### 1 Form Approved. O.M .B . No. 2070-0012 . Approval Expires 10-31-9 6 

### Lb:S . ENVIRONMENTAL PROTECT~ON AGENCY 

## AGENCY USE ONLY Date of receipt 

# EPA PREMANUFACTUR E NOTICE ( 7 

### FOR NEW CHEMICAL SUBSTANCE S When DOCUMENT CONTROL OFFICER completed OFFICE OF POLLUTION PREVENTION scnd this AND TOXIC SUBSTANCES, 740 7 forin to U.S . E .P.A. 401 M STREET, SW

ddMW_WASHINGTON, D.C. t E nter the total nttmber of pages in the Premanufacture Notice • • 

### Mftf GENERAL INSTRUCTIONS 7'S 0 3 C M 0 2 • You must provide al l information requested in this form to the extent that it is known to or reasonably asce rtainable by you . Make reasonable estimates if you do not have actual data . • Before you complete this form, you should read the "Instructions Manual for Premanufactu re Notification" ( the Instructions Manual is available from the Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603) . • 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 Abs tracts (CA) Name of the new You are required to submit all test data in your possession or control and to chemical substance, even if you claim the iden tity as confidenti al. You may authorize provide a desc ri ption of all other data known to or reasonably ascert ainable by another person to submit chemical identity informati on for you, but your submission will you, if these data are related to the health and environmental effects on th e not be complete and the re view will not begin un til EPA receives this inforrro tion. A letter manufacture, processing, distribution in commerce, use, or disposal of the ne w in support of your submission should refe rence your TS user fee identifi cati on number. chemical substance. Stand ard literature citations may be submitted for data in the You must submit an original and two copies of this notice including a ll test data . If you open scientific literature . Complete test data (written in Engli~hi not summaries claimed any informati on as confidential, a single sanitized copy must also be submitted . 4£ of data. must be submitted if they do not apoear in the open literatu re. You should clearly identify whether test data is on the substance or on an analog . Also, the Pa rt II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE chemical composition of the tested materi al should be characte rized . Followin g are examples of test data and other data. Data should be submitted according to If the re are several manufacture, processing, or use operati ons to be described in Pan II, the requirements of §720 .50 of the Premanufacture Notification Rule (40 CFR secti ons A and B of this no tice, re produce the sec tions as needed . Part 720) . Part ID- LIST OF ATTACHMENTS Test Da ta ( Check Below any included in this notice) Attach addi ti onal sheets if there is not enough space to answer a ques tion fully. La bel each • Environmental fate data ❑ Yes • Other data ® Yes continua ti on sheet with the corresponding sec tion heading. In Pa rt DI , fist these attachments, any test data or other data and any op ti onal informa tion included in the notice . • Health effects data ® Yes Risk assessment s • Environmental effects data ❑ Yes Structurelactivity re lationships OPTIONAL INFORMATION • Physical/Chemical Properties* ® Yes Test data not in the possession or control of the submitter You may include any informa tion that you want EPA to consider in evaluating the ne w substance. On page 11 of this form, space has been provided for you to desc ri bed • A physical and chemical proper ti es worksheet is located on the last page of this fo rm. po lluti on prevention and recycling informa tion you may have re gar ding the new substance . TYPE OF NOTICE ( Check Only One) So-called "binding" boxes are included throughout this form for you to indicate you r willingness to be bound to certain statements you make in this sec tion, such as use, PMN (Premanufacture Noti ce) rV producti on volume, protecti ve 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 exempti on appli cations (~" ' such as TMEA, LVE, LOREX) where INTERMEDIATE PMN (submitted in sequence with fiplroduct PM1~ certain information provided in such notification is binding on the submitter when th e Agency approves the exemp ti on application, checking a binding box in this no tice does not Z-1 ~'7j by itself prohibit the submitter from later deviating from the informa ti on (except chemical SNUN (Significant New Use No ti ce) n) t 3(`r-1 Cr' ,-d, identity) reported in the form ❑ ,,,~ ~i TMEA (Test Marketing Exemption App lication) CONFIDENTIALITY CLAIMS ❑

_ . _.__ t , 1 LVE (Low Volume Exemption) @ 40 CFR 723 .50(Q;~ C .4 CD You may claim any inform a ti on in this noti ce as confiden tial. To asse rt a claim on the form, mark (X) the confidenti al box next to the infoumation that you claim as con fi den ti al . ❑ LOREX (Low Release/Low Exposure Exemption) CFR 723 .50(c)(2) To assert a claim in an attachment, circle or bracket the informa ti on you claim as confidential. 1_vou claim information in ► v notices as confidential. you must also orovid e a sanitized version of the notice . (including attac t++Pn
. For addi tional instructions on ❑ LVE Modification ❑ LOREX Modification claiming information as confidential, read the Instructi ons Manual . ❑ IS THIS A CONSOLIDATED PMN? ❑ Yes

Mar k (x) if any informati on in this no tice is claimed as confidenti al. It of chemical s (Pre noti ce Communicati on It required, enter # on page 3) EPA FORM 7710-25 (Rev . 5-95) / Replaces p re vious editi ons of EPA Form 7710=25 .

### p . 2 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 of this 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: 1 . The company named in Part I, section A, subsection I a of this 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 of the 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 of the 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 : ® The Company named in Part I, Section A has remitted the fee of $2500 specified in 40 CFR 700 .45(b), o r ❑ The Company named in Part I, Section A has remitted the fee of-$1000 for an Intermediate PMN (defined @ 40 CFR 700.43) in accordance with 40 CFR 700.45(b), or ❑ The Company named in Part I Section A is a small business concern under 40 CFR 700 .43 and has remitted a fee of $100 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)(1) or a Low release and low exposure exemption (LoRex) application in accordance with 40 CFR 723 .50(c)(2), check the following certification statements : ❑ 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 of 40 CFR 723 .50. ❑ The manufacturer is familiar with the terms of this section and will comply with those terms ; and ❑ The new chemical substance for which the notice is submitted meets all applicable exemption conditions . ❑ If this application is for an LVE in accordance with 40 CFR 723 .50(c)(1), the manufacturer intends to commence manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 day review period . The accuracy of the statements you make in this notice should renect your best prediction of the anticipated facts regarding the chemical substanc e described herein . Any knowing and willful mistnte retalio ts subject to criminal penalty pursuant to 18 USC 1001 . Confidential Signa and ti tle of Authorized Official ( Original Signature R uired) Date
Manager, Kodak Park Site Vice resident, Eastman Kodak Company II Signature of agent -(if applicable) Date

EPA FORM 7710-25 (Rev . 5-95) Page 2 -

### p . 3 Part I -- GENERAL INFORMATIO N Section A -- SUBMITTER IDENTIFICATION ConfiM ar k ) the "Confidenti al" box next to any subsection you claim as confidential dential I a . Person Name of authorized official Positio n Submitting Manager, Kodak Park Site Vice President, Notice (in U .S .) Mr . Charles C . Barrentine Eastman Kodak Compan y



### Company Eastman Kodak Comqanv Mailing address (number and street) 1669 Lake Avenu e City, State, ZIP Code 

### Rochester, New York 1465 2 b . Agent (if Name of authorized official Position applicable) Company

Mailing address (number and street) City, State, ZIP Code Telephone Area Code Numbe r

c . If you are submitting this notice as part of a joint submission, mark (X) this box . ❑ Joint Submitter (if Name of authorized official Positio n applicable) Company

Mailing address (number and street) City, State, ZIP Code Telephone ~ Area Code Number
2 . Technical Name of authorized official Positio n Contact (in Section 5 Technical Contact , U .S .) 

### Mr. James R . Humphreys Chemical and Equipment Regulatory Information Section

Compan y 

### Eastman Kodak Company Mai ling address (number and street ) 

### Health, Safety, and Environment, Bldg . 320, Kodak Park City, State, ZIP Code Telephone Area Code Numbe r 

### Rochester, New York 14652-6267 585 ; 722-4749 3 . If you have had a preno tice communica tion (PC) concerning this notice and EPA assigned a PC Number to the notice, enter the number . Mark (X) ~ ► ® if none 4 . If you previously submitted an exemption application for the chemica l substance covered by this notice, enter the exemp tion number assigned by (~ Mark X --- ► EPA. If you previously submitted a PMN for this substance enter the PMN L

# - .77 

# -03 2 

# 8 O 

# El number assigned by EPA (i .e . withdrawn or incomplete) . if non e S . If you have submitted a notice of Bona fide intent to manufacture or import for the chemical substance covered by this notice, enter the notice number Mark (X) ---~ ® assigned by EPA . 10 if non e 1 . ❑ Manufacture 2
. ❑ Import 6 . Type of Notice - Mark (X) Only Only 3 . ® Both ❑ Binding Option ❑ Binding Option Mark (X) Mark (X) EPA FORM 7710-25 (Rev . 5-95) Page 3

### p . 4 Part I -- GENERAL INFORMATION - - Continued Section B -- CHEMICAL IDENTITY INFORMATION : You must provide a currently cor rect Chemical Abstracts (CA) name of the substance based on the ninth Collective Index ( 9CI) of CA nomenclature rules and conventions . Mark (X) the "Confidential" box next to any item you claim as confi dential Complete either item I (Class I or 2 substances) or 2 (Polymers) as appropri ate . Complete all other items . If another person will submit chemical identity information for you (for either Item I or 2), mark ( X) the box at the right . _ ConfiIdentify the name, company, and address of that person in a continuation sheet . 10 El dential 1 . Class I or 2 chemical substances (for de finitions of class I and class 2 substances, see the Instructions Manual )
a . Class of substance
- Mark (X) 1 ® Class I or 2 ❑ Class 2 b . Chemical name ( Currently correct Chemical Abs tr acts (CA) Name that is consistent with TSCA Inventory li stings for simil ar substances . For Class 1 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) . 

### 1 H-Benz(e)indolium, 1,1,2,3-tetramethyl-, salt with 4-methylbenzenesulfonic acid (1 :1 )

c . Please identify which method you used to develop or obtain the specified chemical identi ty information report ed in this notice : (check one) . ® Method 1 (CAS Inventory Expert Service - a copy of the Identi fication ❑ Method 2 (Other Source) report ob ta ined from the CAS Invento ry Expe rt Services must be submitted as an attachment to this notice) 

## See page 

## 2 1 d . Molecular formula and CAS Registry Number (if a number already exists for the subs ta nce)
C16H18N .C7H703S CAS# 141914-99- 0

e . For a class I substance, provide a complete and correct chemical structure diagram . For a class 2 substance -( 1) List the immediate precursor substances with their respective CAS Registry Num bers . (2) Describe the nature of the reaction or process . (3) Indicate the range of composition and the typical composition ( where appropri ate) . ( 4) Provide a correct represen ta tive or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained .

CP 0 =5=0
\ / I



# +

❑ M ark ( X) this box if you attach a continuation sheet . EPA FORM 7710-25 (Rev . 5-95) Page 4

### p . 5 Part I -- GENERAL INFORMATION -- Continued Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 2. Polymers (For a definition of polymer, see the Instructions Manual .) Confidential a . Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture . Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) below 500 and below 1,000 absolute molecular weight of that composition . Describe the methods of measurement or the basis for your estimates : GPC ❑ Other ❑ : (Specify) Not applicable

i) lowest number average molecular weight : _Not applicableii) maximum weight % below 500 molecular weight : Not applicableiii) maximum weight %o below 1000 molecular weight : Not appllcable_ ❑ Mark (X) this box if you attach a continuation sheet . b . 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 polymer. (2) - Mark (X) this column if entry in column (1) is confidential . (3) - Indicate the typical weight percent of each monomer or other reactant in the polymer . (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 of each monomer or other reactant that may be present as a residual in the polymer as manufactured for

commercial purposes . (7) - Mark (X) this column if entry in column (6) is confidential .Monomer or other reactant and CAS Registry Number Confi- Typical Identity Confi- Maximum Confidential composition Mark (X dential residual dential (I (2) (3) (4) (5) (6) (7) Not applicable % %


### % % ~ 9b

% % ❑ M ark (X) this box if you attach a continuation sheet . c . Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice (check one) . ❑ Method 1(CAS Inventory Expert Service - a copy of the identification report ❑ Method 2 (other source)

obtained from CAS Inventory Expert Service must be submitted as as attachment to this notice) d . The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers . Not applicabl e e . Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained. Not applicabl e

❑ Mark (X) this box if you a tt ach a continuation sheet . EPA FORM 7710-25 (Rev . 5-95) Page 5

### p . 6 Part I -- GENERAL INFORMATION -- Continue d Section B-- CHEMICAL IDENTITY INFORI VIATION -- Continued 3 . Impuritie s (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 wei ght % of each impurity. If there are unidentified impurities, estimate their total weigh tImpurity and CAS Registry Number Maximum Confipercent dential (a) (b ) 

### Unknown 2% % % % % % %

❑ 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 Non e
❑ Mark (X) this box if you attach a continuation sheet . 5 . Trade identification - List trade names for the new chemical substance identified in subsection t or 2 . Non e ❑ 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 . Not applicable . The chemical name has not been claimed confidential .

❑ Mark (X) this box if you attach a continuation sheet . 7 . Byproducts - Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance . Provide the CAS Registry

Number if available_ Byproduct CAS Registry Number Confi- (1) (2) dential 

### N,N-Diethylethanamine hydrochloride 554-68- 7 Benzenamine hydrochloride 142-04-1 4-Methylbenzenesulfonic acid, compound with N,N-diethylethanamine (1 :1) 15404-00-9 N-Phenylacetamide 103-84-4 ❑ Mark (X) this box if you attach a continuation sheet . EPA FORM 7710-25 (Rev . 5-95) Page 6

## p . 7 Part I -- GENERAL INFORMATION -- Continue d 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 k r, 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) 7,500 11,00 0 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 of the 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 ent (ies) in column (8) is (are) confidential business information (CBI)
. Category of use (1) CBI Binding Produc- CBI °k 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- Bindin g

for 

### finishing polyester fi bers) (2) (4) (5) (6) (7) limited sumer trial mercial 

### Option (9) 

### Chemical intermediate used in the 100% 100 % manufacture of a dye in imaging % media/products

%

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

. In addition include estimates of the concentration of the new chemical substance as expected in consumer products and describe the chemical reactions by which this substance loses its identity in the consumer product
. ❑ 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 of that category . Read the use Instructions Manual for examples of gene ri c use descri ptions. desc

### ription 

### Chemical intermediate, destructive use

❑ 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 °P° ° for the safe handing, transport, use, or disposal of the new substance . List in part M hazard information you include . Mark (x) ® Mark (X) this box if you attach hazard information
. See pages 15-2 0 EPA FORM 7710-25 (Rev . 5-95) page 7

## p . 8 Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEAS E Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) the "Confidential" box next to any item you claim as confidentia l 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 fu rt her industrial processing or use o erations after import . You must descri be these operations . See instructions manual 1 . Operation description Confia . Identity -- Enter the identity of the site at which the operation will occur . dential

Name 

### Kodak Park Site address (number and street ) 

### 1669 Lake Avenue City, County, State, ZIP cod e 

### Rochester, Monroe, New York 1465 2 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 . ❑ Mark (X) this box if you attach a continuation sheet . b . Type -- Mark (X) ® Manufacturing ❑ Processing ❑ Use c . Amount and Duration -- Complete I or 2 as appropriate Maximum kg/batch (100% new chemical t Hours/batch , Batches/year substafice) t ' 

### I . 

### Batch 189 ~ 24 ; 58

Maximum kg/batch (100% t,cw chemical Hours/batch ~ Batches/year substmse) t t

t t 2 . Continuous t t d . Process description ❑ Mark (X) to indicate your willingness to have your process description binding . (t) 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 kg/batch on a 100% new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc .), and of all 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 .

❑ Mark (X) this box if you attach a continuation sheet . EPA FORM 7710-25 (Rev . 5-95) Page 8

### p . 9



## Part II-- HUMAN EXPOSURE AND ENVIRON MENTAL RELEASE -- Continued Section 

### A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continue d 2 . Occupational Exposure -- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance, number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any item you claim as confidential

. (1) -- 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 (1) 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 form(s) of the new chemical substance (e .g ., solid : crystal, granule, powder, or dust) and % new chemical substance (if part of a mixture) at the time of exposure
. (7) --Mark (X) this column if entry in column (5) is confidential business information (CBD
. (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 (CB D . (10) and (11) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year

. (12) -- Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI)
.

Worker activity CBI Protective Equipment/ Binding Physical fornu(s) Binding CBI # of CB[ Maximum duration CBI (i .e ., bag dumping, filling drums) Engineering Controls Option and % new Option Workers His/day Days/y r Mark (a) substance Mark (x) Expose d (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12 ) 

### Loading the filtration equipment See pages 15-20 Slurry 3 0 .3 30 <10% Unloading the filtration See pages 15-20 Damp solid 3 0 .5 30 equipment and loading the -85 % drying equipmen t Loading the containers See pages 15-20 Dry solid 3 0 .5 30 -100% Cleaning of the filtration See pages 15-20 Damp solid 3 0 .2 30 equipment -85% Cleaning of the drying See pages 15-20 Dry solid 3 0 .1 30 equipment -100% ® Mark (X) this box if you attach a continuation sheet . See pages 15-2 0 3 . Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new chemical substance released and other release and disposal information . Mark (X) the "Coofidentiaf" 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 kg/batch)

. (3) -- Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI)
. (4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site 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) of releases to water . Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers of the POTW (Publicl 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) CBt Number released releas e (1) (2a) (2b) ~ .g - k Bindin g (3) (4) (5a) ~ Mark(X) (5b) (6) 1 None < 1 incineration Incineration (>99 .99% DRE) Non e

kg/batch container N 2 one <0 .1 industrial sewer o Biological treatment/Incineration (>99 .9% DRE) <0 .1 kg/day kg/batc h 3 None <0 .5 recovery tank Silver recovery/Biological treatment/Inc >99% None

kg/batch

(7) Mark (X) the ~ POTW provide name(s) below : CBI Navigable ~ Other - Specify Provide NPDES # CBI destination(s) of waterway releases to water . NY-000-1643 Mark (X) this box if you attach a continuation sheet . See pages 13 and 3 7 EPA FORM 7710-25 (Rev . 5-95) Page 9

## P . 10 Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEAS E Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark ( X) the "Confidential" box next to any item you claim as confidentia l Complete section A for each type of man ufacture, processing, or use operation involving the new chemical substance at indust ri al sites you control . Importers do not have to complete this section for operations outside the U .S . ; however, you may still have repo rt ing requirements if there are further industrial processing or use operations after import . You must desc ri be these operations . See instructions man ual 1 . Operation description Confia . Identity -- Enter the identity of the site at which the operation will occur . dential

Name 

### Kodak Par k Site address (number and street) 

### 1669 Lake Avenue City, County, State, ZIP code 

### Rochester, Monroe, New York 1465 2 If the same operation will occur at more th an one site, enter the number of sites . Identify the ; additional sites on a continuation sheet, an d if an y of the sites have significan tly different production rates or operations, include all the information requested in this section for those sites as attachments . ' ❑ Mark ( X) this box if you attach a continuation sheet . b . Type -- Mark (X) E] Manufacturing ❑ Processing ® Use c . Amount and Duration -- Complete I or 2 as appropriate Maximum kg/batch ( ioo % t ew chemical Hours/batch Batches/year substmtce) 1 . Batch 126 1 87

Maximum kg/batch ( ioo% t,ew chemical ; Hours/batch Batches/year substaue) t 2 . Continuous d . Process description ❑ Mark ( X) to indicate your willingness to have your process description binding . (1) Diagram the major unit operation steps and chemical conversions . Include interim storage and transpo rt 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 kg<Vbatch on a 100% new chemical substance basis), and entry point of all s ta rting materials and feedstocks ( including reac ta nts, solvents, catalysts, etc .), and of all 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 .

❑ Mark ( X) this box if you attach a continuation sheet . EPA FORM 7710-25 (Rev . 5-95) Page 10

### P . 11



## Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section 

### A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER -- Continued 2 . Occupational Exposure -- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance, number of works exposed, and duration of activity . Mark (X) the "Confidential" box next to any item you claim as confidential

. (1) -- 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 (1) 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 form(s) of the new chemical substance (e .g ., solid: crystal, granule, powder, or dust) and % new chemical substance (if part of a 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 of the activity for any worker in hours per day and days per year

. (12) -- Mark (X) this column if entries in columns (10) and (11) are confidential business information (CBI)

.

Worker activity CBI Protective Equipment/ Binding Physical forms(s) Binding CBI # of CBI Maximum duration CBI (i .e ., bag dumping, filling drums) Engineering Controls Option and % new Option Workers Ws/day Days/yr M (x) substance Mark (x) Exposed (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12 ) Loading the reaction vessel See pages 15-20 Dry solid 3 0 .2 45 -100% Disposal of LVE chemical See pages 15-20 Dry solid 3 0 .1 45 container liner -100% 

### % 

# T1 % 

# r i -1 ® Mark (X) this box if you attach a continuation sheet . See 

## pages 15-2 0 3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the 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 Id(3)

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

. (3) --Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI)

. (4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site 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) of releases to water . Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers of the POTW (Publicl Owned Treatment Works) . Mark (X) if the POTW name or NPDES # is confiden tial business information (CBI)
. Release Amount of new substance CBI Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CB1 Number released releas e (1) (2a) (2b) 8m . k (4) Binding (3) (5a) I M ark (x) (Sb) (6) 1 None <0 .1 incineration container Incineration (>99 .99% DRE) ' Non e kg/batch

(7) Mark (X) the ❑ POTW provide name(s) below : CBI ❑ Navigable ❑ Other - Specify provide NPDES # CBI destination(s) of waterway releases to water
. ® Mark (X) this box if you attach a continuation sheet . See page 1 3
EPA FORM 7710-25 (Rev . 5-95) Page I 1

### p . 12



## Part II-- HUMAN EXPOSURE AND ENVIRON MENTAL RELEASE -- Continued Section 

### B -- INDUSTRIAL SITES CONTROLLED BY OTHER S 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 of processing, 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 addi ti onal sites on a continuati on sheet . 1 . Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential . (1) -- 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 of release, 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) : 

### Not applicable # of sites 

# Not applicabl e

El Mark (X) this box if you attach a continuation sheet . 2. Worker Exposure/Environmental Releas e (1) -- 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 (if in mixture), and any protective equipment and engineering controls, if any, used to protect workers . (7) -- Estimate the percent of the 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 of the new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch) . (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 of the new substance to the environment . (14) -- Identify byproducts which may result from the operation . (3),(5),(8), 11),(13) and (15 -- Mark ( ) this column if any of the proceeding entries are con fidential business information (CBI) . Letter # of CBI Duration CBI Protective Equip . / % in CB1 Release Amount of CBI Media of Release CBI of Workers of Engineering Controls/ Form Number New & Contro l Act- Exposed Exposure Physical Form and % ulation Substance Technology Released ivity new substanc e (1) (2) (3) (4a) (4b) (5) (6) (7) (8) (9) (IOa) (10b) (11) (12) (13) 

### Not applicabl e

I_7 I (14) -- Byproducts : (15) ~ Mark (X) this box if you attach a continuation sheet. EPA FORM 7710-25 (Rev . 5-95) Page 12

### p . 13 

# 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 of risks 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 of waste 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 of production and/or improved operation efficiency of the new chemical substance in comparison to existing chemica l 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
. Purification and acetone wash liquors from collection equipment along with acetone cleaning liquors from the reaction vessel will be sent to solvent recovery
. WASTE MANAGEMEN T KODAK PARK, ROCHESTER, N .Y
. All wastes containing the notified substance are sent to control technologies prior to release to the environment . Aqueous wastes are sent to the company's on-site wastewater treatment facility (WWTU) that is operated in compliance with state and federal regulations . Selected solvents are purified and recycled . Non-recyclable organic wastes are combusted in the company's on-site rotary kiln incinerator that is also operated in compliance with state and federal regulations . Occasionally wastes may be sent off site for treatment at an approved contract facility or for metals reclamation
.

❑ Mark (X) this box if you attach a continuation sheet .
EPA FORM 7710-25 (Rev . 5-95) Page 13

### p . 14 

# Part III -- LIST OF ATTACHMENT S
Attach continuation sheets for sections of the form an d test data an d other data ( including physical/chemical propert ies and structure/activity information), an d optional information after this page . Clearly identify the attachment an d the section of the form to which it relates, if appropri ate . 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 an y information in an attachment as confidential . You must include with the s anitized copy of the notice form a sanitized version of any attachment in which you claim information as confidential .Attachment name Attachment Confia~e number(s) dential 

### Material Safety Data Sheet ( MSDS) 15-2 0 CAS Invento ry Expe rt Service Name 21 Other Data : Estimations of Health and Environmental Fate and Effects 22-37 Health Effects Data - Including Summa ry of Toxicological Information 38-81 Physical/Chemical Data 82-101

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

EPA FORM 7710-25 ( Rev . 5-95) Page 14

### MATERIAL SAFETY DATA SHEET p .15

~ 000003883/F/US A ~ Approval Date : 12/17/2002 ~ Print Date : 12/17/2002 Page 1

------------------------------------------------------------------------------ FOR USE ONLY WITHIN EASTMAN KODAK COMPANY AND ITS SUBSIDIARIES
. PRIOR APPROVAL IS REQUIRED FOR DISTRIBUTION OF THIS MSDS TO ANYONE OTHER THAN A KODAK EMPLOYEE . PHONE : THE KODAK ROCHESTER HEALTH, SAFETY AND ENVIRONMENT - MSDS SERVICES GROUP (72-27178 )

------------------------------------------------------------------------------ 1 . CHEMICAL PRODUCT AND COMPANY IDENTIFICATIO N Product Name : 1,1,2,3-Tetramethyl-lH-benz(e)indolium salt with 4-methylbenzene-sulfonic acid (1 :1 ) Product Identification Number(s) : 1001845 1 Manufacturer/Supplier : EASTMAN KODAK COMPANY, Rochester, New York 1465 0 For Emergency Health, Safety & Environmental Information, call (585) 722-5151 Synonym(s) : KAN 924758, CIN 1001845 1 Molecular Formula : C16 H18 N . C7 H7 03 S Molecular Weight : 395 .5 2 IMPORTANT NOTE : The EPA has granted a Low Volume Exemption for this chemical
. Exposure control requirements must be followed when there is a potential to come in contact with the dry chemical
.

------------------------------------------------------------------------------ 2 . COMPOSITION/INFORMATION ON INGREDIENT S Weight y- Component - (CAS Registry No . ) 100 1,1,2,3-tetramethyl-lH-benz(e)indolium salt with

4-methylbenzenesulfonic acid (1 :1) (141914-99-0)

------------------------------------------------------------------------ 3 . HAZARDS IDENTIFICATION ~ POWDERED MATERIAL MAY FORM EXPLOSIVE DUST-AIR MIXTURES ~ CAN DECOMPOSE AT ELEVATED TEMPERATURE S ~ MAY CAUSE NERVOUS SYSTEM DAMAGE BASED ON ANIMAL DAT A 

### ~ HARMFUL IF INHALED, ABSORBED THROUGH SKIN, OR SWALLOWE D ~ THE TOXICOLOGICAL PROPERTIES OF THIS MATERIAL HAVE NOT BEEN FULLY INVESTIGATED Eastman Kodak Hazard Ratings : R-3, S-2, F-1, C-1T

--------------------------------------------------------------------



# ~ A5

### MATERIAL SAFETY DATA SHEET p .16

000003883/F/US A Approval Date : 12/17/2002 Print Date : 12/17/2002 Page 2

------------------------------------------------------------------------------ 4 . FIRST-AID MEASURE S Inhalation : Move to fresh air . Treat symptomatically . Get medical attention if symptoms occur . Eyes : Immediately flush with plenty of water for at least 15 minutes . Get medical attention . Skin : Immediately flush with plenty of water for at least 15 minutes while removing contaminated clothing and shoes . Get medical attention if symptoms occur . Wash contaminated clothing before reuse . Destroy or thoroughly clean contaminated shoes . Ingestion : Induce vomiting as directed by medical personnel . Never give anything ~ by mouth to an unconscious person . Call a physician or poison control cente r ~ immediately .

------------------------------------------------------------------------------ 5 . FIRE FIGHTING MEASURE S Extinguishing Media : Water spray, carbon dioxide ( C02), dry chemica l Special Fire-Fighting Procedures : Wear self-contained breathing apparatus and protective clothing . Fire or excessive heat may produce hazardous decomposition products . Hazardous Combustion Products : Carbon dioxide, carbon monoxide, oxides of nitrogen, oxides of sulfu r Unusual Fire and Explosion Hazards : Powdered material may form explosive dust-air mixtures . Fire or high temperatures may cause decomposition .

------------------------------------------------------------------------------ 6 . ACCIDENTAL RELEASE MEASURE S Collect up and put in a suitable container . Avoid generation of dust . Clean surface thoroughly to remove residual contamination .

------------------------------------------------------------------------------ 7 . HANDLING AND STORAG E 

### ~ Personal Precautionary Measures : Do not breathe dust . Avoid contact with eyes, ~ skin, and clothing . Use with adequate ventilation . Wash thoroughly afte r ~ handling . Prevention of Fire and Explosion : Keep away from heat . Powdered material may form explosive dust-air mixtures . Minimize dust generation and accumulation . Use with adequate ventilation . Keep away from sources of ignition . Refer to NFPA Pamphlet No . 654, "Prevention of Fire and Dust Explosions in the Chemical, Dye, Pharmaceutical, and Plastics Industries ." Keep from contact with oxidizing materials . 

# J tP

### MATERIAL SAFETY DATA SHEET p, 1 7

000003883/F/USA Approval Date : 12/17/2002 Print Date : 12/17/2002 Page 3

------------------------------------------------------------------------------ Storage : Keep container closed .

------------------------------------------------------------------------------ 8 . EXPOSURE CONTROLS/PERSONAL PROTECTIO N Exposure Limits : Not establishe d Ventilation : Good general ventilation (typically 10 air changes per hour) should be used . Ventilation rates should be matched to conditions . Supplementary local exhaust ventilation, closed systems, or respiratory protection may be needed in special circumstances such as poorly ventilated spaces, mechanical generation of dusts, heating, drying, etc . Respiratory Protection : As a condition of an EPA Low Volume Exemption Exposure Control requirement for this chemical an approved respirator must be worn when there is a potential for exposure to the dry chemical substance . Respirator type : NIOSH-approved with an APF (assigned protection factor) of greater than or equal to 10 . In the United States : If respirators are used, a program should be instituted to assure compliance with OSHA Standard 29 CFR 1910 .134 . 

### Eye Protection : Wear safety glasses with side shields (or goggles) . Skin Protection : Wear impervious gloves and protective clothing appropriate for the risk of exposure . Recommended Decontamination Facilities : Eye bath, washing facilities, safety showe r

------------------------------------------------------------------------------ 9 . PHYSICAL AND CHEMICAL PROPERTIE S Physical Form : Solid Color : Purpl e Odor : Not availabl e Specific Gravity (water = 1) : Not available Vapor Pressure : Not availabl e 

### Vapor Density (Air = 1) : Not available Volatile Fraction by Weight : Not available Melting Point : Not availabl e Solubility in Water : Not available pH : Not applicabl e Flash Point : Not applicable, combustible solid

--------------------------------------------------------------------- 10 . STABILITY AND REACTIVIT Y Stability : Stable . Safe handling temperatures are dependent on specific conditions of use and are typically substantially below the onset temperature

. Consult your technical safety experts . Exotherm onset temperature : 226°C by HPDT A



# 17

### MATERIAL SAFETY DATA SHEET p .18

000003883/F/US A Approval Date : 12/17/2002 Print Date : 12/17/2002 Page 4

------------------------------------------------------------------------------ Incompatibility : Strong oxidizing agent s Hazardous Polymerization : Will not occur .

------------------------------------------------------------------------------ 11 . TOXICOLOGICAL INFORMATIO N Effects of Exposure : General : The toxicological properties of this material have not been fully investigated and its handling and use may be hazardous . This chemical is the subject of a Low Volume Exemption . The EPA has identified potential concerns for : Neurotoxicity, developmental toxicity . Inhalation : Harmful if inhaled . Eyes : May be irritating . Skin : Harmful if absorbed through skin . Ingestion : Harmful if swallowed . May cause irritation of the gastrointestinal tract . Acute Toxicity Data : Oral LD-50 (male rat) : 312 mg/kg Oral LD-50 (female rat) : 441 mg/kg Skin irritation : non e

------------------------------------------------------------------------------ 12 . ECOLOGICAL INFORMATIO N This section has not been completed .

------------------------------------------------------------------------------ 13 . DISPOSAL CONSIDERATION S Discharge, treatment, or disposal may be subject to national, state, or local laws . Incinerate . Since emptied containers retain product residue, follow label warnings even after container is emptied .

------------------------------------------------------------------------------ 14 . TRANSPORT INFORMATION For transportation information, call the Kodak Worldwide Transportation Hazmat Hot Line : (585) 722-2400 between 8 a .m . and 5 :00 p .m . (Eastern Standard Time), Monday through Friday .



### ------------------------------------------------------------------------------

### MATERIAL SAFETY DATA SHEET p .19

000003883/F/US A Approval Date : 12/17/2002 Print Date : 12/17/2002 Page 5

------------------------------------------------------------------------- 15 . REGULATORY INFORMATION - Material(s) known to the State of California to cause cancer : Non e - Material(s) known to the State of California to cause adverse reproductive effects : Non e - Carcinogenicity Classification (components present at 0 .1% or more) : - International Agency for Research on Cancer (IARC) : Non e - American Conference of Governmental Industrial Hygienists (ACGIH) : None - National Toxicology Program (NTP) : Non e - Occupational Safety and Health Administration (OSHA) : Non e - Chemical(s) subject to the reporting requirements of Section 313 or Title III of the Superfund Amendments and Reauthorization Act (SARA) of 1986 and 40 CFR Part 372 : Non e

------------------------------------------------------------------------------ 16 . OTHER INFORMATION US/Canadian Label Statements : WARNING ! MAY CAUSE NERVOUS SYSTEM DAMAGE BASED ON ANIMAL DATA HARMFUL IF INHALED, ABSORBED THROUGH SKIN, OR SWALLOWED POWDERED MATERIAL MAY FORM EXPLOSIVE DUST-AIR MIXTURES CAN DECOMPOSE AT ELEVATED TEMPERATURE S THE TOXICOLOGICAL PROPERTIES OF THIS MATERIAL HAVE NOT BEEN FULLY INVESTIGATED Do not breathe dust . Minimize dust generation and accumulation
. Avoid contact with eyes, skin, and clothing
. Keep container closed . Use with adequate ventilation . Wash thoroughly after handling . FIRST AID : If swallowed, induce vomiting immediately as directed by medical personnel . Never give anything by mouth to an unconscious person . Call a physician or poison control center immediately . If inhaled, move to fresh air . Treat symptomatically . In case of contact, immediately flush eyes and skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes . Get medical attention . Wash contaminated clothing before reuse . Destroy or thoroughly clean contaminated shoes
. Keep out of reach of children
. Do not handle or use until safety precautions in Material Safety Data Sheet (MSDS) have been read and understood
. Additional hazard precautions for containers greater than 1 gallon of liquid or 5 pounds of solid : Since emptied containers retain product residue, follow label warnings even / 

# q

### MATERIAL SAFETY DATA SHEET p'20

000003883/F/US A Approval Date : 12/17/2002 Print Date : 12/17/2002 Page 6

------------------------------------------------------------------------------ after container is emptied . IN CASE OF FIRE : Use water spray, carbon dioxide ( C02), dry chemical . IN CASE OF SPILL : Sweep or scoop up and remove .

------------------------------------------------------------------------------ The information contained herein is furnished without warranty of any kind . Users should consider these data only as a supplement to other information gathered by them and must make independent determinations of suitability and completeness of information from all sources to assure proper use and disposal of these materials and the safety and health of employees and customers and the protection of the environment .



# ao

### p . 2 1



# Inventory Expert Service 

# (fl 3
division of the American Chemical Society Phone : 800-631-1884 . 614447-3600 ( ext 2308) Fax 614-447-3747 E-mail: ansvvers@cas .org

INVENTORY EXPERT SERVICE REPORT

TES-ORDER NUMBER : 18799
REGISTRY NUMBER : 141914-99-0

`A INDEX NAM E =H-Benz(eJindolium, 1,1,2,3-tetramethyi-, salt with 4-me :hylbenzenesulfonic acid ( : :1 )

Please print the above CA Index Name on the appropriate page of your PMN . If CAS has made any corrections ( marked in red) to your IRS order, please make these same corrections to your Pt N before submitting it to the EPA .

t G / 2540 Oknnrtgy River Rood • O . Box 3343 • Columbus, Ohio 432 1 0-0 334

### p . 22

OTHER DATA : 

## ENVIRONMENTAL FATE AND EFFECTS ESTIMATIONS
Testing Laboratories : Health and Environment Laboratories Eastman Kodak Company Rochester, New York 14652
Chemical Name : 1H-Benz(e)indolium, 1,1,2,3-tetramethyl-, salt with 4-methylbenzenesulfonic acid (l :1)
Estimations : Structure-Activity Estimations of Health and Environmental Fate Pages 23-37 and Effects



# 22

### p . 23 P2-2002-0 5 

## Page 1 of 15
AMENDED FINAL REPOR T 1,1,2,3-Tetramethyl-lH-benz(e)indolium salt with 4-methylbenzene sulfonic acid

HAEL No . 2002-0030 KAN 924758- 6 CAS No . 141914-99-0 CIN 10018451

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL FATE AND EFFECT S

AUTHORS Rodney J . Boatman, Ph .D . Mari anne P . Hirsch, Ph .D . TESTING FACILITY Toxicological Sciences Health and Environment Laborato ri es Eastman Kodak Company Rochester, NY 14652-6278

US A
STUDY SPONSOR Eastman Kodak Company
STUDY COMPLETION DAT E February 25, 200 2 AMENDED STUDY COMPLETION DATE

December 4, 200 2 

# a,3

### p . 24 P2-2002-0 5 

## Page 2 of 15

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT

This page has intentionally been left incomplete .

### p . 25 P2-2002-0 5 

## Page 3 of 15 SIGNATURE PAG E STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRON ME NTAL FATE AND EFFECTS



# a 30 ~ Mari e P . Hirsch, Ph .D . Month/Day/Year Author and Sr . Toxicologis t Ecotoxicology

K J . 1 2 y102 Rodney J. Bo tman, Ph .D . Month/Day/Year Author and Technical Associat e 

## Biochemical and Analytical Toxicology



# ~ L yZ002

_ Do gl C . Topping, ., DABT Month/Day/Year Unit Director Toxicological Sciences



# a5

### p . 26 P2-2002-05 

## Page 4 of 15 TABLE OF CONTENTS Page Number CHEMICAL IDENTIFICATION INFORMATION 5 Testing Facility 5 Project Participants 5 Sponsor 5 Chemical Structure 5 Chemical Characterization 5 ABSTRACT 6 INTRODUCTION AND ME 

## THODS 7 

## RESULTS AND CONCLUSIONS 7 REFERENCES 9 APPENDIX 1 . Output from the EPI Computer Program [1 

## ] 10 APPENDIX 2 . Output from the ECOSAR Computer Program [2] 12 APPENDIX 3 . Output from the E-FAST Computer Program [3] 13



# a~

### p . 27 P2-2002-0 5 

## Page 5 of 15 CHEMICAL IDENTIFICATION INFORMATIO N Testing Facility Toxicological Science s Health and Environment Laboratories Eastman Kodak Company Rochester, New York 14652 US A Project Participants Report Authors : Rodney J . Boatman, Ph .D . Mari anne P . Hirsch, Ph .D . Sponso r Eastman Kodak Company Chemical Structure
I \ /
O=S= O ~- N*

~ Chemical Characterizatio n Chemical Name : 1,1,2,3-Tetramethyl-lH-benzeneindolium salt with 4-methylbenzene sulfonic aci d HAEL No . : 2002-0030 KAN : 924758-6 Molecular Formula : C16 H18 N1 . C7 H7 03 S1 Molecular Weight : 395 .5 2 CAS No
. : 141914-99-0 CIN : 10018451 SMILES (cation only) : CC1(C)c2c3c(ccc2N=C1C)cccc3 Chemical Classification (ECOSAR) : "Neutral Organics "



# ~7

### p . 28 P2-2002-0 5 

## Page 6 of 15 STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL FATE AND EFFECT S 1,1,2,3-Tetramethyl-lH-benz(e)indolium salt with 4-methylbenzene sulfonic acid

HAEL No . 2002-0030 KAN 924758- 6 CAS No . 141914-99-0 CIN 10018451

ABSTRACT Environmenta l The environmental fate and effects of the test substance were estimated by using the EPIWIN [1], ECOSAR [2], and E-FAST [3] computer programs . The test substance was categorized as belonging to the "Neutral Organics" chemical class . Based on the BIOWIN [1] and Expert Survey [1] results, it is likely the test substance would be moderately persistent in the environmental media to which it is expected to partition . The log Kow value was estimated to be -0 .10, yielding a calculated bioconcentration factor (BCF) of 3 .2 . This BCF indicates the test substance has a low potential to bioconcentrate in aquatic organisms . The ECOSAR [2] computer program predicted effect values for the test substance for fish, daphnids, and green algae to be > 1000 mg/L . The E-FAST [3] computer program predicted that the on-site wastewater treatment facility in Kodak Park would not discharge effluent containing the test substance at levels greater than the concentration of concern (8042 μg/L) during manufacturing operations . Health The test substance was not analyzed using the OncoLogic® computer program [4] due to the lack of a recognized carcinogenic determinant . The carcinogenic potential of this material is expected to be low .

### p . 29 P2-2002-0 5 

## Page 7 of 15 STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL FATE AND EFFECT S 1,1,2,3-Tetramethyl-lH-benz(e)indolium salt with 4-methylbenzene sulfonic acid

HAEL No . 2002-0030 KAN 924758- 6 CAS No . 141914-99-0 CIN 10018451
INTRODUCTION AND METHOD S Structure-activity relationships (SARs) were used to predict the environmental fate and aquatic toxicity of the test substance . Structures were entered into computer programs using the SMILES (Simplified Molecular Input Line Entry System) notation [5] and by entering the log octanol-water partition coefficient (Kow) [1] . The Estimation Programs Interface (EPI) computer program developed by Syracuse Research Corporation [1] was used to compute estimates of the log Kow value and estimates of biodegradability of this chemical . The ECOSAR computer program developed by the U .S . EPA [2] was used to provide estimates of environmental toxicity . Estimation of aquatic environment exposure/risk was generated by the U .S . EPA E-FAST computer program [3], beta version . RESULTS AND CONCLUSIONS This fate and effects report focuses on the quaternary cation . The environmental fate and effects of 4-Methylbenzene sulfonic acid (tosylate) have been reported elsewhere [6]
. Environmental The ECOSAR [2] chemical classification chosen for this chemical structure was "Neutral Organics" . Persistence (P2 ) The EPIWIN [1] computer program predicted a low to moderate probability of rapid biodegradation, and the Ultimate Survey Model estimated that mineralization would occur within the timeframe of "weeks-months" . Therefore, the test substance may be moderately persistent in the environmental media to which it is expected to partition : water (49 .4%), soil (50 .5%), and sediment (0 .1%) . Bioconcentration (B 1 ) The log Kow value for the test substance was estimated to be -0 .10, yielding a calculated bioconcentration factor (BCF) of 3 .2 . This BCF indicates the test substance has a low potential to bioconcentrate in aquatic organisms
.

### p . 30 P2-2002-0 5 

## Page 8 of 15 Toxicity (Ti ) The ECOSAR [2] computer program predicted acute effect values for the test substance for fish, daphnids, and green algae to be > 1000 mg/L . According to U .S . EPA assessment criteria [7], the test substance would be classified as being in the "low concern level" category . Aquatic Environment Exposure/Risk The following values were used as input for the E-FAST program : 58 batches/yr, <0 .1 kg/batch to waste, and 0 .0 % removal during wastewater treatment . The E-FAST [3] computer program predicted that the on-site wastewater treatment facility in Kodak Park would not discharge effluent containing the test substance at levels greater than the concentration of concer n (8042 μg/L) during manufacturing operations . Health 

## Estimated Carcinogenicity The carcinogenic potential of the test substance is expected to be low based on the lack of a recognized carcinogenic determinant . Site-Specific Human Exposure from Drinking Water and Fish Consumptio n Based on estimated release of test substance to the Genesee River from manufacturing operations in Rochester, New York, human intake from drinking water is calculated to be 3 .48 X 10-8 mg/kg/day . Similarly, human intake from fish consumption is estimated to be 4 .77 X 10-'° mg/kg/day . Given such low estimated human exposure levels, no human health hazard is anticipated due to release of this material to the environment from manufacturing operations . Amended Study Repor t The original study report has been amended to include a revised water solubility estimate and revised manufacturing volumes . The EPIWIN estimate for water solubility originally entered into the ECOSAR program has replaced with a water solubility estimate generated from the ECOSAR program . The revised output from the ECOSAR program has been included in Appendix 2 . The revised E-FAST report has been included in Appendix 3 .



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### p . 31 P2-2002-0 5 

## Page 9 of 15 REFERENCE S 1 . Meylan, W . 1993 . User's Guide for the Estimation Programs Interface (EPI) , Version 1 .2, Syracuse Research Corporation, Syracuse, NY 13210
. 2 . Nabholz, J .V . and Cash, G . 1998 . ECOSAR Class Program, MS-Windows Version 0 .99, United States Environmental Protection Agency, Health and Environmental Review Division, Environmental Effects Branch, Washington, DC
. 3 . Brennan, T ., U.S . EPA - OPPT, "E-FAST - Exposure and Fate Assessment Screening Tool", beta version, www .epa.gov/opptintr/exposure . 4 . Woo, Y-T ., Lai, D .Y ., Argus, M .F., and Arcos, J .C . 1995 . "Development of StructureActivity Relationship Rules for Predicting Carcinogenic Potential of Chemicals", Toxicol . Lett . 79 :219-228 . 5 . Weininger, A . 1988 . "SMILES, a Chemical Language and Information System . 1 . Introduction to Methodology and Encoding Rules ." J . Chem . Inf. Comput . Sci . 28 :31-36 . 6 . "Handbook of Environmental Data on Organic Chemicals", vol . 2, Karel Verschueren , John Wiley and Sons, Inc .,New York, 2001, p 2016 . 7 . Smrchek, J ., Clements, R ., Morcock, R ., and Rabert, W. 1993 . "Assessing Ecological Hazard Under TSCA : Methods and Evaluation of Data," Environmental Toxicology and Risk Assessment , ASTM STP 1179, W . Landis, J .S . Hughes, and M .A . Lewis, Eds ., American Society for Testing and Materials, Philadelphia, pp . 22-39
.



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## Page 10 of 15 Appendix 1 . Output from the EPI Computer Program [1], cation onl y SMILES : CC1(C)c2c3c(ccc2N(C)=C1C)cccc3 CHE M MOL FOR : C16 H18 Ni MOL WT : 224 .3 3 ------------------------------ EPI SUMMARY (v3 .10) -------------------------- Physical Property Inputs : Water Solubility (mg/L) : ------ Vapor Pressure (mm Hg) . ------ Henry LC (atm-m3/mole) . ------ Log Kow (octanol-water) : ------ Boiling Point (deg C) . ------ Melting Point (deg C) . ------ 

### Log Octanol-Water Partition Coef (SRC) : Log Kow (KOWWIN v1 .66 estimate) = -0 .1 0 Boiling Pt, Melting Pt, Vapor Pressure Estimations (MPBPWIN v1 .40) : Boiling Pt (deg C) : 483 .38 (Adapted Stein & Brown method) Melting Pt (deg C) : 204 .84 (Mean or Weighted MP ) VP(mm Hg,25 deg C) : 9 .01E-010 (Modified Grain method) Water Solubility Estimate from Log Kow (WSKOW v1 .40) : Water Solubility at 25 deg C (mg/L) : 3 .988e+00 4 log Kow used : -0 .10 (estimated) no-melting pt equation used ECOSAR Class Program (ECOSAR vO .99g) : 

### Class(es) found : Neutral Organic s Henrys Law Constant (25 deg C) [HENRYWIN v3 .10] : Bond Method : 1 .55E-011 atm-m3/mol e Group Method : Incomplet e Henrys LC [VP/WSol estimate using EPI values] : 6 .669E-015 atm-m3/mole Probability of Rapid Biodegradation (BIOWIN v4 .00) : Linear Model . 0 .4568 Non-Linear model . 0 .1301 Expert Survey Biodegradation Results : Ultimate Survey Model : 2 .4913 (weeks-months) Primary Survey Model : 3 .3706 (days-weeks Readily Biodegradable Probability (MITI Model) : Linear Model . 0 .154 1 

### Non-Linear Model . 0 .076 0 Atmospheric Oxidation (25 deg C) [AopWin vl .90] : Hydroxyl Radicals Reaction : OVERALL OH Rate Constant = 9 .2743 E-12 cm3/molecule-sec Half-Life = 1 .153 Days (12-hr day ; 1 .5E6 OH/cm3) Half-Life = 13 .840 Hr s 

### Ozone Reaction : No Ozone Reaction Estimatio n Soil Adsorption Coefficient (PCKOCWIN v1 .66) : Koc : 7 .835E+00 4 

### Log Koc : 4 .89 4 Aqueous Base/Acid-Catalyzed Hydrolysis (25 deg C) [HYDROWIN v1 .67] : Rate constants can NOT be estimated for this structure !



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### p . 33 P2-2002-0 5 Page 11 of 15 BCF Estimate from Log Kow (BCFWIN v2 .14) : Log BCF = 0 .500 (BCF = 3 .162) log Kow used : -0 .10 (estimated) Volatilization from Water : Henry LC : 1 .55E-011 atm-m3/mole (estimated by Bond SAR Method) Half-Life from model River : 5 .658E+007 hours (2 .357E+006 days) Half-Life from Model Lake : 6 .172E+008 hours (2 .572E+007 days) Removal In Wastewater Treatment : Total removal : 1 .85 percent Total biodegradation : 0 .09 percent Total sludge adsorption : 1 .76 percent Total to Air : 0 .00 percent Level III Fugacity Model :

Mass Amount Half-Life Emissions (percent) (hr) (kg/hr) Air 0 .00468 27 .7 1000 Water 49 .4 900 1000 Soil 50 .5 900 1000 Sediment 0 .0917 3 .6e+003 0 Persistence Time : 791 hr



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## Page 12 of 15 Appendix 2 . Output from the ECOSAR Computer Program [1], cation onl y SMILES : CC1(C)c2c3c(ccc2N(C)=C1C)cccc3 CHE M CAS Num : ChemIDi : ChemID2 : ChemID3 : MOL FOR : C16 H18 N i 

### MOL WT : 224 .3 3 Log Kow : -0 .10 (User entered) Melt Pt : Wat Sol : 1 .383E+005 mg/L (calculated) ECOSAR vO .99g Class(es) Found

------------------------------ Neutral Organics
Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm) Neutral Organic SAR : Fish 14-day LC50 20322 824 (Baseline Toxicity ) Neutral Organics : Fish 96-hr LC50 15663 .328 Neutral Organics : Fish 14-day LC50 20322 .824 Neutral Organics : Daphnid 48-hr LC50 14517 .241 Neutral Organics : Green Algae 96-hr EC50 8042 .369 Neutral Organics : Fish 30-day ChV 1438 .415 Neutral Organics : Daphnid 16-day EC50 297 .087 Neutral Organics : Green Algae 96-hr ChV 238 .937 Neutral Organics : Fish (SW) 96-hr LC50 1299 .823 Neutral Organics : Mysid Shrimp 96-hr LC50 20224 .79 3 mg/kg (ppm) dry wt soil Neutral Organics : Earthworm 14-day LC50 6119 .05 0 

### Note : * = asterick designates : Chemical may not be soluble

enough to measure this predicted effect . Fish and daphnid acute toxicity log Kow cutoff : 5 .0 Green algal EC50 toxicity log Kow cutoff : 6 .4 Chronic toxicity log Kow cutoff : 8 . 0 MW cutoff : 1000

------------------------------------------------------------------------------



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## Page 13 of 15 Appendix 3 . Output from the E-FAST Computer Program [3 ]
ENVIRONMENTAL RELEASES Release Activity : Manufacture Release Description : WATER LANDFILL INCINER LAND/INCIN FUGITIVE Total Releases : 5 .80 0 .00 0 .00 0 .00 0 .00 (kg/yr) (kg/yr) (kg/yr) (kg/yr) (kg/yr ) Release Days/yr : 58 .00 0 .0 Per Site Release : 0 .10 0 .00 0 .00 0 .00 0 .00 (kg/day) (kg/yr) (kg/yr) (kg/yr) (kg/day ) 

# I SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO"SURFACE WATER RELEASES RELEASE ACTIVITY : Manufacture FACILITY NAME : EASTMAN KODAK Company FACILITY LOCATION : ROCHESTER, NY 1465 2 RECEIVING WATER NAME : GENESEE R REACH NUMBER : 04130003001 FACILITY ON REACH : Yes DICHARGE TYPE : direct NPDES PERMIT # : NY0001643 DATA SOURCE : FacSrch EXPOSED POPULATION : Adult WWT REMOVAL, RELEASE PRE-TREAT BCF: DAYS RELEASE (kg/day) RELEASE:_(kg/day)` (L/kg) 0 .00 58 .00 0 .10 0 .10 3 .20

AQUATIC EXPOSURE ESTIMATES - SURFACE WATE R FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MI .,D) 3565 .86 1528 .48 1054 .22 851 .76 NA CONCENTRATION (μg/L) 2 .80E-02 6 .54E-02 9 .49E-02 0 .12 NA

### p . 36 P2-2002-0 5 

## Page 14 of 15 SITE-SPECIFIC HUMAN EXPOSURES TO SURFACE WATER RELEASES

DRINKING WATER INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED ~AT :-- BW IR (years) (years) (kg) (L/day) Cancer LADD . (mg/kg/day) 3 .48E-08 30 .00 75 .0071 .80 1 .40 LADC , , (mg/1 :) 1 .78E-06 30 .00 75 .00,!!"~, NA NA Chronic Non-Cancer` '~ ADD, (mg/kg/day) '-N/A 30 .00" 30 .00- - 71 .80 1 .4 0



## . . . ADC . (mg/L-) N/A ; 30 :00 30 .00 NA NA Acute (mg/kg/day) N/A 1 .00 day 1 .00 day 71 .80 6 .00 ADR


## FISH INGESTION EXPOSURE ESTIMATES ASSUNIPTIONS Exposure Units Results ED AT, . BW I R (years) -~ ~ (years)- _ (kg) (g/day) Cancer - LADD~ t (mg/kg/day) 4 .77E-10 30 .00 75 .00 71 .80 6 .00 LADC P, , (mg/kg) 5 .70E-06 30 .00 75 .00 NA NA Chronic Non-Cance r ADD , (mg/kg/day) N/A 30 .00 30 .00 71 .80 6 .00 ADC P, , (mg/kg) N/A 30 .00 30 .00 NA NA Acute ADR~ , (mg/kg/day) _F-N/A 1 .00 day 1 .00 day 71 .80 129 .00



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## Page 15 of 15 SITE-SPECIFIC AQUATIC EXPOSURES TO SURFACE WATER RELEASES

FACILITY NAME : EASTMAN KODAK Compan y FACILITY LOCATION : ROCHESTER, NY 14652 RECEIVING STREAM NAME : GENESEE River REACH NUMBER : 04130003001 FACILITY ON REACH : Yes DISCHARGE TYPE : Direct NPDES PERMIT # : NY0001643 DATA SOURCE : FacSrch STATION ID : N/A PERIOD OF RECORD :N/A # OBSERVATIONS : N/A # STATIONS ON REACH : N/A 50%ILE FLOW : 6914 .60 10%ILE FLOW : 1054 .22 EFFLUENT FLOW :126 .89 ` RESULTSti : ` _ Days/yr Release Loading Waste Wate r COC (μg/L) yr exceeded exceeded day~~year (kg/site/day) Treatment (%)

. 8042 :'00 0 00 - 0 :00 ' 129-1 .00, 0 :10 ` i0 .00



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HEALTH EFFECTS DAT A


## Testing Laboratories : Health and Environment Laboratories Eastman Kodak Compan y Rochester, New York 14652

Chemical Name : 1H-Benz(e)indolium, 1,1,2,3-tetramethyl-, salt with 4-methylbenzenesulfonic acid (1 :1) Studies Conducted : Acute Oral Toxicity in the Rat Pages 39-70 Acute Dermal Irritation Study in the Rabbit Pages 71-81

Studies In-Process : Four-Week Oral Toxicity Study in the Rat Skin Sensitization Study in the Guinea Pig Acute Eye Irritation Study in the Rabbit



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STUDY TITL E 1,1,2, 3-TETBAMETfiYL-1H-B Kw Z(B)IADOLIUlI 4- M THYLBSN ZffiIRSULpORATE ACUTE ORAL TOXICITY STUDY IN THE RA T HASI. NUMBER : 90-0105 1 AN : 924758

FINAL REPOR T

AUTHOR Kenneth P . Shepard, B .S .

PERFORMING LABORATOR Y Toxicological Sciences Laboratory Health and Environment Laboratories

Eastman Kodak Company 1100 Ridgeway Avenue B-320 Kodak Park Rochester, New York 14652-361 5

USA

LABORATORY PROJECT ID HAEL Number : 90-0105

STUDY SPONSO R Eastman Kodak Company

STUDY COMPLETION DATE February 11, 1991

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Q .A . INSPECTION STATE ME NT 

### (CFR 58 .35(B)(7) 792 .35(B)(7) 160 .35(B)(7)) !' iTDY : 90-0105-1 STUDY DIRECTOR : TOPPING,D .C . ;CESSION NUMBER : 92475 8
STUDY TYPE : ACUTE ORAL LDSO 

## 2ai (AUDITOR, QU ITY ASSURANC ~JNIT) DATE
THE BEST OF MY KNOWLEDGE, THIS FINAL REPORT ACCURATELY DESCRIBES THE ME THODS AND STANDAR D 'ERATING PROCEDURES, AND THE REPORTED RESULTS ACCURATELY REFLECT THE RAW DATA . THIS STUDY .S INSPECTED BY 1 OR MORE PERSONS OF THE QUALITY ASSURANCE UNIT OF THE HAEL, EASTMAN KODAK
,MPANY, ROCHESTER, N .Y . AND WRITTEN STATUS REPORTS WERE SUBMITTED ON THE FOLLOWING DATES :

-------------------------------------------------------------------------------------------- INSPECTION PHASE(S) STATUS REPORT DATES INSPECTED DATES
------- --------- ----------- 07/25/90 PROTOCOL APPENDIX SUBMISSION 08/15/90 PROTOCOL APPENDIX SUBMISSIO N

REPEAT - ADDITIONAL DOSE LEVEL(S) ADDED 08/23/90 PROTOCOL APPENDIX SUBMISSIO N



### REPEAT - ADDITIONAL DOSE LEVEL(S) ADDE D 08/29/90 NECROPSY 08/29/90 01/29/91 FINAL REPORT REVIEW 01/29/9 1



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COMPLIANCE WITH GOOD LABORATORY PRACTICE STANDARD S To the best of the signer's knowledge and belief, the study described by this report was conducted in compliance with the following Good Laborato ry Practice Standards :

Annex 2 of the Organization for Economic Cooperation and Development Guidelines for Testing of Chemicals C(81)30 ( Final) as required by Council Directive 87/18/EEC of December 18, 1986 .

Doug E(, . Topping4 h .D . Date Study Director 

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TABLE OF CONTENTS Page Number ABSTRACT 5 PERFORMING LABORATORY 6 SPONSOR 6 STUDY DATES 6 STUDY DIRECTOR 6 OTHER KEY PERSONNEL 6 PURPOSE/OBJECTIVE 6 TEST SUBSTANCE 7 TEST SYSTEM 7 HUSBANDRY AND ENVIRONMENTAL CONDITIONS 7 TEST PROCEDURES AND CONDITIONS 8 RESULTS 9 DATA ANALYSIS 12 DISCUSSION AND INTERPRETATION 13 CONCLUSION 14 DATA STORAGE 14 REFERENCES 15 SIGNATURE PAGE 16 PATHOLOGIST'S REPORT Appended

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STUDY TITLE 1,1,2,3-TETBAMSTHYL-IH-BENZ(B)IRDOLIUM 4-MET'HYI .BF.FZSRESULF'OHATE

ACUTE ORAI TOXICITY STUDY IN THE RAT HASL AilliBEE : 90-0105 KAA : 924758

ABSTRACT
An oral toxicity study was conducted with 1,1,2,3-tetramethyl-lHbenz(e)indolium 4-methylbenzenesulfonate in male and female rats administered single doses of 312, 625, 1250, or 5000 mg/kg of the test material by gavage . Five male rats were also administered single doses of 156 mg/kg of the test material by gavage . All animals at the 1250 and 5000 mg/kg dose levels died after exposure to the test material . In addition, four of five males and all females at the 625 mg/kg dose level and three of five males at the 312 mg/kg dose level died after exposure to the test material . All remaining animals survived to scheduled necropsy . Abnormal clinical signs associated with the test material included slight to severe weakness, vasodilatation, reduced feces, dehydration, and piloerection . Tremors and convulsions were seen prior to death in animals which died on the day of dosing . No treatment-related changes were observed at necropsy in animals which survived to scheduled necropsy . The primary treatment-related changes observed in animals which died after administration of the test material were necrosis and hemorrhage in the glandular gastric mucosa and necrosis in the small intestine . The test material was considered to be a gastric irritant . Based on an acute oral LD50 of 312 mg/kg in male rats and 441 mg/kg in female rats, and the criteria set forth by Hodge and Sterner (1949), the test material was classified as moderately toxic by the oral route .



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PERFORMING LABORATOR Y Toxicological Sciences Laborator y Health and Environment Laboratories (HAEL) Eastman Kodak Company 1100 Ridgeway Avenue B-320 Kodak Park Rochester, New York 14652-3615 US A
SPONSOR Eastman Kodak Company
STUDY DATE S Study Initiation : July 25, 1990 Experiment Initiation : July 25, 1990 Experiment Completion : October 22, 1990 Study Completion : February 11, 1991
STUDY DIRECTO R Douglas C . Topping, Ph .D ., DABT
OTHER KEY PERSONNE L John N . Mosher, B .S ., and Chris M . Ashley, Study Technicians Kenneth P . Shepard, B .S ., Principal Investigato r Milan S . Vlaovic, D .V .M ., Ph .D ., Pathologis t Gordon J . Hankinson, D .V .M ., M .S ., Pathologist, Laboratory Animal Medicine
PURPOSE/OBJECTIVE The purpose of the study was to determine the estimated single dose oral LD50 of the test compound in male and female rats and the clinical signs of toxicity associated with a single oral dose .



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TEST SUBSTANC E Chemical Name : 1,1,2,3-tetramethyl-lH-benz(e)indolium 4- methylbenzenesulfonate CAS Registry Number : Not availabl e HAEL Laboratory Number : 90-0105 KAN : 92475 8 

### CIN : Not availabl e SRID or Lot I .D . Number : W18451-1001 R-2 Physical State and Appearance : Violet solid Received at Performing Laboratory : July 18, 199 0 Composition : Refer to composition information included in the notification

when applicable .
TEST SYSTEM Species : Ra t Strain : CD®(SD)BR VAF/P1us " Source : Charles River Laboratories, Kingston, NY, US A No . of Animals : 5 of each sex for the 312, 625, 1250, and 5000 dose groups 5 males for the 156 dose grou p Sex : Male and Femal e Body Weight Range at Dosing (g) : (M) 188 - 228 (F) 160 - 184 Age : Approximately 6-10 weeks ol d
HUSBANDRY AND ENVIRON ME NTAL CONDITIONS Housin g All animals were individually housed in suspended stainless steel mesh cages . Environmental Condition s A photoperiod of 12 hours light from 6 a .m . to 6 p .m . was maintained . Room temperature was maintained at 72-74°F . Relative humidity was maintained at 53-60% . Diet and Wate r Agway® Prolab" Animal Diet (RMH 3000) certified pellets, and water, obtained from the Monroe County (NY) Water Authority, were available ad libitum . No known contaminants which would interfere with the outcome of the study were expected to be present in feed or water from these sources . Analyses of feed and results of quarterly analyses of water are maintained on file within the testing laboratory . Isolation Rats were isolated and monitored for at least five days after arrival and before release to the testing facility .

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HUSBANDRY AND ENVIRONMENTAL CONDITIONS CONT . Animal Identificatio n All rats were identified by cage numbers and uniquely numbered metal ear tags .
TEST PROCEDURES AND CONDITION S 

### Test Procedure Guidelin e OECD Guideline for Testing of Chemicals : Guideline 401, Dated 12 May, 1981 ; (Annex V, test B .1) . Protocol and SOP Deviation s The 156 mg/kg dose group (males) was inadvertently euthanatized on Day 13, rather than Day 14 . Day 13 body weights were collected on the euthanatized animals prior to necropsy . This deviation did not have any effect on the outcome of the study . Randomization A clinical examination was performed on each animal to ensure that only healthy animals were utilized . The procedure for including animals in the study was to randomly select and assign animals from the same shipment to each dose level . Randomization was done by computer-generated lists using the Automated Animal Toxicology System or a table of random numbers . After assignment of animals to individual groups, the body weights were determined to ensure that individual body weight variation did not exceed :t20% . 

### Dose Level s 156, 312, 625, 1250, and 5000 mg compound/kg body weigh t Administered doses were based on nominal concentrations of the test material in the vehicle . Identification Numbers of Animals Used 156 mg/kg males : 421 - 42 5 312 mg/kg males : 351 - 355 312 mg/kg females : 366 - 370 625 mg/kg males : 356 - 360 625 mg/kg females : 371 - 375 1250 mg/kg males : 361 - 365 1250 mg/kg females : 376 - 380 5000 mg/kg males : 251 - 255 5000 mg/kg females : 256 - 260 Dosing Regim e A single dose of the material was administered by gavage to animals that had been fasted overnight . Variability in test volume was minimized by adjusting the concentration to ensure similar dosing volumes at all dose levels .

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TEST PROCEDURES AND CONDITIONS CONT . Control Substance Non e Vehicle The vehicle was distilled water . Clinical Observation s Animals were observed at least three times on the day of dosing and once each workday thereafter for the duration of the observation period (a total of 13 or 14 calendar days) . Observation included, but was not limited to : examination of the hair, skin, eyes, motor activity, feces, and urine
. Animals were checked for mortality on weekend days . Body Weight Determination s Body weights were collected on the day of dosing, on Day 7, and at termination of the observation period . Necropsv All animals dying during the course of this study were promptly necropsied

. Animals which survived were necropsied at the completion of the observation period .
RESULTS Summarv
DOSE NO . RATS NO . DEATHS TIME OF DEATH WEIGHT GAIN* WEIGHT GAIN * m/k DOSED M F M F 1 WEEK M F 2 WEEK M F 156 5,0 0,- ------------ 5+,-- 5+,-- 312 5,5 3,0 Day 3 or Day 5 2+,5+ 2+,5+ 625 5,5 4,5 135 Minutes - Day 1 1+,-- 1+,-- 1250 5,5 5,5 35 - 170 Minutes -- ,-- --~-- 5000 5,5 5,5 35 - 40 Minutes -- ,-- --~-- *+= Number of animals gaining weigh t - = Number of animals losing weight


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RESULTS CONT . Clinical Observations 

### SUMMARY OF CLINICAL SIGN S DOSE (mjz/kA) CLINICAL SIGN NO OF RATS AFFECTED 156 Appeared Clinically Normal 5 M 312 Slight to Moderate Weakness 5M,5F

Vasodilatation 5M,5F Piloerection 5M,5F Reduced Feces 5M,5F Dehydration 1M Death 3M Clinically Recovered 2M,5 F 625 Moderate Weakness 5M,SF

Vasodilatation 5M,5F Piloerection 5M,5F Reduced Feces 1M Death 4M,SF Clinically Recovered 1 M 1250 Moderate to Severe Weakness 5M,5F

Tremors 5M,5F Convulsions 5M,5F Vasodilatation 1M,4F Piloerection 1M,4F Death 5M,5 F 5000 Severe Weakness SM,5F Tremors 5M,5F Convulsions 5M,5F 

### Death 5M,5F



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RESULTS CONT . 

### Individual Body Weights MALES

DOSE ANIMAL INDIVIDUAL DY WEIGHTS (mg/kg) NUMBER DAY 0 DAY 7 DAY 1 3

421 2 1 2 2 * 422 218 285 319 * 

### 156 42 199 271 307 *

424 188 272 318 * 425 221 296 342 * * Body weights were collected following euthanasia . MALES DOSE ANIMAL INDIVIDUAL BODY WEIGHTS (mg/kg) NUMBER DAY 0 DAY 7 DAY 1 4



### 351 22 8 352 190 241 317 312 353 225 361

354 19 9 355 202 6 200 357 19 1 625 358 20 2

59 195 253 319 360 22 2 361 226 362 195 1250 363 203



### ---

364 20 2 365 205

--- 251 21 3 252 207 -- j. 5000 253 217

254 20 255 1 8



### LO



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RESULTS CONT . Individual Body Weights Cont . FEMALES DOSE ANIMAL INDIVIDUAL BODY WEIGHTS (R) m/k NUMBER DAY 0 DAY-7 DAY 1 4



### 366 182 214 2 4 367 163 204 218 312 368 181 220 24 5

369 181 240 268 370 170 229 254 37 1 372 182 625 373 184

74 17 1 

### 375 167 376 162 377 17 2 1250 378 173

379 166 380 184 256 173 257 17 7 5000 258 174

259 160 260 17 6 

### Necropsy and Histopathology Finding s See the attached pathology report for necropsy findings . No tissue was collected for microscopic examination .
DATA ANALYSI S The LD50 was obtained using the method of Well (1952) . The results were as follows : LD50 IN MALE RATS : 312 mg/kg - 95% C .I . 201 - 484 mg/kg LDSO IN FEMALE RATS : 441 mg/kg - 95% C .I . 334 - 583 mg/k g No dose/mortality curve was constructed since graphs become statistically useful only with the use of large numbers of animals and dose groups .

. .N

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265285 Z TX-91-24 Page 13 of 16
DISCUSSION AND INTERPRETATIO N All animals died within 40 minutes after administration of a limit dose of 5000 mg/kg . Abnormal clinical signs noted before death included severe weakness, tremors, and convulsions . For the selection of additional dose levels, a range finding screen was conducted utilizing one animal of each sex per dose level, with body weights ranging between 201-259 grams . Dose levels of 2500, 1250, 625, and 312 mg/kg, with the test material administered as a 12 .5% solution in distilled water, were selected for the range finding screen . Both animals of each sex in the 1250 and 2500 mg/kg dose groups died after administration of the test material . All remaining animals survived a 14-day period . Based on the range finding results, dose levels of 1250, 625, and 312 mg/kg were selected for the oral toxicity study . In the acute oral toxicity study, the test material was administered using distilled water as the vehicle . Variability in test volume was minimized by adjusting the concentration to ensure similar dosing volumes at all dose levels . In these dose groups, no abnormal clinical observations were noted immediately after dosing . At the 1250 mg/kg dose level, severe weakness, tremors, and convulsions were noted in all animals ten minutes after administration of the test material . Four of five males and one of five females died prior to the one-hou r clinical examinations . Abnormal clinical signs noted in the remaining animals at this dose level included moderate weakness, vasodilatation, and piloerection . All remaining animals at this dose level died prior to the four-hour examinations . At the 625 mg/kg dose level, moderate weakness, vasodilatation, and piloerection were noted for all animals on the day of dosing . In addition, one of five males died between the one- and four-hour examinations . At the time of clinical examinations on the day after administration of the test material, three of the remaining four males and all five females had died . Abnormal clinical signs for the remaining male were limited to moderate weakness and reduced feces on the day following dosing and Day 2 of the study . No other abnormal clinical observations were noted for this male during the study . The remaining male survived to scheduled necropsy, and gained weight normally . At the 312 mg/kg dose level, slight weakness was noted in all animals ten minutes after dosing . Moderate weakness, vasodilatation, and piloerection were noted for all animals at the one- and four-hour examinations . On the day following administration of the test material and on Day 2 of the study, moderate weakness was noted for all males while slight weakness was observed for all females . A reduced amount of feces was also noted for all animals at these examinations . In addition, dehydration was seen on Day 2 for one of five males . Over the weekend ( Days 3 and 4), only mortality checks were performed . A single male was found dead on Day 3, and two additional male s



### ~~

### p . 52

265285 Z TX-91-24 Page 14 of 16

DISCUSSION AND INTERPRETATION CONT . were found dead prior to clinical examinations on Day 5 of the study . At the time of clinical examinations on Day 5, all remaining animals-in this dose group appeared clinically normal . No other abnormal clinical observations were noted in this dose group during the study .= All remaining animals survived to scheduled necropsy, and gained weight normally . Due to the number of deaths of males at the 312 mg/kg dose level, an additional group of five males, administered a dose of 156 mg/kg, was added to the study . No deaths or abnormal clinical signs were noted in this dose group during the study . All animals gained weight normally . The five males in this dose group were inadvertently euthanatized a day earlier tha n scheduled (Day 13 as opposed to Day 14) . Body weights were recorded after euthanasia and prior to necropsy . This deviation had no significant result on the outcome of the study . At all dose levels, no treatment-related changes were observed at necropsy for animals which survived the observation period . Primary treatment-related changes observed at necropsy for animals which died after exposure of the test material were necrosis and hemorrhage in the glandular gastric mucosa and necrosis in the small intestine . A record of the incidence and severity of all gross abnormalities is presented in computer-generated tables which follow the appended pathology report . The cause of death for animals which died after exposure to the test material was not determined, however, necrosis and hemorrhage in the glandular gastric mucosa and necrosis in the small intestine contributed to the deaths . The test article was a gastrointestinal irritant as evidenced by diffuse necrosis and hemorrhage in the glandular gastric mucosa and diffuse necrosis in the mucosa of the duodenum and jejunum . No tissue was collected for microscopic examination because of the short time period between dose administration and deaths and the absence of significant lesions other than the obvious signs of gastrointestinal necrosis and hemorrhage .
CONCLUSION Based on an acute oral LD50 of 312 mg/kg in male rats and 441 mg/kg in female rats, and the criteria set forth by Hodge and Sterner (1949), the test material was classified as moderately toxic by the oral route .


### DATA STORAG E All test results presented in this report are supported by raw data which are maintained in the archives of the Health and Environment Laboratories, Eastman Kodak Company . 

# 52-

### p . 53
265285 Z TX-91-24 Page 15 of 16
REFERENCE S Bodge, H .C . and Sterner, J .H . (1949) . Tabulation of toxicity classes . Am . Indust . HvA . Quart ., 10 : 93-96 . Well, C .S . (1952) . Tables of convenient calculations of medium-effective dose (LD50 or ED50) and instructions in theirlise . Biometrics , 8 : 249-263 .



### Ef '72

### p . 54

265285 Z TX-91-24 Page 16 of 16
SIGNATURE PAGE



## 3t 

# . 144 

# j Principal Investigator Dat e Report Autho r

~ 

# :3~ -r

l Dire 9 r, Mamma n Toxicology Section Date Study Directo r

Di ct , Toxicologi a Sciences Laboratory Dat e



# 54

### p . 55

Study No . 90-010 5 Acc . No . 924758
PATHOLOGY REPOR T Compound : 1,1,2,3-Tetramethyl-lH-benz(e)indolium

4-methylbenzenesulfonate Male rats given 5000, 1250, 625, 312 or 156 mg/kg and female rats given 5000, 1250, 625, or 312 mg/kg of the test material by gavage, as part of an acute oral toxicity study, were necropsied . Necropsy lesions are listed in computer-generated tables . The cause of death for rats which died after exposure to the test material was not determined, however, necrosis and hemorrhage in the glandular gastric mucosa and necrosis in the small intestine contributed to the deaths . GROSS PATHOLOG Y Male Rats - 5000 mg/kg dose group : Treatment-related changes included test article in the stomach (5/5), diffuse necrosis (5/5) and grey discoloration (5/5) in the glandular gastric mucosa, focal necrosis in the duodenal serosa (1/5) and hepatic capsule (4/5), and pancreatic hemorrhage (1/5) . In addition, the contents of the duodenum (4/5), jejunum (4/5), and ileum (2/5) were watery . All rats died on the day of dosing . Male Rats - 1250 mg/kg dose group : Treatment-related changes included test article in the stomach (5/5), diffuse necrosis (5/5) of the glandular gastric mucosa, blue discoloration (3/5) of the non-glandular gastric mucosa, and watery (1/5) jejunal contents . All rats died on the day of dosing . Hale Rats - 625 mg/kR dose zroup : Treatment-related changes in a single rat which died on the day of dosing and three rats which died on Day 1 included test article in the stomach (4/4) ; diffuse necrosis (3/4), hemorrhage (1/4), and blue discoloration (1/5) of the glandular gastric mucosa, and blue discoloration (2/4) of the non-glandular gastric mucosa . In addition, the hair of the face was discolored red (1/4) and the inguinal hair showed yellow urine stain (2/4) . No treatment-related changes were observed in a single rat which survived the 14-day observation period . Male Rats - 312 mg/kg dose Rroup : Treatment-related changes in a single rat which died on Day 3 and two rats which died on Day 5 included yellow (2/3) or brown (1/3) fecal stain on the inguinal hair and porphyrin stain (3/3) on the hair of the face . No treatment-related changes wer e observed in two rats which survived the 14-day observation period . Male Rats - 156 mg/kg dose zroup : No treatment-related changes were observed . All rats survived the 13-day observation period
. 

# 55

### p . 56 - 2 - Study No . 90-010 5 Acc . No . 924758
Female Rats - 5000 mA/kR dose group : Treatment-related changes*included test article in the stomach (5/5) ; diffuse necrosis (5/5) and grey discoloration (5/5) in the glandular gastric mucosa ; and water contents in the duodenum (4/5), jejunum (4/5), and ileum (2/5) . All rats died on the day of dosing . Female Rats - 1250 mK/kg dose group : Treatment-related changes included test article in the stomach (5/5), diffuse necrosis (5/5) in the glandular gastric mucosa, and blue discoloration (1/5) in the non-glandular gastric mucosa . Diffuse necrosis was observed in the mucosa of the duodenum (2/5) and jejunum (2/5) . The intestinal contents were red in the duodenum (1/5) and red (1/5) and watery (2/5) in the jejunum . In addition, the inguinal hair was stained yellow (2/5) or grey (1/5) by urine, and the hair of the face was either wet by saliva (2/5) or discolored red (2/5) . All rats died on the day of dosing . Female Rats - 625 mg/kg dose Rroup : Treatment-related changes included test article in the stomach (5/5), diffuse necrosis (3/5) and hemorrhage (1/5) in the glandular gastric mucosa, blue discoloration (2/5) in the non-glandular gastric mucosa, and yellow urine stains (5/5) on the inguinal hair . All rats died on Day 1 . Female Rats - 312 mg/k& dose group : No treatment-related changes were observed . All rats survived the 14-day observation period . All other lesions listed in the attached tables were not considered treatment-related . Corvnents : The test article was a gastrointestinal irritant as evidenced by diffuse necrosis and hemorrhage in the glandular gastric mucosa and diffuse necrosis in the mucosa of the duodenum and jejunum . No tissue was collected for microscopic examination because of the short time period (24 hours) between dose administration and deaths and the absence of significant lesions other than the obvious signs of gastrointestinal necrosis and hemorrhage .

Milan S . Vlaovic, D .V .M ., Ph .D . 

# 2Z ~~lo Reviewed 

### )(Y/ X Gordon J }~ankinson, D .V .M ., M .S .

✓ MSV :cpp 10/15/90 5 ~ 6186T

### p . 57 SUMMARY GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT ~ 900105A0 COMPOUND 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 GROUP 156 .000 312 .000 625 .000 1250 .000 5000 .000 AG/KG MG/KG MG/KG MG/KG MG/KG M M M M M TRACHEA 5 5 5 5 5 LUNGS 5 5 5 5 5 THYMUS 5 5 5 5 5 HEMORRHAGE 2 0 3 3 2 HEART 5 5 5 5 5 ESOPHAGUS 5 5 5 5 5 STOMACH 5 5 5 5 5 STOMACH CONTENTS-TEST ARTICLE PRESENT e 0 4 5 5 STOMACH . GLANDULA R DISCOLORATION,BLUE 0 0 1 e 0 NECROSIS, DIFFUSE 0 0 3 5 5 HEMORRHAGE 0 0 1 0 0 DISCOLORATION . NOS 0 0 0 0 5 STOMACH, NON-GLANDULAR DISCOLORATION,BLUE e 0 2 3 0 DUODENUM 5 5 5 5 5 SEROS A NECROSIS, FOCAL 0 0 0 0 1 INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 0 0 0 0 4 JEJUNUM 5 5 5 5 5 INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 0 0 0 1 4 ILEUM 5 5 5 5 5 INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 0 0 0 0 2 CECUM 5 5 5 5 5 COLON 5 5 5 5 5 RECTUM 5 5 5 5 5 LIVER 5 5 5 5 5 HEPATIC CAPSUL E NECROSIS . FOCAL 0 0 0 0 4 KIDNEYS 5 5 5 5 5 URINARY BLADDER 5 5 5 5 5 PITUITARY GLAND 5 5 S 5 5 ADRENALS 5 5 5 5 5 PANCREAS . NOS 5 5 5 5 5 HEMORRHAGE 0 e 0 e 1 THYROID GLANDS 5 5 5 5 5 PARATHYROID GLANDS 5 5 5 5 5 NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED, OR IN THE CASE OF ABNORMAL FINDINGS , THE NUMBER OF TISSUES WI~H EACH ABNORMALIT Y I r REVIEWED BY : DATE :~~,- j c ACCEPTED BY DATE : ~~



# 57

### p . 58 SUI .bIARY GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900105A0 COMPOUND { 90-0105 SOFTWARE VERS ~ 3 .0 ACCESSION NUMBER 92475 8 GROUP 156 .000 312 .000 625 .000 1250 .000 5000 .000 MG/KG MG/KG MG/KG MG/KG MG/KG M M M M M SPLEEN 5 5 5 5 5

► IESENTERIC LYMPH NODES 5 5 5 5 5 BONE MARROW 5 5 5 5 5 BRAIN 5 5 5 5 5 EYES 5 5 5 5 5 SALIVARY GLANDS 5 5 5 5 5 ADIPOSE TISSUE 5 5 5 5 5 SKIN, NOS 5 5 5 5 5 HAIR 5 5 5 5 5 HAIR OF iNGUINAL REGION DISCOLORATION,YELLOw 0 2 2 e 0 DISCOLORATION,BROwN 0 1 0 0 0 HAIR OF FAC E PORPHYRIN 0 3 0 0 0 DISCOLORATION .RED 0 0 1 0 0 ACCESSORY SEX ORGANS ( MALE) 5 5 5 5 5 EPIDIDYMIDES 5 5 5 5 5 TESTES 5 5 5 5 5 BODY AS A WHOLE, NOS 0 3 0 0 0 AUTOLYSIS 0 3 0 0 0 NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED, OR IN THE CASE OF ABNORMAL FINDINGS , THE NUMBER OF TISSUES wILH EACH ABNORMALIT Y



# 1 7 ^ - '/`
~~ ~ ~`i,~ ~ t~ • / ~ ~ ~ DATE : / C ACCEPTED BY DATE : REVIEWED BY :



# 58

### p . 59 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900 1 05A0 COMPOUND 90-0105 SOFTWARE VERS ~ 3 .0 ACCESSION NUMBER 92475 8 156 .000 MG/KG GROUP - M ANIMAL / 421 422 423 424 425 DAYS ON TEST 13 13 13 13 1 3 TRACHEA X X X X X LUNGS X X X X X THYMUS X X X HEMORRHAGE 1 1 HEART x x x X x ESOPHAGUS X X X X X STOMACH X X X X X DUODENUM x x X X X JEJUNUM X X X X X ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X X X MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X HAIR X X X X X ACCESSORY SEX ORGANS ( MALE) X X X X X EPIDIDYMIDES X X X X X TESTES X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1- M INIMAL,2- MINOR, 3-MODERATE,4-SEVERE P-PRESENT,A- SENT, .-SEE COMMENT REPORT ( FORM / 2), X-NORMAL BUT NOT COLLECT 7 REVIEWED BY : , DATE : IG• j•`j~ ACCEPTED BY : DATE : J•, ;

~

### p . 60 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMEti1 i 900105A0 COMPOUND 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 312 .000 MG/KG GROUP - M ANIMAL ~ 351 352 353 354 355 DAYS ON TEST 5 14 14 3 5 TRACHEA X X X X X L UNGS X X X X X THYMUS X X X X X HEART X X X X X ESOPHAGUS X X X X X STOMACH X X X X X DUODENUM X X X X X JEJUNUM X X X X X ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X X X MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X *HAIR X X HAIR OF INGUINAL REGION DISCOLORATION,YELLOW 1 2 DISCOLORATION,BROWN 3 HAIR OF FAC E PORPHYRIN 1 1 2 ACCESSORY SEX ORGANS ( MALE) X X X X X EPIDIDYMIDES X X X X X TESTES X X X X X BODY AS A WHOLE . NO S AUTOLYSIS 3 3 3 KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL .2-MI NOR, 3 -4+10DERATE,4-SEVERE P-PRESENT,A-ABSENT,1 !~ EE CC~AM ENT REPORT ( FORM # 2), X=NORMAL BUT NOT COLLECTE Q i REVIEWED BY : DATE : /C --z - i - c ACCEPTED BY :~ Y.,1 ;~~,t,, DATE :

~

### p .61 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900105A0 COMPOUND 1 90-0105 SOFTWARE VERS # 3 .0 ACCESSION NUMBER 92475 8 625 .000 MG/KG GROUP - M ANIMAL / 356 357 358 359 360 DAYS ON TEST 1 1 1 14 0 TRACHEA X X X X X LUNGS X X X X X THYMUS X X HEMORRHAGE 1 1 2 HEART X X X X X ESOPHAGUS X X X X X STOMACH X STOMACH CONTENTS-TEST ARTICLE PRESENT P P P P STOMACH . GLANDULA R DISCOLORATION,BLUE 2 NECROSIS, DIFFUSE 2 2 2 HE M ORRHAGE 1 STOMACH, NON-GLANDULA R DISCOLORATION,BLUE 1 3 DUODENUM X X X X X JEJUNUM X X X X X ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLAN D S X X X X X SPLEEN X X X X X MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X •HAIR X X X HAIR OF INGUINAL REGIO N DISCOLORATION,YELLOW 1 1 HAIR OF FAC E DISCOLORATION .RED 2 ACCESSORY SEX ORGANS ( MALE) X X X X X EPIDIDYMIDES X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2- MINOR, 3-MODERATE,4- SEVERE P-PRESENT,A-ABSEyT,• SE COMMENT REPORT ( FORM /2), X
-NORMAL BUT NOT COLLECTE D REVIEWED BY : /`/ ✓ ~ ~ L DATE : G 3-y(ACCEPTED BY :~ `~,7~ ~ ~'l'~', _ l .i_ :~ • T,- 

### ~• DATE : ~ . ~~ . . 

# / (01

### p . 62 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900105A0 COMPOUND 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 625 .000 MG/KG GROUP - M ANIMAL t 356 357 358 359 360 DAYS ON TEST 1 1 1 14 0 TESTES X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2-MINOR .3-MODERATE,4-SEVERE P-PRESENT,A-ABStNT,•-SEE COMMENT REPORT (FORM 12) . X-NORMAL BUT NOT COLLECTE D REVIEWED BY :~ . DATE ./ ~ . .3 ACCEPTED BY DATE )



# 62-~

### p . 63 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT / 900105A0 COMPOUND / 90-0105 SOFTWARE VERS ~ 3 .0 ACCESSION NUMBER 92475 8 1250 .000 MG/KG GROUP - M ANIMAL / 361 362 363 364 365 DAYS ON TEST e 0 0 e 0 TRACHEl . X X X X X LUNGS X X X X X THYMUS X X HEMORRHAGE 1 1 1 HEART X X X X X ESOPHAGUS x x X X X STOMACH STOMACH CONTENTS-TEST ARTICLE PRESENT P P P P P STOMACH . GLANDULA R NECROSIS, DIFFUSE 2 2 2 2 2 STOMACH, NON-GLANDULA R DISCOLORATION,BLUE 2 1 1 DUODENUM X X X X X JEJUNUM X X X X INTESTINAL CONTENT S INTESTINAL CONTENTS-WATER Y ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X X X M ESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GL A NDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X HAIR X X X X X ACCESSORY SEX ORGANS ( MALE) X X X X X EPIDIDYMIDES X X X X X TESTES X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2- MINOR . 3-#10DERATE,4- SEVERE P-PRESENT,A-A ENT,+TSEE CO ► .4 .1ENT REPORT ( FORM /2), X-NORMAL BUT NOT COLLECjED , /• REVIEWED BY : pATE :iG _'j(ACCEPTED BY A : . • ~ ' . ~ I~~i'EIt DATE :' 

# Co3

### • p . 64 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT / 900105A0 COMPOUND / 90-0105 SOFTWARE VERS ~ 3 .0 ACCESSION NUMBER 92475 8 5000 .000 MG/KG GROUP - M ANIMAL 251 252 253 2 5 4 255 DAYS ON TEST e 0 0 0 0 TRACHEA . X X X X X LUNGS x x x x x THYMUS X X X HEMORRHAGE 1 1 HEART X X X X` X ESOPHAGUS X X X X X • STCMAACH STOMACH CONTENTS-TEST ARTICLE PRESENT P P P P P STOMACH . GLANDULAR NECROSIS, DIFFUSE 3 3 2 3 3 DISCOLORATION, NOS 2 2 1 2 2 DUODENUM SEROSA NECROSIS, FOCAL i INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 2 2 2 2 JEJUNUM X INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 2 2 2 2 ILEUM X X X INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 2 2 CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X HEPATIC CAPSUL E NECROSIS . FOCAL 1 1 1 1 KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X HEMORRHAGE 2 THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X X X MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X' X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X HAIR X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2-MINOR,3-#AODERATE,4-SEVERE P-PRESENT,A- ABSENT •-~EE COMMENT REPORT ( FORM / '2), X
- NORMAL BUT .,NOT COLLECTED , REVIEWED BY : DATE : - . _ 

# ~ 3. y~ ACCEPTED BY : DATE :
i3~ !

### p . 65 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT / 900105A0 COMPOUND 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 5000 .000 MG/KG GROUP - M ANIMAL f 251 252 253 254 255 DAYS ON TEST e 0 0 0 e ACCESSORY SEX ORGANS (MALE) X X X X X EPIDIDYMIDES X X X x x TESTES X x x x X KEY :N-NORMAL A TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2-MINOR, 3-MODERATE,4-SEVERE P-PRESENT .A-AB ENT, .COMMENT REPORT (FORM /2), XwNORMAL8UT NOT COLLECTEP 

### l- DATE : w ~~ ACCEPTED BY,~} . E : 

## C/ 31c REVIEWED 

### BY : 

## 4111 2-) DAT

l5[~

### p . 66 SUMMARY GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT / 900105A0 COMPOUND 90-0105 SOFTWARE VERS {{ 3 .0 ACCESSION NUMBER 92475 8 GROUP 156 .000 312 .000 625 .000 1250 .000 5000 .000 MG/KG MG/KG MG/KG MG/KG MG/KG F F F F F TRACHEA 0 5 5 5 5 LUNGS 0 5 5 5 5 THY~MUS 0 5 5 5 5 HEMORRHAGE 0 0 3 1 5 HEART 0 5 5 5 5 ESOPHAGUS 0 5 5 5 5 STOMACH 0 5 5 5 5 STOMACH CONTENTS-TEST ARTICLE PRESENT 0 0 5 5 5 STOMACH, NON-GLANDULAR DISCOLORATION .BLUE 0 0 2 1 0 STOMACH, GLANDULA R NECROSIS, DIFFUSE 0 0 3 5 5 HEM ORRHAGE 0 0 1 0 0 DISCOLORATION, NOS 0 0 e 0 5 DUODENUM 0 5 5 5 5 MUCOS A NECROSIS . DIFFUSE 0 0 0 2 0 INTESTINAL CONTENT S DISCOLORATION,RED 0 0 0 1 0 INTESTINAL CONTENTS-WATERY 0 0 0 0 4 JEJUNUM 0 5 5 5 5 1AUCOS A NECROSIS . DIFFUSE 0 0 0 2 0 INTESTINAL CONTENT S DISCOLORATION,RED 0 0 0 1 0 INTESTINAL CONTENTS-WATERY 0 0 0 2 4 ILEUM 0 5 5 5 5 INTESTINAL CONTENT S INTESTINAL CONTENTS-WATERY 0 0 0 0 2 CECUM 0 5 5 5 5 COLON 0 5 5 5 5 RECTUM 0 5 5 5 5 LIVER 0 5 5 5 5 KIDNEYS 0 5 5 5 5 URINARY BLADDER 0 5 5 5 5 PITUITARY GLAND 0 5 5 5 5 ADRENALS 0 5 5 5 5 PANCREAS . NOS 0 5 5 5 5 THYROID GLANDS 0 5 5 5 5 PARATHYROID GLANDS 0 5 5 5 5 NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED . OR IN THE CASE OF ABNORMAL FINDINGS . THE NUMBER OF TISSUES WIfiH EACH ABNORMALIT Y REVIEWED BY : DATE : ~` - .3•• L, ; ACCEPTED BY DATE : • ~

( .L~ ~

### p . 67 SUMMARY GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT # 900105A0 COMPOUND f 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 GROUP 156 .000 312 .000 625 .000 1250 .000 5000 .000 MG/KG MG/KG MG/KG MG/KG MG/KG F F F F F SPLEEN 0 5 S 5 S MESENTERIC LYMPH NODES 0 5 5 5 5 BONE MARROW 0 5 5 5 5 BRAIN 0 5 5 5 5 EYES 0 5 5 5 5 SALIVARY GLANDS 0 5 5 5 5 ADIPOSE TISSUE . 0 5 5 5 5 SKIN . NOS 0 5 5 5 5 HAIR 0 5 5 S 5 HAIR OF INGUINAL REGIO N DISCOLORATION,YELLOW 0 0 5 2 0 DISCOLORATION, NOS e 0 e 1 0 HAIR OF FAC E HAIRCOAT-WET BY SALIVA 0 0 0 2 e DISCOLORATION,RED 0 0 0 2 0 FALLOPIAN TUBES 0 5 5 5 5 VAGINA 0 5 5 5 5 UTERUS 0 5 5 5 5 HYDROMETRA 0 1 0 0 0 OVARIES 0 5 5 5 5 CERVIX UTERI e 5 5 5 5 NUMBERS REPRESENT NUMBER OF TISSUES EXAMINED . OR IN THE CASE OF ABNORMAL FINDINGS , THE NUMBER OF TISSUES WITH-,EACH ABNORMALITY REVIEWED BY : DATE : /c, ACCEPTED BY : DATE : . ~. ., v



# ~7

### p . 68 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900105A0 COMPOUND ~ 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 312 .000 MG/KG GROUP - F ANIMAL ~ 366 367 368 369 370 DAYS ON TEST 14 14 14 14 1 4 TRACHEA X X X X X LUNGS X X X X X THYMUS X X X X X HEART X X X X X ESOPHAGUS X X X X X STOMACH X X X X X DUODENUM X X X X X JEJUNU,! X X X X X ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS, NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X x x MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X x x HAIR X X X X X FALLOPIAN TUBES X X X X X VAGINA X X X X X UTERUS X X X X HYDROMETRA 1 OVARIES X X X X X CERVIX UTERI X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL .2-MINOR . 3-M0DERATE,4-SEVERE P-PRESENT,A-ABSENT, .-S COMMENT REPORT (FORM J2) . X=NORAAAL BUT NOT COLLECTE D REVIEWED BY : `~ DATE : /( --7( : ACCEPTED BY :~~ DATE : 

# Cog

### p . 69 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT f 900105A0 COMPOUND f 90-0105 SOFTWARE VERS 3 .0 ACCESSION NUMBER 92475 8 625 .000 MG/KG GROUP - F ANIMAL 371 372 373 374 375 DAYS ON TEST 1 1 1 1 1 TRACHEA X X X X X LUNGS X X X X X THYMUS X X HEMORRHAGE 3 2 1 HEART X X X X X ESOPHAGUS X X X X X STOMAC H STOMACH CONTENTS-TEST ARTICLE PRESENT P P P P P STOMACH, NON-GLANDULA R DISCOLORATION,BLUE 3 2 STOMACH . GLANDULA R NECROSIS . DIFFUSE 2 2 2 HEMORRHAGE 1 DUODENUM X X X X X JEJUNUM X X X X X ILEUM X X X X X CECUM X X X X X COLON X X X X X RECTUM X X X X X LIVER X X X X X KIDNEYS X X X X X URINARY BLADDER X X X X X PITUITARY GLAND X X X X X ADRENALS X X X X X PANCREAS . NOS X X X X X THYROID GLANDS X X X X X PARATHYROID GLANDS X X X X X SPLEEN X X X X X MESENTERIC LYMPH NODES X X X X X BONE MARROW X X X X X BRAIN X X X X X EYES X X X X X SALIVARY GLANDS X X X X X ADIPOSE TISSUE X X X X X SKIN, NOS X X X X X *HAI R HAIR OF INGUINAL REGION DISCOLORATION,YELLOW 1 3 1 2 2 FALLOPIAN TUBES X X X X X VAGINA X X X X X UTERUS X X X X X OVARIES X X X X X KEY :N-NORMAL AND TISSUE COLLECTED FOR HISTOPATHOLOGY,1- M INIMAL,2- MINOR . 3- WDERATE,4-SEVERE P-PRESENT,A-ABSENT, .-$~E COMMENT REPORT ( FORM f2) . X- NORMAL BUT OT COLLECTE D REVIEWED BY : DATE : . . 3 C ACCEPTED BY~~ .!~~1 A~1r~1 , : . _ DATE : f',/ f ' (/"/ i (



# a9

### p . 70 INDIVIDUAL ANIMAL GROSS PATHOLOGY INCIDENCE TABL E EXPERIMENT # 900105A0 COMPOUND f 90-0105 SOFTWARE VERS {~ 3 .0 ACCESSION NUMBER 92475 8 625 .000 MG/KG GROUP - F ANIMAL / 371 372 373 374 375 DAYS ON TEST 1 1 1 1 1 CERVIX UTERI X X X X X KEY :N-NORMAL ApI D TISSUE COLLECTED FOR HISTOPATHOLOGY,1-MINIMAL,2-MINOR,3-MODERATE,4-SEVERE P-PRESENT,A-ABSENT,•- EE COMMENT REPORT (FORM /'2), X
- NORMAL BUT NOT COLLECTE D REVIEWED BY : ~ ✓ ~~~ DATE : 

# , C 376 ACCEPTED BY~ti .•~~^ ~`,I lm i. LC . DATE : ( ~/w~ `, t l L



# '7

# o

### p . 71
265283 X TX-91-22 Page 1 of 11
STUDY TITL E 1,1,2,3- 1H-BENZ(B)INDOLI m 4-mrTHYLBF .PZSI I' SIILFORATE ACQTE DERMAL IRRITATION STUDY IN THE IPAR I T 

### HABI. P[TM EE : 90-0105 LAN : 924758

FINAL REPORT

AUTHOR Kenneth P . Shepard, B .S .

PERFORMING LABORATOR Y Toxicological Sciences Laboratory Health and Environment Laboratories

Eastman Kodak Company 1100 Ridgeway Avenue B-320 Kodak Park Rochester, New York 14652-361 5

USA

LABORATORY PROJECT ID HAEL Number : 90-0105

STUDY SPONSO R Eastman Kodak Company



### STUDY COMPLETION DATE February 1, 1991 

# rh

### p . 72 265283X TX-91-22 Page 2 of 1 1



### Q .A . INSPECTION STATEMENT (CFR 58 .35(B)(7) 792 .35(B)(7) 160 .35(B)(7)) STUDY : 90-0105-1 STUDY DIRECTOR : TOPPING,D .C . ACCESSION 1PUM

ffiER : 92475 8
STUDY TYPE : ACUTE DERMAL IRRITATION TEST

~ ✓. .ya ~ ~ Q•~r~~ ~ 9 ~9 / (AUDITOR, Q ALITY ASS CE UNIT) DAT E



### - -------------------- r0 THE BEST OF MY KNOWLEDGE, THIS FINAL REPORT ACCURATELY DESCRIBES THE METHODS AND STANDARD ) PERATING PROCEDURES, AND THE REPORTED RESULTS ACCURATELY REFLECT TEE RAW DATA ., THIS STUDY iAS INSPECTED BY 1 OR MORE PERSONS OF THE QUALITY ASSURANCE UNIT OF THE $AEL, EASTMAN KODAK ".OMPANY, ROCHESTER, N .Y . AND WRITTEN STATUS REPORTS WERE SUBMITTED ON THE FOLLOWING DATES : INSPECTION PHASE(S) STATUS REPORT ~ DATES INSPECTED DATE S 07/31/90 PROTOCOL APPENDIX SUBMISSIO N 08/02/90 CLINICAL SIGNS AT 48 ERS . 08/02/90 01/29/91 FINAL REPORT REVIEW 01/29/9 1



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### p . 73
265283 X TX-91-22 Page 3 of 11
COMPLIANCE WITH GOOD LABORATORY PRACTICE STANDARD S To the best of the signer's knowledge and belief, the study described by this report was conducted in compliance with the following Good Laboratory Practice Standards :

Annex 2 of the Organization for Economic Cooperation and Development Guidelines for Testing of Chemicals C(81)30 ( Final) as required by Council Directive 87/18/EEC of December 18, 1986 .

Douglas C . Topping . D . Date Study Director 

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### p . 74

265283 X TX-91-22 Page 4 of 11
TABLE OF CONTENTS Page Number ABSTRACT 5 PERFORMING LABORATORY 6 SPONSOR 6 STUDY DATES 6 STUDY DIRECTOR 6 OTHER KEY PERSONNEL 6 PURPOSE/OBJECTIVE 6 TEST SUBSTANCE 7 TEST SYSTEM 7 HUSBANDRY AND ENVIRON ME NTAL CONDITIONS 7 TEST PROCEDURES AND CONDITIONS 

### 8 RESULTS 9 DATA ANALYSIS 10 DISCUSSION AND INTERPRETATION 10 CONCLUSION 10 DATA STORAGE 10 

### SIGNATURE PAGE 11



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### p . 75 265283 X TX-91-22 Page 5 of 11
STUDY TITL E 1,1,2, 3- 1H-BEFZ ( E) INDOLID!! 4-p iBTgYI .BEHZHRBSIILFOHATE ACUTE DERMAL IBYITATIOr STUDY I N THE R ABBI T HABI . NUMBER : 90 -0 105 nA : 924758

ABSTRACT
A dermal irritation study was conducted with 1,1,2,3-tetramethyl-lHbenz(e)indolium 4-methylbenzenesulfonate by administering single doses of 0 .5 gram of the test material to rabbits topically for four hours . Slight yellow staining at the application site was evident on all anima l s at the one-hour examinations . The staining persisted to termination of the study . No other abnormal clinical signs or signs of irritation were observed at any time during the study . All animals survived the 14-day observation period, and all gained weight normally . Based on weight gain and survival rate, no signs of percutaneous absorption were evident . The test material was classified as not irritating to skin, as defined in the 5th Adaptation on the EC Classification, Packaging, and Labelling of Dangerous Substances .



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### p . 76

265283 X TX-91-22 Page 6 of 11
PERFORMING LABORATOR Y Toxicological Sciences Laborato ry Health and Environment Laboratories Eastman Kodak Company 1100 Ridgeway Avenue B-320 Kodak Par k 

### Rochester, New York 14652-3615 US A
SPONSOR Eastman Kodak Company
STUDY DATE S Study Initiation : July 31, 1990 Experiment Initiation : July 31, 1990 Experiment Completion : August 14, 1990 Study Completion : Februa ry 1, 1991
STUDY DIRECTO R Douglas C . Topping, Ph .D ., DABT
OTHER KEY PERSONNE L John W . Mosher, B .S ., and Chris M . Ashley, Study Technicians Kenneth P . Shepard, B .S ., Principal Investigato r 

### Gordon J . Hankinson, D .V .M ., M .S ., Laborato ry Animal Medicine PURPOSE/OBJECTIVE The purpose of the study was to determine the potential of the test compound to cause primary irritation of mammalian skin .



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### p . 77

265283 X TX-91-22 Page 7 of 11
TEST SUBSTANC E Chemical Name : 1,1,2,3-tetramethyl-lH-benz(e)indolium 4- methylbenzenesulfonate CAS Registry Number : Not availabl e 

### HAEL Laboratory Number : 90-0105 KAN : 92475 8 CIN : Not availabl e 

### SRID or Lot I .D . Number : W18451-1001 R-2 Physical State and Appearance : Violet solid Received at Performing Laboratory : July 18, 199 0 Composition : Refer to composition information included in the notification

when applicable .
TEST SYSTEM Species : Rabbit Strain : Hra :(NZW)SP F Source : Hazelton Research Animals, Denver, PA, U .S .A . No . of Animals : 3 Sex : Male and/or Femal e Body Weight Range at Dosing (g) : 3561 - 3803 Age : Young Adults (At least three months old)
HUSBANDRY AND ENVIRONMENTAL CONDITIONS Housin g All animals were individually housed in suspended stainless steel mesh cages . Environmental Condition s A photoperiod of 12 hours light from 6 a .m . to 6 p .m . was maintained . Room temperature was maintained at 69-72°F . Relative humidity was maintained at 53-57% . 

### Diet and Wate r Agway® ProlabTM High Fiber Rabbit Diet certified pellets, and water, obtained from the Monroe County ( NY) Water Authority, were available ad libitum . No known contaminants which would interfere with the outcome of the study were expected to be present in feed or water from these sources . Analyses of feed and quarterly analyses of water are maintained on file within the testing laboratory . 

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### p . 78

265283 X TX-91-22 Page 8 of 11

AUSBANDRY AND ENVIRON ME NTAL CONDITIONS CONT . Isolation Rabbits were isolated and monitored for at least five days after arrival and before release to the testing facility . 

### Animal Identification All rabbits were identified by cage numbers and uniquely numbered metal ear tags .
TEST PROCEDURES AND CONDITIONS Test Procedure Guidelin e OECD Guideline for Testing of Chemicals : Guideline 404, Dated 12 May, 1981 ; ( Annex V, test B .4) . 

### Dose Leve l 0 .5 gram of compound/animal Identification Numbers of Animals Used 521 - 52 3 

### Dosing Regim e The hair was removed from an area of the dorsal skin with an electric clipper . A single dose of the material was placed in contact with the skin using a fiber pad and an occlusive wrap to hold the test material in place for four hours . At the end of the exposure period, the test material was removed with acetone and running water . 

### Control Substanc e No control substance was used . Ad j acent areas of untreated skin of each animal served as a control for the test area . Vehicle No vehicle was used . The test material was administered as a solid moistened with water . Clinical Observation s The site of application was examined at 1, 24, 48 and 72 hours, and 7 and 14 days after removal of the occlusive patch . Observations included estimation of erythema, edema, necrosis, eschar formation, scarring, erosion, and staining caused by the material as well as general systemic effects . 

# 7g

### p . 79
265283 X TX-91-22 Page 9 of 11
TEST PROCEDURES AND CONDITIONS CONT 

### Body Weight Determination s Body weights were collected on the day of dosing and one and two weeks after dosing . 

### F ecrousv No necropsies were performed at the conclusion of the 14-day observation period .
RESULTS Clinical Observations for Erythema and Edema
ANIMAL DOSE RESPONSE ( AT SITE OF APPLICATION) 1 NUMBER (gram) 1 HR 24 HR 48 HR 72 HR 7 DAYS 14 DAYS 521 0 .5 0,0 0,0 0,0 0,0 0,0 0,0 522 0 .5 0,0 0,0 0,0 0,0 0,0 0,0 523 0 .5 0,0 0,0 0,0 0,0 0,0 0, 0 1 Graded as described in OECD Guideline 404 (Annex V test B .4) (e ry thema, edema )
Descri p tion of Serious Lesions and Irritation Other Than Erythema and Edema No irritant response or serious lesion was noted . Slight staining ( yellow) was noted at the application site on all animals at the one-hour examinations and persisted to termination of the study . 

### Toxic Effects Other Than Irritatio n No toxic effects were noted during the study . Weight Gai n All animals gained weight normally during the study . Individual Body Weight s

ANIMAL INDIVIDUAL BODY WEIGHTS ( Q) WEIGHT NUMBER DAY 0 DAY 7 DAY 14 GAIN 521 3803 389 3966 +163 522 3573 36 5 3815 242 523 3561 36 72 3788 +22 7



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### p . 80

265283 X TX-91-22 Page 10 of 11
DATA ANALYSI S Not applicabl e


### DISCUSSION AND INTERPRETATION A dose of 0 .5 gram was applied to the skin after the hair was removed with an electric clipper . An occlusive wrap was used to hold the test material against the skin for a period of four hours . No irritant response was seen at any time during the study . Slight staining (yellow) was noted at the application site on all animals one hour after termination of exposure . Staining persisted to the Day 14 examinations . All animals survived to termination of the 14-day observation period, and all gained weight normally . Based on weight gain and survival rate, no signs of percutaneous absorption were evident .
CONCLUSION The test material was classified as not irritating to skin, as defined in the 5th Adaptation on the EC Classification, Packaging, and Labelling of Dangerous Substances .
DATA STORAG E All test results presented in this report are supported by raw data which are maintained in the archives of the Health and Environment Laboratories, Eastman Kodak Company .

### p . 81

265283 X TX-91-22 Page 11 of 11
SIGNATURE PAGE


# V q

# k Principal Investigator Dat e 

### Report Autho r

Director Mammali Toxicology Section Date Study Directo r

Di ctor, Toxicoloii ✓ 1 Sciences Laboratory Dat e



# V~

### p . 82

PHYSICAL / CHEMICAL DAT A 

## Testing Laboratories : Analytical Technology Division, Chemicals Quality Services Division, & Health and Environment Laboratories Eastman Kodak Compan y Rochester, New York 14652 Chemical Name : 1H-Benz(e)indolium, 1,1,2,3-tetramethyl-, salt with 4-methylbenzenesulfonic acid (l :1) Physical state : Purple Solid
Data : Purity 98-103 area percent Results for sample 1-320671 Pages 83-84 UV-Vis Spectrum Page 8 5 LC/MS Data and Spectra Pages 86-88 Proton NMR Spectra Pages 89-93 IlZ Spectrum Page 94 Chemicals Safety Data Sheet Pages 95-100 DTA Screen Page 10 1



# 82

### p . 83



# Results for Sample 1-32067 1 Originator ' PEDREIRA VICTOR 

## P Batch 

## Name ' ACH34844 

## Charge# : 456 

## CIN/KAN : 10018451 

## Sample 

## Point : RN 

## PRODUCT : 10018451RN 

## Group : SCD 

## GRADE-CODE PROD-SPEC 

## Test Schedule : 10018451RN 

## Category : NORMAL 

## Notebook#/Sample 

## Name : Mikon Customer : PEDREIRA_V 

## Test Stat Analysis T Result Units Min Max

Component Nam e A CASSA05774/1 ~ Test Histor y SCD18451 N 100 .6 w/w% 97 105 Lambda Max N 262 nm Absorptivity at Lambda Max N 94 .91 L/g c m Comp Dev N 0 .0058 CASS Record Number N 332848 CASS Method N 5774 Syringe # T 608 9 A ICPSALOW /1 ( Test Histor y 

## aluminum N <2 .0 ug/g 10 antimony N <2 .0 ug/g boron N <0 .5 ug/g cadmium N <0 .2 ug/g 3 calcium N <2 .0 ug/g 30 chromium N 0 .61 ug/g 3 cobalt N <0 .3 ug/g copper N <0 .3 ug/g 3 iron N 0 .57 ug/g 15 lead N <3 .0 ug/g 5 magnesium N 0 .20 ug/g 15 manganese N <0 .05 ug/g 3 molybdenum N <3 .0 ug/g nickel N <0 .5 ug/g 3 potassium N <12 ug/g silicon N <1 .0 ug/g 35 sodium N 11 ug/g tin N <2 .0 ug/g 3 titanium N <0 .5 ug/g zinc N 0 .59 ug/g 10 FileId T A1030502 .tx t A MISSAAPP /1 ~ Test Histor y 

# 93

## p . 84

color T viole t form T soli d A NMRSAH1 /1 I Test History NMR RESULT 0 Consistent with structure NMR B Ye s A MASS-SPEC /1 1 Report Manager I Test History Report Word Document A Report Word Document Specifications displayed are the current specifications in WIMS-db .

ResultsSpecsForSample .CFM on WIMS was accessed on 08i13/2002 at 2 :22 PM by 1583606 . Eastman Kodak Company - Internal Use Only



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