dead-time and the retention times, capacity factors (k) and 

### 10910 Pow values forthe reference standards are shown in the following tables: 

### Table 10.2 Dead Time Retention Time (mins) Injection 1 Injection 2 Mean Retention Time (mins) Thiourea 2.323 2.324 2.324 

### Table 10.3 Standard Retention Time (mins) Mean Retention Time (mins) Capacity 

### Factor

(k) LOQICl k Log 10 Pow Injection 1 Injection 2 2-Butanone 3.051 3.052 3.052 0.313 -0.504 0.3 Benzene 4.661 4.663 4.662 1.006 2.80 x 10-3 2.1 Toluene 5.657 5.660 5.659 1.435 0.157 2.7 Naphthalene 6.381 6.385 6.383 1.747 0.242 3.6 Phenanthrene 9.394 9.400 9.397 3.044 0.483 4.5 Triphenylamine 16.854 16.854 16.854 6.254 0.796 5.7



### 90PROJECT NUMBER: 014510193 PAGE 65 

### Figure 10.1 Calibration Curve

HPLC PowCall1lmlan CW'YI _ k**~** UIII
_ o 

# 2.1. v.a

_ lUG 

# i 2.!IlO 11.157

... OAII 1.!IlO 0:''11

A-41III 

# .-a,:m 

# ,.­ 0.81

0.67.

DZI**~i~~--~--~~--~--~----~--~--**

-Q.24 0.78 1.76 2.78 3.•78 4.71 5.78 1og10Paw 

### Partition coefficientof

### sample The retention times, capacity factors and log10 Pow 

### values determined for the sample are shown in the following tables:

91PROJECT NUMBER: 014510193 PAGE 66



### 10.5 Discussion Substances having a log10 Pow greater than 3 are regarded as having the potential to bioaccumulate in the environment.**.-------~~--------~.-------.---.------------** 

### ..**-----------------------*.-----.-~------.-------~---------------------------_.,** 

# · · 

# · · · 

# · ·**:------------------.--------*------~---------.-------.---------** ..._--- ...

### _-----------------------------------.-------------~ 

### 10.6 Conclusion The partition coefficient of the test material has been determined and is shown in the following table:



## .. -------.-.--.----.--- 

## ...--.--

## ...**-~------------** 

## ...**---.--.---~---** 

### ...--.-.--.-

## ...

# -----....

## --- ....

## ------... --------_

### .. _----------_

## ...:



# .

92PROJECT NUMBER: 014510193 PAGE 67 

### 11. FLASH POINT 11.1 Method The flash point was determined using a closed cup equilibrium method, Method A9 Flash Point of Commission Regulation (EC) No 

### 44012008 of

### 30 May 

### 2008. 11.2 Procedure An aliquot (2 ml for temperatures below 70c

### C and 4ml for temperatures over 70°C) ofthe test material was injected into the sample cup of the Setaflash 

### 30000-0 tester. The sample was heated and allowed 

## to equilibrate at the set temperature. The test flame was introduced into the sample cup for approximately 

### 2 seconds by sliding the cup shutter open. Observations were made for ignition ofthe vapour. If no ignition occurred, the temperature was increased and the testflame re-introduced. This was repeated until the lowest reproducible temperature at which a flash occurred, using a fresh sample, was determined, or until the sample boiled. 

### 11.3 Calculation The flash point temperature was corrected to a pressure of 

### 101.325 kPa using Equation 

### 11.1. Equation 11.1 FP 

### ==C +0.23(101.325-8) Where: FP 

# = corrected flash point 

### (0C) C 

# = observed flash point 

### (0C) 

## B 

# = ambient atmospheric pressure (kPa)



### 93PROJECT NUMBER: 0145/0193 PAGE 68 

### 11.4 Results The results are shown in thefollowing table:

................ _ ......................... ____ 00_ .............. ____ ............................................ _ .. - ............. _ .............. _ ..................... _ .......... - ....................... "' .......... - ............................. "':



### 94PROJECT NUMBER: 0145/0193 PAGE 69

95PROJECT NUMBER: 014510193 PAGE 70 

### 11.5 Conclusion



### .....

### -.--.-- 

## ...

## ---­ The flash point ofthe test material has been determined to**b~**

# . ''''
....**-~**

### ......

### -......

### -- ..........-- .. 

### 11.6 Reference Based on. Anon (1983) Paints, Varnishes. Petroleum and Related Products ­ Determination of Flash Point - Rapid Equilibrium Method. 

### International Standard ISO 3679-1983 (EJ. 

### Second Edition - 1983-12-01, 

### P1-7 and Anon (1989) Flash Point of Liquids by Setaflash Closed-Cup Apparatus. ASTM0-3278-89, 

### P1-7.



### 96PROJECT NUMBER: 0145/0193 PAGE 71 

### 12. EXPLOSIVE PROPERTIES 12.1 Method The explosive properties were predicted using Method A 14 Explosive Properties of Commission Regulation (EC) No 44012008 of30 May 2008. 

### 12.2 Procedure The structure ofthe test material was assessed for chemical groups that imply explosive properties. Examples ofsuch groups are C-C unsaturated, C-metal. N-metal, contiguous oxygen atoms, contiguous nitrogen atoms, N-halogens. O-halogens. N-O. Examples of these groups are given below.**StnJctur.aIFeatu~s** Examples 

### C-C unsaturated Acetylenes, acetylides, 1,2 dienes C-metal, N-metal Grignard reagents, organo-lithium compounds Contiguous oxygen atoms Peroxides, ozonides Contiguous nitrogen atoms Azides, aliphatic azo compounds, diazonium salts, hydrazines, sulphonyl hydrazides N-halogens Chloramines, fluoroamines O-halogens Chlorates, perchlorates, iodosyl compounds N-O Hydroxylamines, nitrates, nitro compounds, N-oxides, 1,2-oxazoles Full structural details are given in Bretherick's Handbook of Reactive Chemical Hazards, 

### 4th Edition, Butterworths, London. 1990. 

### 12.3 

## Results The test material hasthe following chemical structures:



### 97PROJECT NUMBER: 014510193 PAGE 72 

### 12.4 Conclusion Based on the chemical structure ofboth components ofthe test material the result for the explosive properties has been predicted;················:


# . . ....

### --_

### .................... '



### 98PROJECT NUMBER: 014510193 PAGE 73 

### 13. AUTO·IGNrnON TEMPERATURE (LIQUIDS AND GASES) 13.1 Method The auto-ignition temperature was determined by heating aliquots ofthe test material in a flask and observing for any ignition. Testing was conducted using Method A15 AutoIgnition Temperature (Liquids and Gases) of Commission Regulation (EC) No 44012008 of30 May 2008. 

### 13.2 Procedure The test flask was heated in a flask heater. Aliquots oftest material (tested as received) were injected into the flask using a syringe and the flask was observed for signs of ignition over a 300 second period. This procedure was repeated, varying the sample size, as necessary, until the lowest temperature at which ignition, ifany, occurred within 300 seconds of insertion, was determined. 

### 13.3 Results



# ........**.T.~~. ~~.~~I~** **.~~ .~h~~I).** **iI)J.~~ f~~I~W!~.9.** **~~Q!~.:** 

### ................................................................

99PROJECT NUMBER: 014510193 PAGE 74



# . .______.._ .. ..__.____..________...__.... ____...__.______.________.__.__._._*._
.... .._._________..._.._.______________ .. 

# .**~ ~** **~_. _.~~** **~** J

100PROJECT NUMBER: 014510193 PAGE 75



### 13.5 Reference Anon 

### (1987). Electrical Apparatus for Explosive Gas Atmospheres. Part 4: Method of Test for Ignition Temperature. IEC Publications 

### 79-4, 

### P1-19.

101PROJECT NUMBER: 014510193 PAGE 76 

### 14. OXIDISING PROPERTIES (LIQUIDS) 14.1 Method The oxidising properties were predicted using Method A21 Oxidising Properties (Liquids) of Commission Regulation (EC) No 

### 44012008 of

### 30 May 

### 2008. 

### 14.2 Procedure The structure of the test material was assessed for chemical groups that would imply oxidising properties. Examples of such groups are nitrates, metal oxides, hypofluorites, difluoroaminopolynitroaryls, perchlorates, bromates and iodites. Full structural details are given in Bretherick's Handbook of Reactive Chemical Hazards. 4th 

### Edition, Butterworths, London, 1990. 

### 14.3 Results The test material has the following chemical structures:


### .-

## .....**--------~-----.-** 

## ...

# -- ....

## -.--- ...--.-----.-- 

## ..

## -......**-----.----------~--.--** 

## .. --------------.-.-------_._._, , , 

# · · · ·

14.4 Conclusion Based on the chemical structures of each component, the result for the oxidising properties has been predicted

# f·····
..····..1



# . 

# . -..

### ---- ........

### -- .....**~**

102PROJECT NUMBER: 014510193 PAGE 77 

### 15. ADSORPTION COEFFICIENT 15.1 Method The determination was carried out using the HPLC screening method. Method C19 Adsorption Coefficient of Commission Regulation (EC) No 

### 440/2008 of 30 May 2008 and in accordance with Method 121 of the DECO Guidelines for Testing of Chemicals, 22 January 2001. 

### 15.2 Procedure Preparation ofsample solution Test material (0.1014 g) was diluted 

## to 100 ml with acetonitrile. 

### Preparation ofdead time solution The dead time was determined by measuring the retention time of formamide (purity* :i!99.5%, 1.43 x 103 

### mgll solution in mobile phase). 

### Preparation of reference standard solutions Solutions of reference standards (see following table) were prepared in acetonitrile. 

### Table 15.1 Standard Purity (%)* Concentration (mgll) Acetanilide 99+ 104 Phenol 99+ 114 Atrazine 97.4 100 Isoproturon 99.8 100 TriadimenoJ 98.4 110 Linuron 99.5 109 Naphthalene**~9.0** 139 Endosulfan-diol 99,8 106 Fenthion 97.8 101 a-Endosulfan 99.6 103 Phenanthrene 0::97.0 105 Diclofop-methyl 99.5 104 

### DDT 98 120

.. value quoted by supplier

103PROJECT NUMBER: 014510193 PAGE 78 

### Determination of retention time The sample, dead time and reference standard solutions were injected in duplicate using the following HPLC parameters: HPLC System Agilent Technologies 1100, incorporating autosampler and workstation Column Zorbax

### 58 CN**5~m** 

### (250 x 4.6 mm id) Column temperature 40°C Mobile phase acetonitrile:water (55:45 

### v/v) Typical pH of mobile phase 

### 7.2 Flow-rate 1.0 ml/min Injection volume 20**~I** 

### UVdetectorwavelength dead time and reference standards: 210 nm sample: 220 nm 

### Construction ofcalibration curve A calibration curve was constructed from the retention time data of the dead-time and reference standard solutions (Figure 15.1). The capacity factors (k) for the reference standards were calculated using Equation 15.1. 

### Adsorption coefficient ofsample The capacity factor was calculated using Equation 15.1 and the log1oKoc value detennined using Equation 15.2 with reference to the calibration curve (Figure 15.1).

104PROJECT NUMBER: 0145/0193 PAGE 79 

### Typical Chromatography Dead Time
VWD1 A, WIMllength=210 nm (PFT235\OO1·0101.D) mAU

1000

600

400



### Naphthalene Reference Standard
VWD1 A. Wave!eng\h"210 nm (PFT235\010-1001.D) 0 mAU

2000

1500

1000 "' 

### . ; 500

0 

## )

[) 2:5 

### ;; 7'!i**1'~ 1~** **~** ,'.. 17.&**-~**

105PROJECT NUMBER: 014510193 PAGE 80 

### Typical Chromatography



# . . :_-_.

__......... __

### ....... -_ ......... __ ...........••....

## -.-- .........

## -.....**~.-------** 

## ...

## -........**-.-.~-** 

### ...

## --.--_... _-- .......... '



### 106

### 8 PROJECT NUMBER: 0145/0193 PAGE 81 

### 15.3 Calculation 15.3.1 Capacityfactor The capacity factor was determined using Equation 15.1. 

### Equation 15.1

where:


## = capacity factor 

### = retention time (min) 

## = dead time (min) 

### 15.3.2 Adsorption Coefficient The adsorption coefficient was calculated using Equation 15.2. 

### Equation 15.2
v _ 

### Log fO 

### k - A LOg10 ''OC
- 

### ---:;:"":'::""8-­ where: 

## Koc 

# = adsorption coefficient 

### k 

# = capacity factor 

### A 

# = intercept ofthe calibration curve (Figure 15.1) 

### = slope 

### ofthe calibration curve (Figure 15.1)

107PROJECT NUMBER: 014510193 PAGE 82 

### 15.4 Results Calibration The retention times of formamide and the retention times, capacity factors (k) and 

### 10910 

## Koc values forthe reference standards are shown in the two following tables: Table 

### 15.2 Dead Time Retention Time (mins) Mean Retention Time (mins) Injection 1 Injection 2 Fonnamide 2.589 2.588 2.589 

### Table 

### 15.3 Standard Retention Time (mins) Mean Retention Time (mins) Capacity Factor (k) Log,o k 

### Log 10 

### Koc: Injection 1 Injection 2 Acetanilide 3.362 3.362 3.362 0.299 -0.525 1.25 

# I Phenol 3.462 3.461 3.462 0.337 -0.472 1.32

Atrazine 4.163 4.162 4.163 0.608
. -0.216 1.81 Isoproturon 4.250 4.249 4.250 

### I 0.642, -0.193 ' 1.86 Tliadimenol 4.678 4.678 4.678 0.807 ' -9.30 

### x 10.2 2.40 Llnuron 5.053 5.056 5.065 0.953 -2.11)( 10- 2 2.59 Naphthalene 5.440 5.440 5.440 1.10 ' 4.20 X 10.2 2.75 Endosulfan-dlol 5.113 5.113 5.113 0.975 -1.09 

### x 10.2 3.02 Fenthion 6.821 6.818 6.820 1.64 0.213 3.31 a-Endosulfan 8.693 8.695 8.694 2.36 0.373 4.09 Phenanthrene 7.056 7.055 7.056 1.73 0.237 4.09 Diclofop-methyl 8.378 8.376 8.377 2.24 0.350 4.20 DDT 12.842 12.838 12.840 3.96 0.598 5.63

108PROJECT NUMBER: 0145/0193 PAGE 83 

### Figure 15.1 Calibration Curve


### HPLC KOCClUbl'ltlonCUrve**~.** 

# j ,.. 4S25 1__ -0.472 Q 1.810**-o~e** 

## 1._ 0(1.1.**~ .~!-02**  2.8110**~~** 'iillE,QI 2.

### no .Q03E,QI 3.Q20 -1.tl17E,02 3310 Q.213

...oao o.m 

### ...., om <l2OO 

### o.a 

# 5_ OJIIII "'-..0.713 

### a-C1.248 ,"&.17.\ 

### O.

Q



## •**~.&'~--~--T-----~~----~--~--~-----T-** 0.81 

### 3.S1 5.81 

### log10t(oc

109PROJECT NUMBER: 014510193 PAGE 84 

### Adsorption coefficient of sample The retention times, capacity factors and log10 

## Koc values determined for the sample are shown in the following table: _w __________________**·~~** __________ •__ ••________________**---------~---------.------------------------~------------.-----------~.--:** 

# · · · · 

# · · · · · · 

# · · ·

110PROJECT NUMBER: 014510193 PAGE8S 

### 16.8 Conclusion The adsorption coefficient 

### (Koc) ofthe test material has been determined and is shown in the following table: 

# .--...

# ----..**-.~-.--** 

## ...**-~.-** 

## ..

# -...

## -.--..

# -.....

# -.....

# -..................--_

### .....

# ---.--_...

### ----

## ..

# ------- ...**---_.--~----.----.-.-.--~**

# . 

# .

........ _-_

## ....

# --- •..••.•.... _-_

## .. -------------

## ... --_

## ....... ---_

## ......._-

## .. _------_

## .. __

## .--_........... ------._------

## .. -_._.-.--­

111PROJECT NUMBER: 014510193 PAGE 86 

### 16. FAT SOLUBILITY 16.1 Method The determination was carried out using a procedure based on Method 116 ofthe OECD Guidelines for Testing of Chemicals, 12 May 1981. 

### 16.2 Procedure 16.2.1 Preliminary 

## test A mixture of test material and liquefied coconut oil (see Appendix 1) was prepared at 48.5% test material and shaken at 

### 3rC for at least 12 hours. After this period the mixture was visually assessed for excess test material. 

### 16.2.2 Definitive test Mixtures (see following table) of test material and liquefied coconut oil (see Appendix 1 for Certificate ofAnalysis) were added to seven separate vessels. 

### Table 16.1 Mass ofTest Material (g) Mass of Coconut Oil (9) Sample Number 18.0098 1 2.0450 4.4703 2 16.0682 6.0083 14.0114 3 4 2.4006 17.6046 5 2.8092 17.2110 3.2709 6 16.8199 7 3.6348 16.4363 

### After the addition of the liquefied coconut oil, the samples were shaken at 37.0 

### ± 0.5°C for 3 hours and equilibrated at 37.0 

### ± 0.5°C for at least one hour, then shaken for a further 18% hours at 37.0 

### ± 0.5°C and equilibrated at 37.0 

### ± O.soC for one hour and visually assessed for dissolution ofthe test material.

112PROJECT NUMBER: 014510193 PAGE 87 

### 16.3 

### Results 16.3.1 Preliminary test
. ...................................................s 

# . --..**-~---.--.~-.-** 

### ...**--.-------.~-------** 

### ....-------.-.- .-----_._._----- .... 

# . .

113PROJECT NUMBER: 014510193 PAGE 88 

### 16.4 Discussion 

### .---.-------..-- ..**~---~-** 

### .....**-------.~*.~--.------.¥-** 

### ..**-----------~------------.~-.---------** 

### ..**-----------.-.---~--------.---.-----:** 

# · · 

# · · 

# · · · ·



# ·

.......__ .....................__ ...... __ ...... _ ...................._ ........................_ ...................._ ...........___ .... _......................................__ .................._ ..............._ ..............._...... c 

# · The composition of the coconut oil is shown in Appendix 1. It was necessary to use coconut oil for the determination as the standard fat produced by the NATEC Company detailed in the OECD Guideline is no longer in production. Coconut oil has been identified as the most appropriate SUbstitute as attempts to locate an alternative manufacturer of standard fat, including communication directly with the OEeD, 

### have been unsuccessful. 

### 16.5 Conclusion

......... , 

### ...-_.--------------

### ....

## - ...._--_

### ....... _-_

### .... --_

### ..... _-

### .......... _-_

### ............... -----------

### .... -_

### ...

## ---... _

### .....-......

## - ....---_.------

### ..--_..

# ­

114PROJECT NUMBER: 014510193 PAGE 89 

### Appendix 1 Coconut Oil Certificate ofAnalysis 

# Cert[ficate**of~naly'sis** 

# . 1fiIiiMA-"'. r:tFE:H'
Product Number ProductBrand CAS Numb.r
TIST APPEARANCE (COLOR) APPeARANCE (FORM) REMARKS ON OC MEL l1NG POINT NMR SPECTRUM 1H IODINE VALUE ACID VALUE SAPONIFICATION VALUE DATE OFQC-RELEASE

Edellraud SthWlrzler. Manager Quail" Control Buchs,SWltzeriand COCOnutaufrom Cocosnuc/fllm. mp 20-28 'C(Rl) 60893 FLUKA 8001-31-8
LOT 'UQnReSUL TI FAINTLY YEU.OW HONEY LIKE LIQUID C12:046.8%. Ct4:0 19.0%. 016:0 9.9%. C18:1 7.5%. C18:2 7.9% 250 CORRESPONDS 11 0.09 250 08/0CTI04

115PROJECT NUMBER: 0145(0193 PAGE 90 

### Appendix 2 Statement of GLP Compliance in accordance with Directive 

### 2004l9/EC



# ,DH) De P

.8rtment

### ~ ofHealth



### TIlE DEPARTMENT OFHEALTH OFTBE GOVERNMENT OFTBEIJNrI'ED

### KINGDOM GOOD LABORATORYPRACTICE STA:I'EMENrO}i'COMPLIANCE If(ACCORDANCEWrmDnutCfiVElOlW9IEC
TESTTYPE RarlnnLaboratorlosLtd. Anall'HcaJIClillical Chemistry SbardlowBuSinessPark EnvinmmentalFate .LondonRosd Envil"ODme.ntalTox.1cology SbardlOw Mutagellic:ity Derby . PhysJChem DE712GD Toxicology

1.9tbAulUst Z008

A general inspection for compliance witb the Principles of<J1)od Labor.atory Praotice was carriedout**~tthe** aboVe

### test facllit)' aspattQfthe t1l{GLPCompUancc PrQgl'lUllme. At the time ofinspection no**~eviations** were**foun~** 

### of**~ufficienl** magnitude to affect the.**~ratidity** ofnon-elinklilstu.dies performed atthesefaci:\iues.

# ~~ 

# 11"'°"( })t.Andl-ewI.Gra,. .... . Head,UK GLPMomtorhlgAuthority
. . . ... •



### 116

### STATEMENT

TITLE OF SruDY Mutagenicity Test of Karenz MT (Mixture of PEMB and PE3MB) Using Microorganisms (Study Code KOl-4229)

I, the undersigned, hereby declare that this report provides a correct English translation of the fina] report ofthe above-mentioned study issued on March 5,2009.

Study Director: 

# Ard 24-, 2009 Shozo Ogura Date CERIHita Chemicals Evaluation and Research Institute, Japan

117

### !Receipt No. 836-08-T -5965\ 

# cERi
STUDY CODE: KOl-4229



# FINAL REPORT

MUTAGENICITY TEST OF KARENZ MT (MIXTURE OFPEMB AND PE3MB) USING MICROORGANISMS

March 2009



### CERI Hita Chemicals Evaluation and Research Institute. Japan

11 B

### GLP 

### STATEMENT CERlHita Chemicals Evaluation and Research Institute, Japan Sponsor: Showa Denko K.K. Title: Mutagenicity Test of Karenz MT (Mixture of PEMB and PE3MB) Using Microorganisms Study Code: KOl-4229
I, the undersigned, hereby declare that this study was conducted in compliance with "Standards to be observed by Testing Institutions for Toxicity Investigations" (Ministry of Labor, Notification No.76, September 1, 1988; partially revised on March 29, 2000) and "Concerning Standard of the Testing Facilities Conducting the Test Relating to the New Chemical Substances" (Notification No. 1121003 of the Phannaceutical and Food Safety Bureau, MHLW, No.3 (2003.11.17) ofthe Manufacturing Industries Bureau, METI & 

### No. 031121004 ofthe Environmental Health Department, MOE (November 21,2003)). Management: Signed in original March 5, 2009 Takaharu Hara

11 119

### GLPSTATEMENT CERI Hita Chemicals Evaluation and Research Institute, Japan Sponsor: ShowaDenko K.K. Title: Mutagenicity Test of 

### Kmnz MI (Mixture of PEMB and PE3MB) Using Microorganisms Study Code: KOl-4229
I, the undersigned, hereby declare that this study was conducted in compliance with "Standards to be observed by Testing Institutions for Toxicity Investigations" (Ministry of Labor, Notification No.76, September 1, 1988; partially revised on March 29, 2000) and "Concerning Standard of the Testing Facilities Conducting the Test Relating to the New Chemical Substances" (Notification No. 1121003 of the Phrumaceutical and Food Safety Bureau, MHL

### W, No.3 (2003.11.17) ofthe Manufacturing Industries Bureau, 

### MEn & 

### No. 031121004 ofthe Environmental Health Department, MOE (November 21,2003». I also confinued that this report accurately reflected the raw data and the test data were valid. Study Director: Signed in original March 5, 

### 2009 Shozo Ogura



### iii 120KOl-4229 1/2 

### QUALITY ASSURANCE STATEMENT CERI Hita Chemicals Evaluation and Research Institute, Japan Sponsor: Showa Denko 

### K.K. Title: Mutagenicity Test of Karenz MT (Mixture of PEMB and PE3MB) Using Microorganisms Study Code: KOl-4229 This study was inspected by Quality Assurance Unit of CERI Hita, Chemicals Evaluation and Research Institute, Japan. The dates inspected and the dates reported these results to the study director and management are as follows. Phase Date ofInspection Date Reported to Study Director and Management Protocol January 13,2009 January 13, 2009 Confinnation ofthe Answer from Study Director (Protocol) January 14,2009 January 14,2009 Approval ofProtocol January 15,2009 January 15,2009 Protocol Amendment January 16, 2009 January 16,2009 COllfinnation ofthe Answer from Study Director (Protocol Amendment) January 16,2009 January 16, 2009 Preparation ofTest Substance January 22, 2009 January 22, 2009 Treatment ofTest Strains January 22, 2009 January 22, 2009 Approval ofProtocol Amendment January 23, 2009 January 23, 2009 Culture Condition and Observation and Colony Count January 26,2009 January 26,2009 Raw Data and Draft Final Report March 4, 2009 March 4, 2009 Re-inspection of Draft Final Report March 5, 2009 March 5, 2009 Final Report March 5, 2009 March 5, 2009 The inspection result of following phase was reported to the study director and management based on the report ofprocess-based inspection relevant to this study type and timeframe.

iv 121

### KOl-4229 

### 2/2
Phase Date ofInspection Date Reported to Study Director and Management Examination of Solubility of the Test Substance October 10, 2008 March 5,2009 Preparation and Management of Positive Control Substances September 4, 2008 March 5, 2009 Preparation of Culture Medium and Rea.gents December 8, 2008 March 5, 2009 Management ofTest Strains April 21, 22, 29, 30 and May 1,2008 March 5, 2009 Pre-cultures ofTest Strains December 11 and 12,2008 March 5, 2009 I, the undersigned, hereby declare that this study was conducted in compliance with "Standards to be observed by Testing Institutions for Toxicity Investigations" (Ministry ofLabor, Notification No.76, September 1, 1988; partially revised on March 29, 2000), "Concerning Standard ofthe Testing Facilities Conducting the Test Relating to the New Chemical Substances" (Notification No. 1121003 of the Phannaceutical and Food Safety Bureau, MHLW, No. 3 (2003.1] .17) of the Manufacturing Industries Bureau, METI & 

### No. 031121004 ofthe Environmental Health Department, MOE (November 21, 2003)). This study was also conducted in compliance with "Standards for Toxicity Investigations" (Ministry of Labor, Notification No.77, September 1, 

### 1988 and Notification No.67, June 2, 1997), "Procedures of Mutagenicity Test Using Microorganisms and Evaluati.on of Test Results" (Ministry of Labor, Official Notification, February 8, 1999), "Ill Mutagenicity test" of"Reverse-Mutation Assay in Bacteria" prescribed in "Testing Methods Relating to the New Chemical Substances" (Notification No. 1121002 ofthe Phannaceutical and Food Safety Bureau, MHLW, No. 2 (2003.11.13) ofthe Manufacturing Industries Bureau, METI & 

### No.031121002 ofthe Environmental HealthDepartment, MOE (November 21,2003)). I, the undersigned. hereby declare that this report provides an accurate description ofthe methods and procedures used in this study and that the reported results accurately reflect the raw data obtained. Head, Quality Assurance Unit:

___**S:.tig..,n..:::;e.::::.d~in.!-o:::.!n::J'**

### gi;>!i:.!!n=al'--

__March 5, 2009 Ryuichiro MizUb'llchi

v 

### 122

### KOI-4229

TITLE SPONSOR TESTING FACILITY PURPOSE OF STUDY TESTING METIIOD GLP COMPLIANCE PERlOD OF STUDY 

### TABLE OF CONTENTS Page

............................., ..........."......................... 2

................................................................... 2

................................................................... 2

................................................................... 2

................................................................... 2

................................................................... 2

................................................................... 3 LOCATION AND PERlOD FOR RETENTION OF DATA ............. 3 RETENTION OF ORlGINAL DOCUMENTS .................... 3 STUDY DIRECTORAND NAMES, ASSIGNED SECTIONS AND JOB ASSIGNMENT OF PERSONNEL .................... 4 AUTHOR OF FINAL REPORT .................... 4 SUMMARY 

### 5 MATERIALS AND METHODS 1. TEST SUBSTANCE AND POSITIVE CONTROL SUBSTA};CES 6 2. BACTERIAL STRAINS .................................................... 8 3. MEDIUM AND S9 MIX .................................................... 8 4. PRE-CULTURES OF THE TEST STRAINS ............................. 9 5. PREPARATION OF TEST SUBSTANCE AND POSITIVE CONTROL SUBSTANCES ................................................... 10 6. METHODS .................................................... 11 7. OBSERVATION AND COLONY COUNTING .................... 12 8. JUDGEMENT CRITERIA OF TEST RESULTS .................... 12 FACTORS AFFECTED RELIABILITY OF TEST .................... 12 TEST RESULTS 1. DOSE FINDING TEST 12 2. MAINTEST 13 DISCUSSION AND CONCLUSION 13 TABLE AND FIGURE

TABLES .................................................... 14 FIGURES (DOSE-RESPONSE CURVES) ..................................... 16 HISTORlCAL DATA 

### ]8 1­ 123

### KOI-4229
Study Code: 

### KO] -4229 Test Substance Code: HR7645 Sponsor Code: S-0170 TITLE Mutagenicity Test of Karenz MT (Mixture of PEMB and PE3MB) Using Microorganisms SPONSOR Showa Denko 

### K.K. 13-9, Shiba Daimon I-Chorne, Minato-ku, Tokyo 105-85] 8, Japan TESTING FACILITY CERI Hita Chemicals Evaluation and Research Institute, Japan 822, 3-chome, Ishii-machi, Hila, Oita 877-0061, Japan PURPOSE OF STUDY The ability of the test substance to induce mutations was investigated by using 

### Salmonella typhimurium and 

### Escherichia coli. TESTING METHOD This study was conducted in accordance with "Standards for Toxicity Investigations" (Ministry ofLabor, Notification No.77, September 1,1988 and Notification No.67, June 2, 1997), "Procedures of Mutagenicity Test Using Microorganisms and Evaluation of Test Results" (Ministry of Labor, Official Notification, February 8, 1999), "III Mutagenicity test" of "Reverse-Mutation Assay in Bacteria" prescribed in "Testing Methods Relating to the New Chemical Substances" (Notification No. 1121002 ofthe Pharmaceutical and Food Safety Bureau, MHLW, No. 2 (2003.11.13) of the Manufacturing Industries Bureau, METI & 

### No.031I21002 ofthe Enviromnental Health Department, MOE (November 21, 2003)). GLP COMPLIANCE This study was conducted in compliance with "Standards to be observed by Testing Institutions for Toxicity Investigations" (Ministry of Labor, Notification No.76, September 1, 1988; partially revised on March 29, 2000), "Concerning Standard ofthe Testing Facilities Conducting the Test Relating to the New Chemical Substances" (Notification No. 1121003 ofthe Pharnlaceutical and Food Safety Bureau, MHLW, No. 

### - 2 124

### KOI-4229

3 (2003.11.17) ofthe Manufacturing Industries Bureau, METI & 

### No. 031121004 ofthe Environmental Health Department, MOE (November 2],2003)). PERIOD OF STUDY Commencement ofStudy: January 8, 2009 Initiation ofExperiment

(Initiation ofTreatment ofDose Finding Test): January 22, 2009 Completion ofExperiment

(Completion ofColony Count): February 2, 2009 Completion ofStudy: March 5, 2009 LOCATION AND PERIOD FOR RETENTION OF DATA Raw data, protocol, letter of test request, questiormaire, final report and other documentation records will be retained in the archives and the test substance will be retained at the test substance storage room ofthe testing racility for 10 years after the date of the notification specified under Item 1 of Article 57-3 of Industrial Safety & 

### Health Law. Date of the notification will be communicated from the sponsor to the testing facility. They also will be retained for 10 years after the date ofthe notification specified under Article 4, Paragraph 1 or Paragraph 2, Article 4-2, Paragraph 2, Paragraph 3 or Paragraph 8, Article 5-4, Paragraph Article 24, Paragraph 2 or Article 25-3, Paragraph 2 of Notification on Testing Methods Relating to the New Chemical Substances. The sponsor \vill communicate the date of the notification to the testing facility. Treatment ofdata after tennination ofthe retention period will be carried out with the approval ofthe sponsor. RETENTION OF ORIGINAL DOCUMENTS 

### An original and a duplicate ofprotocol and protocol amendment were drawn up. The fonner will be retained at the testing facility. The latter was sent to the sponsor. 

### An original final report is drawn up and will be retained at the testing facility. A copy of the'original final report that was recognized to be an accurate copy by the study director will be sent to the sponsor.

- 3 ­ 125KOl-4229

STUDY DIRECTOR AND NAMES, ASSIGNED SECTIONS AND JOB ASSIGNMENT OF PERSONNEL Study Director:
Study Staff:

Management:

Person in Charge ofStorage ofArchives:

Person in Charge ofTest Substance Management:

AUTHOROF FINAL REPORT Study Director: Shozo Ogura Section 

### 3, CERI Hita Shozo Ogura, Shinya Wakamatsu, Erika Mizuguchi and Mari Yoshimoto Section 

### 3, CERl Hita (Preparation ofthe test substance, observation and
. count ofnumber ofrevertant colonies) TakaharuHara CERlHita

Shizuka Kouda General Affairs Section, CERl Hita

Haruhiko Tajima Section 

### 1, CERlHita
Signed in original March 5, 2009

Shozo Ogura

- 4 --­ 126

### KOl-4229

SUMMARY
The ability of Karenz MT (Mixture of PEMB and PE3MB) to induce mutations was investigated using Salmonella typhimurium 

### strains TAIOO, TA1535, TA98 and TA1S37 and Escherichia coli 

### strain WP2uvrA 

### with a pre-incubation method in the presence and absence ofa metabolic activation system (89 mix). As a result, the mutagenicity ofthe test substance was judged to be negative because the numbers of revertant colonies in the test substance treatment groups were less than two times that in each negative control in all test strains with and without 89 mix. Therefore, it is concluded that Karenz MT (Mixture ofPEMB and PE3MB) has no ability to induce mutations under the present test conditions.

5 127

### KOl-4229


### MATERIALS AND METHODS 1. TEST SUBSTANCE AND POSITIVE CONTROL SUBSTANCES 1.1 Test Substance (InformationProvided by the Sponsor)**l--··········---·····~~--·····-·----··-··----·-·-····-** ..-.---.- ... -- .. ---.--- ..**-.---~.--.-** ...-... -----.-.---.....--....... 

# · · 

# · · · · · 

# · · · · 

# · · ·

, 

# · · · 

# · · · · · · 

# · · · · · · · · ·

- 6 ­ 128

### KOl-4229
7) Physicochemical properties

8) Storage conditions Stored at room temperature (cabinet No. 1 in the test substance storage room, pennissible range: 1 0-30°C) and to avoid contact with oxide. 9) Precautions Gloves, a mask, a head cap, safety glasses and a lab coat were worn. The test substance was used in the draft since peculiar stink. 1 2 Positive Control Substances Name Manufacturer Lot No. Appearance Purity Grade AF-2·) 

### Wako Pure Chemical Industries Ltd. WAP0369 Red-yellow crystalline powder 100.2% Special grade
NaN3•2 

### Wako Pure Chemical Industries Ltd. KLN3948 White crystalline powder 99.8% Special grade ICR-19t'3 Polysciences, blC. 

### 534652 Yellow crystalline powder 

# - - 2AA*4 Wako Pure Chemical Industries, Ltd. ASMII01 Yellow-greenbrown powder 97.4% 

# - *1: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide *2: Sodium azide *3: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl) aminopropylamino]acridine·2HCI *4: 2-Aminoanthraccne 1) Storage conditions Stored in a cool and dark place (refrigerator No. 005 in the test substance storage room ofthe main building, pennissible range: I-lO°C). 

### - 7 129KOl·4229
2) Precautions Gloves, a mask, a head cap, safety glasses and a lab coat were worn. 2. BACTERlAf, STRAINS 2.1 Strains and Reason for Selection 

### Salmonella typhimurium (8. 

### typhimurium) strains TAlOO, TAIS3S, TA98 and TA1S37 and 

### Escherichia coli (E. coli) strain 

### WP2uvrA were used. 

### S. 

### typhimul'ium strains and E. 

### coli strain were supplied from Dr. Taijiro Matsushima, Japan Bioassay Research Center, on March 13, 2003 and on September 20, 2003, respectively. These test strains have been recommended to use for the mutagenicity test using microorganisms in "Standards for Toxicity Investigations" and "Testing Methods Relating to the New Chcmical Substances". 

### 2.2 Storage Amino acid requirement, sensitivity to ultraviolet-rays, lfa membrane mutation, presence or absence ofplasmid pKMIOI and negative and positive control values of test strains were examined in the testing facility. Dimethyl sulfoxide (DMSO, Lot No. VV035, 100.0% in purity, spectrophotometric grade, DOJrNDO Laboratories) was added to fresh overnight cultures ofthe test strains which had been confinned to have these properties at a volume ratio of0.9: 

### 10. The mixture was frozen as a stock culture in an ultra-deep freezer (the Ames test room No. 

### 1 of the main building, MDF-293AT, 

### SANYO Electric Biomedical Co., Ltd.) below ·80°C. The mixture was thawedjustbefore use. 

### 3. MEDIUMANDS9MIX 3.1 Medium 

### 1) Minimal glucose agar plate Tesmedia AN (Oriental Yeast Co., Ltd.) was used. Lot No.: ANI760KX (manufactured onNovember 13,2008) 

### 2) Soft agar A solution containing 0.5 mM histidine and 0.5 

### mM biotin for 

### S. 

### typhimurium strains or 0.5 

### mM tryptophan for E. 

### coli strain was added to a soft agar solution containi.ng 0.6 w/v% agar (Bacto Agar, Lot No. 8014026, Dlfco Laboratories) and 0.5 w/v% NaC] at a volume ratio 

### of 1to 10.

- 8 -. 130

### KOl-4229

3.2 S9 Mix 1) Rat liver S9 S9 (Lot No. 08100307, manufactured on October 3, 2008, Oriental Yeast Co., Ltd.) prepared from the liver of 7 week-old male SD rats (body weight: 206.0±S.8 g) administered with phenobarbital and 5,6-benzoflavone was used. The S9 was cryopreserved in an ultra-deep freezer (MDF-293AT in the Ames test room No. I of the main building, SANYO Electric Biomedical Co., Ltd.) below -80°C until use. S9 was thawedjust before use. 2) Composition ofS9 mix S9 mix was prepared using Cofactor 

### J® (Lot No. 999801, Oriental Yeast Co., Ltd.) for S9 mix immediately before use. One milliliter of S9 mix consisted of8 limol MgCh, 33 limo] KCl, 5 limol Glucose-6-phosphate, 4 limol NADPH, 4 limol NADH, 100 limoI sodium-phosphate buffer (pH 7.4) and 0.1 mL ofS9. 4. PRE·CULTURES OF THE TEST STRAINS Thirty microliters (for TAl00), 5-IiL (for WP2uvrA), 

### and 20-IiL(for TA98, TA1535 and TA1S37) aliquots of frozen stock culture of bacterial strains were respectively inoculated to 11 mL ofNutrient broth No.2 (Lot No. 464616, OXOID Ltd.) in each Ltube (volume: 27 mL). The culture was incubated at 37±0.5°C for 9 hours by shaking at about 50 times/minute in a seesaw type of shaker (MONOSIN-IIA, Taitec Corporation). The number of viable cells was calculated from O.D. value at 660 nm measured by a photo meter (Miniphoto 518R, Taitec Corporation) at the end of incubation to calculate the number ofviable cells. It 

### was confinned that the numbers ofviable cells were more than 2.3 x 1 09 

### cells/mL in Salmonella typhimurium and more than 3.8xJ09 

### cells/mL in Escherichia coli strain. When the numbers of viable cells were more than 2.7xI09 

### cells/mL in Salmonella typhimurium and more than 4.2xl09 celIs/mL in Escherichia coli strain, the O.D. value was measured at 660 nm by a photo meter (the same above) and were adjusted with Nutrient broth No. 2 at 2.3-2.7x 1 09 

### cells/mL and at 3.8-4.2x 109 

### cells/mL, respectively. The culture was used without adjusting when the Salmonella typhimurium strains were in the range of 2.3-2.7x 109 

### cells/mL. The final numbers ofprepared viable cells are shown below: Test TAIOO TA1535 WP2uvrA 

### TA98 TAt537 Dose finding test 2.7 2.6 4.1 2.5 2.6 Main test 2.7 2.6 

### 4.1 2.7 

### 2.6 (x 109

### cells/mL)



### -9­ 131

### KOI-4229

5. PREPARATION OF TEST SUBSTANCE AND POSITIVE CONTROL SUBSTANCES 5.1 Preparation ofTest Substance 1) 

### Solvent DMSO (Lot No. WF032, 100.0% in purity, spectrophotometric grade, DOJfNDO Laboratories) was used. 2) Reason for selection ofsolvent The test substance was insoluble in distilled water (infonnation provided by the sponsor) and was soluble in DMSO at 500 mg/mL. 

### The test substance solution of 500 mg/mL prepared with DMSO was no change in color nor heat generation at room temperature within 2 

### hours after preparation. Therefore, DMSO was preferably selected a'i 

### a solvent. The test substance solution of 50.0 mg/mL 

### prepared with DMSO was no change in color nor heat generation at room temperature within 2 hours after preparation. 3) 

### Preparation method DMSO was added to the test substance and mixed by a tube mixer to make a 50.0 mg/mL solution. The test substance solution was diluted with the same solvent to give each required concentration. 4) 

### Preparation time The test substance solutions were prepared immediately before use, kept under yellow lamps at room temperature and used within 2 hours. 5.2 Preparation. ofPositive Control Substances 1) 

### Preparation method NaN3 was dissolved in distilled water (distilled water for injection, Lot No. K8B81, Otsuka Pharmaceutical Factory Inc.). AF-2, ICR-191 and 2AA were dissolved in DMSO (Lot No. VV035). 2) Storage conditions Positive control solutions were stored in an ultra-deep freezer (the Ames test room No.1 ofthe main building, MDF-293AT, SANYO Electric Biomedical Co., Ltd.) below -80°C. The solutions were thawed before use.

- 10
­ 132KOI-4229

6. METHODS The test was perfonned by the pre-incubation method with and without S9 mlX. Triplicate plates were used for the negative control group, and duplicate plates were used for the test substance treatment group at each dose and the positive control group in the test. The test code number, name oftest strain, presence or absence of S9 mix and dose level were noted on each plate. 6.1 Procedures After 0.1 mL of the test substance solution, solvent or the positive control solution, 0.5 mL of 0.1 M sodium phosphate buffer (PH 7.4) or S9 mix and 0.1 mL of the bacterial culture were added to a test tube, the mixture was shaken at 37±0.5"C for 20 minutes. Two milliliters of the soft agar were then added to each tube and the mixture was poured onto a minimal glucose agar plate. The number of revertant colonies was counted after incubation at 37±O.5°C for 48 hours. 6.2 Sterility The highest concentration of the test substance solution (0.1 mL) and S9 mix (0.5 mL) were respectively mixed with 2 

### rnL ofthe soft agar and were poured onto each minimal glucose agar plate in order to examine bacterial contamination. The plates were incubated at 37±0.5°C for 48 hours. 6.3 Negative Control and Positive Controls The solvent used in the tests was employed as a negative control and the following positive controls were used for each bacterial strain. TA100 1'A1535 

### WP2uvrA TA98 TA1537 AF-2 NaN3 AF-2 AF-2 ICR-191 -S9 mix 0.01 0.5 0.0] 0.1 0.5 2AA 2AA 2AA 2AA 2AA +S9 mix 

### 1 

### 2 10 0.5 

### 2 (Unit: Jlg/plate) 6.4 Dose Selection 

### 1) Dose finding test A total ofsix doses consisting of5000 flg/plate as the highest dose and five lower doses diluted with a geometricprogression of4 were set. 

### 2) Maintest The results ofthe dose finding test showed that the number ofrevertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was not observed at any doses in the groups of treatment in all test strains with and without 89 mix. 

### The precipitation ofthe test substance was observed at 1250 t-tg/plate or more in all test strains without 89 mix.



### - 11
­ 133

### KOI-4229
Therefore, in the main test without S9 mix, the highest dose was selected at 5000 Ilg/plate as observed the precipitation and lower 5 doses of 2500, 1250, 625 and 313 flgiplate diluted with a geometric progression of 2, were employed. In the main test with S9 mix, the highest dose was selected at 5000 Jlg/plate and lower 5 doses of2500, 1250, 625 and 313 Ilg/plate diluted with a geometric progression of 2, were employed. 7. OBSERVATION AND COLONY COUNTING 

### 7.1 Observation The precipitation of the test substance was observed by macroscopically and the bacterial growth inhibition was observed by using a stereomicroscope, at the end of the incubation period. 7.2 Colony Counting For the plates in which the precipitation of the test substance was observed, the number of colonies was counted with a manual counter, and the other plates were counted by using a colony analyzer (CA-I1D, System Science Ltd.). Square correction and miss counting correction were performed in colony analyzer. 

### 8. JUDGEMENT CRITERIA OF TEST RESULTS The test substance was judged to be positive when the number of revertant colonies increased to twice ormore than that inthe negative control in 

### a concentration-dependent manner and also the reproducibility ofthe test results was obtained. 

### 111 all other cases, it wasjudged to be negative. Any statistical methods were not used.

FACTORS AFFECTED RELIABILITY OF TEST There were no factors that might have affected the reliability ofthe test.
TEST RESULTS 1. DOSE FINDING TEST The test result is shown in Table 1 and the dose-response curves are shown in Figs. 1 and 2. No increases in the number ofthe revertant colonies ofany test strain were observed in the test substance lrealment groups with or without S9 mix. Growth inhibition was not observed at any dose with or without S9 mix. The precipitation ofthe test substance was observed at 1250 Jlg/plate or more in nll test

- 12 ­ 134

### KOl-4229

strains without S9 mix. 2. MAIN TEST The test result is shown in Table 2 and the dose-response curves are shown in Figs. 3 and 4. No increases in the number ofthe revertant colonies ofany test strain were observed in the test substance treatment groups with or without S9 mix. Growth inhibition was not observed at any dose with or without 89mix. The precipitation ofthe test substance was observed at 1250 flg/plate or more in all test strains without S9 mix. DISCUSSION AND CONCLUSION The mutagenicity ofthe test substance wasjudged to be negative because the number ofthe revertant colonies at all dose levels of the test substance was less than twice that of the negative control for each test strain in the test. The numbers oftbe revertant colonies in the negative and positive controls were within the range ofhistorical data in the testing facility. The numbers ofthe revertant colonies in the positive controls were two or more times higher than those of the negative control. Microbial contamination was not observed in the dose finding test or the main test. This indicates that the present test data are valid. Therefore, it was concluded that Karenz MT (Mixture of PEMB and PE3MB) did not ability to induce mutations under the present test conditions.

- 13
­ 135

### KOl-4229

Table 1 Results ofthe dose finding test
Test substanec' Karcnz MT (mixture ofPEMB and PE3MB) 

### - Test Period From January 22, 2009 to January 26, 2009 Wlth(+)or Test substance Number ofrevenant colOnies per plate witbout(-} dose Base-pair substitution type Framcshift type

S9mix (!lglpJate) TAJOO TA1535 WP2/JvrA TA98 TAlS37 Negative 95 91 16 8 

# 1314 27 20 19 15 20 control ](14 ( 97 15 ( ( 29 26 ( 22 10 ( 15 112 7 27 23 13 4.88 120 ( 116 6 ( 7 42 ( 35 19 ( 21 13 { 13 105 10 30 IS 15 195 95 ( 100 8 ( 9 27 ( 29 18 ( 17 13 I 14 -59 mix 102 II 31 19 12 18.1 95 ( 99 l! ( II 20 ( 26 22 ( 21 26 ( 19 98 18 25 19 22 313 136 f 117 7 ( 13 27 ( 26 23 ( 21 II ( 17 !!6 8 33 22 B 1250 t 116 ( 101 7 { 8 30 ( 32 18 ( 20 7 ( 8 115 S 36 17 7 5000 t 94 ( 105 7 ( 6 39 ( 3ij 26 ( 22 7 ( 7 Negative 104 116 14 12 34 28 38 45 35 34 control 116 ( 112 12 ( 13 38 ( 33 34 ( 39 22 ( 30 107 14 30 28 15 4.88 96 ( 102 7 ( II 36 ( 33 18 ( 23 20 ( 18 105 II 34 21 16 19.5 94 ( 100 8 ( 10 43 ( 39 28 ( 25 25 ( 21 +59 mix lOS 5 30 27 20 78.l 99 ( 104 10 ( 8 35 ( 33 29 ( 2S 20 ( 20 128 10 33 27 29 313 126 { 127 13 (**!~** 26 ( 30 34 I 31 20 ( 25 128 12 44 30 8 1250 108 ( 118 13 ( 13 41 ( 43 28 ( 29 14 ( 11 J 12 5 36 30 7 5000 96 ( 104 7 ( 6 31 ( 34 31 ( 31 7 ( 7 Chemical AF·2 NaN
.. Af-:2 AF-2 ICK·l9! Positive Dose(!,g/plale) 001 OJ 0.01 O.J 0,5 control Numbf:rof 614 530 314 521 1659 -S9 mix revenant .",)Qrueslpl<llf 592 ( 603 405 ( 468 308 ( 311 512 ( 517 1501 ( 1580 Chemica 2M 2AA 2AA 2M 2M Positive Dose(JAg/plale) I :2 10 0.5 2 control Number of 1015 249 674 268 247 +S9 mix teift.rtant colrJfli¢!lplatt 909 ( 962 242 ( 246 594 ( 1i34 261 ( 278 221 ! 234 (Notes] • ( ): The mean number ofcolonies per plate,
, t: Precipitate oftcst substance was observed at all plates. • AF-2: 2-(2-Furyl)·3-(5-nitro-2-furyl}acrylllmide • NaN): Sodium azide • ICR·191: 2-Methoxy·6·ch]oro-9-!3-{2-chloroethyl)aminopropylamillo]a"ridinc'2HCl • 2M: 2-Aminoanthraccne

- 14 136KOl-4229

Table 2 Results ofthe main test
Test substance: Kllrenz MT (ml:((urc ofPEMB and PE3MB) TeSI Period From january 29, 2009 10 February 2, 2009 Wlth(+)or Test substance Number of revertant COlOnies per plate wilhoUl(-) dose 

# rf substitution type Frarnesbift tYJl{':

S9mix (lLg!platc) TAIOO TA 1535 WP2ul'rA TA98 TA1537 Negative ll5 102 13 14 28 22 22 25 3 13 control n ( J03 3 ( 10 33 ( 28**2~** ( 25 13 ( 10 115 7 28 21 to 313 118 ( 117 7 ( 7 23 ( 26 21 ( 21 ) 8 ( 

# " 111 II 31 25 4 -S9 mix 625 105 ( 108 6 { 9 30 { 31 20 [ 23 6 { 5 98 7 34 25 6 1250 t 109 ( 104 8 ( H 29 { 32 26 ( 26 6 { 6 116 12 35 15 5 2500 t 103 ( 110 12 ( 12 28 ( 32 15 { 15 6 ( 6 94 7 23 25 7 

### I 5000 t 122 ( 108 8 ( g 28 ( 26 22 [ 24 4 ( 6 Negative 117 108 10 8 3; 31 36 34 27 22 control 116 ( 114 3 ( 7 36 ( 33 27 ( 32 22 ( 24 103 6 37 26 15 313 107 ( 105 R ( 7 22 ( 30 30 { 28 16 ( 16 147 8 2S 16 14 +S9mix 625 132 ( 140 5 ( 7 33 ( 29 28 I 22 8 ( I) 115 10 28 35 II 1250 III ( 113 5 ( 8 28 ( :;l8 25 ( 30 16 ( 14 III 5 31 47 6 2500 112 t 112 1 ( 6 28 ( 30 21 I 37 8 ( 7 126 13 35 35 R 5000 108 ( 117 8 ( II 34 ( 35 27 ( 31 6 ( 7 Chemical M-2 NaN, AF-2 AF-2 JCR-191 Positive Dose(J.lg!plate) 0.01 0.5 0.01 0,1 0.5 control Numbel of 692 347 394 541 1561 -S9mix**fe~rtant** colonies/plate 655 ( 674 340 ( 344 360 ( 377 490 ( 516 1320 ( 1441 Chemical 2AA 2AA 2AA .AA 2AA Positive Dose(vg!plate) 1 2 10 05 2 conlml Numbetof 889 191 649 375 293 +S9mix**JlIl:vm~nt** CilhmKe$/plate 1188 ( 1039 213 ( 202 665 ( 651 367 ( 371 274 ( 284 [NQles] • (): Til.: meannurnber ofcolonies per plate. · t: Precipitate oflest substance was observed at all plates. • AF-2: 2-(2-Furyl)-3-(S-nitro-2-furyl)acrylamide • NaN): Sodium azide • ICR-191: 2-Methoxy-6-chlQro-9-p-(2-chlorocthyJ)aminopropylamino]acridine' 2HCI • 2AA: 2-Arninoanthracene

15 137KOl-4229

140



### ., 120 'iii 

### -a.

... 100 

### ., Po 

### Ji d 0 80 '0 u 

## i 1:: 60 

### , 

### ., -+-TAlOO -----TAlS35 --tr-- WP2uvrA**~TA98 ~**  -----TAl537


### .... 0 

# r

... .8 E 

### :z ::> 40



## o 4.88 5000 19.5 7S.1 313 1250 Test substance dose**(~glplate)** Fig. 1 

### Dose-response curve without 89 mix in the dose finding test

140 

# r 120**~** 

### -a. 

## 8. 100**.~** § -+-TAlOO 

### "8 80 

# I -----T A1535 --tr-- WP2uvrA 60**~TA98 ~**  -+-TAlS37 'c> 

# : .8 § 

### :z 

### o ' -'--.--,.-'--------........--­ 

## o 4.88 19.5 78.1 313 12S0 SOOO Test substance dose**(~glplatc)** 

### Fig. 2 Dose-response curve with S9 mix in the dose finding test

- 16 ­ 138

### KO]-4229

140 

### j 120 Q.

....**~** 100 -+-TAIOO 

### so
___TAJ535 -o-WP2uvrA 60 --*-TA98 ---TAL537 40

# 2Of~:=:;~~~

o c,

____**~_**



### o 313 625 1250 2500 5000 Test substance dose ()lglplate) Fig. 3 Dose-response curve without S9 mix in tbe main test

160 c 140 120 • 100 -+-TAIOO ---TA1535 80 -o-WP2uvrA --*-TA98 60 ---TA1537



### o 313 625 1250 2500 5000 Test substance dose (}4g1pJate) Fig. 4 Dose-response curve with S9 mix 

### in the main test



### - 17
­ 139

### KOI-4229



# HISTORICAL DATA (Tesmedia AN) July 2008
- December 2008 

### Negative Control (Mean±3S.D.) -S9 mix +S9mix TAl00 TAI535 WP2u1.'rA TA98 TAl537 TAIOO TAl53S WP2uvrA TA98 TA 1537 Mean 

### S.D.

.... _ ........ __ ............ w ..... _

Upper Limit 105 15 150 10 4
..........

### -...

22 24 7
................. 45 22 6
....

### -.......

40 9 4
..............

21 112 17
...........

163 9 3
...............

### ­ 18 29 7
.................­ ...

## -­ 50 31 7

.....

### -...-....

52 20 6 

### -......_ ..... 38 Lower Limit 60 1 3 4 1 61 J 8 10 2



### Positive Control (Mean±3S.D.) -S9mix +89 mix TAtoO TA1535 WP2uvrA TA98 TAI537 TAIOO TAl535 WP2uvrA TA98 TAI537 Chemical
....................... "".......... AF-2 NaN) .............. AF-2 ........... ..... AF-2
.............. JCR·19J .............. 2M

_

.............,. 2M
.... ..........

### ­ 2M

..................... 2AA
.., ......_,., ...

### ­ 2M 

## -_.... '......

### ­ Dose (Ilglplate) 0.01 0.5 0.01 0.1 0.5 I 2 10 0.5 2

Mean 662 380 329 510 1533 943 229 617 279 234 S.D.
................................... ,. 96
................ 53
............. 72


### ..

### ----­ ....... 78

............

### ­ 192 110 

### -.........__.. 28
............... 10.3 "'... '"' ......... ­ ..... 39
............ 34
............... Upper Limit 950 539 545 744 2109 1273 313 926 396 336 Lower Limit 374 221 113 276 957 613 145 308 162 J32 [Notes] • AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide 

### • NaN): Sodium azide • ICR-191: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine'2HCI • 2AA: 2-Aminoanthracene



### 18
­ 140

### STATEMENT

TITLE OF STUDY 

### Chromosomal Aberration Test of Karenz MT (Mixture of PEMB and PE3MB) Using Cultured Mammalian Cells (Study Code:**K06~1279)**



### I, the undersigned, hereby declare that this report provides a correct English translation ofthe final report (Study Code:**K06~1279,** 

### issued on Apri115, 2009) audited by Quality Assurance Unit ofeERIHita, Chemicals Evaluation and Research Institute, Japan.

Renge Suzuki 

### Date

CERI Hita Chemicals Evaluation and Research Institute, Japan

141

# cERi I Receipt No. 837-08-T-5966 STUDY CODE: K06-1279



# FINAL REPORT

CHROMOSOMAL ABERRATION TEST OF KARENZMT (MIXTURE OF PEMB AND PE3MB) USING CULTURED MAMMALIAN CELLS

April,2009

CERI Hita Chemicals Evaluation and Research Institute, Japan

142

### K06-1279


### GLP STATEMENT CERI Hita Chemicals Evaluation and Research Institute, Japan Sponsor: Showa Denko K.K. Title: Chromosomal Aberration Test 

### of Karenz MT (Mixture of PEMB and PE3MB) Using Cultured Mammalian Cells Study Code: K06-1279
I, 

### the undersigned, hereby declare that this study was conducted in compliance with "Concerning Standard ofthe Testing Facilities Conducting the Test Relating to the New Chemical Substances" on Japanese GLP (Notification No. 1121003 of the Pharmaceutical and Food Safety Bureau, MHLW, No.3 (November 17, 2003) of the Manufacturing Industries Bureau, MET! & No. 031121004 ofthe Environmental Health Department, MOE (November 21, 2003). I also confirnled that this 

### report accurately reflected the raw data and the test data were valid. Study Director: Signed in original April 15,2009 Shozo Ogura

11 143K06-1279 

### 112 QUALITY ASSURANCE STATEMENT CERI Hita Chemicals Evaluation and Research Institute, Japan Sponsor: Showa Denko K.K. Title: Chromosomal Aberration Test of Karenz MT (Mixture of PEMB and PE3MB) Using Culturcd Mammalian Cells Study Code: K06-1279 This study was inspected by Quality Assurance Unit of CERI Hita, Chemicals Evaluation and Research lnstitute, Japan. The datcs inspected and the dates reported these results to the study director and the management are as follows. Phase Date ofInspection Date Reported to Study Director and Management Protocol November 28, 2008 November 28,2008 Cell Pre-culture November 28, 2008 November 28, 2001{ Preparation ofTest Substance December 1,2008 December 1, 2008 Treatment ofCells December 1,2008 December 1, 2008 Confirmation of the Answer from Study Director (Protocol) December 2, 2008 December 2, 2008 Protocol Amendment December 16, 2008 December 16.2008 Confirmation of the Answer from Study Director (Protocol Amendment) December 17,2008 December 17,2008 Protocol Amendment (No.2) January 7, 2009 January 7,2009 Protocol Amendment (No.3) January 15,2009 January 15,2009 Confirmation of the Answer from Study Director (Protocol Amendment (No.3) January 16, 2009 January 16,2009 Observation ofSpecimens March I3, 2009 March 13, 2009 Protocol Amendment (No.4) March 23, 2009 March 23, 2009 Raw Data and Draft Final Report April 9, 2009 April 9, 2009 Re-inspection of Raw Data and Draft Final Report April 10, 2009 April 10, 2009 Draft. Final Report (Second) April 14, 2009 April 14, 2009 Re-inspection of Drall 

### Final Report (Second) April 15,2009 April 15,2009 Final Report April 15, 2009 April 15, 2009
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