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

PREMANUFACTURE

NOTICE ( 7

FOR NEW CHEMICAL SUBSTANCE S

When DOCUMENT CONTROL OFFICER

completed OFFICE OF POLLUTION PREVENTION

scnd this AND TOXIC SUBSTANCES, 7407

forin to U.S. E.P.A. 401 M STREET, SW

ddMW_WASHINGTON, D.C.

tE

nter the total nttmber of page

PremanufactureNotice • s in the •

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 descri 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

in support of your submission should refe rence your TS user fee iden . A letter manufacture, processing, distribution in commerce, use, or disposal of the ne w tifi cati on number

You must submit an original and two copies of this notice including a . chemical substance. Stand ard literature citations may be submitted for data in the ll test data

claimed any informati on as confidential, a single sanitized copy must also be submitted . If you open scientific literature . Complete test data (written in Engli~hi not summaries . 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).

PartID- LIST OF ATTACHMENTS Test Data (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 assessments

• 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 ribed • A physical and chemical properti 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,

producti on volume, protecti ve equipment . . . This option is intended to reduce delays that

PMN (Premanufacture Notice) rV

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

Except in the case of exempti on applications (~" 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 tice) 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,

To asse

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) rt 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 pre 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 SignatureR 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 INFORMATION

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 Position

Submitting Manager, Kodak Park Site Vice President,

Notice (in U.S .) Mr. Charles C. Barrentine Eastman Kodak Company

Company

Eastman Kodak Comqanv

Mailing address (number and street)

1669 Lake Avenue

City, State, ZIP Code

Rochester, New York 14652

b . Agent (if Name of authorized official Position

applicable)

Company

Mailing address (number and street)

City, State, ZIP Code Telephone Area Code Number

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 Number

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-.77-0328 O El

number assigned by EPA (i .e . withdrawn or incomplete). if none

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 none

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 definitions 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 listings 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 21

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 +

❑ Mark (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 applicable

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

Not applicable

❑ 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 . Impurities

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

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

(b) - Estimate the maximum wei ght % of each impurity % . . If there are unidentified impurities, estimate their total weigh t

Impurity and CAS Registry Number Maximum Confipercent dential

Unknown 2%

(a) (b)

%

%

%

%

%

%

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

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

None

❑ 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 .

None

❑ 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 -- Continued

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

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

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

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

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

10,000 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 11,000

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 generi c use descri ptions.

description 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 15-20

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 furt her industrial processing or use o erations after import. You must describe 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/yr

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 equipment

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

equipment -100% .1 30

® Mark (X) this box if you attach a continuation sheet . See pages 15-20

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 Binding

(3) (4) (5a) ~ Mark(X) (5b) (6)

1 None < 1 incineration Incineration (>99

kg/batch container .99% DRE) None

2 one <0 N .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 37

EPA FORM 7710-25 (Rev . 5-95) Page 9
P. 10

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

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 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 ribe 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 code

Rochester, Monroe, New York 14652

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, and if an y 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) 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 sta 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

%

® Mark (X) this box if you attach a continuation sheet . See pages 15-20

r i -1

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) .

Number released releas

Release Amount of new substance CBI Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CB1

e

(1) (2a) (2b) 8m. k

(4) Binding

(3) (5a) I Mark (x) (Sb) (6)

1 None <0.1 incineration container Incineration (>99 .99% DRE) ' None

kg/batch

(7) Mark (X) the

❑ POTW provide name(s) below : CBI ❑

Navigable ❑ Other - Specify provide NPDES # CBI

destination(s) of waterwa

y

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 OTHERS

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

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

section B for each type 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 Release

(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 substance

(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 and test data and other data ( including physical/chemical properties and

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

which it relates, if 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 any information in an attachment as confidential . You must include with the sanitized copy of the notice form a sanitized

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

Attachment name Attachment Confia~e number(s) dential

Material Safety Data Sheet (MSDS) 15-20

CAS Invento ry Expert 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 IDENTIFICATION

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 DATA

~ 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 MEASURES

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 center

~ immediately .

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

5 . FIRE FIGHTING MEASURES

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 . JtP
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

shower

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

9 . PHYSICAL AND CHEMICAL PROPERTIE S

Physical Form : Solid

Color : Purple

Odor : Not available

Specific Gravity (water = 1) : Not available

Vapor Pressure : Not available

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 agents

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 : none

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

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 : None

- Material(s) known to the State of California to cause adverse reproductive

effects : None

- Carcinogenicity Classification (components present at 0 .1% or more) :

- International Agency for Research on Cancer (IARC) : None

- American Conference of Governmental Industrial Hygienists (ACGIH) : None

- National Toxicology Program (NTP) : None

- 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 : None

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

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. 21

(fl3 Inventory Expert Service

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 NAME

=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

P2-2002-05

Page 1 of 15

AMENDED FINAL REPORT

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 EFFECTS

AUTHORS

Rodney J. Boatman, Ph .D.

Mari anne P. Hirsch, Ph .D.

TESTING FACILITY

Toxicological Sciences

Health and Environment Laboratories

Eastman Kodak Company

Rochester, NY 14652-6278

USA

STUDY SPONSOR

Eastman Kodak Company

STUDY COMPLETION DAT E

February 25, 200 2

AMENDED STUDY COMPLETION DATE

December 4, 2002

a,3
p. 24

P2-2002-05

Page 2 of 15

GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT

This page has intentionally been left incomplete .
p. 25

P2-2002-05

Page 3 of 15

SIGNATURE PAGE

STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRON MENTAL

FATE AND EFFECTS

a 30 ~

Mari e P. Hirsch, Ph .D. Month/Day/Year

Author and Sr . Toxicologist

Ecotoxicology

K J. 1 2 y102

Rodney J. Bo tman, Ph .D. Month/Day/Year

Author and Technical Associate

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 METHODS 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

P2-2002-05

Page 5 of 15

CHEMICAL IDENTIFICATION INFORMATION

Testing Facility

Toxicological Sciences

Health and Environment Laboratories

Eastman Kodak Company

Rochester, New York 14652

US A

Project Participants

Report Authors: RodneyJ. Boatman, Ph .D.

Marianne P. Hirsch, Ph.D .

Sponsor

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 acid

HAEL No.

: 2002-0030

KAN: 924758-6

Molecular Formula: C16 H18 N1. C7 H7 03 S1

Molecular Weight: 395.52

CAS No.: 141914-99-0

CIN : 10018451

SMILES (cation only): CC1(C)c2c3c(ccc2N=C1C)cccc3

Chemical Classification (ECOSAR): "Neutral Organics "

~7
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STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL

FATE AND EFFECTS

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.
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STRUCTURE-ACTIVITY ESTIMATIONS OF HEALTH AND ENVIRONMENTAL

FATE AND EFFECTS

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.
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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 Report

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 .

35
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Page 9 of 15

REFERENCES

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.

3~
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Appendix 1. Output from the EPI Computer Program [1], cation onl y

SMILES : CC1(C)c2c3c(ccc2N(C)=C1C)cccc3

CHEM

MOL FOR : C16 H18 Ni

MOL WT : 224 .33

------------------------------ 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+004

log Kow used : -0 .10 (estimated)

no-melting pt equation used

ECOSAR Class Program (ECOSAR vO .99g) :

Class(es) found :

Neutral Organics

Henrys Law Constant (25 deg C) [HENRYWIN v3 .10] :

Bond Method : 1 .55E-011 atm-m3/mol e

Group Method : Incomplete

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 .1541

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 Hrs

Ozone Reaction :

No Ozone Reaction Estimation

Soil Adsorption Coefficient (PCKOCWIN v1 .66) :

Koc : 7 .835E+00 4

Log Koc : 4 .894

Aqueous Base/Acid-Catalyzed Hydrolysis (25 deg C) [HYDROWIN v1 .67] :

Rate constants can NOT be estimated for this structure !

3Z
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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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Appendix 2. Output from the ECOSAR Computer Program [1], cation onl y

SMILES : CC1(C)c2c3c(ccc2N(C)=C1C)cccc3

CHEM

CAS Num:

ChemIDi :

ChemID2 :

ChemID3 :

MOL FOR : C16 H18 Ni

MOL WT : 224 .33

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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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 WATER

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
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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 1.40

. . .

ADC.(mg/L-) N/A ; 30:00 30.00 NA NA

Acute

ADR (mg/kg/day) N/A 1.00 day 1 .00 day 71.80 6.00

FISH INGESTION EXPOSURE ESTIMATES

ASSUNIPTIONS

Exposure Units Results ED AT,

. BW IR

(years) -~ ~ (years)- _ (kg) (g/day)

Cancer

- LADD~ t (mg/kg/day) 4.77E-10 30.00 75.00 71.80 6.00

LADCP,, (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

ADCP,, (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

3C~
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SITE-SPECIFIC AQUATIC EXPOSURES TO SURFACE WATER RELEASES

FACILITY NAME: EASTMAN KODAK Company

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: `

Release_ Days/yr Loading Waste Water

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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p. 38

HEALTH EFFECTS DATA

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 TITLE

1,1,2, 3-TETBAMETfiYL-1H-BKwZ(B)IADOLIUlI 4-M THYLBSNZffiIRSULpORATE

ACUTE ORAL TOXICITY STUDY IN THE RAT

HASI. NUMBER : 90-0105 1AN: 924758

FINAL REPORT

AUTHOR

Kenneth P . Shepard, B .S .

PERFORMING LABORATORY

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 SPONSOR

Eastman Kodak Company

STUDY COMPLETION DATE

February 11, 1991

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Q .A . INSPECTION STATEMENT

(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 METHODS 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 SUBMISSION

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 01/29/91

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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(,

Study Director

. Topping4 h .D . Date

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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 LABORATORY

Toxicological Sciences Laboratory

Health and Environment Laboratories (HAEL)

Eastman Kodak Company

1100 Ridgeway Avenue

B-320 Kodak Park

Rochester, New York 14652-3615

USA

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 PERSONNEL

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 SUBSTANCE

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 ENVIRONMENTAL CONDITIONS

Housing

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 Identification

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 Levels

156, 312, 625, 1250, and 5000 mg compound/kg body weight

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 Regime

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

None

Vehicle

The vehicle was distilled water .

Clinical Observations

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

47
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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 5M

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 1M

1250 Moderate to Severe Weakness 5M,5F

Tremors 5M,5F

Convulsions 5M,5F

Vasodilatation 1M,4F

Piloerection 1M,4F

Death 5M,5F

5000 Severe Weakness SM,5F

Tremors 5M,5F

Convulsions 5M,5F

Death 5M,5F

49
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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 21 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 14

351 228

352 190 241 317

312 353 225 361

354 199

355 202

6 200

357 191

625 358 20 2

59 195 253 319

360 222

361 226

362 195

1250 363 203

364 202 ---

365 205

251 213 ---

252 207

-- j

.

5000 253 217

254 20

255 1 8

LO

7
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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 14

366 182 214 24

367 163 204 218

312 368 181 220 245

369 181 240 268

370 170 229 254

37 1

372 182

625 373 184

74 171

375 167

376 162

377 172

1250 378 173

379 166

380 184

256 173

257 177

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/kg

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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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 males

~~
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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 than

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 STORAGE

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-
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REFERENCES

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
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SIGNATURE PAGE

3t . 144 j

Principal Investigator Date

Report Autho r

~ :3~-rl

Dire 9 r, Mamma n Toxicology Section Date

Study Directo r

Di ct , Toxicologi a Sciences Laboratory Date

54
p. 55

Study No . 90-0105

Acc . No . 924758

PATHOLOGY REPORT

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 were

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 . 90-0105

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 924758

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 . GLANDULAR

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

I r

Y

REVIEWED BY : DATE:~~,- j c ACCEPTED BY DATE: ~~

57
p. 58

SUI.bIARY GROSS PATHOLOGY INCIDENCE TABLE

EXPERIMENT f

900105A0 COMPOUND { 90-0105

SOFTWARE VERS ~ 3 .0

ACCESSION NUMBER 924758

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 FACE

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 924758

156 .000 MG/KG GROUP - M

ANIMAL /

421 422 423 424 425

DAYS ON TEST 13 13 13 13 13

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- MINIMAL,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 924758

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 FACE

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

AUTOLYSIS 3 3

. NO S

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 924758

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

STOMACH, NON-GLANDULA

HEM ORRHAGE 1

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 GLAND 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 REGION

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 COLLECTED

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 924758

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 . GLANDULAR

NECROSIS, DIFFUSE 2 2 2 2 2

STOMACH, NON-GLANDULAR

DISCOLORATION,BLUE 2 1 1

DUODENUM X X X X X

JEJUNUM X X X X

INTESTINAL CONTENTS

INTESTINAL CONTENTS-WATERY

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 GL ANDS 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 251 252 253 254 255

DAYS ON TEST e 0 0 0 0

TRACHEA. X X X X X

LUNGS x x x x x

THYMUS X X

HEMORRHAGE 1 1

X

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 CONTENTS

INTESTINAL CONTENTS-WATERY 2 2 2 2

JEJUNUM X

INTESTINAL CONTENT S

INTESTINAL CONTENTS-WATERY 2 2 2 2

ILEUM X X X

INTESTINAL CONTENTS

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 924758

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

E : ~~ ACCEPTED BY,~}. l- DATE : w C/ 31c REVIEWED BY :

41112-)

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

HEMORRHAGE 0 0 1 0 0

DISCOLORATION, NOS 0 0 e 0 5

DUODENUM 0 5 5 5 5

MUCOSA

NECROSIS . DIFFUSE 0 0 0 2 0

INTESTINAL CONTENTS

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 CONTENTS

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 924758

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 REGION

DISCOLORATION,YELLOW 0 0 5 2 0

DISCOLORATION, NOS

HAIR OF FACE

e 0 e 1 0

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

HYDROMETRA 0 1 0 0 05

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 924758

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 COLLECTED

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 924758

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

STOMACH

STOMACH CONTENTS-TEST ARTICLE PRESENT P P P P P

STOMACH, NON-GLANDULAR

DISCOLORATION,BLUE 3 2

STOMACH . GLANDULAR

NECROSIS

HEMORRHAGE 1

. DIFFUSE 2 2 2

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

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-MINIMAL,2-MINOR . 3-WDERATE,4-SEVERE P-PRESENT,A-ABSENT, .-$~E COMMENT REPORT ( FORM f2) . X-NORMAL BUT OT COLLECTED

REVIEWED BY : DATE : . . 3 C ACCEPTED BY~~.!~~1A~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 924758

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 COLLECTED

REVIEWED BY : ~ ✓ ~~~ DATE : ,C 376 ACCEPTED BY~ti.•~~^ ~`,Ilmi. LC. DATE : ( ~/w~ `, t lL

'7 o
p. 71

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Page 1 of 11

STUDY TITLE

1,1,2,3- 1H-BENZ(B)INDOLIm 4-mrTHYLBF.PZSI I' SIILFORATE

ACQTE DERMAL IRRITATION STUDY IN THE IPAR IT

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

FINAL REPORT

AUTHOR

Kenneth P . Shepard, B .S .

PERFORMING LABORATORY

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 SPONSOR

Eastman Kodak Company

STUDY COMPLETION DATE

February 1, 1991

rh
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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 1PUMffiER : 92475 8

STUDY TYPE : ACUTE DERMAL IRRITATION TEST

~✓. .ya ~ ~ Q•~r~~ ~9 ~9 /

(AUDITOR, Q ALITY ASS CE UNIT) DATE

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

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 DATES

07/31/90 PROTOCOL APPENDIX SUBMISSION

08/02/90 CLINICAL SIGNS AT 48 ERS . 08/02/90

01/29/91 FINAL REPORT REVIEW 01/29/9 1

17Z
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COMPLIANCE WITH GOOD LABORATORY PRACTICE STANDARDS

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

Study Director

C . Topping . D . Date

73
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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 10

DISCUSSION AND INTERPRETATION 10

CONCLUSION 10

DATA STORAGE 10

SIGNATURE PAGE 11

7~
p. 75

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STUDY TITLE

1,1,2,3- 1H-BEFZ(E) INDOLID!! 4-piBTgYI.BEHZHRBSIILFOHATE

ACUTE DERMAL IBYITATIOr STUDY IN THE RABBIT

HABI. NUMBER : 90-0105 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 animal 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 .

75
p. 76

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Page 6 of 11

PERFORMING LABORATORY

Toxicological Sciences Laborato ry

Health and Environment Laboratories

Eastman Kodak Company

1100 Ridgeway Avenue

B-320 Kodak Park

Rochester, New York 14652-3615

USA

SPONSOR

Eastman Kodak Company

STUDY DATE S

Study Initiation : July 31, 1990

Experiment Initiation : July 31, 1990

Experiment Completion : August 14, 1990

Study Completion : February 1, 1991

STUDY DIRECTOR

Douglas C . Topping, Ph .D ., DABT

OTHER KEY PERSONNEL

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 ., Laboratory 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 .

7(o
p. 77

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Page 7 of 11

TEST SUBSTANCE

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, 1990

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

Housing

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 Water

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 .

77
p. 78

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Page 8 of 11

AUSBANDRY AND ENVIRON MENTAL 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 . Adj 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

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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 .

Fecrousv

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 ption 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 Gain

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 3672 3788 +227

79
p. 80

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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 STORAGE

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

265283X

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Page 11 of 11

SIGNATURE PAGE

Vqk Principal Investigator Date

Report Autho r

Director Mammali Toxicology Section Date

Study Director

Di ctor, Toxicoloii✓ 1 Sciences Laboratory Dat e

V~
p. 82

PHYSICAL / CHEMICAL DATA

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 85

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 101

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 History

SCD18451 N 100.6 w/w% 97 105

Lambda Max N 262 nm

Absorptivity at Lambda Max N 94 .91 L/g cm

Comp Dev N 0.0058

CASS Record Number N 332848

CASS Method N 5774

Syringe # T 6089

A ICPSALOW /1 ( Test History

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 History

93
p. 84

color T violet

form T solid

A NMRSAH1 /1 I Test History

NMR RESULT 0 Consistent with structure

NMR B Yes

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

84
p. 85

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