of chemicals 

r 

Form A roved. O.M.B. No. 2070-0012. A ires 10-31-96. 

U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY 

Dal e of receipt 

ft PREMANUFACTURE 


~EPA NOTICE


FOR NEW CHEMICAL SUBSTANCES 

\\ h~11 DOCUMENT CONTROL OFFICER 


,01111'kkd OFFICE OF POLLUTION PREVENTION 


'~Ild tlil' AND TOXIC SUBSTANCES, 7407 


Itlllllltl U.S. EPA 401 M STREET, SW 


WASHINGTON, D.C. 20460 


nter the total number of pages 96 


in the Premanufacture Notice 


GENERAL INSTRUCTIONS 

You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do 

not have actual data. 

• 	 Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual IS available from the Toxic 

Substances Control Act (TSCA) Information Service by calling 202-554- I 404, or faxing 202-554-5603). 

• 	 If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, 

your user fee ID number must also appear on your corresponding fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226), P.o. 

360399M, Pittsburgh, PA 15251-6399, Attn. TSCA User fee. 

Part 1-GENERAL INFORMATION 	 TEST DATA AND OTHER DATA 

You must provide the currently correct Chemical Abstracts (CA) Namc oflhe new You are required to submit all test data in your possession or control and to 
 chemical substanee, even if you claim the identity as confidential. You may authorize 
 provide a description of all other data known to or reasonably ascertainable by another person to submit chemical identity information for you, but your submission will 

you, if these data are related to the health and environmental effects on the not be complete and the review will not begin until EPA receives this information. A letter manufacture, processing, distribution in commerce, use, or disposal of the new in support of your submission should reference your TS user fee identification number. chemical substance. Standard literature citations may be submitted for data in the You must submit an original and two copies of this notice including all test data. Ifyou 

open scientific literature. Complete test data (written in English), not summaries claimed any information as confidential, a single sanitized copy must also be submitted. 

ofdata, must be submitted ifthey do not appear in the open literature. You should 

clearly identitY whether test data is on the substance or on an analog. Also, the 

chemical composition ofthe tested material should be characterized. Following 

are examples of test data and other data. Data should be submitted according to 

If there are several manufacture, processing, or use operations to be described in Part II, the requirements of §720.50 ofthe Premanulacture Notification Rule (40 CFR 

sections A and B of this notice, reproduce the sections as needed. Part 720). 

Part 11- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

Part Ill-LIST OF 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 Other data 0 Yes 


continuation sheet with the corresponding section heading. In Part Ill, list these 


attachments, any test data or other data and any optional information included in the notice. Health effects data 181 Yes Risk assessments 


Environmental effects data DYes Stmcttlre/activity relationships 

OPTIONAL INFORMATION 	 Pllysical/Chemical Properties' 181 Yes Test data not in the possession 

or control of the submitter 

You may include any information that you want EPA to consider in evaluating the new 

substance. On page 11 ofthis form, space has been provided for you to described A physical and chemical properties worksheet is located on the last page of this form. 

pollution prevention and recycling information you may have regarding the new substance. 

TYPE OF NOTICE (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 

production volume, protective equipment. .. This option is intended to reduce delays that 

routinely accompany the development of consent orders or Significant New Use Rules. 

Except in the case of exemption 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 submitter when the 

Agency approves the exemption application, checking a binding box in this notice does not D SNUN (Significant New Use Notice) by itself prohibit the 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 CFR 723.50(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. If vou claim information in the notices as confidential you must also provide D 	 LVE Modification D LOREX Modification a sanitized version of the notice (including attachments). For additional instmctions on 


claiming information as confidential, read the Instructions Manual. 


IS THIS A CONSOLIDATED PMN? D Yes


Mark (x) if any information in this notice is claimed as confidential # 

rT1 

C"') 

c:n 

'A FORM 7710-25 (Rev. 5-95) 	 I Replaces previous editions of EPA Form 7710-25.
.r--------------------c--~~--~~--~~~--~------~~------------~~~~--~--~~--------~ Public reporting burden for this collection of information is estimated to average 110 hours per response, including time for reviewing 

instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 

- information. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for 

reducing this burden, to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M. St., S.W., Washington, D.C. 

20460; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503. 

CERTIFICATION 

I certify that to the best of my knowledge and belief: 

I. 	 The company named in Part I, section A, subsection la ofthis notice form intends to manufacture or import for a 

commercial purpose, other than 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 and truthful as ofthe date of submission. 

3. 	 I am submitting with this notice all test data in my possession or control and a description of all other data known to or 

reasonably ascertainable by me as required by §720.50 ofthe Premanufacture Notification Rule. 

Additional Certification Statements: 

If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following user fee certification 

statement that applies: 

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

o The Company named in Part I, Section A has remitted the fee of$1 000 for an Intermediate PMN (defined @ 40 CFR 

700.43) in accordance with 40 CFR 700.45(b), or 

o The Company named in Part I Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of$1 00 

in accordance with 40 CFR 700.45(b). 

If you are submitting a low volume exemption (LVE) application in accordance with 40 CFR 723.50(c)(l) or a Low release 

and low exposure exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), check the following certification 

statements: 

o The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial 

purposes, other than in small quantities solely for research and development, under the terms of40 CFR 723.50. 

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

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

o If this application is for an LVE in accordance with 40 CFR 723.50(c)(l), the manufacturer intends to commence 

manufacture ofthe exempted substance for commercial purposes within I year of the date ofthe expiration ofthe 30 day 

review period. 

The accuracy of the statements you malre in this notice should reReet your hest prediction of the anticipated facts regarding the chemical substance 


described herein. Any knowin!!: and willful misinterpretation is subiect to criminal penalty pursuant to 18 USC 1001. 
 Confidential 

Signature and title of Authorized Official (Original Signature Required) Date 

I!i/LLrL 	 7' /l. ~ /Of4" 

Signature ofag6nt ,apPlicablev 	 Date'7 ~/' I / 

EPA FORM 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 submitting this notice as part of ajoint submission, mark (X) this uu;'.-----------------____ ...,LJ 

Joint Submitter (if 

applicable) 

Name of authorized official 

Company 

Mailing and street) 

2. Technical 

Contact (in 

U.S.) 

3. 

City, State, ZIP Code 

Name of authorized official 

4. Ifyou previously submitted an exemption application for the chemical 

substance covered by this notice, enter the exemption munber assigned by 

EPA. If you previously submitted a PMN for this substance enter the PMN 

number assigned by EPA (i.e. withdrawn or incomplete). ~ 

5. 

6. Type ofNotice - Mark (X) 

I. 

D 

Manufacture 

Only 

Binding Option 

Mark 

12. 

I 

I 

I 

Position 

Telephone 

Position 

Telephone 

Import 

Only 

Mark (X) 

ifnone 

Mark (X) 

ifnone 

Mark (X) 

ifnone 

Binding Option 

Mark 

I 

I 3. 

I 

I 

I 

D Both 

Confidential 

EPA FORM 7710-25 (Rev. 5-95) Page 3 

Complete either item I (Class I or 2 substances) or 2 (Polymers) as appropriate. 	

substance based on 

If another person will submit chemical identity information for you (for either Item I or 2), mark (X) the box at the right. 


the of that in a continuation 


I. Class I or 2 chemical substances (for definitions of class 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 (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. 


For Class I substances a CA Index Name must be provided, For Class 2 substances either a CA Index Name or CA Preferred Name must 

be provided, which ever is appropriate based on CA 9CI nomenclature rules 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 of the Identification D Method 2 (Other Source) 


report obtained from the CAS Inventory Expert Services must be 


submitted as an attachment to this 


d. 	 Molecular formula and CAS Registry Number (if a number already exists for the substance) 

N/A CAS# 

N/A 

e, 	 For a class I substance, provide a complete and correct chemical structure diagram. For a class 2 substance - (I) List the immediate 


precursor substances with their respective CAS Registry Numbers. (2) Describe the nature of the reaction or process, (3) Indicate the 


range of composition and the typical composition (where appropriate). (4) Provide a correct representative or partial chemical structure 


diagram, as complete as can be known, if one can be reasonably ascertained. 


N/A 

attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) 	 Page 4 
a. Indicate the number-average weight ofthe lowest molecular weight composition of the polymer you intend to manufacture. 

Confidential 

Indicate maximum weight percent oflow molecular weight species (not including residual monomers, reactants, or solvents) below 500 and X 

below 1,000 absolute molecular weight of that composition. 

Describe the methods of measurement or the basis for your estimates: GPC 0 Other 0: (SpecifY) 

i) lowest number average molecular weight: 

ii) maximum weight % below 500 molecular weight: 

iii) maximum weight % below 1000 molecular weight: 

attach a continuation sheet. 

You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the 

"Confidential" box next to any item you claim as confidential 

(I) - Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of 

the poIymer. 

Mark (X) this column ifentry in column (I) is confidential. 

Indicate the typical weight percent of each monomer or other reactant in the polymer. 

(2) -

(3) -

(4) - Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the polymer 

description on the TSCA Chemical Substance Inventory. 

(5) - Mark (X) this column if entries in columns (3) and (4) are confidential. 

(6) - Indicate the maximum weight percent ofeach monomer or other reactant that may be present as a residual in the polymer as manufactured for 

commercial purposes. 

Mark this column if is confidential. 

Monomer or other reactant and CAS Registry Number 

% 

% 

% 

% 

% 

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

[8] Method I (CAS Inventory Expert Service - a copy ofthe identification report 0 Method 2 (other source) 

obtained from CAS Inventory Expert Service must be submitted as 

as attachment to this 

d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers. 

See Services Inv,..nt,nru 

e. Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained. 

CONFIDENTIAL 

% 

% 

% 

% 

% 

attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 5 
Part I -- GENERAL INFORMATION -- Continued 

Section B-­ 'A r 1UJ<,J'j 1 11 r INFORMATION -- Continued 

3. Impurities 

(a) - Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide 

the CAS Registry Number if available. If there are unidentified impurities, enter "unidentified." 

(b) - Estimate the maximum weight %of each impurity. If there are unidentified' estimate their total we i gilt%. 

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 if you attach a continuation sheet. 

4. Synonyms - Enter any chemical synonyms for the new chemical identified in subsection I or 2. Confidential 

None 

D Mark (X) this box if you 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 if you attach a continuation sheet. 

6. Generic chemical name ­ If you claim chemical identify as confidential, you must provide a generic name for your substance that reveals 

the specific chemical identity of the new chemical substance to 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 if you attach a continuation sheet. 

7. Byproducts ­ Describe any bypro ducts resulting from the manufacture, processing, use, or disposal ofthe new chemical substance. Provide the CAS Registry 

Number if available. 

CAS Registry Number Confi­ uJI'(~)u", (2) dential 

None 

[ ] Mark (X) this box if you attach a "()ntinll~ti()n sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 6 
Part I -- GENERAL INFORMATION -- Continued 

Section C -- PRODUCTION, IMPORT, AND USE INFORMATION: 

Mark (X) the "Confidential" box next to any item you claim as confidential. 

1. Production volume -- Estimate the maximum production volume during the first 12 months of production. Also estimate the maximum 

production volume for any consecutive 12-month period during the first three years of production. Estimates should be on 100% new chemical 

substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than 

10,000 kg/yr, specify the volume and mark (x) in the binding box. If granted, you are bound to this volume 

Maximum first 12-month production (kg/yr) Maximum 12-month production (kglyr) Confi- Binding 

(100% new chemical substance basis) (100% new chemical substance basis) dential Option 

Mark (x) 

CONFIDENTIAL CONFI DENTIAL X 

2. Use Information -- You must make separate confidentiality claims for the description of the category of use, the percent of production volume 

devoted to each category, the formulation of the new substance, and other use information. Mark (X) the "Confidential" Box next to any item 

you claim as confidential. 

a. (1) -­ Describe each intended category of use ofthe new chemical substance by function and application .. 

(2) -­ Mark (X) this column if entry column (1) is confidential business information (CBI). 

(3) -­ Indicate your willingness to have the information provided in column (1) binding. 

(4) -­ Estimate the percent of total production for the first three years devoted to each category of use. 

(5) -­ Mark (X) this column if entry in column (4) is confidential business information (CBI). 

(6) -­ Estimate the percent of the 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 of use. 

(7) -­ Mark (X) this column if entry in column (6) is confidential business information (CBI). 

(8) -­ Indicate % of product volume expected for the listed "use" sectors. Mark more than one box if appropriate. Mark (X) to indicate 

your willingness to have the use type provided in (8) binding. 

(9) -­ Mark (X) this column if entry(ies) in column (8) is (are) confidential business information (CBI). 

Category of use (1) CBI Binding Produc- CBI %in CBI % of substance expected per use CBI 

Option tion % Form­ (8) 

(by function and application i.e. a dispersive dye Mark (x) ulation Site- Con-* Indus- Com- Binding 

for finishing polyester fibers) (2) (3) (4) (5) (6) (7) limited sumer trial mercial Option (9) 

Silicone textile treatment X 100 % 89% X X 

% % 

% % 

% % 

% % 

% % 

% % 

* If you have identified a "consumer" use, please provide on a continuation sheet a detailed description ofthe use(s) of this chemical substance in consumer products. 

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 if you attach a continuation sheet. 

b. Generic If you claim any category of use description in subsection 2a as confidential, enter a generic description ofthat category. Read the 

use Instructions Manual for examples of generic use descriptions. 

description 

N/A 

D Mark (X) this box if you attach a continuation sheet. 

3_ Hazard Information -- Include in the notice a copy of reasonable facsimile of any 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 if you attach hazard information. 

EPA FORM 7710-25 (Rev. 5-95) Page 7 
Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER ~o.nIJ(lI:nI'lal 

claim 

box next to any you 

Complete section A for each type of manufacture, processing, or use operation involving the new chemical substance at industrial sites you 

control. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting requirements if 

there are further industrial or use after' You must describe these See instructions manual 

l. Confiof the site at which the nn,-rlltum will occur. dential 

Site address (number and street) 

City, County, State, ZIP code 

If the same operation will occur at more than one site, enter the number of sites. IdentifY the 

additional sites on a continuation sheet, and if any of the sites have significantly different 

production rates or operations, include all the information requested in this section for those 

sites as attachments. 

Use 

Maximum kglbatch (100"10 new chemioal I Hourslbatch I Batches/year 

substance) I 

N/A I 	 I 

I 

2. Continuous 

(I) 	 Diagram the major unit operation 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 (by kg/day or kglbatch on a 100% new chemical substance basis), and entry point ofall starting materials and 

feedstocks (including reactants, solvents. catalysts, etc.), and ofall products, recycle streams. and wastes. Include cleaning chemicals (note frequency if not 

used daily or per batch.). 

(3) 	 IdentifY by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. 

N/A 

attach a continuation sheet. 

I. Batch 

d. Process description Mark (X) to indicate your willingness to 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 confidentiality claims for the description ofworker activity, physical form of the new chemical substance, 

number ofworks exposed, and duration of activity, Mark (X) the "Confidential" box next to any item you claim as confidential, 

(I) -­ Describe the activities (i.e, bag dumping, tote filling, unloading drums, sampling, cleaning, etc,) in which workers may be exposed to the substance, 

(2) -- Mark (X) this column if entry in column (I) is confidential business information (CBI), 

(3) -- Describe any protective equipment and engineering controls used to protect workers, 

(4) and (6) --Indicate your willingness to have the information provided in column (3) or (5) binding, 

(5) --Indicate the physical formes) ofthe new chemical substance (e,g., solid: crystal, granule, powder, or dust) and % new chemical substance (if part ofa 

mixture) at the time of exposure, 

(7) -- Mark (X) this column if entry in column (5) is confidential business information (CBI), 

(8) -- Estimate the maximum number of workers involved in each activity for all sites combined, 

(9) -- Mark (X) this column if entry in column (8) is confidential business information (CBI), 

(10) and (11) -- Estimate the maximum duration ofthe activity for any worker in hours per day and days per year, 

(12) -- Mark (X) this column ifentries in columns (10) and (II) are confidential business information (CBI), 

Worker activity eBI Protective Equipment! 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 if you attach a continuation sheet. 

3. Environmental Release and Disposal-- You must make separate confidentiality 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) -- Enter the number of each release point identified in the process description, part II, section A, subsection I d(3), 

(2) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology (in kg/day or kglbatch), 

(3) -- Mark (X) this column if entries in columns (I) and (2) are confidential business information (CBI), 

(4) -- IdentifY the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specifY» to 

which the new substance will be released from that release point. 

(5) -- a, Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. For releases 

disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste, On a continuation sheet, for 

each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate 

the amount released to the environment after control technology (in kg/day), 

(6) --Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI), 

(7) -- IdentifY the destination(s) ofreleases to water, Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or 

NPDES numbers of the POTW (Publici Owned Treatment Works), Mark (X) if the POTW name or NPDES # is confidential business information (CBI), 

Release Amount of new substance CBI Media of Control technology and efficiency (you may wish to optionally attach efficiency data) 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 POTW provide name(s) below: CBI o Navigable D Other - SpecifY provide NPDES # CBI 

- destination(s) of waterway 

releases to water, 

] Mark (X) this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 9 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued 

Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS 

Complete section B for typical processing or use operations involving the new chemical substance at sites you do not control. Importers do not have to complete this 

section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions Manual. Complete a separate 

section B for each type ofprocessing. or use operation involving the new chemical substance. If the same operation is performed at more than one site describe the 

typical operation common to these sites. IdentifY additional sites on a continuation sheet. 

1. Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential. 

(I) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e.g. 5 gallon pails, 55 gallon 

drums, rail cars, tank trucks, etc). On the diagram, identifY by letter and briefly describe each worker activity. (2) -- Provide the identity, the approximate weight 

(by kg/day or kg/batch, on an 100% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all 

products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- IdentifY by number the points ofrelease, 

including small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the # of sites (remember to identify the 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. Worker ExposurefEnvironmental Release 

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

(2) -- Estimate the number of workers exposed for all sites combined. 

(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) -- Describe physical form of exposure and % new chemical substance (ifin mixture), and any protective equipment and engineering controls, if any, used to 

protect workers. 

(7) -- Estimate the percent ofthe new substance as formulated when packaged or used as a final product. 

(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(10) -- Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kglbatch). 

(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration, POTW, or other 

(specify) and control technology, if any, that will be used to limit the release ofthe new substance to the environment. 

(14) -- IdentifY byproducts which may result from the operation. 

(3), (5), (8), 1 I), (13) and (15) -- Mark (X) this column ifanv oflhe 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 if you attach a continuation sheet, 

EPA FORM 7710-25 (Rev. 5-95) Page 10/ 
CUSTOMER PROCESSING PROCESS DESCRIPTION 

(FORMULATION) 

(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 Softener will 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 of the product per 

pound, customers would have every incentive to ensure complete removal of the 

product from the drum. Based on our experience with similar materials, Dow Corning 

would expect that only about 0.5 - 1.0 Kg DOW CORNING® 2-8500 Hydrophilic 

Softener would remain in a standard 220 kg drum after use by the customer. 

Pursuant to Dow Corning's commitment to 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 promote the most economical and environmentally responsible 

use of containers. This program is available to all of our customers using drums and 

permits customers to virtually eliminate the problem of disposing 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 independent auditors to verify that they meet our environmental, health and safety 

standards. 

Prior to pick-up, the ContainerNet® program requires that drums be drip dry, all labels 

and closures must be in place, and the end user must provide a current Material Safety 

Data Sheet (MSDS) for the 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 unlikely that any residual 

DOW CORNING® 2-8500 Hydrophilic Softener would be released to the environment 

or flushed to a publicly owned treatment facility. Accordingly. we anticipate 0 kg/year 

pre- and post-treatment environmental release of the PMN chemical substance 

resulting from disposal of spent packaging by textile formulators. 

Page ""10&:4­

13 
Part 11-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued 

Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS 

Complete section B for typical processing or use operations involving the new chemical substance at sites you do not controL Importers do not have to complete this 

section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions ManuaL Complete a separate 

section B for each type ofprocessing, or use operation involving the new chemical substance. Ifthe same operation is perfonned at more than one site describe the 

typical operation common to these sites. Identify additional sites on a continuation sheet. 

1. Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidentiaL 

(I) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specifY - e.g. 5 gallon pails, 55 gallon 

drums, rail cars, tank trucks, etc). On the diagram, identifY by letter and briefly describe each worker activity. (2) -- Provide the identity, the approximate weight 

(by kg/day or kglbatch, on an 100% new chemical substanee basis), and cntry point of all feedstocks (including reactants, solvents and catalysts, etc) and all 

products, recycle streams, and wastes. Include cleaning chemicals (note frequency ifnot used daily or per batch). (3) --IdentifY by number the points ofrelea~e, 

including small or intennittent releases, to the environment of the new chemical substance. (4) Please enter the # of sites (remember to identify the locations of 

these sites on a continuation sheet): 

30 

# of sites 

Customer Processing (Application): continued, page 10.6 

Mark (X) this box if you attach a continuation sheet. 

2. Worker Exposure/Environmental Release 

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

(2) -- Estimate the number of workers exposed for all sites combined. 

(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year. 

(6) -- Deseribe physical fonn of exposure and % new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to 

protect workers. 

(7) -- Estimate the percent of the new substanee as fonnulated when packaged or used as a final product. 

(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified. 

(10) -- Estimate the amount of the new substanee released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kglbatch). 

(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surfaee water, on-site or off-site land or incineration, POTW, or other 

(specifY) and control technology, if any, that will be used to limit the release of the new substanee to the environment. 

(14) -- Identify byproducts which may result from the operation. 

I (3), (5), (8), 11), (13) and (15) - Mark (X) this column if any of the proceeding entries are confidential business infonnation (CBI). 

Letter #of CBI Duration CBI Protective Equ ip. I (t/ojn CBI Release Amount of CBI Media of Release CBI 

of Workers of Engineering Controlsl 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 if you attach a continuation sheet, 

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

''+ 
CUSTOMER PROCESSING DESCRIPTION 

(APPLICATION) 

(40 Kg/Day)* Emulsion APPLICATION • Water - (PADDING OR (A)(1) 

Textile -

- EXHAUST APPL.) -

" 

THERMAL DRYING 

(CURING) 

" 

Treated Textile 

* Containing 7.1 Kg New Chemical Substance TSDCC245 

Page~ 

IS­
CONFIDENTIAL 


Page 1&.TI~ 
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 per year, with each 

site using 40 kg/day of formulated textile treatment containing (18 weight percent) 

7.1 kg of the new chemical substance. For reasons of efficiency and cost effectiveness, applicators require exhaustion of 95-99 percent of the finish solids onto the fabric. 

Dow Corning has performed a laboratory evaluation of the exhaust characteristics of 

the new chemical substance and established that under typical application conditions 

(1.7 weight percent new chemical SUbstance in aqueous bath, adjusted to pH 4 with 

acetic acid), 99.0 weight percent of the new chemical substance was exhausted onto 

the test fabric after only 60 minutes. Accordingly, even assuming that 100 percent of 

application would occur via padding, with periodic dumping of the 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 of 0.07 kg per day per site for the new 

chemical substance. If we assume 90 weight percent removal of the new chemical 

substance through waste water treatment, a post-treatment environmental release of 

0.007 kg per day per site is obtained. Application of the above discussed 99.0 percent 

exhaust rate to partitioning of the new chemical substance during waste water treatment provides a post-treatment environmental release of 0.0007 kg per day per site. 

Page-4&.&­

11 
OPTIONAL POLLUTION PREVENTION INFORMATION 

To claim information in this section as confidential circle or bracket the specific information that you claim as confidential. 

In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce 

or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal 

of the PMN substance. Please include new information pertinent to pollution prevention, including source 

reduction, recycling activities and safer processes or products available due to the new chemical substance. 

Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological 

modification, process and procedure modification, product reformulation, raw materials substitution, and/or 

inventory control. Recycling refers to the reclamation of useful chemical components from wastes that would 

otherwise be treated or released as air emissions or water discharges, or land disposal. Descriptions of pollution 

prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance 

with existing regulatory requirements and can be either quantitative or qualitative. The EPA is interested in the 

information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting 

ofrisks to other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In 

addition, information on the relative cost or performance characteristics of the PMN substance to potential 

alternatives may be provided. 

All information provided in this section will be taken into consideration during the review of this 

substance. See Instructions Manual and Pollution Prevention Guidance manual for guidance and 

examples. 

Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in the 

volume manufactured; (3) a reduction in the generation ofwaste materials through recycling, source reduction or other means; (4) a 

reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in 

the cost ofproduction and/or improved operation efficiency ofthe new chemical substance in comparison to existing chemical 

substances used in similar application; or (6) the extent to which the new chemical substance may be a substitute for an existing 

substance that poses a greater overall risk to human health or the environment. 

The new chemical substance will be supplied as a formulated mixture containing 89 weight percent of the new chemical 

substance to textile formulators who typically will formulate the mixture at 10-20 weight percent (9-18 weight percent new 

chemical substance) into aqueous emulsions along with appropriate nonionic surfactants. Formulators will supply such 

textile treatment formulations to textile mills for use as textile softeners, offering superior softening performance when 

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 new chemical substance. 

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

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

I~ 
Part III -- LIST OF ATTACHMENTS 

Attach continuation sheets for sections ofthe form and test data and other data (including physical/chemical properties and 

structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to 

which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page 

numbers of each attachment 

. Mark (X) the "Confidential" box next to any attachment name you claim as confidential. Read the Instructions Manual for guidance on 

how to claim any information in an attachment as confidential. You must include with the sanitized copy of the notice form a sanitized 

version of any attachment in which you claim information as confidential. 

Attachment name Attachment Confipage number(s) dential 

I 

Material Safety Data 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 of TX-81-2001-17 in Albino Rats III 

An Acute Eye Irritation Study of TX-81-2001-17 in the New Zealand White Rabbit IV 

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

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

An Acute Static Toxicity Test of TX-81-2001-17 with Daphnia magna VII 

An Acute Static Toxicity Test of TX-81-2001-17 with Rainbow Trout VIII 

Genetic Evaluation of TX-81-2001-17 in Bacterial Reverse Mutation Assays IX 

i 

I 

D Mark (X) this box if you attach a continuation sheet Enter the attachment name and number. 

EPA FORM 7710-25 (Rev. 5-95) Page Ioi:­
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET 

To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you provide and 

include it in the notice. IdentifY the property measured, the page of the notice on which the property appears, the value of the 

property, the units in which the property is measured (as necessary), and whether or not the property is claimed as confidential. The 

physical state of the neat substance should be provided. These measured properties should be for the neat (100% pure) chemical 

substance. Properties that are measured for mixtures or formulations should be so noted (% PMN substance in --.J. You are not 

required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplifY review and ensure that 

confidential information is properly protected. You should submit this worksheet as a supplement to your submission oftest data. 

This worksheet is not a substitute for submission oftest data. 

Property Mark (X Page Value Measured OJ Confiif numbe Estimate dential 

(a) provided (b) (c) Mark (X) 

(M or E) (d) 

Physical state of neat substance X (s) X (I) (g) M 

Vapor pressure 

@ 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 

Melting temperature DC 

Boiling / sublimation temperatureCaJ. torr pressure DC 

I 

Spectra 

Dissociation constant 

Particle size distribution 

Octanol/ water partition coefficient 

Henry's Law constant 

Volatilization from water 

Volatilization from soil 

pH @ concentration 

Flammability 

Explodability 

I Adsorption / coefficient 

Other - Specify Viscosity M 4,000 cps M 

EPA FORM 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 OF THE SUBSTANCE AND OF THE COMPANY 

Dow Corning Corporation 

South Saginaw Road 

Midland, Midland 48686 

24 Hour Emergency Telephone: (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 may cause 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 
DOW CORNING 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 of Overexposure 

No known applicable information. 

Medical Conditions Aggravated by Exposure 

No known applicable information. 

The above listed potential effects of overexposure are based on actual data, results of studies performed upon similar 

compositions, component data and/or expert review of the product. Please refer to Section 11 for the detailed toxicology 

information. 

4. FIRST AID MEASURES 

Eye: Immediately flush with water for 15 minutes. Get medical attention. 


Skin: Remove from skin and wash thoroughly with soap and water or waterless 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 or water 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 spray to keep fire exposed 

containers cool. 

Unusual Fire Hazards: None. 
DOW CORNING DOW CORNING CORPORATION 

Material Safety Data Sheet 

Page: 3/8 

DOW CORNING(R) 2-8500 HYDROPHILIC SOFTENER 

Hazardous Decomposition Products 

Thermal breakdown of this product during fire or very high heat conditions may evolve 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 whether to 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 of steam, 

solvents or detergents. Dispose of saturated absorbant or cleaning materials 

appropriately, since spontaneous heating may occur. Local, state, and federal laws and 

regulations may apply to releases and disposal of this 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 

of this MSDS provide information regarding certain federal and state requirements. 

Note: See section 8 for Personal Protective Equipment for Spills. Call Dow Corning Corporation, (517) 496-5900, 

if additional 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, or fumes. Keep 

container closed. Do not take internally. 

Static electricity will accumulate and may ignite vapors. Prevent a possible fire hazard by bonding and grounding 

or inert gas purge. Keep container closed and away from 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: TWA 50 ppm. 

Methyl alcohol forms on contact with water or humid air. Provide adequate ventilation to control exposures 

within guidelines of Worksafe 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 
DOW CORNING 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 of shift. 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 of existing engineering 

controls. 

Suitable Respirator: Self-contained breathing apparatus (SCBA) or other 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, or fumes. 


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 for formaldehyde. 


Note: These precautions are for room temperature handling. Use at elevated temperature or aerosol/spray applications may 

require added precautions. 
DOW CORNING 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 @ 25Q C: 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. 

1O. STABILITY AND 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. 
DOW CORNING 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 Water Treatment 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 T oxicit <=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 classify the ecotoxicity of this product when ecotoxicity data is listed above. Please read the other information 

presented in the section conceming the overall ecological safely of this 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, if additional 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. 
DOW CORNING 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, if additional information is required. 

15. REGULATORY INFORMATION 

Contents of this MSDS comply with the OSHA Hazard Communication Standard 29 CFR 1910.1200. 

TSCA Status: For R&D purposes only. One or more of the components of this product may not be 

listed on the TSCA inventory of chemical substances. Product should be used solely for 

scientific experimentation, research or analysis under the supervision of technically 

qualified individuals. 

EPA SARA Title 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 of California under the 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. 

New Jersey 
DOW CORNING 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 of the intended use and determine whether they are appropriate. 

(R) indicates Registered Trademark 
DOW CORNING 

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 Inventory Expert Service 


A division of the American 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 

30 
DOW CORNING 

TSCA SECTION 5(a) PREMANUFACTURE NOTIFICATION 

TOXICOLOGICAL STUDIES 

TSCA CONFIDENTIAL BUSINESS INFORMATION CLAIMS 

For purposes of Premanufacture Notification under Section 5(a) of the 

Toxic Substances Control Act (TSCA), the general PROPRIETARY 

designation on the attached toxicological studies has been waived by Dow 

Corning Corporation. 

Only the specific chemical identity of the test substance is being claimed 

as TSCA Confidential Business Information (TSCA CBI) in the attached 

studies and, in compliance with the provisions of 40 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, of the 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 

31 

DOW CORNING 

TSCA SECTION 5(a) PREMANUFACTURE NOTIFICATION 


TOXICOLOGICAL STUDIES 


TEST MATERIAL CHEMICAL IDENTITY 


The New Chemical Substance (TSDCC245) which is the subject of this 

Premanufacture Notification (PMN) is described as follows: 

CASRN: [ CONFIDENTIAL] 

NAME: [CONFIDENTIAL] 

STRUCTURE: [ CONFIDENTIAL] 

The attached toxicological data which are being submitted in support of this 

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 


CONCLUS IONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 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 (LDSO > 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: 

Toxicology 

E.~ 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: 

Toxicology 

E.~ 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~ i 
TABLE 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. Posi tive/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. 	Con j unc tival 

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 


CONCLUS IONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 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. 

Authors: R-.

Claire R. DeVries, B.S. 

Waheed H. Siddiqui, Ph.D. 

Approved By: 

E.~ Toxicology Department 

Typed By: 

~,,-(4y Karen L. Davis cV dJo~ 

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 


Mor tality Da ta 

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 


CONCLUS IONS. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 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: 

Toxicology 

E.J.~~ 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 


We I1-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 ••• /II • • • • • • • • • • 0

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< DOW 
TABLE 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 

Le 1.0 (0.6-1.4 ppm) 1.1 (0.7-1.5 ppm) 50 

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 00 ••• 0 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 5

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 220 C ± 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~:::Tt.RY: fOR us" WlTlli~~ DOW 
TABLE 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 7.8 
DOW 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 (LC SO ) 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 LC could not be calculated SO 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: 

Cecil 

~~2 L. Frye, ~. 

Typed By: 

7<6 

FRC Pi:IETI·.~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;'~ CNly~ 
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 

MgC1 2 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) Dimethylsulfoxide 

N-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 37oc. 
-5­

1. Direct Plate Incorporation Method 

Nonactivation Assay 

To a sterile 13 x 100 rom test tube placed in a 430C 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: 

Toxicology 

E.J~ Department 

Typed By: 

Karen 

~c;l.J~ 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 1 El 


1:'UYfE :2 ~! 1 450 18 16 14 1 5 20 


oj ~)

F'l.o'~' or I::: :3 	 2:~:' :3B(-) 15 20 15 16 .:.. 

"')r) 1-1 MEi~,j\l ... J!. 	 413 17 ; 8 14 I 1,:S ~, 0-) S.D. 	 3~:::: ~: .:.. 0 3 4 


ACT I \lol~ TID N TEST ___0 T 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. /, S o,Do' _,0 ~.~••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 

,.-	 MEAN "7 8 	 88 6 ;) 4 7 -.J 

-r S.D. i 13 i 	 -.J 2 0 0

~;CTIVATION TEST"--TA-1537 

PLATE 1 1 4 172 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 SOL V 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 SOL V 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 1 B 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 

ACT IVI;TI ON TI:: S' T'-'-' T A _.. c; fJ 

"X i. 	 "X";' PLtlTE 	 \.J\.J i 000 \_, I 44- 3€l r) "Z"':i PL.ATE ...'- 42 1000 40 ....J ,,_ ~56 

F)LrITE "">." ,.) 40 i OO() 3D 36 36 

ME?-IN 39 i 000 3D 37 36 ~., "k' I.i . . D 	 ... J 0 6 i 

B.J.MILLER 

(UG/F'Lf-YrE) 

2~500 

1 6 

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/PLATE 

TABLE 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 

PLATE '1.':- i60 1000 168 136 136 i 04 92 


I='L(")TE 3 160 1000 176 182 1 1 ') .., 136 84
 1 , ..,") t1 Et-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.... 1i~)0 

PLATE 1 7") """A".. 1000 156 i :'56 12B i 04 PL(.~lE 2 i 3t; i (H:)0 1..I.'..L '"", 14(,) i i 6 128 98 "1 PI... {:,TE ,J 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/PLATE 

TABLE VI 

TEST MATERIAL 81-2001-17 PREPARED BY: B.J.MILLER 

INITIATION DATE: 9-22-81 

NONACTIVATION TEST--WP2 

F(EVEf.:T t,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) F'Lr=iTE 34 i 000 ~. I' _.....' \.}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.. 	 S.D. 'j II ..} ~) .... ""T 3 	 "'" -' 

ACTIVt=ITION lEST .. ·· .. ··I..JP2 

PLATE 36 3::~0 20 36 4~) 3(? 41 

PL.r-ITE 2 33 4i 0 3':t "1"7 4') ..:>. 	 ~~9 40 

PL.(.:ITE 3 "7(.) 	 ''''c''t 36 ~50B " 3D .. ~'.J: 38 41 

liE(~N 346 30 37 40 38 40 ~,

I~t:~ -r _/ .., ,.J 1 	 4~ (-) 0

******************************************************************************* * 	NONACTIVATION MNNG 10 UG/PL.ATE 

ACTIVATION ANTH 10 UG/PL.ATE 

SOLVENT DMSO 50 UL./F'L.ATE