ofchemicals r Form A roved. O.M.B. No. 2070-0012. A ires 10-31-96. U.S. ENVIRONMENTAL PROTECTIONAGENCY 

### AGENCYUSE ONLY Daleofreceipt 

# ft PREMANUFACTURE NOTICE

# ~EPA FOR NEW CHEMICALSUBSTANCES \\**h~11** DOCUMENTCONTROLOFFICER ,01111'kkd OFFICE OF POLLUTION PREVENTION**'~Ild** tlil' ANDTOXIC SUBSTANCES, 7407 Itlllllltl U.S. EPA 401 M STREET, SW WASHINGTON, D.C. 20460 nterthetotal number ofpages 

### 96 in the PremanufactureNotice GENERAL INSTRUCTIONS You mustprovide all information requested in this form to the extentthat it is known to or reasonablyascertainable byyou. Make reasonable estimates ifyou do nothave 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- I404, or faxing 202-554-5603). • Ifa user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above theTS-user fee identification numberyou have generated. Remember, your user fee IDnumber mustalso appearonyour corresponding fee remittance, which is sentto EPA, HQ AccountingOperations Branch (PM-226), P.o. 360399M, Pittsburgh, PA 15251-6399,Attn. TSCA User fee.

Part 1-GENERAL INFORMATION TEST DATA AND OTHERDATA You must provide the currently correct Chemical Abstracts (CA) Namc oflhenew You are required to submitall testdata in yourpossession orcontrol and to chemical substanee, even ifyou claim the identityas confidential. You may authorize provide a description ofall other dataknown to orreasonably ascertainableby anotherperson to submit chemical identity information foryou, but your submission will you, ifthese dataare related to the health and environmental effects onthe not be complete and the review will not begin until EPA receives this information. Aletter manufacture, processing, distribution in commerce, use, ordisposal ofthe new in support ofyour submission should referenceyour TS userfee identification number. chemical substance. Standard literaturecitationsmaybe submitted for data in the You must submit an original and two copies ofthis notice including all test data. Ifyou open scientific literature. Completetest data (written in English), not summaries claimed any information as confidential, a single sanitized copymust also be submitted. ofdata, mustbe submitted iftheydo not appear in the open literature. You should clearly identitY whethertestdata is on the substance oron an analog. Also, the chemical composition ofthe tested material should be characterized. Following areexamples oftestdata and otherdata. Data should be submitted accordingto Ifthere are several manufacture, processing, oruse operations to be described in Part II, the requirements of§720.50ofthe Premanulacture Notification Rule (40 CFR sections A and B ofthis notice, reproduce the sections as needed. Part 720). Part 11- HUMAN EXPOSURE ANDENVIRONMENTAL RELEASE

Part Ill-LISTOF ATTACHMENTS Test Data (Check Below any included in this notice) Attach additional sheets ifthere is not enough space to answer a question thlly. Label each Environmental fate data DYes Otherdata 0 Yes continuation sheet with the corresponding section heading. In Part Ill, list these attachments, any test data or otherdata and any optional information included in the notice. Health effects data 181 Yes Risk assessments Environmental effects data DYes Stmcttlre/activityrelationships OPTIONAL INFORMATION Pllysical/Chemical Properties' 181 Yes Test data not in the possession or control ofthe submitter You may include any information that you want EPA to consider in evaluating the new substance. On page 11 ofthis form, spacehasbeen provided for you to described Aphysical and chemical properties worksheet is located on the last page ofthis form. pollutionprevention and recycling informationyou may have regarding the new substance. TYPEOFNOTICE (Check Only One) So-called "binding"boxes are included throughout this form for you to indicate your \0 

# "" willingness to be bound to certain statements you make in this section, such as use, 

### [2J PMN (Premanufacture Notice) 

### o productionvolume, protective equipment.
.. This option is intended to reduce delays that routinely accompany the development ofconsent orders or SignificantNew Use Rules. Except in the case ofexemption applications (such as TMEA, LVE, LOREX) where 

## D INTERMEDIATE PMN (submitted in sequence with final produet PMl!4­ certain information provided in such notification is binding on the submitterwhen the Agency approves the exemption application, checking a binding box in this notice does not 

## D SNUN (Significant New Use Notice) by itselfprohibitthe submitter from later deviating from the information (except chemical identity) reported in the form. 

## D TMEA (Test Marketing Exemption Application) CONFIDENTIALITY CLAIMS 

## D LVE (Low Volume Exemption)@40 CFR723.50(c)(I) You may claim any information in this notice as confidential. To assert a claim on the fonn, mark (X) the confidential box next to the infonnation that you claim as confidential. 

## D LOREX (Low ReleaseiLow Exposure Exemption) @40eFR 723.50(c)(2) To assert a claim in an attachment, circle or bracket the information you claim as confidential. Ifvou claim information in the notices as confidential you must also provide LVE Modification LOREX Modification 

## D 

## D a sanitized version ofthe notice (including attachments). Foradditional instmctions on claiming information as confidential, read the Instructions Manual. IS THIS A CONSOLIDATED PMN? Yes 

## D Mark (x) ifany information in this notice is claimed as confidential # rT1 C"') 

### c:n

'AFORM 7710-25 (Rev. 5-95) Replacesprevious editions ofEPA Form 7710-25. 

# I**.r--------------------c--~~--~~--~~~--~------~~------------~~~~--~--~~--------~** Public reporting burden for thiscollection ofinformation is estimated to average 110 hours per response, includingtime for reviewing instructions, searchingexisting data sources, gathering and maintainingthe dataneeded, and completing and reviewing the collection of



### - information. Send comments regarding the burden estimate orany otheraspect ofthis collection ofinformation, including suggestions for reducing thisburden, to Chief, Information Policy Branch, PM-223, U.S. Environmental ProtectionAgency, 401 M. St., S.W., Washington, D.C. 20460; and to the Office ofManagement and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503. 

### CERTIFICATION
I certifythattothe bestofmy knowledge and belief: I. The company named in Part I, sectionA, subsection laofthis notice form intendsto manufacture orimport for a commercial purpose, otherthan in small quantities solely for research and development, the substance identified in Part I, Section B. 2. All information provided in this notice is complete andtruthful as ofthe date ofsubmission. 3. I am submittingwiththis notice all test data in my possession orcontrol and a description ofall otherdataknownto or reasonably ascertainable byme as requiredby §720.50 ofthe PremanufactureNotification Rule.
AdditionalCertification Statements: Ifyou are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following userfee certification statementthat applies: 

## IZI The Company named in PartI, Section A hasremittedthe fee of$2500 specified in 40 CFR700.45(b), or 

# o The Companynamed inPartI, SectionA has remitted the fee of$1000 for an Intermediate PMN (defined @40 CFR 700.43) in accordancewith40 CFR700.45(b), or 

# o The Company named in PartI SectionA is a small business concern under40 CFR700.43 andhasremitted a fee of$100 in accordance with40 CFR700.45(b). Ifyou are submittinga lowvolumeexemption (LVE) application in accordance with40 CFR723.50(c)(l)ora Low release and low exposureexemption (LoRex) application in accordance with40 CFR723.50(c)(2), checkthe following certification statements: 

# o The manufacturer submittingthis notice intends to manufacture or import the new chemical substance for commercial purposes, otherthan in small quantities solelyfor research and development, underthe terms of40 CFR 723.50. 

# oThe manufacturer is familiar with the terms ofthis section and will comply with thoseterms; and 

# oThenewchemical substance for which the notice is submittedmeets all applicable exemption conditions. 

# o Ifthis application is for anLVEin accordance with 40 CFR723.50(c)(l), the manufacturer intends to commence manufacture ofthe exempted substance for commercialpurposes within I year ofthe date oftheexpirationofthe 30 day reviewperiod.
Theaccuracy ofthe statementsyou malrein this noticeshould reReet your hest predictionofthe anticipated facts regardingthechemical substance described herein. Any knowin!!: andwillful misinterpretationis subiectto criminal penalty pursuantto 18 USC 1001. Confidential Signature andtitle ofAuthorized Official (Original Signature Required) Date 

# I!i/LLrL 7'

# /l.**~** /Of4" Signature ofag6nt ,apPlicablev Date'7**~/'** I /

EPAFORM 7710-25 (Rev. 5-95) Page 2 I, lao Person Submitting Notice (in U.S.)

b. Agent (if applicable) Road

Company Mailing address (number and street) City, State, ZIP Code Telephone

c. Ifyou are submittingthis notice as partofajointsubmission, mark (X) this

# uu;'.-----------------

____ ...,LJ Joint Submitter (if applicable) Nameofauthorized official Company Mailing and street)

2. Technical Contact (in U.S.)

3. City, State, ZIP Code

Nameofauthorized official

4. Ifyou previously submitted an exemption application for the chemical substance covered by this notice, enterthe exemption munberassigned by EPA. Ifyou previously submitted aPMN forthis substance enterthe PMN number assigned byEPA (i.e. withdrawn or incomplete).**~** 5.

6. Type ofNotice

- Mark (X) I. 

## D Manufacture Only BindingOption Mark 12. I I I Position

Telephone

Position

Telephone

Import Only Mark (X) ifnone
Mark (X) ifnone
Mark (X) ifnone

BindingOption Mark I I 3. I I I 

## D Both Confidential

EPA FORM 7710-25 (Rev. 5-95) Page 3Completeeither item I (Class I or2 substances) or 2 (Polymers) as appropriate. substance based on

Ifanotherperson will submit chemical identity information for you (foreitherItem I or 2), mark (X) the box attheright. the ofthat in a continuation I. Class I or 2 chemical substances (for definitions ofclass I and class 2 substances, see the Instructions Manual) a. Class ofsubstance

- Mark (X) I 

## D Class I or 2 

## D Class 2 b, Chemical name (CurrentlycorrectChemical Abstracts (CA) Namethatis consistentwith TSCAInventory listings for similar substances. ForClass I substances a CAIndexName mustbe provided, For Class 2 substanceseithera CAIndexNameorCA Preferred Namemust be provided, which everis appropriate based on CA9CInomenclaturerules and conventions). 

### N/A

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

## D Method I (CAS Inventory Expert Service - a copy ofthe Identification 

## D Method 2 (Other Source) reportobtained from the CAS Inventory Expert Services mustbe submitted as an attachmentto this d. Molecular formula and CAS Registry Number (ifa number already exists for the substance) 

### N/A CAS# 

### N/A

e, For a class I substance, provide a complete and correct chemical structurediagram. For a class 2 substance

- (I) Listthe immediate precursor substanceswith theirrespective CAS RegistryNumbers. (2) Describethe nature ofthe reaction orprocess, (3) Indicate the range ofcomposition andthetypical composition (where appropriate). (4) Provide a correctrepresentative orpartial chemical structure diagram, as complete as canbe known, ifone can bereasonably ascertained. 

### N/A

attach a continuation sheet.

EPA FORM 7710-25 (Rev. 5-95) Page 4a. Indicate the number-average weight ofthe lowestmolecularweight composition ofthe polymeryou intend to manufacture. Confidential Indicate maximum weight percentoflowmolecular weightspecies (notincludingresidual monomers, reactants, orsolvents) below 500 and X below 1,000 absolute molecular weight ofthat composition. Describe the methods ofmeasurement orthe basis foryour estimates: GPC

## 0 Other 

## 0:(SpecifY) i) lowest number average molecularweight: ii) maximum weight % below 500 molecularweight: iii) maximumweight% below 1000molecularweight: attach a continuation sheet. You must make separate confidentiality claims for monomer or otherreactant identity, composition information, and residual information. Mark (X)the "Confidential" box nextto any item you claim as confidential (I)
- Provide the specific chemical name and CAS Registry Number (ifa numberexists) ofeach monomerorother reactant used in the manufacture of the poIymer. Mark (X) this column ifentry in column (I)is confidential. Indicate the typical weightpercentofeach monomer or otherreactantin the polymer. (2)

- (3)

- (4)

- Mark (X)the identity column ifyou want amonomeror other reactant used attwo weightpercent orlessto be listed as part ofthe polymer description on the TSCA Chemical Substance Inventory. Mark (X) this column ifentries in columns (3) and (4) are confidential. (5)

- (6)

- Indicate the maximum weight percentofeach monomer or otherreactant thatmay be presentas aresidual in the polymer as manufactured for commercial purposes. Mark this column if is confidential. Monomerorotherreactant and CAS Registry Number

% % % %

%

c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice (checkone). 

### [8] Method I (CAS Inventory Expert Service - acopy ofthe identification report 

## 0 Method 2(othersource) obtained from CAS Inventory Expert Service mustbe submitted as as attachmentto this d. The currently correctChemicalAbstracts (CA) name for the polymerthat is consistent with TSCA Inventory listings for similar polymers. See Services Inv,..nt,nru e. Provide acorrectrepresentative orpartial chemical structure diagram, as complete as can be known, ifone can be reasonably ascertained.
CONFIDENTIAL % % % % %

attach acontinuation sheet.

EPA FORM 7710-25 (Rev. 5-95) Page 5

### Part I -- GENERAL INFORMATION -- Continued Section B-­ 'Ar 1UJ<,J'j 1 11 r INFORMATION

-- Continued 3. Impurities (a) 

### - Identify each impurity thatmay 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 "unidentified." (b) 

### - Estimate the maximum weight%ofeach impurity. Ifthere are unidentified' estimate their total weigilt%. Impurity and CAS Registry Number Maximum Confipercent dential (a) (b) Decamethylcyclopentasiloxane (CASRN 541-02-6) 0.4 % Octamethylcyclotetrasiloxane (CASRN 556-67-2) 0.6% Cyclosiloxanes, di-Me (CASRN 69430-24-6) 0.4% % % % % 

### [ ] Mark (X) this box ifyou attach a continuation sheet. 4. Synonyms

- Enter any chemical synonyms for the new chemical identified in subsection I or2. Confidential None 

## D Mark (X) this box ifyou attach a continuation sheet. 5. Trade identification

- List trade names for the new chemical substance identified in subsection I or 2. None 

## D Mark (X) this box ifyou attach a continuation sheet. 6. Generic chemical name ­ Ifyou claim chemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity ofthe new chemical substanceto the maximum extent possible. Refer to the TSCA Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names. Amino-functional siloxane



# . D Mark (X) this box ifyou attach a continuation sheet. 7. Byproducts

­ Describe any byproducts resulting from the manufacture, processing, use, or disposal ofthenew chemical substance. Provide the CAS Registry Number ifavailable. CAS Registry Number Confi­**uJI'(~)u",** (2) dential None



## [ ] Mark (X) this box ifyou attach a**"()ntinll~ti()n** sheet.

EPAFORM 7710-25 (Rev. 5-95) Page 6

### PartI

-- GENERAL INFORMATION

-- Continued Section C

-- PRODUCTION,IMPORT,AND USE INFORMATION: Mark (X) the "Confidential" box next to any itemyou claim as confidential. 1. Production volume

-- Estimatethe maximum production volume duringthe first 12 months ofproduction. Also estimate the maximum production volume for any consecutive 12-month period duringthe first three years ofproduction. Estimates should be on 100%new chemical substance basis. For a Low Volume Exemption application, ifyou choose to have your notice reviewed at a lower production volume than 10,000 kg/yr, specifythe volume and mark (x) in the binding box. Ifgranted, you are bound to this volume Maximum first 12-monthproduction (kg/yr) Maximum 12-monthproduction (kglyr) Confi- Binding (100% new chemical substance basis) (100% new chemical substance basis) dential Option Mark (x) CONFIDENTIAL CON FI DENTIAL X 2. Use Information

-- You mustmake 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. (1)

-­ Describe each intended category ofuse ofthe new chemical substance by function and application
.. (2)

-­ Mark (X) this column ifentry column (1) is confidential business information (CBI). (3)

-­ Indicate your willingness to havethe information provided in column (1) binding. (4)

-­ Estimate the percent oftotal production for the first threeyears devoted to each category ofuse. (5)

-­ Mark (X) this column ifentry in column (4) is confidential business information (CBI). (6)

-­ Estimate the percent ofthe new substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for commercial purposes at sites under your control associated with each category ofuse. (7)

-­ Mark (X) this column ifentry in column (6) is confidential business information (CBI). (8)

-­ Indicate % ofproduct volume expected for the listed "use" sectors. Mark more than one box ifappropriate. Mark (X) to indicate your willingness to have the usetype provided in (8) binding. (9)

-­ Mark (X) this column ifentry(ies) in column (8) is (are) confidential business information (CBI). Category ofuse (1) CBI Binding Produc- CBI %in CBI % ofsubstanceexpected per use CBI Option tion % Form­ (8) (by function and application i.e. adispersive dye Mark (x) ulation Site- Con-* Indus- Com- Binding for finishing polyesterfibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercial Option (9) Silicone textile treatment X 100 % 89% X X

% % % % % % % % % % % % * Ifyou have identified a "consumer" use, please provide on acontinuation sheet adetailed description oftheuse(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 substance loses its identity in the consumer product. 

# D Mark (X) this box ifyou attach acontinuation sheet. b. Generic Ifyou claim any category ofuse description in subsection 2a as confidential, enter ageneric description ofthatcategory. Read the use Instructions Manual for examples ofgeneric use descriptions. description N/A


# D Mark (X) this box ifyou attach acontinuation sheet. 3_ Hazard Information

-- Include in the notice acopy 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 Option for the safe handing, transport, use, or disposal ofthe new substance. List in part 1II hazard information you include. Mark (x) X 

## I:8J Mark (X) this box ifyou attach hazard information.

EPA FORM 7710-25 (Rev. 5-95) Page 7Section A-- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER**~o.nIJ(lI:nI'lal** claim box nextto any you Complete section A for each typeofmanufacture, processing, oruse operation involvingthe new chemical substanceat industrial sitesyou control. Importers do nothaveto complete this section for operations outsidetheU.S.; however, you may still have reporting requirements if there are further industrial oruse after' You mustdescribe these Seeinstructions manual l. Confiofthe siteat which the nn,-rlltum will occur. dential

Site address (number and street) City, County, State, ZIP code
Ifthe sameoperation will occuratmore than one site, enterthe numberofsites. IdentifY the additional siteson a continuation sheet, and ifany ofthe sites have significantly different productionrates oroperations, include allthe information requested in this section forthose sitesas attachments.

Use

Maximum kglbatch (100"10 new chemioal I Hourslbatch I Batches/year substance) I N/A I I I 2. Continuous (I) Diagramthe majorunitoperation steps and chemical conversions. Include interim storage and transport containers (specifY- e.g. 5 gallon pails, 55 gallon drum, rail car,tank truck, etc.). (2) Provide the identity, the approximate weight (bykg/day orkglbatch on a 100% new chemical substance basis), and entrypointofall startingmaterials and feedstocks (including reactants, solvents. catalysts, etc.), and ofall products,recycle streams. and wastes. Includecleaning chemicals (note frequency ifnot used daily or perbatch.). (3) IdentifY by numberthe points ofrelease, includingsmall or intermittentreleases, to the environmentofthe new chemical substance. N/A

attach a continuation sheet. I. Batch

d. Process description Mark (X) to indicateyourwillingnessto have your process description binding.

EPA FORM 7710-25 (Rev. 5-95) Page 8

### Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section A

-- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER-- Continued 

## I 2. Occupational Exposure

­ You must make separate confidentialityclaims for the description ofworker activity, physical form ofthe new chemical substance, numberofworks exposed, and duration ofactivity, Mark (X) the "Confidential" box next to any item you claim as confidential, (I)
-­Describethe activities (i.e, bag dumping, tote filling, unloading drums, sampling, cleaning,etc,) in which workers may be exposed to the substance, (2)

--Mark (X) this column ifentry in column (I) is confidential business information (CBI), (3)

--Describe any protectiveequipment and engineeringcontrols 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) ofthenew chemical substance (e,g., solid: crystal, granule, powder, or dust) and % new chemical substance (ifpartofa mixture) at thetime ofexposure, (7)

--Mark (X) this column ifentry in column (5) is confidential business information (CBI), (8)

--Estimate the maximum number ofworkers involved in each activity for all sites combined, (9)

--Mark (X) this column ifentry in column (8) is confidential business information (CBI), (10) and (11)

-- Estimatethe maximum duration ofthe activity for any worker in hours per dayand days per year, (12)

-- Mark (X) this column ifentries in columns (10) and (II) are confidential business information (CBI), Worker activity eBI ProtectiveEquipment! Binding Physical fonns(s) Binding eBI #of eBI Maximum duration eBI (i.e" bag dumping, filling drums) Engineering Controls Option and % new Option Workers Hrs/day Dayslyr Mark (x) substance Mark (x) Exposed (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) N/A X

!



# o Mark (X) this box ifyou attach a continuation sheet.

3. EnvironmentalRelease andDisposal-- You mustmake separateconfidentiality claims for the release number and the amount ofthe new chemical substance released and other release and disposal information, Mark (X) the "Confidential" box next to each item you claim as confidential, (1)

--Enterthenumber ofeach release point identified in the process description, partII, section A, subsection Id(3), (2)

--Estimatethe amount ofthe newsubstance released (a) directlyto the environmentor (b) into control technology (in kg/dayorkglbatch), (3)

--Mark (X) this column ifentries in columns (I) and (2) areconfidential business information (CBI), (4)

--IdentifY the media(stack air, fugitive air (optional-see Instruction Manual), surface water, on-siteoroff-site land or incineration, POTW, orother (specifY» to which thenew substancewill bereleased from thatrelease point. (5)

-- a, Describe control technology, ifany, and control efficiencythatwill be used to limitthe release ofthenewsubstance to theenvironment. For releases disposed ofon land, characterizethe disposal method and statewhether itis approved for disposal ofRCRAhazardous waste, On a continuation sheet, for each site describe any additional disposal methods thatwill be used and whetherthe waste is subjectto secondary ortertiaryon-sitetreatment. b. Estimate the amountreleased to theenvironment after control technology (in kg/day), (6) --Mark (X) this column ifentries in columns (4) and (5) are confidential business information (CBI), (7)

--IdentifYthe destination(s) ofreleases to water, Please supplyNPDES (National PollutantDischarge Elimination System) numbers for direct discharges or NPDES numbers ofthe POTW (Publici OwnedTreatmentWorks), Mark(X) ifthe POTW nameorNPDES # is confidential business information (CBI), Release Amount ofnew substance CBI Media of Control technology andefficiency (you maywishto optionallyattach efficiencydata) CBI Number released release (6) I

(1) (2a) (2b) e.g, stack air I Binding (3) (4) (Sa) 1 Morlc(X) (5b) N/A I I I I I I I I I I I I I 1 I (7) Mark (X) the 

# o POTWprovide name(s) below: CBI 

# o Navigable 

# D Other

- SpecifY provide NPDES# CBI



### - destination(s) of waterway releases to water,



### ] Mark (X) this box ifyou attach a continuation sheet.

EPA FORM 7710-25 (Rev. 5-95) Page9

### Part 11-- HUMANEXPOSUREAND ENVIRONMENTAL RELEASE

-- Continued Section B

-- INDUSTRIAL SITESCONTROLLED BY OTHERS Complete section B for typical processingor use operations involving the new chemical substance at sites you do not control. Importers do not have to completethis section for operations outsidethe U.S.; however, you must reportanyprocessingor use activities after import. Seethe Instructions Manual. Complete a separate section B for each type of processing. oruse operation involvingthenew chemicalsubstance. Ifthe same operation is performed atmore than one site describe the typical operation common to these sites. IdentifY additional sites on acontinuation sheet. 1. Operation Description

-- To claim information in this section as confidential, circle or bracketthe specific information thatyou claim as confidential. (I)

-- Diagram the major unitoperation steps and chemical conversions, including interim storage and transportcontainers (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)

-- Provide the identity, the approximateweight (by kg/dayorkg/batch, on an 100% new chemical substance basis), and entry point ofall feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnot used dailyorper batch). (3)

-- IdentifY by number the points ofrelease, including small orintermittentreleases, to theenvironment ofthe new chemical substance. (4) Please enterthe # ofsites (rememberto identifythe locations of these sites on a continuation sheet): 10 # ofsites
Customer Processing (Formulation): continued, page 10.2

Mark (X)this box ifyou attach a continuation sheet. 2. WorkerExposurefEnvironmental Release (I)

­ From the diagram above, providethe letter for each worker activity. Complete 2-8 for each worker activity described. (2)

--Estimate thenumber ofworkers exposed for all sites combined. (4)

--Estimatethe typical duration ofexposureper worker in (a) hours per day and (b) days peryear. (6)

--Describephysical form ofexposure and % new chemical substance (ifin mixture), and any protectiveequipment and engineering controls, ifany, used to protectworkers. (7)

--Estimate the percentofthenew substance as formulated when packaged orused as a final product. (9)

--From the process diagram above, enterthe number ofeach release point. Complete 9-13 for eachrelease point identified. (10)

-- Estimate the amountofthenew substance released (a) directly to the environmentor (b) into control technology to the environment (in kg/day or kglbatch). (12)

-- Describe mediaofrelease i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site oroff-site land or incineration, POTW, orother (specify) and control technology, ifany, thatwill be used to limitthereleaseofthe new substancetothe environment. (14)

-- IdentifY byproducts which may resultfrom theoperation.

(3), (5), (8), 1I), (13) and (15)

-- Mark (X) this column ifanvoflhe**proceedin~** entries are confidential business information{CBI). Letter # of CBl Duration CBt Protective Equip. I %in CBI Release Amount of CBl Media ofRelease CBI

of Workers of Engineering Controlsl Fonn- Nwnber New & Control Act- Exposed Exposure Physical Form and % ulation Substance Technology ivity new substance Released (I) (2) (3) (4a) I (4b) (5) (6) (7) (8) (9) (lOa) I (lOb) (II) (12) (13) (A) 2 4 I 25 I See MSDS 9-18 (1 ) 0.0 I 0.0 See page I ! kg/btch1kg/btch 10.2 (B) 1 2 I 25 ISee MSDS 9-18 I I I I I I I I I I I I (14)

-- Byproducts: (15) None Mark (X)this box ifyou attach a continuation sheet,
EPA FORM 7710-25 (Rev. 5-95) Page 10/

## CUSTOMER PROCESSING PROCESS DESCRIPTION (FORMU LATION)
(400 Kg/Batch)* A1 (60 Kg/Batch) SF1



## .... 

# - EMULSIFICATION (A)(1) (140 Kg/Batch) SF2 (1400 Kg/Batch) S1
PACKAGING 

### (B) (DRUM-OFF) 

# " 2,000 Kg Emulsion Containing 356 Kg New Chemical Substance TSDDC245

*Containing 356 Kg New Chemical Substance TSDDC245

Page**1~** 

# II

## CONFIDENTIAL

Page 1-EHr 

# 12­

## CUSTOMER PROCESS DESCRIPTION (FORMULATION, CONTINUED)

Section B.2.(12) Media of Release & Control Technology Release (1), Continued: DOW CORNING® 2-8500 Hydrophilic Softenerwill be supplied to industrial customers in standard drums. Customers most likely will empty the drums using a dip tube, tilting the drum to ensure removal of remaining product. Given the cost ofthe product per pound, customers would have every incentiveto ensure complete removal ofthe productfrom the drum. Based on our experience with similar materials, Dow Corning would expectthat only about 0.5 - 1.0 Kg DOW CORNING® 2-8500 Hydrophilic Softenerwould remain in a standard 220 kg drum after use bythe customer. Pursuantto Dow Corning's commitmentto Responsible Care®, Dow Corning provides technical information and experience to customers to promote and support waste and release reduction. Dow Corning recommends that its customers use the ContainerNet® collection program to promotethe most economical and environmentally responsible use ofcontainers. This program is available to all ofour customers using drums and permits customers tovirtually eliminate the problem ofdisposing of residual material left in drums. The ContainerNet® program relies upon experienced, knowledgeable companies that recondition drums and other containers. The companies are audited by Dow Corning and independentauditors to verify that they meet ourenvironmental, health and safety standards. Priorto pick-up, the ContainerNet® program requires that drums bedrip dry, all labels and closures must be in place, and the end user must provide a current Material Safety Data Sheet (MSDS) forthe product. ContainerNet® reconditioners normally use a pre-flush with a 15% caustic solution that later is reused and recycled in a separate process. The drums then are de-headed and placed in a furnace at 1300°F. This process makes it highly unlikelythat any residual DOWCORNING® 2-8500 Hydrophilic Softenerwould be released tothe environment orflushed to a publicly owned treatmentfacility. Accordingly. we anticipate 0 kg/year pre- and post-treatment environmental release ofthe PMN chemical substance resulting from disposal ofspent packaging by textile formulators.

Page ""10&:4­ 

# 13

### Part 11-- HUMANEXPOSURE AND ENVIRONMENTALRELEASE -- Continued Section B -- INDUSTRIALSITES CONTROLLEDBY OTHERS Complete section B fortypical processingor 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 oruse activities afterimport. Seethe Instructions ManuaL Complete aseparate sectionB for each type of processing, oruse operation involving the newchemicalsubstance. Ifthe same operation is perfonned at more than one site describe the typical operation common tothese sites. Identify additional sites on acontinuation sheet. 1. OperationDescription

-- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidentiaL (I)

-- Diagramthe major unitoperation steps and chemical conversions, including interim storage and transport containers (specifY

- e.g. 5gallon pails, 55 gallon drums, rail cars, tank trucks, etc). On the diagram, identifY by letter and briefly describe each worker activity. (2)

-- Provide the identity, the approximate weight (by kg/day orkglbatch, on an 100%new chemical substanee basis), and cntry pointofall feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnotused daily or per batch). (3) --IdentifY by numberthe points**ofrelea~e,** including small or intennittentreleases, to the environmentofthe new chemical substance. (4) Please enterthe# ofsites (rememberto identify the locations of these sites on acontinuation sheet): 30 #ofsites
Customer Processing (Application): continued, page 10.6

Mark (X) this box ifyou attach acontinuation sheet. 2. WorkerExposure/Environmental Release (I)

--From the diagram above, provide the letter for each workeractivity. Complete 2-8 for each worker activity described. (2)

--Estimate the numberofworkers exposed for all sites combined. (4)

--Estimate the typical duration ofexposure perworker in (a) hours perday and (b) days peryear. (6)

--Deseribephysical fonn ofexposure and % new chemical substance (ifin mixture), and any protective equipment and engineering controls, ifany, used to protectworkers. (7)

-- Estimate the percentofthe new substanee as fonnulated when packaged orused as afinal product. (9)

--Fromthe process diagram above, enterthe number ofeach release point. Complete 9-13 for each release point identified. (10)

-- Estimate the amount ofthe new substanee released (a) directly to theenvironmentor(b) into control technologyto the environment (in kg/day orkglbatch). (12)

-- Describe mediaofrelease i.e. stack air, fugitive air(optional-see Instructions Manual), surfaee water, on-site oroff-site land or incineration, POTW, orother (specifY) and control technology, ifany, thatwill be used to limitthe release ofthe new substanee to the environment. (14)

-- Identify byproducts which may resultfrom the operation. I

(3), (5), (8), 11), (13) and (15)

- Mark (X) this column ifany ofthe proceedingentries are confidential business infonnation (CBI). Letter #of CBI Duration CBI Protective Equi p. I (t/ojn CBI Release Amount of CBI Media ofRelease CBI of Workers of EngineeringControlsl Fonn- Number New & Control Act- Exposed Exposure Physical Fonn and % ulation Substance Technology ivity new substanee Released (I) (2) (3) (4a) I (4b) (5) (6) (7) (8) (9) (lOa) I (lOb) (11) (12) (13) (1) 2 8 1 250 See MSDS 1 (1) 0.0 I 0.07 See page 1 kg/d 1 kgJd 10.8 I 1 I I 1 1 I I 

# : I I 1 I 1(14)

-- Byproducts: (IS) None Mark (X) this box ifyou attach a continuation sheet,
EPA FORM 7710-25 (Rev. 5-95)**Page~** 

# ''+

## CUSTOMER PROCESSING DESCRIPTION (APPLICATION)

(40 Kg/Day)* APPLICATION Emulsion 

# • (PADDING OR Water (A)(1) 

# - - EXHAUSTAPPL.) Textile 

# - - " THERMAL DRYING (CURING) 

# " Treated Textile

* Containing 7.1 Kg New Chemical Substance TSDCC245**Page~** 

# IS­

## CONFIDENTIAL

Page 1&.T## I~

## CUSTOMER PROCESS DESCRIPTION (APPLICATION, CONTINUED)

Section 8.2.(12) Media of Release & 

### Control Technology Release (1), Continued: Customer application will occur at 25-30 applicator sites, 250 days peryear, with each site using 40 kg/day offormulated textile treatment containing (18 weight percent) 7.1 kg ofthe new chemical substance. For reasons ofefficiency and cost effectiveness, applicators require exhaustion of95-99 percent ofthe finish solids onto the fabric. Dow Corning has performed a laboratory evaluation ofthe exhaust characteristics of the new chemical substance and established that undertypical application conditions (1.7 weight percent new chemical SUbstance in aqueous bath, adjusted to pH 4 with acetic acid), 99.0 weight percent ofthe new chemical substance was exhausted onto the test fabric after only 60 minutes. Accordingly, even assuming that 100 percent of application would occurvia padding, with periodic dumping ofthe exhausted bath, as opposed to application via an exhaust procedure, in which the exhausted bath simply is replenished by addition of new formulated textile treatment, we calculate a maximum daily pre-treatment environmental release of0.07 kg per day per site for the new chemical substance. Ifwe assume 90 weight percent removal ofthe new chemical substance through waste watertreatment, a post-treatment environmental release of 0.007 kg perday per site is obtained. Application ofthe above discussed 99.0 percent exhaust rate to partitioning ofthe new chemical substance during waste watertreatment provides a post-treatment environmental release of0.0007 kg per day per site.

Page-4&.&­ 

# 11

## OPTIONALPOLLUTIONPREVENTIONINFORMATION Toclaim information in this section as confidential circle orbracket the specific informationthat you claim as confidential. 

### Inthis section youmayprovide information notreported elsewhere inthis form regarding your effortsto reduce orminimizepotential risks associated with activities surrounding manufacturing, processing, use and disposal ofthe PMN substance. Please include newinformationpertinentto pollutionprevention, including source reduction, recycling activities and saferprocesses orproducts available due to the newchemical substance. Sourcereduction includes the reductionin the amountortoxicity ofchemical wastes by technological modification, process and procedure modification, productreformulation, rawmaterials substitution, and/or inventorycontrol. Recycling refers to the reclamation ofuseful chemical components from wastes thatwould otherwise be treated orreleased as air emissions orwater discharges, orland disposal. Descriptions ofpollution prevention, source reduction andrecycling should emphasize potential riskreduction subsequentto compliance withexistingregulatoryrequirements and canbe eitherquantitative orqualitative. The EPAis interested in the informationto assess overall netreductions intoxicity orenvironmentalreleases andexposures, notthe shifting ofrisks to other environmental mediaor non-environmental areas (e.g., occupational or consumer exposure). In addition, information onthe relative costorperformance characteristics ofthe PMN substance to potential alternatives maybeprovided. 

### All informationprovided in this sectionwill betakenintoconsideration duringthe review ofthis substance. SeeInstructionsManual and Pollution Prevention Guidancemanualforguidanceand examples. Describe the expected netbenefits, such as (1) an overall reduction in riskto human health orthe environment; (2) a reduction in the volume manufactured; (3) a reduction in the generation ofwaste materials through recycling, source reduction orothermeans; (4) a reduction in potentialtoxicity orhuman exposure and/orenvironmental release; (5) an increase in productperformance, a decrease in the costofproductionand/or improved operation efficiency ofthe new chemical substance in comparisonto existing chemical substances used in similarapplication; or(6) the extenttowhichthe new chemical substance may be a substitute for an existing substancethatposes a greater overall riskto human health orthe environment. The newchemical substance will be supplied as a formulated mixture containing 89 weight percent ofthe new chemical substance to textile formulators who typically will formulate the mixture at 10-20weight percent (9-18 weight percent new chemical substance) into aqueous emulsions along with appropriate nonionic surfactants. Formulators will supply such textile treatmentformulations to textile mills for use as textile softeners, offering superior softening performancewhen compared to currently available hydrophilic silicone fabric softeners. Application typically will occur by padding or exhaust application, followed by drying! thermal curing to afford cured treated textiles, obviating any further occupational exposure to, or environmental release of, the newchemical substance.



# o Mark (X) this boxifyou attach a continuation sheet.

EPA FORM 7710-25 (Rcv.5-95) Page+'!""

## I~

### PartIII -- LIST OFATTACHMENTS
Attach continuation sheets for sections oftheform and test dataand other data (includingphysical/chemical properties and structure/activity information), and optional information after this page. Clearly identify the attachment and the section ofthe form to which it relates, ifappropriate. Number consecutivelythe pages ofthe attachments. In the column below, enter the inclusive page numbers ofeachattachment

. Mark (X)the "Confidential"box next to any attachment name you claimas confidential. Read the Instructions Manual for guidanceon

howto claim any information in an attachment as confidential. You must include with the sanitized copy ofthe notice form a sanitized version ofany attachment in which you claim information as confidential. Attachmentname Attachment Confipage number(s) dential I MaterialSafetyData Sheet(MSDS) DOW CORNING®2-8500 Hydrophilic Softener CAS Registry Services Inventory Export Service Report: New Chemical Substance TSDCC245 II An Acute Oral Toxicity Study ofTX-81-2001-17 in Albino Rats III An Acute Eye Irritation Study ofTX-81-2001-17 in the NewZealand White Rabbit IV An Acute Dermal Toxicity Study ofTX-81-2001-17 in Rabbits V An Acute Dermal Irritation Study ofTX-81-2001-17 in Rabbits VI An Acute Static ToxicityTest ofTX-81-2001-17 with Daphnia magna VII An Acute Static Toxicity TestofTX-81-2001-17 with RainbowTrout VIII Genetic Evaluation ofTX-81-2001-17 in Bacterial Reverse Mutation Assays IX

i I



## D Mark (X) this box ifyou attach acontinuation sheet Enterthe attachmentname and number.

EPA FORM 7710-25 (Rev. 5-95) Page Ioi:­PHYSICALAND CHEMICALPROPERTIES WORKSHEET To assistEPA's review ofphysical and chemical properties data, please complete the following worksheetfor datayou provide and include itin thenotice. IdentifY the property measured,thepage ofthe notice on whichthe property appears, the valueofthe property, the units in whichthe property is measured (as necessary), and whether or not the property is claimed as confidential. The physical stateofthe neat substance should be provided. These measured properties should be for the neat(100%pure) chemical substance. Propertiesthatare measured for mixtures orformulations should be so noted (% PMN substance in--.J. You are not required to submitthis worksheet; however, EPAstronglyrecommends thatyou do so, as itwill simplifY reviewand ensure that confidential information is properlyprotected. You should submitthis worksheet as a supplementto your submission oftestdata. This worksheet is not a substitute for submissionoftestdata. Property Mark (X Page Value Measured OJ Confiif numbe Estimate dential (a) provided (b) (c) Mark (X) (M orE) (d) Physical state ofneat substance X (s) X (I) (g) M Vaporpressure @ Temperature 

### °C Torr Density/relative density Specific gravity (25°C) X 1.2 M Solubility @ Temperature 

### °C

Solvent gIL 

## I S()lubility in water @ Temperature 

### DC gIL

Meltingtemperature 

### DC Boiling/ sublimationtemperatureCaJ. torrpressure 

### DC 

### I Spectra Dissociation constant Particle size distribution Octanol/waterpartitioncoefficient Henry'sLawconstant Volatilization from water Volatilization from soil pH @ concentration Flammability Explodability I Adsorption/ coefficient Other

- Specify Viscosity M 4,000 cps M

EPAFORM 7710-25 (Rev. 5-95) Pager4*"**~**

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER Page: 1/8



### 1. IDENTIFICATION OFTHE SUBSTANCE AND OF THE COMPANY Dow Corning Corporation South Saginaw Road Midland, Midland 48686 24 Hour EmergencyTelephone: (517) 496-5900 Customer Service: (517) 496-6000 Product Disposal Information: (517) 496-6315 CHEMTREC: (800) 424-9300 MSDS No.: 03321444 Generic Description: Organofunctional Siloxane Physical Form: Liquid Color: Translucent white Odor: Some odor Revision Date: 1999/11/18

NFPA Profile: Health 2 Flammability 2 Instability/Reactivity 0 Note: NFPA=National Fire Protection Association 2. OSHA HAZARDOUS COMPONENTS

CAS Number Wt% Coml2onent Name None >60.0 Aminofunctional siloxane 90604-31-2 10.0 - 30.0 Fatty alcohols 556-67-2 0.5 - 1.5 Octamethylcyclotetrasiloxane 541-02-6 0.1 - 1.0 Decamethylcyclopentasiloxane
The above components are hazardous as defined in 29 CFR 1910.1200. 3. EFFECTS OF OVEREXPOSURE Acute Effects Eye: Skin: Inhalation:
Oral: Direct contact maycause severe irritation. May cause moderate irritation. Vapor and/or mist irritating to the respiratory tract. Overexposure by inhalation may cause drowsiness, dizziness, confusion or loss of coordination. May cause irritation to the mouth, throat and stomach. Prolonged/Rel2eated EXl20sure Effects Skin: No known applicable information. Inhalation: Product generates methyl alcohol which may cause blindness and damage to nervous

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet Page: 2/8 

### DOW CORNING(R) 2-8500 

### HYDROPHILIC SOFTENER system. Oral: Product generates methyl alcohol which may cause blindness and possibly death if swallowed. Signs and Symptoms ofOverexposure No known applicable information. Medical Conditions Aggravated by Exposure No known applicable information. The above listed potential effects ofoverexposure are based on actual data, results ofstudies performed upon similar compositions, component data and/or expert review ofthe product. Please referto Section 11 forthe detailed toxicology information. 4. FIRST AID MEASURES Eye: Immediatelyflush with waterfor 15 minutes. Get medical attention. Skin: Remove from skin and wash thoroughlywith soap and water orwaterless cleanser. Get medical attention if irritation or other ill effects develop or persist. Inhalation: Remove to fresh air. Get immediate medical attention. Oral: Get medical attention. Comments: Treat according to person's condition and specifics of exposure. NG MEASURES Flash Point: > 142 OF 1> 61°C Closed Cup Autoignition Not determined. Temperature: Flammability Limits in Air: Not determined. Extinguishing Media: On large fires use dry chemical, foam orwater spray. On small fires use carbon dioxide (C02), dry chemical or water spray. Water can be used to cool fire exposed containers. Fire Fighting Measures: Self-contained breathing apparatus and protective clothing should be worn in fighting large fires involving chemicals. Determine the need to evacuate or isolate the area according to your local emergency plan. Use water sprayto keep fire exposed containers cool. Unusual Fire Hazards: None.

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet Page: 3/8 

### DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER
Hazardous Decomposition Products Thermal breakdown ofthis product during fire orvery high heat conditions mayevolve the following hazardous decomposition products: Carbon oxides and traces of incompletely burned carbon compounds. Silicon dioxide. Nitrogen oxides. Chlorine compounds. Formaldehyde. 6. ACCIDENTAL RELEASE MEASURES Containment/Clean up: Determine whetherto evacuate or isolate the area according to your local emergency plan. Observe all personal protection equipment recommendations described in Sections 5 and 8. For large spills, provide diking or other appropriate containment to keep material from spreading. If diked material can be pumped, store recovered material in appropriate container. Clean up remaining materials from spill with suitable absorbant. Clean area as appropriate since some silicone materials, even in small quantities, may present a slip hazard. Final cleaning may require use ofsteam, solvents or detergents. Dispose ofsaturated absorbant orcleaning materials appropriately, since spontaneous heating may occur. Local, state, and federal laws and regulations may applyto releases and disposal ofthis material, as well as those materials and items employed in the cleanup of releases. You will need to determine which federal, state and local laws and regulations are applicable. Sections 13 and 15 ofthis MSDS provide information regarding certain federal and state requirements. Note: See section 8 for Personal Protective Equipmentfor Spills. Call Dow Corning Corporation, (517) 496-5900, ifadditional information is required. 7. HANDLING AND STORAGE Use with adequate ventilation. Product evolves flammable methyl alcohol when exposed to water or humid air. Provide ventilation during use to control exposure within Section 8 guidelines or use air-supplied or self-contained breathing apparatus. Avoid eye contact. Avoid skin contact. Do not breathe vapor, mist, dust, orfumes. Keep container closed. Do not take internally. Static electricitywill accumulate and may ignite vapors. Prevent a possible fire hazard by bonding and grounding or inert gas purge. Keep container closed and awayfrom heat, sparks, and flame. 8. EXPOSURE CONTROLS' PERSONAL PROTECTION Component Exposure Limits

CAS Number Component Name Exposure Limits None Aminofunctional siloxane See methyl alcohol comments. 90604-31-2 Fatty alcohols Vendor guide: TWA50 ppm.

Methyl alcohol forms on contact with water or humid air. Provide adequate ventilation to control exposures within guidelines ofWorksafe Australia: TWA 200 ppm. STEL, 250 ppm, skin absorption; OSHA PEL: TWA 200 ppm and ACGIH TLV-skin: TWA 200 ppm, STEL 250 ppm. Engineering Controls

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet Page: 4/8 

### DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER
Local Ventilation: Recommended. General Ventilation: Recommended. Personal Protective Equipment for Routine Handling Eyes: Use chemical worker's goggles. Skin: Wash at mealtime and end ofshift. Contaminated clothing and shoes should be removed as soon as practical and thoroughly cleaned before reuse. Chemical protective gloves are recommended. Suitable Gloves: Silver Shield(R). 4H(R). Inhalation: Use respiratory protection unless adequate local exhaust ventilation is provided or air sampling data show exposures are within recommended exposure guidelines. Industrial Hygiene Personnel can assist in judging the adequacy ofexisting engineering controls. Suitable Respirator: Self-contained breathing apparatus (SCBA) orother supplied-air respirator. Personal Protective Eguipment for Spills Eyes: Skin:

Inhalation/Suitable Respirator: Precautionary Measures:
Comments: Use full face respirator. Wash at mealtime and end of shift. Contaminated clothing and shoes should be removed as soon as practical and thoroughly cleaned before reuse. Chemical protective gloves are recommended. Use self-contained bre?thing apparatus (SCBA) or other supplied-air respirator.
Avoid eye contact. Avoid skin contact. Do not breathe vapor, mist, dust, orfumes. Keep container closed. Do not take internally. Use reasonable care. Product evolves flammable methyl alcohol when exposed to water or humid air. Provide ventilation during use to control exposure within Section 8 guidelines or use air­ supplied or self-contained breathing apparatus. When heated to temperatures above 150 degrees C in the presence of air, product can form formaldehyde vapors. Formaldehyde is a potential cancer hazard, a known skin and respiratory sensitizer, and an irritant to the eyes, nose, throat, skin, and digestive system. Safe handling conditions may be maintained by keeping vapor concentrations within the OSHA Permissible Exposure Limit forformaldehyde.
Note: These precautions are for room temperature handling. Use at elevated temperature oraerosol/spray applications may require added precautions.

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet DOW CORNING(R) 2w8500 HYDROPHILIC SOFTENER Page: 5/8

9. PHYSICAL AND CHEMICAL PROPERTIES Physical Form: Liquid Color: Translucent white Odor: Some odor Specific Gravity @ 25°C: 1.2 Viscosity: 5,000 cSt Freezing/Melting Point: Not determined. Boiling Point: > 35C/95F Vapor Pressure @ 25QC: Not determined. Vapor Density: Not determined. Solubility in Water: Not determined. pH: Not determined. Volatile Content: Not determined. Note: The above information is not intended for use in preparing product specifications. Contact Dow Corning before writing specifications. 1

### O. STABILITYAND REACTIVITY Chemical Stability: Hazardous Polymerization: Conditions to Avoid: Materials to Avoid: Stable. Hazardous polymerization will not occur. None. Oxidizing material can cause a reaction. 11. TOXICOLOGICAL INFORMATION Acute Toxicology Data for Product Complete information is not yet available. Component Toxicology Information Complete information is not yet available. Special Hazard Information on Components No known applicable information. 12. ECOLOGICAL INFORMATION Environmental Fate and Distribution No specific information is available.

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet Page: 6/8 

### DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER
Environmental Effects No specific information is available. Fate and Effects in Waste WaterTreatment Plants No specific information is available. Ecotoxici Classification Criteria Hazard Parameters (LC50 or EC50) High Medium Low Acute Aquatic Toxicity (mg/L) <=1 >1 and <=100 >100 Acute Terrestrial Toxicit <=100 >100 and <= 2000 >2000 This table is adapted from "Environmental Toxicology and Risk Assessment". ASTM STP 1179, p.34, 1993. This table can be used to classifythe ecotoxicity ofthis product when ecotoxicity data is listed above. Please read the other information presented in the section conceming theoverall ecological safely ofthis material. 13. DISPOSAL CONSIDERATIONS RCRA Hazard Class (40 CFR 261) When a decision is made to discard this material, as received, is it classified as a hazardous waste? No State or local laws may impose additional regulatory requirements regarding disposal. Call Dow Corning Corporate Environmental Management, (517) 496-6315, ifadditional information is required. 14. TRANSPORT INFORMATION DOT Road Shipment Information (49 CFR 172.101) Proper Shipping Name: COMBUSTIBLE LIQUID, N.O.S. Hazard Technical Name: CYCLOSILOXANE Hazard Class: COMBUSTIBLE LIQUID UN/NA Number: NA1993 Packing Group: 111 Ocean Shipment (lMOG) Not subject to IMDG code.

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER Page: 7/8

Air Shipment (lCAO)
Not subject to ICAO regulations. Call Dow Corning Transporation, (517) 496-8577, ifadditional information is required. 15. REGULATORY INFORMATION Contents ofthis MSDS comply with the OSHA Hazard Communication Standard 29 CFR 1910.1200. TSCA Status: For R&D purposes only. One or more ofthe components ofthis product may not be listed on the TSCA inventory ofchemical substances. Product should be used solely for scientific experimentation, research oranalysis underthe supervision oftechnically qualified individuals. EPA SARATitle III Chemical Listings Section 302 Extremely Hazardous Substances: None. Section 304 CERCLA Hazardous Substances: None. Section 312 Hazard Class: Acute: Yes Chronic: Yes Fire: Yes Pressure: No Reactive: No Section 313 Toxic Chemicals: None present or none present in regulated quantities. Supplemental State Compliance Information California

Warning: This product contains the following chemical(s) listed by the State ofCalifornia underthe Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) as being known to cause cancer, birth defects or other reproductive harm. None known. Massachusetts No ingredient regulated by MA Right-to-Know Law present. NewJersey

### DOWCORNING 

## DOW CORNING CORPORATION Material Safety Data Sheet DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER Page: 8/8

CAS Number Wt % Component Name None > 60.0 Aminofunctional siloxane 90604-31-2 10.0 - 30.0 Fatty alcohols Pennsylvania CAS Number Wt % Component Name None > 60.0 Aminofunctional siloxane 90604-31-2 10.0 - 30.0 Fatty alcohols 16. OTHER INFORMATION Prepared by: Dow Corning Corporation These data are offered in good faith as typical values and not as product specifications. No warranty, either expressed or implied, is hereby made. The recommended industrial hygiene and safe handling procedures are believed to be generally applicable. However, each user should review these recommendations in the specific context ofthe intended use and determine whether they are appropriate. (R) indicates Registered TrademarkDOWCORNING



### CAS REGISTRY SERVICES INVENTORY EXPERT SERVICE REPORT NEW CHEMICAL SUBSTANCE TSDCC245

RGD99160

Dow Comill).; Corporatioll :\1idland. \lichi)!;<tll 4HliH(i-O!J\H Phone; (.) 17) ,1L)fi-40()()

# Clli InventoryExpert Service

A division oftheAmerican Chemical Society Phone: 800-631-1884, 614-447-3600 (ext. 2308) Fax: 614-447-3747 E-mail: answers@cas.org

# CO~~FIDENTIAL
INVENTORY EXPERT SERVICE REPORT

IES-ORDER NUMBER: [ 

### ]
REGISTRY NUMBER: [ 

## I

CA INDEX NAME 

### [ ]

please print the above CA Index Name on the appropriate page of your PHN•



# . . .f' If this box 

### is checked, CAS has made correction(s) marked in red to

# ~ your IES order. Please make the same correction(s) to your PHN before submitting it to the EPA.

2540 Olentangy River Road P.O. Box 3343 Columbus, Ohio 43210-0334 

# 30DOWCORNING



### TSCA SECTION 5(a) PREMANUFACTURE NOTIFICATION TOXICOLOGICAL STUDIES TSCA CONFIDENTIAL BUSINESS INFORMATION CLAIMS

For purposes of Premanufacture Notification under Section 5(a) ofthe Toxic Substances Control Act (TSCA), the general PROPRIETARY designation on the attached toxicological studies has been waived by Dow Corning Corporation. Onlythe specific chemical identity ofthe test substance is being claimed as TSCA Confidential Business Information (TSCA CBI) in the attached studies and, in compliance with the provisions of40 CFR 720.80 and 40 CFR 720.95, accordingly has been designated with brackets ([]) in both the confidential and sanitized copies, and has been deleted from the sanitized copy, ofthe studies.

Submitter:

# ~ Dale: 

# I,IffJ Rhys G. Daniels, Ph.D. Regulatory Compliance Specialist Health and Environmental Sciences DOW CORNING CORPORATION

RGD99162

Do" (:orllillg (:orporalioll**~lidl~lIId.** rVlichigan**·Hl(jH6-il99~** Pholle (:; 17) 4\i(i·4000 

# 31DOWCORNING



### TSCA SECTION 5(a) PREMANUFACTURE NOTIFICATION TOXICOLOGICAL STUDIES TEST MATERIAL CHEMICAL IDENTITY
The New Chemical Substance (TSDCC245) which is the subject ofthis Premanufacture Notification (PMN) is described as follows: CASRN: [ CONFIDENTIAL] NAME: [CONFIDENTIAL] STRUCTURE: [ CONFIDENTIAL] The attached toxicological data which are being submitted in support ofthis Premanufacture Notification were generated using a material identified as DOW CORNING® 2-B075 Amino Functional Fluid, designated in the attached studies as TX-B1-2001-17, and a 35 weight percent aqueous emulsion of DOW CORNING(r) 2-B075 Fluid, designated in the attached studies as TX-B1-2001­ 20. The amino-functional siloxane is described as follows: CASRN: [ CONFIDENTIAL] NAME: [CONFIDENTIAL] STRUCTURE: [ CONFIDENTIAL]

RGD98164

Dow (:Ol'tlill).( (:orpol'alion Midl,wel. Michii!:an**4H6Hl~09(14** Phone: (.')17) 4<)()-4000

### oow CORNING CORPORATION Health & 

### Environmental Sciences Toxicology Department

An 

### Acute Oral Toxicity Study with**TX-8l-~00l-l7** 

### in Albino Rats

ABSTRACT

An acute oral study was designed to either establish a non-lethal dose level of 5000 mg/kg of body weight or to determine the LDSO of Tx-8l-200l-l7 in the Sprague-Dawley rat. The procedure followed was in accordance with the acute oral toxicity studies specified in the "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979. A single dose of 5000 mg/kg was administered to 10 rats (S/sex). No deaths, no obvious effects on body weight gains or food consumption and no visible changes in animal behavior or any gross signs of toxicity were observed in any of the animals for 14 days. Terminal sacrifice of all the animals showed no gross pathological alterations in the tissues and organs examined. On the basis of the data presented in this report, it is concluded that TX-8l-200l-l7 is essentially non-toxic when ingested on an acute basis by laboratory rats.



# 33-2­



### TABLE OF CONTENTS

PAGE ABSTRACT. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • 1


### TEST MATERIAL.................................................... 3

METHOD. • • • • • • • • • • • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3



### RESULTS ••••••••

# .

# ..

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

# . . .. . .

# . ..

# .. . . . . . . . .

# . . . . . . . . .

# .. . .

# .. . . 3

CONCLUSIONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4

REFERENCES. • • • • • • • • • • • • • • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4



### SIGNATURE OF AUTHORS............................................. 5

QUALITY ASSURANCE STATEMENT...................................... 6



### TABLES I. Acute Oral Toxicity of TX-81-2001-17 in Albino Rats

- Mortality Data



# 3¥ PROPRIETARY: FOR USE WITHiN DOW CORNING CCR?ORATiON ONLY,-3­



### TEST MATERIAL A clear yellow liquid identified as TX-Sl-200l-l7 was submitted to the Toxicology Department for an assessment of acute toxicological properties.
METHOD Ten (S/sex) Sprague-Dawley young albino rats (Harlan Industries, Cumberland, Indiana) weighing approximately 2S0 ± 

### 40 grams were employed in this study. Animals were maintained in controlled laboratory conditions for at least seven days prior to initiation of the test and only suitable animals of normal health were employed in the study. All rats were housed individually in conventional design stainless steel, wire mesh bottom cages. The animals were maintained on a diet of PURINA® Rodent Chow and fresh water ad libitum. Each rat was individually identified by a permanent ear tag. The test material was administered as received. The animals were fasted for about 16 hours before administration of the compound and were weighed just prior to dosing. A dose of SOOO mg/kg was administered by oral intubation using a hypodermic food syringe fitted with a rubber catheter. The animals were then allowed food and water ad libitum and were observed for 14 days. All animals were weighed 24**hour~** 

### 7, and 14 days after the administration of the test material. The animals were observed frequently on the first day of dosing and twice a day thereafter at least four hours apart. Individual observations for mortalities and behavior or other reactions were made for each animal. A necropsy and complete gross pathologic examination was performed on all rats at the termination of the study.
RESULTS The results of the acute oral toxicity study conducted on TX-Sl-200l-17 are presented in Table I. No deaths occurred and no obvious effects on body weight gains or food consumption were noted. In addition, no visible changes in animal behavior or any signs of toxicity were observed. Terminal sacrifice of all the animals did not reveal any gross pathological alterations in the tissues and organs examined. On the basis of these observations, the oral LDSO of TX-Sl-200l-17 is considered to be greater than 5000 mg/kg body weight in albino rats.

### -4­

CONCLUSIONS Under the conditions of this test, TX-8l-200l-l7 is essentially non-toxic when ingested on an acute basis by laboratory rats and a single dose of the test material at a level of 5000 mg/kg body weight (LD

### SO > 

### 5000 mg/kg) is considered as a non-lethal dose.
REFERENCES "O.B.C.D. Short-Term and Long-Term Toxicology Grouns Final Report," published in December, 1979.

### -5­

This Report constituted of pages 1-6, and Table I, signed this 5th day of November , 1981.

Authors: Claire R. DeVries, B.S.

l\'aheed H. Siddiqui, Ph.D.

Approved By:

# E.~ Toxicology Department



# 37-6­



### QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology**nepartm~nt,** 

### Dow Corning Corporation, Midland, Michigan. This study was conducted according to the FDA Good Laboratory Practice Regulations. The results of the report accurately reflect the data generated. All raw data is located at Dow Corning Corporation.

Study Started: September 9, 1981 Study Completed: September 23, 

### 19A1 Date Audited: September 9, 1981 Report Issued: November 5, 1981

Benjamin....Hl 

### Franklin • 

### Quality Assurance Health 

### &Environmental Sciences Dow Corning Corporation Midland, Michigan 48640

Date:

.""TABLE I
ACUTE ORAL TOXICITY OF TX-Sl-2001-17 IN ALBINO RATS

Mortality Data Sex Dose (mg/kg) No. Dead/No. Dosed

M 5000 0/5 F 5000 0/5



# 3'1

### DOW CORNING CORPORATION Health & 

### Environmental Sciences Toxicology Department

AN ACUTE EYE IRRITATION STUDY OF TX-8l-200l-l7 IN THE NEW ZEALAND WHITE RABBIT

ABSTRACT

An acute study was designed to evaluate the eye irritation potential of TX-8l2001-17 in New Zealand White rabbits. The procedure followed fulfills the requirements outlined in the "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979. A single instillation of (0.1 mIl of undiluted TX-8l-200l-l7 in the eyes of rabbits followed by washing resulted in slight to moderate conjunctival redness and swelling and very slight and transient corneal opacity. Signs of irritation subsided to slight conjunctival redness at seven days in three of the six animals. All rabbits appeared free of ocular irritation after 14 days. According to O.B.C.D. definition and under the conditions of this test, TX-8l-200l-l7 is an irritant to the eyes of rabbits and therefore a direct eye contact with this material may result in moderate irritation to the eyes.

### -2­



### TABLE OF CONTENTS PAGE ABSTRACT. • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • . • • • • • • • • .. • • • • • • • • • • • • • • 1
INTRODUCTION. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3
TEST MATERIAL•••••••••••••••••••••••••••••••••••••••••• •

__• • • • • • • • • 3

ME'I'HOD. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3
RESULTS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • • • • • • • • • 4 

# CONCLUSIONS...................................................... 4

REFERENCES. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4 

### SIGNATURE OF AUTHORS............................................. 5 QUALITY ASSURANCE STATEMENT
...................................... 6

TABLES I. Grades for Ocular Lesions II. Classification of Test Substances III. Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of TX-Sl-200l-l7 and Washed at 4 Seconds after Treatment IV. Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of TX-Sl-200l-l7 and Washed at 30 Seconds after Treatment V. Mean Eye Irritation Scores of Reactions Following the Instillation of TX-Sl-200l-l7 and Washed at 4 Seconds after Treatment VI. Mean Eye Irritation Scores of Reactions Following the Instillation of TX-Sl-200l-l7 and Washed at 30 Seconds after Treatment 

# 41 r ',.,,......,.

.....

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

### -'\'

. ,_., ...-3­



### INTRODUCTION A sample of TX-Bl-200l-l7 was submitted to the Toxicology Department for an assessment of acute toxicologic properties. The procedure for testing this material was based on methods recommended in the "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979.
TEST MATERIAL A clear yellow liquid identified as TX-Bl-200l-l7 was submitted to the Toxicology Department for an assessment of acute toxicologic properties.
METHOD One group of six young male rabbits (approximately 3.0 kg body weight) of the New Zealand White Strain (Langshaw Farms, Augusta, Michigan) were employed for this study. Animals were kept under observation for at least seven days prior to experimental use and only suitable animals were selected for the study. All the rabbits wer,e housed individually in clean, stainless steel cages that were free of particulate bedding material or other extraneous substances that could irritate the eyes. The animals were maintained on a standard PURINA® Rabbit Chow and water ad libitum. Each rabbit was identified by an individual permanent ear tag. Twenty-four hours before test substance administration, both eyes of each animal were examined for preexisting corneal or conjunctival injury or irritation. One tenth of a milliliter (O.l ml) of undiluted solution of TX-8l-200l-l7 was instilled in the right.eye of each of the rabbits. The instillation of the compound was facilitated by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were gently held together for one second. The left eye remained untreated and served as a control. Treated eyes of three of the six rabbits were washed at four seconds and the remaining three rabbits were washed 30 seconds after the instillation. For both groups, the eyes were washed for five minutes with tepid, flowing tapwater. Behavioral changes of all animals were observed from the time of dosing for indications of pain and discomfort. Both eyes of all rabbits were examined at 1, 24, 48, 72 hours, 7 and 14 days post instillation. Fluorescein stain was used at 24, 48, 72 hours, 7 and 14 days reading. Eyes were examined by hand slit lamp for ocular reaction of the cornea, iris (internal effects) and conjunctivae and scored according to Table I. The test substance was classified according to Table II (I.R.L.G. Proposed Guidelines, 1979). Eyes were also examined for any unusual effects of the lids and nictitating membrane. All animals were observed twice daily for mortality, general activity and signs of toxicity.-4­



### RESULTS Tables III-VI present the eye irritation scores with time. A very slight pain response was exhibited by all test animals after the instillation of TX-81­ 2001-17. All six rabbits exhibited slight to moderate conjunctival redness and swelling through the first 24 hours. When examined at 48 hours, all treated eyes showed slight to moderate irritation. Three of the six rabbits continued to exhibit slight conjunctival redness when examined after seven days. Transient diffuse areas of corneal opacity were observed in four out of six rabbits after 24 hours but all corneas appeared normal when examined at seven days following treatment. Two rabbits showed very slight iridal congestion. After 14 days of treatment, all rabbits were free of ocular irritation. The degree of injury was slightly less in the eyes that were washed at four seconds after treatment than that of 30 seconds. No obvious effects were observed either in food consumption or body weight gains of the rabbits. All of the animals have shown positive reactions as defined by the "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report" and the I.R.L.G. Guidelines. Therefore, the eye irritation test performed with TX-81-2001-17 is regarded as positive. The maximum total mean irritation score (Tables V and VI) of 7.7/13.0 indicates that this material is moderately irritating to the eyes of rabbits.
CONCLUSIONS Under the conditions of this test, direct eye contact with TX-81-2001-17 may result in very slight pain, slight to severe conjunctival redness and swelling and very slight transient diffuse areas of corneal opacity. According to the O.E.C.D. definition, TX-81-2001-17 is an irritant to the eyes of rabbits and therefore a direct eye contact with this material may result in moderate irritation to the eyes. It is'recommended that proper precautions must be taken to avoid eye contact with this material during its industrial use. REFERENCES 1) "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979. 2) Draft I.R.L.G. Guidelines for Selected Acute Toxicity Tests (1979) Testing Standards and Guidelines Work Group, Interagency Regulatory Liasion Group.

Pl\OPR:ETAW(: rOR USc**WITHi~~** DOW f"1l'""J"'-,
....J(;,**\c',··nr-,:;Jt....~,;-:-'''"J C:~lY.** 

### -5­



### This Report constituted of pages 1-6, Tables I-VI, 

### signed this 13th day of November , 1981.

Authors: Claire R.DeVries, B.S.

Waheed H. 

### Siddiqui, Ph.D.

Approved By:

# E.~ Toxicology Department

Typed By:

# @,-e~c/,J~

arer; L. Davis;**rROF~:::TA~Y:** FOR**LJ~2 WITH:~**  DOVI-6­



### QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology Department, Dow 

### Corning Corporation, Midland, Michigan. This study was conducted according to the FDA Good Laboratory Practice Regulations. The results of the report accurately reflect the data generated. All raw data is located at Dow Corning Corporation.

Study Started: September 15, 1981 Study Completed: September 29, 1981 Date Audited: September 15, 1981 Report Issued: 

### November 20, 1981

Date:•• 

### TABLE I Grades for Ocular Lesions

CORNEA Opacity: Degree of density (area most oense taken for reading) No ulceration opacity................................................. 0 

### Scattered or diffuse areas of opacity (other than slight. dulling of normal luster, details of iris clearly visible) ••••••••••••••••• I 

### Easily discernible translucent areas, details of iris slightly obscured.• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • ••• 2 

### Nacreous areas, no details of iris visible, size of pupil barely discernible.. . . . . . . . . . • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 3 

### Opaque cornea, iris not discernible through the opacity••••••••••••••• 4
IRIS Normal. • . • . . . • • • • • • • • • • • • • • • • • • • • • • • • • • • • . . • • • • • • • • • • • • . • . • . • . • . . . • . •. 0 

### Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination any thereof iris still reacting to light (sluggish reaction is positive) •••• o I 

### No reaction to light, hemorrhage, gross destruction (any or all of these) •• ••• • •• •• •• ••• •• ••• ••• • •• • • • • •• • ••• • •• •• •• • •• •• •• •• •• •• •• ••. 2


### CONJUNCTIVAE Redness (refers to palpebral ad bulbar conjunctivae excluding cornea and iris) Blood vessels normal•••••••••••••••••••••••••••••••••••••••••••••••••• 0 

### Some blood vessels definitely hyperemic (injected) •••••••••••••••••••• I Diffuse, crimson color, individual vessels not easily discernible••••• 2 Diffuse beefy red•••••••••••••••••••••.••••••••••••••••.•••••••••.•••• 3 

### Chemosis: Lids and/or nictitating membranes No 

## swelling........................................................... 0 Any swelling above normal (includes nictitating membranes) •••••••••••• 1 Obvious swelling with partial eversion of lids••••••••••••••••••**~** 

### ••••• 2 Swelling with lids about half closed•••••••••••••••••••••••••••••••••• 3 Swelling with lids more than half closed•••••••••••••••••••••••••••••• 4

PROPR:U,\RY: fOR 'JS:: WITHIN DOW

### TABLE II (Cont.)

Severe

Irritant or corrosive** Opacity greater than 2.0. Injury persists 14-21 days.

Corneal perforation or necrosis at any observtion period.
Pannus or phlyctenular reactions.
Iritis grade greater than 1.0 at 1-7 days, all eyes not clear at 14 or 21 days. Conjunctivitis: Redness grades greater than 2.0 at 1-7 days. Chemosis grades greater than 2.0 at 1-7 days. **Opacity grades 2 to 4 and/or perforation of the cornea are considered to be corrosive effects when opacities persist to 21 days.



# '-17 PROFl\:EiARY: FOR US2 WiTH!N DOW CCRN;UG**:02P0,~A;10~ ON~**  iTABLE II 

### Classification of Test Substances

Classification Non-irritant

Irritant Ocular Reaction No positive reactions (opacity, iritis, or conjunctivitis on more than lout of 6 test animals at 1-3 days and all eyes normal at 7th day. Opacity grades 1.0 to 2.0 at any observation up to 7 days. All corneas cleared at 14 days.*
Iritis 1.0 at 1-7 days, but all iritis cleared by 14th day.* Conjunctivitis: Redness grade 2.0 at 1-7 days Chemosis grades greater than 2.0 at 1-7 days.
*If not cleared at 14 days, substance is considered a severe irritant.

### TABLE III Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of 0.1 ml TX-81-2001-17 and Washed Four Seconds after Treatment Examining Interval After Each Instillation Observations No. Positive/No. Dosed Ocular Grading 1 Hr. 24 Hrs. 48 Hrs. 72 

### Hrs. 7 Days 14 Days I. Cornea Cornea Normal: 3/3 2/3 3/3 3/3 .3/3 3/3 Corneal Opacity Very Slight: 1/3 Slight Moderate Marked
II. Iris Iris Normal: 3/3 3/3 3/3 3/3 3/3 3/3 Iridal Irritation:
III. Conjunctivae Redness: Normal 1/3 1/3 2/3 3/3 Slight 2/3 1/3 2/3 1/3 Moderate 3/3 1/3 1/3 Marked Chemosis: Normal 1/3 1/3 2/3 3/3 3/3 Very Slight 1/3 2/3 1/3 Slight 2/3 1/3 Moderate 1/3 Marked Discharge: Normal 3/3 3/3 3/3 3/3 3/3 3/3
Necrosis or Ulceration Not Present 3/3 3/3 3/3 3/3 3/3 3/3


# 49

### TABLE IV Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of 0.1 ml TX-81-2001-17 and Washed 30 Seconds after Treatment

Observations Ocular Grading 1 Hr. Examining Interval After Each Instillation No. Positive/No. Dosed 24 Hrs. 48 Hra. 72 

### Hrs. 7 Day."l 14 Days I. 

### Cornea Cornea Normal: Corneal Opacity Very Slight: Slight Moderate Marked 1/3 2/3 3/3 3/3 3/3 .3/3 3/3

l'I. 

### Iris Iris Normal: 3/3 1/3 2/2 2/3 3/3 3/3 Iridal Irritation: 2/3 1/3 1/3
III. Conjunctivae Redness: Normal 1/3 3/3 Slight 2/3 2/3 Moderate 2/3 2/3 3/3 1/3 Marked 1/3 1/3 Chemosis: Normal 3/3 3/3 Very Slight 2/3 Slight 3/3 1/3 Moderate 2/3 1/3 Marked 1/3 2/3 Discharge: Normal 3/3 3/3 3/3 3/3 3/3 3/3
Necrosis or Ulceration Not Present 3/3 3/3 3/3 3/3 3/3 3/3

PROPRI:::TARY;

### TABLE V Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of 0.1 ml TX-8l-200l-l7 and Washed at Four Seconds after Treatment Mean Eye Irritation Scores* of Reactions at Indicated Time Intervals
Individual Tissue & 

### Scoring Criteria 1 Hr. 24 Hrs. 48 Hrs. 72 Hrs. 7 Days 14 Days
I. Corneal Opacity: 0 0.3 0 0 0 0

Score 0 0.3 0 0 0 0

II. 

### Iridal Inflamation: 0 0 0 0 0 0 Score 0 0 0 0 0 0 III. 

### Conj 

### uncti

### val Irritation: a. Redness 2 1.3 1.0 0.7 0.3 0 b. Chemosis: 2.3 1.0 0.7 0.3 0 0 Score 4.3 2.3 1.7 1.0 0.3 0 Total Scores 4.3 2.6 1.7 1.0 0.3 0

*Scored According to Table I



# 51 PRCPP!ET;"RY: FOR USE**V:lrHI,~** DOW

### TABLE VI Acute Eye Irritation Scores of Albino Rabbits Following the Instillation of 0.1 m1 TX-81-2001-17 and Washed at 30 Seconds after Treatment Mean Eye Irritation Scores* of Reactions at Indicated Time Intervals
Individual Tissue & 

### Scoring Criteria 1 Hr. 24 Hrs. 48 Hrs. 72 Hrs. 7 Days 14 Days
I. Corneal Opacity: 0.7 1 1 1 0 0

Score 0.7 1 1 1 0 0
II. Iridal Inflamation: 0 0.7 0.3 0.3 0 0 Score 0 0.7 0.3 0.3 0 0 III.
a. b. Conjunctival Irritation: Redness Chemosis: 2.3 3.3 2.3 3.7 2 2 1.7 1.7 0.7 0 0 0 Score 5.6 6 4 3.4 0.7 0 Total Scores 6.3 7.7 5.3 4.7 0.7 0

*Scored According to Table I

### DOW CORNING CORPORATION Health & 

### Environmental Sciences Toxicology Department

An Acute Dermal Toxicity Study of TX-81-2001-17 in Rabbits

ABSTRACT

An acute dermal toxicity study ws designed either to establish a non-lethal dose level of 2000 mg/kg of body weight or to determine the LDSO of TX-81­ 2001-17 in albino rabbits. The procedure followed fulfills the requirements outlined in the nO.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report,n published in December, 1979. A single dose of 2000 mg/kg of body weight was applied to intact skin of ten rabbits- (S/sex). No behavioral changes and no obvious effects on body weight gains or food consumption were noted during the 14-day observation period. One male rabbit died on the fourth day of the study. Autopsy of this animal and terminal sacrifice of surviving animals did not reveal any compound related gross pathological alterations in the tissues and organs examined. On the basis of the data presented in this report, it is concluded that TX-81-2001-17 is non-toxic when applied on an acute basis to the intact skin of rabbits and a single dose of this material at a level of 2000 mg/kg of body weight is considered as a nonlethal dose according to O.E.C.D. definition.

### -2­

TABLE OF CONTENTS

PAGE ABSTRACT. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 1


### TEST l4.ATERIAL.................................................... 3

METHOD. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3

RESULTS. • . . • • • • • • • • • . . . • • • • • • . • • • . • • • • • • • • • • • . . • • • • • • • • • • • • • • • • • • 3

CONCLUSIONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4

REFERENCES. • • • • • • • . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4



### SIGNATURE OF AUTHORS•••

# . . . . .

# . .. .

# .. . . .

# . .. . . . .. . .

# . . . . .

# . ..

# . .. . . . . . . . 5


### QUALITY ASSURANCE 

# STATEMENT...................................... 6

TABLES I. Acute Dermal Toxicity of TX-8l-200l-l7 in Rabbits

- Mortality Data

PROPRIET:\RY: fOx U:;: WITH:N DOW CORNING COo.rC'AI:::;':" CNLY.-3­



### TEST MATERIAL A clear yellow liquid identified as TX-8l-200l-17 was submitted to the Toxicology Department for an assessment of acute toxicologic properties. METHOD Ten young albino rabbits (5/sex) of the New Zealand white strain (obtained from Langshaw Farms, Augusta, Michigan), weighing approximately 2.5 kg were employed for this study. Animals were kept under observation for at least seven days prior to initiation of the study and only suitable animals were used for the experiment.**~ll** 

### rabbits were housed individually in clean stainless steel cages in a temperature, humidity and light controlled room. The animals were maintained on a standard**PURINA~** 

### Rabbit Chow and fresh water ad libitum. Each rabbit was identified by an individual'permanent ear tag. Twenty-four hours prior to dermal application, the hair of each rabbit was closely clipped from the dorsal body surface area of the trunk with electric clippers. Just prior to treatment, each rabbit was weighed.**~** 

### single dose of 2.0 g/kg was uniformly applied to**th~** 

### clipped skin (approximately 10% of the total body surface area) of each of the rabbits. The test material was held in close contact for twenty-four hours with a porous gauze dressing and by wrapping the animal in a semiocclusive fashion with a cotton cloth bandage taped to the hair.**~fter** 

### a twenty-four hour exposure period, the bandages were removed and the skins were washed with tap water. Animals were observed frequently after dosing and twice daily over a l4-day period for signs of toxicity and behavioral abnormalities.**~ll** 

### rabbits were weighed at 24 hours, 7, and 14 days post test material application. A complete gross pathological examination was performed on all rabbits at the termination of the study.
RESULTS One of the male rabbits died on the fourth day of the study. The same animal exhibited slight diarrhea during the early part of the study. Autopsy of this animal showed no gross pathological alterations in the tissues or organs except the caecum which was found distended with gas and black patches on the liver and lungs. A definitive cause of death of this animal was not determined, however, in all due probability, it was not treatment related. No abnormalities in the behavior of the surviving rabbits or obvious effects on food consumption were noted. However, two male rabbits exhibited a very slight weight loss during the course of the study. Terminal sacrifice of all surviving animals did not reveal any gross pathological alterations in the tissues and organs examined. On the basis of these observations, the dermal LDSO of TX-8l-2001-l7 is considered to be greater than 2000 mg/k9 in albino rabbits and therefore no additional testing is required according to the O.E.C.D. Short-Term and Long-Term**~oxicology** 

### Groups Final Report.

PROPR:i;TARY: FeR USE WITHIN DOW**CCR":,~G** cocpc:.:,nCN ONLY.

### -4­

CONCLUSIONS Under the conditions of this test, a dose of 2000 mg/kg of body weight 

### Ot TX81-2001-17 is essentially non-toxic when applied on an acute basis to the intact skin of rabbits and is considered a non-lethal dose according to O.E.C.D. definition. REFERENCE..<; "O.E.C.D. Short-Term and Long-Term Toxicologv Groups Final Report," puhlished in December, 197Q.-5­



### This Report constituted of pages 1-6, and Table I, signed this 29th day of October , 1981.


# R-. Authors: Claire R. DeVries, B.S.

Waheed H. 

### Siddiqui, Ph.D.

Approved By:

# E.~ Toxicology Department

Typed By:

# ~,,-(4y 

# cV**dJo~** Karen L. Davis**Fi\C,'F:=Th~\Y: r(;~**  us:: WITHIN DOW ,-" "";";"',**r('\~';.""":'.1Tlr~i** ONLY.-6­



### QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology Department, Dow Corning Corporation, Midland, Michigan. This study was conducted according to the FDA Good Laboratory Practice Regulations. The**resul~s** 

### of the report accurately reflect the data generated. All raw data is located at Dow Corning Corporation.

Study Started: September 10, 1981 Study Completed: September 24, 1981 Date Audited: September 10, 1981 Report Issued: October 29, 1981

# ~. -- ,...., t#"I'

# ~4.**~.r ~.**  Franklin Quality Assurance Health & 

### Environmental Sciences Dow Corning Corporation Midland, Michigan 48640

PRCf1i\i:T;\K'f:**fO~** 0':>: Vr'if;i/;J '00'1,/ COR:-l""" CO:-:i'C;lAT10:, ONLY.

### TABLE I
ACUTE**DER~L** 

### TOXICITY OF TX-8l-200l-l7 IN RABBITS



### Mortality Data
Condition of Skin Sex Dose (mg/kg) No. Dead/No. Dosed

Intact M 2000 

### 1/5 

### Intact F 2000 

### 0/5

### DOW CORNING CORPORATION Health & 

### Environmental Sciences Toxicology Department

An Acute Dermal Irritation Study of TX-Sl-200l-l7 in Rabbits

ABSTRACT

An acute dermal irritation study was designed to determine the skin irritation potential of TX-Sl-200l-l7 to the skin of rabbits. The procedure followed fulfills the requirements outlined in the "O.E.C.D. Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979. A single semiocclusive contact of 0.5 ml of TX-Sl-200l-l7 with the intact skin of six male albino rabbits for four hours resulted in severe redness with slight eschar and slight swelling in all rabbits which persisted for several days. On the basis of the data presented in this report, it is concluded that TX-Sl-200l-l7 is an irritant to the skin of rabbits.-2­

TABLE OF CONTENTS

PAGE ABSTRACT. . • • • • • • • . • • • . • • • • • • • • • • • • • • • • • • • • • • • . . • • • • • • • • • • • • • • • • • • 1

TEST MATERIAL •••••••••••••••.••.••••••••••••.•••••••••• 3

METHOD. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3

RESULTS. • • • • • • • • • • • • . • • • • • • • • • . • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • . 3

CONCLUSIONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4

REFERENCES. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 4

SIGNATURE OF AUTHORS............................................. 5

QUALITY ASSURANCE STATEMENT
...................................... 6

TABLES I. Evaluation of Skin Reaction II. Mean Skin Irritation Scores of TX-81-2001-17 in Male Rabbits 21 Days Following Exposure**r~OI';:::i:T;'RY:** FOR USc WITHIN DOW ,r--.: "'r-: r'-""';,r"t.'r"--'.J 0/'Jt V-3­



### TEST MATERIAL A clear yellow liquid identified as TX-Bl-200l-l7 was submitted to the Toxicology Department for an assessment of acute toxicologic properties.
METHOD 

### Six young male albino rabbits of the New Zealand white strain (obtained from Langshaw Farms, Augusta, Michigan) weighing approximately 2.5 kg were employed for this study. Animals were kept under observation for at least seven days prior to initiation of the study and only suitable animals were used for the experiment. All rabbits were housed individually in clean stainless steel cages in a temperature, humidity and light controlled room. The animals were maintained on a standard**PURINA~** 

### Rabbit Chow and fresh water ad libitum. Each rabb'it was identified by an individual permanent ear tag. Twenty-four hours prior to dermal application, the hair of each rabbit was closely clipped from the dorsal body surface area of the trunk with electric clippers. A single dose of 0.5 ml 1est material was uniformly applied to one intact test site (approximately 6 em ) of each animal. Adjacent areas of untreated skin served as control. The application site was covered with a porous gauze dressing and the animal was then wrapped in a semi-occlusive fashion with a cotton cloth bandage taped to the hair. After a four-hour exposure period, the bandages were removed and the skin was washed with tap water. Animals were observed frequently after dosing and twice a day thereafter until all signs of irritation had subsided for signs of toxicity and behavioral abnormalities. The degree of skin irritation was scored according to Table I at 60 minutes, 24, 4B, 72 and daily thereafter for 21 days after washing for erythema, edema, and other evidence of irritation or injury.
RESULTS Table II presents the skin irritation scores with time. A single contact of TX-Bl-200l-l7 with intact skin for four hours resulted in severe redness with slight eschar and slight swelling in all rabbits which persisted for several days. The degree of injury gradually reduced during the observation period with all animals appearing free of irritation after 21 days. No abnormalities in test animal behavior were noted and no effects on body weight gains or food consumption were observed during the course of the study.

PROPRIETAR.Y: FOR**U~:: VlIT~IN**  'JOW CORNING CC2PC;:Al:8N ONLY.

### -4­

CONCLUSIONS Under the conditions of this test, a four hour, semi-occluded skin contact with 0.5 ml TX-8l-200l-l7 may result in severe irritation to the skin of rabbits.
REFERENCES "OoEoCoDo Short-Term and Long-Term Toxicology Groups Final Report," published in December, 1979.

PRCPR::.:TARY: FOR USE WITHIN DOW**CC-;':-~",NG** CCtiPOr-..Al:GN ONLY.-5­



### This Report constituted of pages 1-6, Tables I & 

### II, signed this 2nd day of November , 1981.

Authors: Claire R. DeVries, B.S.

Waheed H. Siddiqui, Ph.D.

Approved By:

# E.J.~~ Toxicology Department

Typed By:

# ~~~is~J~-6­



### QUALITY ASSURANCE STATEMENT

This report represents data generated by the**~oxico1ogy** 

### Department, Dow Corning Corporation, Midland, Michigan. This study was conducted according to the FDA Good Laboratory Practice Regulations. The results of the report accurately reflect the data generated. All raw data is located at Dow Corning Corporation.**~tudy** 

### Started: September 29, 1981 Study Completed: October 20, 1981 Date Audited: September 29, 1981 Report Issued: November 2, 

### 1981

BenJamln H. Franklin Quality Assurance Health & 

### Environmental Sciences Dow Corning Corporation Midland, Michigan 48640

Date:

rr:cr;.:IET.

....c:y:**ro~** L'S: VIiTH:N DOW**COF.NI~~G COF;.JC~AT;C~J** **C~il** Y.

### TABLE I
EVALUATION OF SKIN REACTION Value Erythema and Eschar Formation No erythema

............ /II •••••••••••••••• /II ••••••••••••••• _._/11 • • • • • • • • • • • 0 

### Very slight erythema (barely perceptible) •••••••••••••••••••••••••.• I 

### WeI1-defi 

### ned erythema
............................................... 2 Moderate to severe 

## erythema......................................... 3 Severe erythema (beet redness) to slight eschar formation (injuries in depth) •••••••••••••••••••••••••••••••••••••••••••••• 4



### Edema Formation No edema•••••••••••••••••••.••.•••••••••••••••••••••• /II 0 ••• /II • • • • • • • • • • 

### Very slight edema (barely perceptible)
.............................. I



### Severe edema (raised more than I 

### millimeter and extending

Severe eschar and/or corrosion••••••••••••••••••••••••••••••••••••••Note Occurence Slight edema {edges of area well defined by definite raising)
....... 2
Moderate edema (raised approximately I 

### milliliter) •••••••••••••••••• 3
beyond the area of exposure)
..................................... 4**r~C"RIETARY:** FOR us:: wm';e< DOWTABLE II Mean Skin Irritation Scores of TX-81-2001-17

in Male Rabbits 21 Days Following Exposure

Parameter Erythema & Eschar: 60 Min.
2 Mean Score Reading: Interval (Time Post Wash) 24 Hrs. 48 Hrs. 72 Hrs. 7 Days 14 Days

3.8 3.5 3.2 2.3 0.5 21 Days
0
Edema Formation: 1.7 2.5 1.5 0.8 0 0 0
Total Scores: 2.7 6.3 5 4 2.3 0.5 0 Primary Irritation Scores: 2.7/8 6.3/8 5/8 4/8 2.3/8 0.5/8 0/8

# ~7**i'~C** r**~I-T' ~"**  ., r 0,:: ."'\'\': fOR USE WITHIN DOW**CC:;k;'~ .-.'·o-.~**  '-""
.. "DOW CORNING CORPORATION Health & Environmental Sciences

ABSTRACT

This test was conducted to make an initial analysis of the potential environmental impact of TX-81-2001-17 in its emulsified form TX-2001-20. All nominal concentrations are expressed as ppm of TX-81-2001-17. After the range-finding test, concentrations of 0.56, 1.0, 1.8, 5.6, and 10 ppm were employed for the definitive test. Close agreement was obtained with a second definitive test ''lith slightly lower nominal concentrations. Each test concentration and control was run in duplicate with approximately ten 1st or 2nd instar Daphnia magna. Survival of test organisms in control vessels exceeded 85% during the 48-hour test period of both tests. The calculated median lethal concentrations and corresponding 95% confidence intervals were: 1st Test 2nd Test 1.0 (0.6-1.4 ppm) 1.1 (0.7-1.5 ppm) 

### Le50 These test indicate that TX-81-2001-17 is moderately to highly toxic to Daphnia magna.**FRO~'i<IETM:<Y:** FS:-C us:**'N:;rI1:~** 'OOYl**CO~NING** C02?ORAi:0N ONLY,-2­

TABLE OF CONTENTS

PAGE ABSTRACT 

# ............................................................ 1

TEST MATERIAL 

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

# ............. 3

METHODOLOGY 

# ......................................................... 3

RESULTS 3

SIGNATURE OF AUTHORS 

# ................................................ 4
QUALITY ASSURANCE STATEMENT 5 00 ••• 0 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

TABLES

- 

### Io Effect of TX-81-2001-17 on Survival of Daphnia magna II. l'later Chemistry Parameters

PKO?R:ETA:('(, ;:CR us:: WJTHIN DOW-3­

TEST MATERIALS A creamy white liquid identified as**~X-81-2001-20** was submitted to determine a 48-hour LC50 of the material to Daphnia magna. The test material is a water miscible emulsion of TX-81-2001-17.
METHODOLOGY The daphnia for acute toxicity testing are raised by laboratory culturing.**~he** original colony of Daphnia magna was obtained from the Duluth Laboratory of the United States Environmental Protection Agency**th~ough** the Dow Chemical Company. The colonies are maintained under static conditions in reconstituted hard water (EPA 660/3-75-009) made from glass-distilled water. Before culture inoculation, the reconstituted water is aerated for 2-4 hours. The colonies are maintained in five-gallon glass aquaria under approximately 1000 footcandle illumination (18/6 light-dark) in an environmental chamber designed to maintain 220C ± lOCo The food for the Daphnia magna is prepared each week by blending 0.25 gm alfalfa meal, 4.0 gm trout chow and 400 ml distilled water. This solution is allowed to settle and the supernatant is used as food. A number of egg-bearing daphnia were isolated prior to the test for a period of 72 hours. The test organisms (0-72 hours old) were transferred prior to testing to fresh unadulterated water and fed 0.25 ml of daphnia food. This acute toxicity test consisted of duplicates of a control and various concentrations of the test material. The test vessels consisted of 250 ml glass beakers, each containing 200 ml of test solution. The test solutions were prepared by adding the appropriate amount of test material to the reconstituted hard water. The test organisms were introduced beneath the surface of the test**v~ssels** within 30 minutes of the addition of the test material. Test duration was 48 hours with observations made daily for mortalities, entrapment and any other untoward effects. The pH and dissolved oxygen content of one test vessel from the control, lowest and highest test concentrations were determined at the end of the test. Median lethal concentration values were determined by probit analysis, maximum likelihood method.
RESULTS The results of both tests are summarized in the tables. The two tests exhibited excellent reproducibility. The calculated median lethal concentration and its corresponding 95% confidence interval for the first test was 1.0 ppm (0.6-1.4 ppm). The result of the second test was lrl ppm (0.7-1.5 ppm). These test results indicate that TX-81-2001-17 is moderately to highly toxic to Daphnia magna.


# 70 PRe PRIETARY: FOR U:: W'THIN DO,,":,

.**COR~iL"'G** CORPORATION ONLY.-4­

Authors:

Approved By:

Typed By:

# ~~~dJ~ Karen L. Davls This report constituted of pages 1-5, and Tables I & II, signed this 29th day of October , 1981.

Ronald B. Annelin

Diane L. Zimmefman

Cecil L. Frye,**Ph~D.**



# 71**PROf~ltTARY:** reI{ US2 WlfHlN**~ow**-5­



### QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology Department, Dow Corning Corporation, Midland, Michigan. This study was conducted according to FDA Good Laboratory Practice Regulations. The results reported accurately reflect the data generated. All raw data is located at 'Dow Corning Corporation.

Study Started: September 9, 1981 Study Completed: September 25, 1981 Date Audited: September 9, 1981 Report Issued: October 29, 1981

Date:

pr;c**f~:::T** t.RY: fOR us"**WlTlli~~** DOWTABLE I Effect of TX-81-2001-20 on Survival of Daphnia magna

Concentration Number Alive At: ppm 

## o Hours 24 Hours 48 Hours Test 1 Control

0.56 1.0 1.8 5.6 10 20 20 20 20 20 20 19 19 18 20 

### 15 18 lq 13 11

7 0 1

Test 2 Control

0.1 0.56 1.0 1.8 5.6 21 19 20 10 20 20 21 19 19

8 15 13 20 19 14

5 8 0

F'ROFi\:ETARY: Fm U::;" WITH;:--! DOW"('ABLE II Water Chemistry Parameters
Test 1 Nominal 

## o Hours 96 Hours Concentration DO 

### .E!!. DO 

## .E!! Control 8.0 mg/1 0.56 7.0 1.0 7.5 1.8 7.5 5.6 7.3 10.0 7.5

Test 2 Control 8.0 mg/1 7.7 6.5 mg/1 

### 7.8 0.56 5.5 5.6 7.6 6.0 

### 7.8DOW CORNING CORPORATION 

### Health & 

### Environmental Sciences Toxicology Department

ABSTRACT



### This test was conducted to make an initial analysis of the potential environmental impact of TX-81-2001-17 in its emulsified form TX-81-2001-20. All nominal concentrations are expressed as ppm of TX-Bl-200l-l7. Based on the rangefinding test, concentrations of 1. 

### 0, 1. 

### 8, 5.6, and 10 ppm w€:'re selected for the definitive test. Each test concentration and control were run in duplicate with approximately ten rainbow trout per test vessel. The median lethal concentration of TX-81-2001-17 in its emulsified form to rainbow trout was 6.1 ppm. The corresponding 95% confidence interval could not be calculated from the data. This test indicates that TX-81-2001-l7 is moderately toxic to rainbow trout.-2­

TABLE OF CONTENTS

PAGE ABSTRACT

......................................... III 1

.............................. .
TEST MATERIAL 

# ..................................................... 3

METHODOLOGY 3

RESULTS 3

SIGNATURE OF AUTHORS 4
QUALITY ASSURANCE STATEMENT 

# .......................................... 5

TABLES

­ I. 

### Effect of TX-81-2001-l7 on Survival of Rainbow Trout II. 

### Water Chemistry Parameters

PROPRiETARY: FOR**us~** WiTHIN**DO~'I r,...,,;~~·"":~** **(,OR?()~Aj;~~J** ONLY.-3­



### TEST MATERIAL A creamy white liquid identified as TX-81-200l-20 was submitted to determine a 96-hour median lethal concentration (LCSO) to rainbow trout. The test material is a water miscible emulsion of TX-Sl-200l-l7.
METHODOLOGY The rainbow trout (Salmo gairdneri) were ohtained from a commerical fish hatchery and acclimated to laboratory conditions for a minimum of two weeks before testing. The test was conducted using charcoal filtered municipal water in polyethylene-lined test vessels maintained at a temperature of 12 ± 

### 20

### C. Lethal concentration (LC) values are calculated by computer using probit analysis, maximum likelihood method (Finney, 1971). The methods used for this static toxicity test with rainbow trout are descrihed in the December, 1979, guidelines of the Organization of Economic Cooperation and Development. The test organisms were fasted for 4S-hours prior to the test and were not fed during the 96-hour test. An initial screening test of a control group and 1, 10, and 100 ppm of test material was conducted. Based on these results, the definitive test was done with concentrations of 1.0, 1.S, 5.6, and 10.0 mg/l. At 48 hours, the fish were transferred to fresh solutions of the test material. The test material was diluted into a liter of water prior to mixing with the remaining water. All concentrations except 100 ppm were tested in duplicate with ten rainbow trout per test vessel. Test duration was 96-hours with daily observations for mortalities, erratic swimming, loss of equilibrium, hyperventilation, hemorrhaging, and discoloration. The pH and dissolved oxygen was taken on control and high concentration vessels at 0, 48, and 96 hours. Dissolved oxygen was measured using a Beckman dissolved oxygen meter. pH was determined with a Orion Ionanalyzer.
RESULTS The results are presented in the tables. The calculated 96-hour LCSO of emulsified TX-8l-200l-l7 to rainbow trout was 6.1 ppm. A single mortality occurred in the controls. The 24 and 48 hour could not be calculated LCSO because of insufficient mortalities (LeSO >10 ppm). This study indicates that TX-Sl-200l-l7 is moderately toxic on an acute basis to rainbow trout in its emulsified form.



# 77**rf;:Cr;:::ET.~:\Y: ro~** **:.;~::** WITH:;>! DOW**CO.;t-~:;--...jC; CC"VG.",';"Tl::~~**  ONLY.-4­

This report constituted of pages 1-5, and Tables I 

### & II signed this 29th day of October , 1981.

Diane L.**Zimm~an**

Approved By:

# ~~2 Cecil L. Frye,

# ~.

Typed By:



# 7<6
FRC Pi:IET**I·.~Y:** FO:l USc WIY:l;N DOW co,s:rIG**CO.:i'O~Ar:Q:--.I** ONLY,

### QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology Department, Dow Corning Corporation, Midland, Michigan. This study was conducted according to FDA Good Laboratory Practice Regulations. The results reported accur.ately reflect the data generated. All raw data is located at Dow Corning Corporation.

Study Started: September 14, 1981 Study Completed: September 25, 1981 Date Audited: September 14, 1981 Report Issued: October 29, 1981



### 'Be!lja**~.** 

### Franklin Quality Assurance Health & 

### Environmental Sciences Dow Corning Corporation Midland, Michigan 48640

Date:**~;:Of:::ET:\;;Y: fC~**  us:: W;TH:N DOW**CO.~t;iSG** (0."0;<",,;0:-1 ONLY.TABLE I Effect of TX-81-2001-17 on Survival of Rainbow Trout

Nominal Concentration Number Alive At: ppm 0 Hours 4 Hours 24 Hours 48 Hours 72 Hours 96 Hours Control 40 40 40 40 40 39 1.0 40 40 40 40 39 37 1.8 20 20 19 19 19 19 5.6 20 20 20 20 20 18 10.0 38 38 37 32 1 0

TABLE II Water Chemistry Parameters

Nominal Concentration 0 Hours 96 Hours ppm DO pH 00 pH Control 10 mg/1 7.3 8.5 7.4 1.0 

### loB 7.4 7.8 7.5 

### 5.6 10.0 10 7.4 7.5 7.5

Pi\CPi\:::TAil'(:**fC~** 'JS2 Y/lTHIN DOW CC**;:~~~:-";G CO.;;:);J.~A;1G;'~**  CNl**y~**

### DOW CORNING CORPORATION Health & 

### Environmental Sciences Toxicology Department

Genetic Evaluation of TX-81-200l-17 in Bacterial Reverse Mutation Assays

ABSTRACT

The test material was evaluated for genetic activity in. the Salmonella typhimurium and Escherichia coli Reverse Mutation assays as outlined in "O.E.C.D. Guidelines for Testing of Chemicals". No evidence of genetic activity was observed.



# sf

### -2­

TABLE OF CONTENTS

ABSTRACT 

# ............................... '"

# ........................... 1



### MATERIALS 

# ...................................................... '"

# ... 3&4

EXPERIMENTAL DESIGN 

# ........................ '"

# .......... '"

# ............. 4&5 OBJECTIVE 

# ......................................................... '" 3

DATA •••••••••••• '" ••••••••••••••••••••••••••••••••••••••••••••••••••• 

### 5,6,7

REFERENCES 

# ........ '"

# ........ '"

# ............. '"

# ......................... 8



### SIGNATURE OF INVESTIGATORS 9


### QUALITY ASSURANCE STATEMENT 

# ..... '"

# ........... '"

# ...................... 10

TABLES

- Overlay Plate Test Results Salmonella typhimurium TA-1535 Table I TA-1537 Table II TA-1538 Table III TA-98 Tah1e IV TA-100 Table V Escherichia coli WP2 uvr A

- Table VI-3­



### OBJECTIVE The objective of this study was to evaluate the test material for genetic activity in the Salmonella typhimurium and Escherichia coli Reverse Mutation Assays as outlined in O.E.C.D. GUIDELINES FOR TESTING OF CHEMICALS (CRF 46 (162)/8-21-81) as part of the Minimum Premarket Data Set for new chemicals.**MATERIAL~** 

### A. Test Material TX-81-2001-17 B. Indicator Microorganisms Salmonella typhimurium, str. TA-1535 TA-1538 TA-100 TA-1537 ,TA-98 Escherichia coli, str. WP2


### C. Activation System Bacteria will be exposed to the test substance both in the presence and absence of a mammalian activation mixture (5-9 mix) prepared in accordance with published protocols (Ames, et al., 1975; Matsushima, et al., 1976). 1. 

### Component Final Concentration/ml MgC12 8**~** 

### moles KCl 33**~** 

### moles NADP 4**~** 

### moles Glucose-6-phosphate 5 moles Sodium phosphate, pH 7.4 100**~** 

### moles Homogenate fraction equivalent**~**



### to 25 mg of wet tissue 2. 5-9 Homogenate A 9000 x**~** 

### supernatant prepared from Sprague-Dawley adult male rat liver induced by AROCLOR 1254 five days prior to kill. Purchased from Litton-Bionetics, Inc., Kensington, Maryland. Stored until use at -76oC. D. positive Control Chemicals Chemicals used for positive controls in the non-activation and activation assays.

### -4­

Assav Chemical* Solvent** Non-activation Sodium Azide (AZ) Water or Saline 9-Amino Acridine (AA) Ethanol 2-Nitrofluorene (NF) DimethylsulfoxideN-Methyl-N-nitro-Nnitrosoquanidine (MNNG) Water Activation 2-Anthramine (ANTH) Dimethylsulfoxide *Concentrations given in Results section. **Previously shown to be non-mutagenic./ E. Solvent Deionized water, absolute ethanol or dimethylsulfoxide (DMSO) used to prepare dilutions of the test material. The solvent employed and concentrations of chemicals are recorded in the Results section.
EXPERIMENTAL DESIGN A. Principle of the Test Method Bacteria are exposed to test chemical with and without metabolic activation and plated on minimal medium. After a suitable period of incubation, revertant colonies are counted and compared to the number of spontaneous revertants in an untreated (solvent) control culture. Positive and negative (solvent) controls are included in each experiment. B. Description of the Test Method At least five different amounts of test chemical per plate separated by half-log intervals will be tested (de Serres and Shelby, 1979). Substances will be tested up to the limit of solubility or toxicity. Toxicity may be evidenced by a reduction in the number of spontaneous revertants, a clearing of the background lawn or by degree of survival of treated cultures. Nontoxic chemicals should be tested to 5 mg/plate before considering the test substance negative. If there is any question about the possible appearance of toxicity or mutagenicity at the high dose of 5 mg/plate, testing may be extended to 10 mg/plate. Plates should be incubated for 48-72 hours at 37o

## c.-5­



### 1. Direct Plate Incorporation Method Nonactivation Assay To a sterile 13 x 100 rom test tube placed in a 430

### C water bath, the following is added in order:
• 2.00 ml of O.ry% 

### agar containing: 0.05 roM 

### histidine and 0.05 roM 

### biotin (Salmonella Assay) 0.05 roM 

### tryptophan (Escherichia coli Assay)
• 0.05 ml of a solution of the test chemical to give the appropriate dose.
• 0.01 ml

- 0.2 ml of indicator organism/so
• 0.50 ml of O.2M phosphate buffer, pH 7.4. This mixture is swirled gently and**t~en** 

### poured over the surface of minimal agar plates. After the top agar has set, the plates are incubated at 370

### C for 4B-72 hours. The number of revertant colonies growing in the plates is counted and recorded. Activation Assay The activation assay will be run concurrently with the nonactivation assay. The only difference is the addition of 0.5 ml of S-9 mix to the tubes in place of 0.5 ml of phosphate buffer which is added in nonactivation assays. All other details are similar to the procedure for**nonactivat~on** 

### assays. All plating is done in triplicate.
DATA A. Data Presentation The data are presented as the number of revertant colonies per plate. The number of revertant colonies on both negative (solvent) and positive control plates are also presented. Individual plate counts, the mean number of revertant colonies per plate and standard deviation are presented for test chemical and positive and negative (solvent) controls.-6­



### B. Statistical Evaluation Data will be evaluated using appropriate statistical methods. C. Results Because the test article and the cells are incuhated in the overlay for approximately two days and a few cell divisions occur during the incuhation period, the test is semiquantitative in nature. Although these features of the assay reduce the quantitation of results, they provide certain advantages not contained in a quantitative suspension test: The small number of cell divisions permits potential mutagens to act on replicating DNA, which is often more sensitive than nonreplicating DNA. The combined incubation of the test article and the cells in the overlay permits constant exposure of the indicator cells for approximately two days. 1. Surviving Populations Plate test procedures do not permit exact quantitation of the number of cells surviving chemical treatment. At low concentrations of the test article, the surviving population on the treatment plates is essentially the same as that on the negative control plate. At high concentrations, the surviving population is usually reduced by some fraction. Our protocol will normally employ several doses ranging over two or three log concentrations. 2. Dose-Response Phenomena The demonstration of dose-related increases in mutant counts is an important criterion in establishing mutagenicity. A factor that might modify dose-response results for a mutagen would be the selection of doses that are too low (usually mutagenicity and toxicity are related). If the highest dose is far lower than a toxic concentration, no increases may be observed over the dose range selected. Conversely, if the lowest dose employed is highly cytotoxic, the test article may kill any mutants that are induced, and the test article will not appear to be mutagenic. 3. Control Tests positive and negative control assays will be conducted with each experiment and will consist of direct-acting mutagens-for nonactivation assays and mutagens that require metabolic biotransformation in activation assays. Negative controls will consist of the test article solvent in the overlay agar together with the other essential components. The negative control plate-7­



### for each strain will give a reference point to which the test data will be compared. The positive control assay will be conducted to demonstrate that the test systems are functional with known mutagens. 4. Evaluation Criteria for Toxicity Complete Toxicity When there are no revertants ohserved on the plate(s) treated with the test compound, the test compound will be defined as toxic to all or any of the indicator strains at that (those) particular dose(s)
. Slight Toxicity When there are fifty percent or less number of revertants on the plate(s) treated with the test compound as compared to the solvent plate(s), the test compound will be defined as slightly toxic to all or any of the indicator strains at that (those) particular dose(s) • 5. Evaluation Criteria for Ames Assay Because the procedures to be used to evaluate the mutagenicity of the test article are semiquantitative, the criteria to be used to determine positive effects are inherently subjective and are based primarily on a historical data base. Most data sets will be evaluated using the criteria established by K. C. Chu, et**~.,** 

### (1981), Mutation Res., 119-132. If the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.-8­



### REFERENCES Ames, B. N., McCann, J. 

### and Yamasaki, E.: Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutageniticy test. Mutation Res. 31, 347-364, 1975 Brusick, D. J.,**~immon,** 

### V. F., Rosenkranz, B. S., Ray, V. A. and**~tafford,** 

### R. S.: An evaluation of the Escherichia coli WP2 and WP2 uvrA reverse mutation assay. Mutation Res.,**~:169-l90,** 

### 1980.
de Serres, F. J. 

### and Shelby, M. D.: Science, 203:563-565, 1979. Green, M. H. C. and Muriel, W. 

### J.: Mutation Res., l!:3-32, 1976. 

### Matsushima, T., Sawamura, M., Hara, K. and Sugimura, T.: In, In vitro metabolic activation in mutagenesis testing. F. J. 

### de Serres, J. 

### R. Fouts, 

### J. R. Bend and R. M. Philpot, (eds.), Elsevier/North-Holland Biomedical Press, Amsterdam, pp.85-S8, 1976. Matsushima, T., Sugimura,**~.,** 

### Nagao, M., Yahagi, T., Shirai, A. and Sawamura, M.: In Short-term test systems for detecting carcinogens. K. H. Norpoth and R. C. Garner, (eds.), Springer-Verlag, Berlin Heidelberg New York, pp.273-285, 1980. Matsushima, T., Talamoto, Y., Shirai, A., Sawamura, M. and Sugimura, T.: The reverse mutation test on 42 coded compounds with the Escherichia coli WP2 system. In press, 1981. McCann, J., 

### Choi, E., Yamasaki, E. and Ames, B. N.: Detection of carcinogens as mutagens in the Salmonella/microsome test: Assay of 300 chemials. Proc. Nat. Acad. Sci.**~:5l35-5l39,** 

### 1975. Vogel, H. J. 

### and Bonner, D. M.: J. 

### BioI. Chern., 218:97-106, 1956.-9­



### This report constituted of pages 1-10, and Tables I-VI, signed this 29th day of October , 1981.

Authors.

# C.JIc.........~**~~cj.Q,** rd). Alan J.

### Isqu~,**P~** Principal Investigator/Study Director

Approved By:

# E.J~ Toxicology Department

Typed By:

# ~c;l.J~ Karen L. Davis

### -10­

QUALITY ASSURANCE STATEMENT

This report represents data generated by the Toxicology Department, Dow Corning Corporation, Midland, Michigan. This study was conducted according to FDA Good Laboratory Practice Regulations. The results reported accurately reflect the data generated. All raw data is located at Dow Corning Corporation.

Study Started: September 22, 1981 Study Completed: September 24, 1981 Date Audited: September 22, 1981 Report Issued: October 29, 1981

BeIljaJll:Frank1in Quality Assurance Health 

### & Environmental Sciences Dow Corning Corporation Midland, Michigan 48640

Date:

### TABLE I



### TEST MATERIAL 81-2001-17 

### PREPARED BY: B.J.MILLER INITIATION DATE: 9-22-81 

### NONACTIVATION TEST--TA-1535 r-;:E:.V[F,T(1N°rS CONC.OF 

### TEST COMPOUND (UG/PLAT[) PEF,**PLi~TI::** SOL\l 

### CON**POSo)~** 

### CON 3i2.5 625 A () 

### 1250 2500 5000 I:'l_**(~TE** 24 

### 410 19 18 15 22 1El 1:'UYfE :2**~!** 

### 1 450 18 16 14 1 5 20 

### oj**~) F'l.o'~'** orI::: :3**2:~:'** :3B(-) 15 

### 20 

### 15 16 .:.. "')r) 

### 1 -1**MEi~,j\l** 

### 413 17 ; 8 

### 14 1,:S

...J!. I**~,** 0-) 

### S.D.**3~:::: ~:**  .:.. 0 3 

### 4 ACTI**\lol~**

### TIDN 

### TEST

___0T**i~o-** i**~:)35** 

### i7 I'")l PL.t,TE 

### 128

...... \.) 8 '1,0)**PL.(~,T[** :2 1

### oj 2 

### 1 ':1 

### 20 Pl..ot,ofE:. ...:......:. 

### oj 

### r- 1 07 0 h.' 'I (}4 20 ::-**~J** '"J"') j1E:t,,000l 

### ooj 34 .-:.. ..:.. 2() 

### 21 1**\~)** ,.OJ l. /, _,0 S o,Do'**~.~** •• I 6 

## ******************************************************************************* 0)(- 

### NONt,CTIVt,TION t,Z 

### 10 UG/F'L.i=i

### TE (iCTI\l(,OrIDN**(:~,j"--olTH** 1 (-)**UG/I:'l...i:~TF ::o~** DLo\/[:(lOr DM,\'C)**~}O** Ul..,ipL.tlTE -)(-.)(..)(­ 

# til

### TABLE II


### TEST MATERIAL 81-2001-17 PREPARED BY: B.J.MILlER INITIATION DATE: 9-22-81 NONACTIVATION TEST--TA-1537 F<EVEI:<TANTS CONC.OF TEST COMPOUND (UG/PLATE) PER PLI:'1TE SOLV CON**POS~~** 

### CON 312.5**62~).**

### 0 1250 2500 5000

"7 

### PLATE 1 

# -, 88 6 

### 10 3 8 c- 

# .., -.J 

### PLATE 2 10 102 ..) 

### 3 4 4 

## -, I I 

### PLATE:: 3 8 

### 76 7 4 "1 3 

### ,.- "7 

### MEAN 8 

### 88 6 ;) 4 7 -.J -r 

### S.D. i 

### 13 i 2 0 0 -.J**~;CTIVATION** 

### TEST"--TA-1537 PLATE 1 1 4 1 72 9 8 

### 13 "1 6 1 •• 

### PLATE 2 12 180 ..:) i 4 

### 11 8 8 

### PLATE: 13 

### 176 1 'j '7 6 "1 5 

### MEAN 13 176 '1i 9 10 '7 

### 6 S.D. 1 4 2 3 3 0 1 

## ******************************************************************************* * NONACTIVATION AA 10 UG/PLATE ACTIVATION ANTH 10 UG/PLATE SOLVENT DMSO 50 UL/PLATE

### TABLE III


### TEST MATERIAL 81-2001-17 PREPARED BY: B.J.MILLER INITIATION DATE: 9-22-81 NONACTIVATION TEST--TA-1538 REVERTANTS CONC.OF TEST COMPOUND (UG/PLATE) PER PLATE SOLV CON POSH CON**312~5** 

### 625.0 1250 2500 5000 PLATE 1 31 

### 1000**7~** wJ 

### 26**~~ ~~**  

### 28 6 

### PLATE 2 3? 

# - 1000**~~ -~**  

### 34 

### 20 23 

### 4 

### PLATE 3**~" ~O**  

### 1000 28 37 23 

### 26 8 

### MEAN 30 1000**-~ j~** **~~ j~**  

### 21**~~ ~~**  

### 6 S.D. , 0 7.**~ ~**  J 1 

### , 2 

### ACTIVATION TEST--TA-1538**~Q ~L** **,~** 

### PLATE 35 1000 40 'w i 

### 4 

### 6 PLATE 2 32 1000 27 31 

### 30 22 5**~~** 

### PLATE 3 31 

### 1000 42 

### 32 i 

### 9 6**,~ ~o** **~,** 

### MEAN 32 

### 1000 36 

### ,**~-** ( i 

### 8 5 

### S.D. 2 0 8 4 3 4 0 

## ******************************************************************************* 

# * NONACTIVATION NF 10 

### UG/PLATE ACTIVATION ANTH 10 UG/PlATE SOLVENT DMSO 50 Ul/PlATE 

## ***

### TABLE IV



### TEST MATERIAL 81-2001-17 

### PREPARED BY: INITIATION DATE: 9-22-81 NONACTIVATION TEST--TA-98 1;:[VEI:;:T**~INT** S' 

### CONe.OF TEST COMPOUND PEl;: PI_i;lE 

### SOLV CON POS·)(· CON 

### 3i2.5 i**2~50** F'I..Ji

### TE 31 i N:)O i C) 

### ,., i .::.' -' i 6 

### PL(")TE 2 26 i 

### (l00 1B 

### 21 ...,r) .r:...:... 

### PL?-ITE " ,oJ 2B i 

### 000 i I:' ._' i 6 i 4**~'1E?-IN 2~:~**  i 

### 000 1""{ i -, i i -, i S ,. D

# .**;.~~** 0 'j "7 ,oJ 4 

### ACTIVI;TION TI::S'

### T'-'-'T A

_ ..

### c;fJ

"X i. "X";' \_, I 

### PLtlTE i 

### 000 44- 3€l \.J\.J r) "Z"':i

....J ,,_ 

### PL.ATE

... '- 42 

### 1000 40**~56** "">." 

### F)LrITE ,.) 

### 40 i OO() 3D 

### 36 36 

### ME?-IN 39 i 

### 000 3D 

### 37 36**~.,** "k' I.i

# . . ... J 

### D 0 

### 6 i 

### B.J.MILLER (UG/F'Lf-YrE)**2~500** 

### 16 i 6 

### 'is 'j 5 (oj


### 42 37 

### 36 :3,) 3 

### 5000 5 6 4

8 D 7 7 

## o 

## ******************************************************************************* * NONACTIVATION NF 10 UG/PLATE ACTIVATION ANTH 10 

### UG/PLATE SOLVENT DMSO 50 UL/PLATETABLE V


### TEST MATERIAL 81-2001-17 PREPARED BY: B.J.MILLER INITIATION DATE: 9-22-81 NOi'··!f.iCT I \/(;T I ON**TE,':.~T····-TA·"1** 

### 00**I:;':EVEF~T ,:~,NT**  S 

### CONC.OF TEST Col"iF-DUND**(UG/F'U~** 

### TE) PEF<**PL!~,TE** 

### SOLV CON**P(JS')~** 

### CON**31:~.l5** 625**~** () i**2~50 2~)00**  

### 5000 PL.r.,"fE i 36 

### 1000 160 120 120 i 

### 12 76 '1 

### PLATE .':- i60 

### 1000 168 136 136 i 04 92 I='L(")TE 3 

### 160 1000 176 182 1 

### 1') 

# .., 

### 136 84 1 ,

..,") t1Et-ti'J :J .:. 

### 1000 168 148 122 1 1'7 

### 84 

### S.D" 1 -z ,J (I 

### 8 2St 

### 12 16 8 

### ACTIVI-'HION TEST--TA
.... 1**i~)0** 

### PLATE 1 7") 

### 156 i :'56 """A".. 

### 1000 12B i 04 

### 1'"", 1 4(,)**PL(.~lE** 2 i 3t; i (H:)0 ..I.'..L i i 

### 6 128 98 "1 ,J 

### PI...{:,TE i 

### 30 1000 144 

### 127 124 120 1 

### 12**MEI~li\1** 

### 132 1(il00 i40 

### 1**3~:)** 1**2~5** 

### 1

## ... ")"":

_.' 

### 104 7; ,,} 

### S.D. 0 1'7 7 H) 4 7 

## .***.*******************.*••••*****************••****************************** 

# * NONACTIVATION AZ 10 UG/PLATE ACTIVATION ANTH 10 

### UG/PLATE SOLVENT DMSO 50 UL/PLATETABLE VI



### TEST MATERIAL 81-2001-17 

### PREPARED BY: B.J.MILLER INITIATION DATE: 9-22-81 

### NONACTI VATION TEST--WP2 F(EVEf.:Tt,N"r

### .S: 

### CONC.OF TEST COMPOUND (UG/PLATE) PEI:( PL.f:,TE Stell_V 

### CON 

### POSH" CON :31 '") ..:­ "'**~:)** ()::!**~5** ,h (-) 1**2~5(-) 2~:;OG** **~:>OOO** "*1 .::) "1",'( "1 C)**~.** I' 

### F'Lr=iTE 34 i 

### 000



## _ .....' \.}I.•• I 35 

### 26 F;·!...r.:,TE**:~~** 3"i "t 

### 000 :34**~\{:.\** ,j (**3~5**

.." ("; "z r) "'I' 

# . ...**F'L(.~T[ ~<;** **::~**4 i (")00 :':) 0' .,..:, (J

...JA_**~3.({·** ".J I._I**i"tF::r~N :~9**  '1 

### 000**:~** '1 

### 32**:5~)** 33 31 c.. 'j II 

### S.D.
..}**~)** 

### .... ""T 3 

### "'" -' 

### ACTIVt=ITION lEST.. ·· ..··I..JP2 

### PLATE 36**3::~0** 

### 20 36**4~)** 3(? 41 "1"7 4') 

### PL.r-ITE 2 33 4i 

### 0 3':t ..:>.**~~9** 40 "7(.) ''''c''t 

### PL.(.:ITE 3 36**~50B** " 

### 3D

..**~'.J:** 38 41**liE(~N** 

### 346 30 37 

### 40 38 40**~, I~t:~**  -r _/..

### , ,.J 1 (-) 0**4~** 

## ******************************************************************************* 

## * NONACTIVATION MNNG 10 UG/PL.ATE ACTIVATION ANTH 10 UG/PL.ATE SOLVENT DMSO 50 UL./F'L.ATE