Form Approved . O.M.B. No . 2070-0012 . Ap roval Expires 10-31-96.

U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY

Date of receipt

PREMANUFACTURE

NOTICE .EPA wn#

ES

! ~~Ilil~~ lilli ~~iiii III'~~ I'il'~~i III~~~, II'~' ►~ 11~~',~,li~~l~~~~~~~ ~~'~~~ 1 ~~~' ~~i ~ 1W1oan~ ~~~~~e(i

in the Premanufacture Notice 50 12~f r

•

GENERAL INSTRUCTIONS 'j

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

not have actual data .

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

Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603) .

• 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 1 525 1-6399, Attn . TSCA User fee .

Part 1- GENERAL INFORMATION TEST DATA AND OTHER DATA

You must provide the currently correct Chemical Abstracts (CA) Name of the new You are required to submit all test data in your possession or control and to provide a

chemical substance, even if you claim the identity as confidential . You may authorize description of all other data known to or reasonably ascertainable by you, if these data are

another person to submit chemical identity information for you, but your submission will related to the health and environmental effects on the manufacture, processing, distribution

not be complete and the review will not begin until EPA receives this information . A in commerce, use, or disposal of the new chemical substance . Standard literature citations letter in support of your submission should reference your TS user fee identification may be submitted for data in the open scientific literature

number . Complete test data (written in . You must submit an original and two copies of this notice including all test data.

If you claimed any information as confidential, a single sanitized copy must also be English), not summaries of data, must be submitted if they do not appear in the ooen

submitted .

literature . You should clearly identify whether test data is on the substance or on an

analog . Also, the chemical composition of the tested material should be characterized .

Following are examples of test data and other data . Data should be submitted according t o

Part Il - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE the requirements of §720 .50 of the Premanufacture Notification Rule (40 CFR Part 720) .

If there are several manufacture, processing, or use operations to be described in Part 11 ,

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

Part III - LIST OF ATTACHMENTS Test Data (Check Below any included in this notice )

Attach additional sheets if there is not enough space to answer a question fully . Label • Environmental fate data ❑ Yes • Other data ❑ Yes

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

attachments, any test data or other data and any optional information included in the • Health effects data ❑ Yes Risk assessments

notice.

Environmental effects data ❑ Yes Structure/activity relationships

• Physical/Chemical Properties* ❑ Yes Test data not in the possession

OPTIONAL INFORMATION or control of the submitter

You may include any information that you want EPA to consider in evaluating the new ' A physical and chemical properties worksheet is located on the last page of this form.

substance. On page 11 of this form, space has been provided for you to described

pollution prevention and recycling information you may have regarding the new TYPE OF NOTICE (Check Only One)

substance .

So-called "binding" boxes are included throughout this form for you to indicate your ❑ PMN (Premanufacture Notice)

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

production volume, protective equipment . . . This option is intended to reduce delays ❑ INTERMEDIATE PMN (submitted in sequence with final product PMN)

that routinely accompany the development of consent orders or Significant New Us e

Rules. Except in the case of exemption applications (such as TMEA, LVE, LOREX )

where certain information provided in such notification is binding on the submitter when ❑ SNUN (Significant New Use Notice)

the Agency approves the exemption application, checking a binding box in this notic e

does not by itself prohibit the submitter from later deviating from the information (except ❑ TMEA (Test Marketing Exemption Application)

chemical identity) reported in the form .

❑ LVE (Low Volume Exemption) (r~ 40 CFR 723 .50(c)(1) CZ

CONFIDENTIALITY CLAIMS c:u

c..s

You may claim any information in this notice as confidential ❑ LOREX (Low Release/Low Exposure Exemption) @ 40 CFR 7~(c)(2) . To assert a claim on th e

form, mark (X) the confidential box next to the information that you claim as {~ ...,

confidential . To assert a claim in an attachment, circle or bracket the information you ❑ LVE Modification ❑ LOREX Modification 4L I - claim as confidential . Ifyouu claim information in the notices as confidential, you must 0

also Provide a sanitized version of the notice, (includine attachments)

For additional IS THIS A CONSOLIDATED PMN' ❑ Yes instructions on claiming information as confidential, read the Instructions Manual

# of chemical s

Mark (x) if any information in this notice is claimed as confidential (Prenotice Communication k required, enter # on page 3) ••

d

EPA FORM 7710-25 (Rev . 5-95) Page 1 Replaces previous editions of EPA Form 7710-25_

;~7~~~ 4
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), or

❑ 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), o r

❑ 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 reflect your best prediction of the anticipated facts regarding the chemical substanc e

described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 USC 1001 . Confidential

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

X

Signature of agent - (if applicable) Date

X

EPA FORM 7710-25 (Rev . 5-95) Page 2
Part I -- GENERAL INFORMATION

Section A -- SUBMITTER IDENTIFICATION ConfiMark (X) the -Confidential" box next to any subsection you claim as confidential dential

1 a . Person Name of authorized official Positio

Submitting X

n

Notice (in U.S.)

Company

Mailing address (number and street)

City, State, ZIP Code

b . Agent (if Name of authorized official Position

applicable)

X

Compan y

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 Position

applicable)

X

Compan y

Mailing address ( number and street)

City, State, ZIP Code Telephone Area Code Number

2 . Technical Name of authorized official Position

Contact (in

U .S) X

Compan y

Mailing address ( number and street )

City, State,ZIP Code Telephone Area Code Number

3 . If you have had a prenotice communication (PC) concerning this notic e

and EPA assigned a PC Number to the notice, enter the number . Mark (X) --► ❑ X

if non e

4 . If you previously submi tt ed an exemption application for the chemica l

substance covered by this notice, enter the exemption number assigned by Mark (X) ~-► ❑ X EPA . If you previously submitted a PMN for this substance enter the if non

PMN number e assigned by EPA (i .e . withdrawn or incomplete). 10

5 . If you have submitted a notice of Bona fide intent to manufacture or import

for the

assigned by EPA

chemical substance

.

covered by this notice, enter the notice number Mark (X) --♦ ❑

if none

X

6

1 . ❑ Manufacture 2. ❑ Import 3. ❑ Bot h . Type of Notice - Mark (X) Only Onl

y

❑ Binding Option ❑ Binding Option

Mark (X) Mark (X)

EPA FORM 7710-25 (Rev . 5-95) Page 3
p. 4

Part I -- GENERAL INFORMATION -- Continue d

Section B -- CHEMICAL IDENTITY INFORMATION : You must provide a currently correct Chemical Abstracts (CA) name ot'the substance based on

the ninth Collective Index (9C1) of CA nomenclature rules and conventions .

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

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

I . Class I or 2 chemical substances (for definitions of class I and class 2 substances, see the Instructions Manual )

a

b

. Class of substance - Mark (X) I ❑ Class I or 2 ❑ Class 2 X

. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances .

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

be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions) .

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

❑ Method I (CAS Inventory Expert Service - a copy of the Identification ❑ Method 2 (Other Source)

report obtained from the CAS Inventory Expert Services must b e

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

submitt ed as an a ttachment to this notice)

E

X

CAS#

X

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

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

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

diagram- as comnlete as can he known . if one can he reasonablv ascertained .

❑ Mark (X) th is 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 X

below 1,000 absolute molecular weight of that composition .

Describe the methods of measurement or the basis for your estimates: GPC ❑ Other ❑: (Specify)

i) lowest number average molecular weight:

ii) maximum weight % below 500 molecular weight:

iii) maximum weight % below 1000 molecular weight:

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

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

"Confidential" box next to any item you claim as confidentia l

(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 ent ry in column ( 1) is confi dential .

(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 Invento ry.

(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

(1) (2) (3) (4) (5) (6) (7

X X X

)

X X X

X X X

X X X

X X X

X X X

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

X X X

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

❑ Method 1(CAS Inventory Expert Se rv ice - a copy of the identification report ❑ Method 2 (other source )

obtained from CAS Inventory Expert Serv ice 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. X

e . Provide a correct representative or pa rtial chemical structure diagram, as complete as can be known, if one can be reasonably asce rt ained . X

❑ Mark (X) this box if you attach a continuation shee t

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

Section B -- CHEMICAL IDENTITY INFORMATION -- Continue d

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 we i ght % of each impurity . If there are unidentifi ed impurities, estimate their total weight % .

Impurity and CAS Registry Number Maximum Confi-

(a) (b)

percent dential

X

X

X

X

X

X

X

❑ 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 . Confidentia l

X

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

5 . Trade identification - List trade names for the new chemical substance identified in subsection I or 2 .

X

❑ 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 .

Modified amidoamine

❑ 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

X

X

X

X

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

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

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

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

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

consecutive 12-month period during the first three years of production . Estimates should be on 100% new chemical substance basis. For a Low Volume Exemption

application, if you choose to have your notice reviewed at a lower production volume than 10,000 kg/yr, specify the volume and mark (x) in the binding box . If

granted, you are bound to this volum e

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

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

Mark (x)

X

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

category, the formulation of the new substance, and other use information . Mark (X) the "Confidential" Box next to any item you claim as confidential .

a. (1) -- Describe each intended category of use 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 entry(ies) in column (8) is (are) confidential business information (CBI) .

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

CBI Option tion % CBI Form- CBI (8) CBI

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

for finishing polyester fi bers) (2) (3) (4) (5) (6) (7) limited sumer t

X X X X

ri al mercial Option (9)

X X X X

X X X X

X X X X

X X X X

X X X X

X X X X

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

Instructions Manual for examples of generic use descriptions.

description

Surfactant for various hard su rface cleaners.

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

3 . Hazard Information - Include in the notice a copy of reasonable facsimile of any hazard warning statement, label, material safety data sheet, or other Binding

information which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices Option

for the safe handing, transport, use, or disposal of the new substance . List in part III hazard information you include . Mark (x)

❑ Mark (X) this box if you attach hazard information .

EPA FORM 7710-25 (Rev . 5-95) Page 7
Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE P- 8

Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) the -Confidential" box next to any item you

claim as confidential

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

not have to complete this section for operations outside the U .S . ; however, you may still have reporting requirements if there are further industrial processing or

use operations after impo rt . You must describe these operations . See instructions manua l

I . Operation description Confia . Identitv -- Enter the identity of the site at which the operation will occur . dential

Name

X

Site address (number and street)

City, County, State . ZIP code

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

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

production rates or operations. include all the information requested in this section for thos e

sites as attachments.

1:1 Mark (X) this box if you attach a continuation sheet .

b . Type --

Mark (X) DManufacturing Processing Ouse X

c. Amount and Duration -- Complete I or 2 as appropriat e

Maximum kg/batch (100% new Hours/batch Batches/year

chemical substance) X

I . Batch

Maximum kg/day ( iooi new enernicai Hours/day Days/year

substance) y

2 . Continuous /~

d . Process description

(1) Diagram the major unit operation steps and chemical conversions

F~ Mark (X) to indicate your willingness to have your process description binding

. Include interim storage and transport containers (specify- e

. X

.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 .

D Mark (X) this box if you attach a continuation shee t

EPA FORM 7710-25 (Rev. 5-95) Page 8
Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Contin ed

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 contidential .

(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 (1 1) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year .

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

Physica l

Worker activity CBI Protective Equipment/ Binding forms (s) Binding CBI # of CBI Maximum Duration CBI

(i .e ., bag dumping, filling drums) Engineering Controls Option and % new Option Workers Hrs/day Days/y r

Mark (x) substance Mark (x) Expose d

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12

X X X X

)

X X X X

X X X X

❑

X X X X

X X X X

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

3 . Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount 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 11, section A, subsection I d(3).

(2) --Estimate the amount ofthe 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 (Publicly Owned Treatment Works) . Mark (X) if the POTW name or NPDES # is confidential business information (CBI) .

Release Amount of new substance Media of release

Number released CBI e.g . stack air Control technology and efficiency (you may wish to optionally attach efficiency data) CBI

(1) (2a) (2b) (3) (4) (5a) Binding (5b) (6)

X X

Mark (X)

X X

X X

X X

X X

(7) Mark (X) the ❑ POTW provide name(s) below : CBI ❑ Navigable ❑ Other - provide NPDES # CBI

destination (s) of releases X waterway Specify X

to wate r

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

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

~R r•I~i=t ~

04 F EB /2!-, P 11 G: 0 1

PUBLIC NOTICE

January 22, 2004 COPY-~.

US Environmenta l Protection Agency

EPA East Buildin g

1201 Constitution Ave, NW

Washington, DC 20004-330 2

ATTN: Confidential Business Information Center (CBIC), Room 6428

RE: Premanufacture Notification P04-13 9

Dear Sir or Madam :

In response to my conversation with Jeff Bauer of your office, enclosed please find an

amendment to page 10 of the above-referenced Premanufacture Notice . This amendment

more accurately reflects the use of this new chemical .

Should you have any questions, or require any further information, please call [

] . Thank you.

Very truly yours,

Manager, Product Safety

I ]

Ref: 04-0005L .doc

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0 0 0 2

11111 2~~ ll Jill P 1111111 IIl

!~MeN-~~" 0y - ( 3~1
P. 11 II

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Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continue d

Section B - INDUSTRIAL STTFS CONTROLLED BY OTHER S

Complete section for typical prooeseing or uqe operationsinvolving the new ohemicil substutoe at sites you do not omtrol.Imporbets do not have to

complete this section for opa~ltaasoWaide the U.S.; however, you must rnport any processing or use activities after impart See the Instructions

Manual. Complete a sq ~tY eation B for each type of prooasirtg, or use apnrtimt bnio(nbtg the new didrtiaai substance. If the same operation is

at more than one site describe the typical operation common to these sates. Identify additional sites on a continuation sheet.

Operation Description - To claim information in this section as confidential, cirde or bracket the sped 8c Information that you cladm as confidential

(1) - Diagram the major unit operation eteps and chemical conversions, Including interim storage and transport containers (specify- e .g. 5 gallon pi d%

55gaBon drma, rail can, tankttucb, etc). On the diagram, identity 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 feedstociu Gnduding reactants,

solvents and catalysle, etc) and of an products, recycle streams, andwastes. Include cleaning chemicals (note frequency if not used dally or per

batch). (3) - Identify by number the points of rderse, including small or intermittent releases,to the environment of the new chemical eu6stanoe.

(4) Please enter the # of sites ( remember to identify the locations of theme sites an a continuation sheet) :

~

~! C

copy,-

Mark ()Q this box if you attach a continuation sheet

.

2 . Warlcer I Reieas e

(1) - From the diagram abom provide the letter for each worker activity . Complete 2-8 for each worker activity described .

(2) - Estimate the number of w aicecs exposed for all ailes combined.

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

(6) -1 Describe of exposure and % newchemical substance (if in mixture), and any protective equipment and engineeringoontro)s us id

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

(9) - Prom the Process diagram above, enter the number of each release paint Complete 9-13 for each release Point identified .

(10) - Estimate the amount of the newsubstance released (a) directly to the environment or (b) into control technology to the environment

On kg/day or kg/batch).

(12) - Describe media ofrelease i.e. stack atr, fugitive air (optLaul-see Itubucarons Manual), surface water, an-aita or off-site land or incineration,

P0IW, or other (specify) and control technology, if any, that will be used to limit the release of the newsubstance to the environment

(14) - Identify byproducts, which may resuit from theoperation.

(3), (5), (8), (11). (13) and (15) - Mark 00 this column if any of the proceeding entries are confidential business information (CBq.

LMM II of CBI Duration CB Protective Equip, / in CBI Release Amount of CBI Media of Release I

of Workers Of Et%ineaingControls/ F10- Number New & Control

Act- Exposed Exposure Physical Fwm and %ulation Substance Technology

ivity newsubstance Released

I

(1 ) (2) 0) t (4b) (5) (6) (7) (8) (9)

~ i

(104) 1 lob 1 113)

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(14) - Byproducts: ~

❑ Mark (?Q this box if you attach a continuation sheet.

FORM EPA 7710-25 (Rev. 5.95) Page 10
p. 12

OPTIONAL POLLUTION PREVENTION INFORMATIO N

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 chemical

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

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

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

.

EPA FORM 7710-25 (Rev . 5-95) Page I I
p. 13

Part III -- LIST OF ATTACHMENTS

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 appropriate . Number consecutively the pages of the attachments . In the column below, enter the inclusive page

numbers of each attachment .

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

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

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

Attachment name Attachment Confipa e number(s) dential

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

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

EPA FORM 7710-25 ( Rev . 5-95) Page 12
p. 14

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEE T

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

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

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

neat substance should be provided . These measured properties should be for the neat (100% pure) chemical substance . Properties that are

measured for mixtures or formulations should be so noted (% PMN substance in _) . You are not required to submit this worksheet ;

however, EPA strongly recommends that you do so, as it will simplify review and ensure that confidential information is properly

protected . You should submit this worksheet as a supplement to your submission of test data . This worksheet is not a substitute for

submission of test da ta .

Property Mark Page Value Measured Confi-

(X) if number or dential

provided Estimate Mark (X)

(a) (b) (c) (M or E) (d)

X

Physical state of neat substance (s) (1) (g)

X

Vapor pressure

Temperature °C To

X

Density/relative density g/cm3

Solubility X

@ Temperature °C

Solvent /

X

Solubility in water Temperature °C g/L

Melting temperature °C

X

X

Boiling / sublimation tem erature torr pressure °C

Spectra

x

Dissociation constant x

X

Particle size distribution

x

Octanol / water pa rtition coefficient

x

Henry's Law constant

x

Volitalization from water

x

Volitalization from soi l

pH concentration x

Flammability x

x

Explodability

X

Adsorption / coefficient

x

Other - Specify

X

X

EPA FORM 7710-25 (Rev

. 5-95) Page 13 Replaces previous editions of EPA Form 7710-25.
p. 1 5

Material Safety Data Shee t

Date Prepared: 8/29/03 Supersedes Date: 8/15/02

1 . PRODUCT AND COMPANY DESCRIPTION

Emergency Phone Numbers :

FOR EMERGENCIES INVOLVING A SPILL, LEAK, FIRE, EXPOSURE OR ACCIDENT CONTACT_ CHEMTREC

(800-424-9300 within the United States or 703-527-3887 for international collect calls) od 'GAERS

(Communication and Emergency Response System) a .

For Product Information :

Chemical Name or Svnonvm :

2 . COMPOSITION/INFORMATION ON INGREDIENTS

Component CAS Reg Number OSHA'

Wwynr Percentage r

3 . HAZARDS IDENTIFICATION

A. EMERGENCY OVERVIEW :

Physical Appearance and Odor:

Warning Statements :

WARNING!! SEVERE SKIN IRRITANT . EYE IRRITANT .

B . POTENTIAL HEALTH EFFECTS :

14
p. 16

Acute Eye :

Irritant. Can cause redness, tearing.

Acute Skin :

Low acute dermal toxicity . Severe irritant . Can cause redness, inflammation .

Acute Inhalation :

Inhalation not likely . Mists may cause upper respiratory tract irritation .

Acute Ingestion:

Practically non-toxic .

Chronic Effects:

This product does not contain any ingredient designated by IARC, NTP, ACGIH or OSHA as probable or

suspected human carcinogens .

4. FIRST AID MEASURES

FIRST AID MEASURES FOR ACCIDENTAL :

Eye Exposure :

Hold eyelids open and flush with a steady, gentle stream of water for at least 15 minutes . Seek medical attention .

Skin Exposure :

In case of contact, immediately wash with plenty of soap and water for at least 5 minutes . Seek medical attention . Remove contaminated clothing and shoes . Clean contaminated clothing and shoes before re-use .

Inhalation :

Inhalation is not an expected route of exposure. If respiratory irritation or distress occurs remove victim to fresh

air. Seek medical attention if respiratory irritation or distress continues .

Ingestion:

If victim is conscious and alert, give 1-2 glasses of water to drink. Do not give anything by mouth to an

unconscious person . Seek medical attention . Do not leave victim unattended .

MEDICAL CONDITIONS POSSIBLY AGGRAVATED BY EXPOSURE :

Skin contact may aggravate existing skin disease .

NOTES TO PHYSICIAN :

All treatments should be based on observed signs and symptoms of distress in the patient . Consideration should

be given to the possibility that overexposure to materials other than this product may have occurred .

Treat symptomatically . No specific antidote available .

5 . FIRE FIGHTING MEASURES

FIRE HAZARD DATA :

Flash Point:

1J
p. 17

Method Used :

Closed cu p

Flammability Limits (vol/vol%): Lower: Upper:

2.6 12.6

Extinguishing Media :

Recommended (small fires) : dry chemical, carbon dioxide, Recommended (large fire) : alcohol foam, universal

foam, water spray, Not recommended : water jet (frothing possible) .

Special Fire Fighting Procedures:

Firefighters should wear NIOSH/MSHA approved self-contained breathing apparatus and full protective clothing .

Unusual Fire and Explosion Hazards :

Product will burn under fire conditions . Closed containers may explode (due to the build-up of pressure) when

exposed to extreme heat .

Hazardous Decomposition Materials (Under Fire Conditions) :

oxides of nitrogen

oxides of carbo n

6 . ACCIDENTAL RELEASE MEASURES

Evacuation Procedures and Safety :

Wear appropriate protective gear for the situation . See Personal Protection information in Section 8 .

Containment of Spill :

Follow procedure described below under Cleanup and Disposal of Spill

.

Cleanup and Disposal of Spill :

Absorb with an inert absorbent. Sweep up and place in an appropriate closed container (see Section 7 : Handling and Storage). Clean up residual material by washing area with water . Collect washings for disposal .

Environmental and Regulatory Repo rting:

Do not flush to drain. Spills may be reportable to the National Response Center (800-424-8802) and to state and/or local agencies.

7. HANDLING AND STORAGE

Minimum/Maximum Storage Temperatures :

4 to 49 C (39 to 120 F )

Handling :

Avoid breathing vapors and mists . Avoid direct or prolonged contact with skin and eyes . In cold weather, this product may stratify and freeze . This does not damage the product. If freezing occurs, thaw and remix before using . Frozen material may be thawed in a warm room . Avoid localized overheating . Vent drums while heating. Mix thoroughly to assure homogeneity .

Storage:

Store in tightly closed containers . Store in an area that is dry, well-ventilated, away from ignition sources, away

from incompatible materials (see Section 10 . Stability and Reactivity), Expected shelf life if stored a t

16
p. 18

recommended temperatures : 2 years .

8 . EXPOSURE CONTROLS/PERSONAL PROTECTION

Introductory Remarks :

These recommendations provide general guidance for handling this product . Because specific work environments

and material handling practices vary, safety procedures should be developed for each intended application . While

developing safe handling procedures, do not overlook the need to clean equipment and piping systems fo r

maintenance and repairs . Waste resulting from these procedures should be handled in accordance with Section

13 : Disposal Considerations .

Assistance with selection, use and maintenance of worker protection equipment is generally available from

equipment manufacturers .

Exposure Guidelines :

Exposure limits represent regulated or recommended worker breathing zone concentrations measured by

validated sampling and analytical methods, meeting the regulatory requirements . The following limits apply to this

material, where, if indicated, S=skin and C=ceiling limit :

PROPYLENE GLYCOL

Notes TWA STEL

AIHA 10 mg/cu m

AIHA 50 ppm

Engineering Controls:

Where engineering controls are indicated by use conditions or a potential for excessive exposure exists, the

following traditional exposure control techniques may be used to effectively minimize employee exposures : general area dilution/exhaust ventilation .

Respiratory Protection:

When respirators are required, select NIOSH/MSHA approved equipment based on actual or potential airborne

concentrations and in accordance with the appropriate regulatory standards and/or industrial recommendations

.

For reasonably foreseeable industrial end uses of this material, respiratory protection should not be necessary.

Eye/Face Protection :

Eye and face protection requirements will vary dependent upon work environment conditions and material handling practices . Appropriate ANSI Z87 approved equipment should be selected for the particular use intended

for this material .

Eye contact should be prevented through use of chemical safety glasses with side shields or splash proof

goggles . An emergency eye wash must be readily accessible to the work area .

Skin Protection:

Skin contact should be minimized through use of gloves and suitable long-sleeved clothing (i .e ., shirts and pants). Consideration must be given both to durability as well as permeation resistance .

Work Practice Controls :

Personal hygiene is an important work practice exposure control measure and the following general measures

should be taken when working with or handling this material :

(1) Do not store, use, and/or consume foods, beverages, tobacco products, or cosmetics in areas where

this material is stored .

(2) Wash hands and face carefully before eating, drinking, using tobacco, applying cosmetics, or using

the toilet.

(3) Wash exposed skin promptly to remove accidental splashes or contact with this material

.

17
P. 19

9. PHYSICAL AND CHEMICAL PROPERTIE S

Physical and Chemical properties here represent typical properties of this product . Contact the business area

using the Product Information phone number in Section 1 for its exact specifications .

Phvsical Appearance :

Odor:

pH :

SDecific Gravitv :

Water Solubility :

Melting Point Range :

Boiling Point Range :

Vapor Pressure :

Vapor Density:

Percent Volatiles by Volume :

Viscosity :

10. STABILITY AND REACTIVITY

Chemical Stability :

This material is stable under normal handling and storage conditions described in Section 7 .

Conditions To Be Avoided:

heat

Materials/Chemicals To Be Avoided :

strong bases

strong acid s

strong oxidizing agents

18
p. 20

strong reducing agent s

The Following Hazardous Decomposition Products Might Be Expected :

Decomposition Type: thermal

oxides of nitrogen

oxides of carbo n

Hazardous Polymerization Will Not Occur.

Avoid The Following To Inhibit Hazardous Polymerization :

not applicabl e

11 . TOXICOLOGICAL INFORMATION

Acute Eye Irritation :

Toxicological Information and Interpretation :

eye - eye irritation, rabbit . Moderately irritating .

Acute Skin Irritation:

Toxicological Information and Interpretation :

skin - skin irritation, rabbit . Severely irritating.

Acute Dermal Toxicity:

Toxicological Information and Interpretation:

LD50 - lethal dose 50% of test species, > 2000 mg/kg, rabbit .

Acute Respiratory Irritation :

No test data found for product .

Acute Inhalation Toxicity :

No test data found for product .

Acute Oral Toxicity :

Toxicological Information and Interpretation :

LD50 - lethal dose 50% of test species, > 5000 mg/kg, rat.

Chronic Toxicity:

This product does not contain any substances that are considered by OSHA, NTP, IARC or ACGIH to be

"probable" or "suspected" human carcinogens .

No additional test data found for product .

12 . ECOLOGICAL INFORMATION

Ecotoxicological Information :

No data found for product .

Chemical Fate Information :

No data found for product .

19
p. 21

13 . DISPOSAL CONSIDERATION S

Waste Disposal Method :

Chemical additions, processing or otherwise altering this material may make the waste management information

presented in this MSDS incomplete, inaccurate or otherwise inappropriate. Please be advised that state and local

requirements for waste disposal may be more restrictive or otherwise different from federal laws and regulations . Consult state and local regulations regarding the proper disposal of this material .

Container Handling and Disposal :

Any containers or equipment used should be decontaminated immediately after use .

EPA Hazardous Waste - N O

14. TRANSPORTATION INFORMATION

Transportation Status : IMPORTANT! Statements below provide additional data on listed DOT

classification .

The listed Transportation Classification does not address regulatory variations due to changes in package size,

mode of shipment or other regulatory descriptors .

US Department of Transportation

Shipping Name:

NOT REGULATE D

15 . REGULATORY INFORMATION

Inventory Status

Inventory Status

UNITED STATES (TSCA) Y

CANADA (DSL) Y

EUROPE (EINECS/ELINCS) Y

AUSTRALIA (AICS) Y

JAPAN (MITI) Y

SOUTH KOREA (KECL) N

Y = All ingredients are on the inventory .

E = All ingredients are on the inventory or exempt from listing .

P = One or more ingredients fall under the polymer exemption or are on the no longer polymer list . All other ingredients are on the inventory or exempt from listing .

N = Not determined or one or more ingredients are not on the inventory and are not exempt from listing .

FEDERAL REGULATIONS

Inventory Issues:

All functional components of this product are listed on the TSCA Inventory .

12"* 0
p. 22

SARA Title III Hazard Classes :

Fire Hazard - NO

Reactive Hazard - NO

Release of Pressure - NO

Acute Health Hazard - YES

Chronic Health Hazard - NO

STATE REGULATIONS :

This product does not contain any components that are regulated under California Proposition 65 .

16. OTHER INFORMATION

National Fire Protection Association Hazard Ratings--NFPA(R) :

2 Health Hazard Rating--Moderat e

1 Flammability Rating--Slight

0 Instability Rating--Minima l

National Paint & Coating Hazardous Materials Identification System--HMIS(R) :

2 Health Hazard Rating--Moderat e

1 Flammability Rating--Slight

0 Reactivity Rating--Minimal

Reason for Revisions :

Change and/or addition made to Section 9 .

Key Legend Information :

ACGIH - American Conference of Governmental Industrial Hygienists

OSHA - Occupational Safety and Health Administratio n

TLV - Threshold Limit Value

PEL - Permissable Exposure Limit

TWA - Time Weighted Average

STEL - Short Term Exposure Limit

NTP - National Toxicology Progra m

IARC - International Agency for Research on Cancer

ND - Not determine d

Disclaimer:

The information herein is given in good faith but no warranty, expressed or implied, is made .

** End of MSDS Document **
p. 23

CONFIDENTIAL BUSINESS INFORMATION

Page 22 has been removed.

Page 22
p. 24

ACUTE ORAL LD60

An acute oral LD50 study was conducted using 5 male and 5 female healthy albino rats . Each rat

was dosed once by gavage with 5000 mg/kg of test material . Feed and water were provided adlibitum after dosing and each rat was observed daily for mortality and other signs of gross toxicity

for 14 days . No mortality was observed . The oral LD50 was determined to be greater than 5000

mg/kg.

Tox Monitor Laboratories, April, 1990 (Ref: PS-1342)

ACUTE DERMAL TOXICITY

An acute dermal LD50 study was conducted using 5 male and 5 female healthy albino rabbits . Animals were dosed via patches containing 2000 mg/kg, applied to shaved skin . Patches were

left in place for 24 hours at which time the sites were cleansed . Food and water were provided

ad-libitum and animals were observed for 14 days for mo rtality and other signs of gross toxicity . No mortality was observed . The dermal LD50 is greater than 2000 mg/kg

Tox Monitor Laboratories, April, 1990 (Ref: PS-1343)

DERMAL IRRITATION

Six albino rabbits were evaluated for erythema, eschar and edema formation on abraded and

intact skin after the application via patches of 0 .5 ml of the test material. The patches were

removed 24 hours after application and the reactions were noted then and again at 72 hours. The

Primary Irritation Index was determined to be 4 .59 which classifies the product as a severe irritant

to rabbit skin under the test conditions.

Tox Monitor Laboratories, April, 1990 (Ref: PS-1341)

OCULAR IRRITATIO N

A test to determine the potential for eye irritation was conducted using six albino rabbits . Each

animal was administered 0 .1 ml of the test material, as supplied, to one eye with the other eye

serving as a negative control . Observations were scored at 1, 24, 48, and 72 hours and again at

7 and 14 days . The Maximum Mean Total Score was determined to be 28 .7 (24 hours) and 2.0 (7

days). It was concluded to be a moderate irritant to rabbit eyes under the conditions of the test . Tox Monitor Laboratories, April, 1990 (Ref : PS-1340)

Summary date : October 10, 1997

2 J
PS-M52

TOX MONITOR LABORATORIES, INC .

REPORT NO . TM 90-62 CLIENT :

ACUTE ORAL TOXICITY

SAMPLE :

SAMPLE PREPARATION : Dosed Nee t

Initial Weight Gain

Rat Body Weight Dose Dose in in 14 Day s

No . Sex (grams) Gm/Kg Grams (grams) Fate

245 M 220 5.0 1.10 109 Survived

246 it 202 " 1.01 108 Survived

2.47 it 218 1

.09 110 Survived

248 225 " 1.13 115 Survived

249 222 1.11 116 Survived

250 F 231 1.16 18 Survived

251 202 1.01 68 Survived

252 218 1.09 38 Survived

253 " 200 1.00 43 Survived

254 201 " 1.01 50 Survived

CAP ID No~S~- (

-o fns

RAVW9d fOt 88C. 6 (e)

On q~~

Program

t3R

24
p. 26

TOX MONTIOR LABORATORIES, INC .

REPORT NO . TM 90-62 CLIENT :

NECROPSY FINDING S

Rat

Number Sex Findings

245 M No gross changes observed

246 M No gross changes observed

247 M No gross changes observed

248 M No gross changes observed

249 M No gross changes observed

250 F No gross changes observed

251 F No gross changes observed

252 F No gross changes observed

253 F No gross changes observed

254 F No gross changes observed

2-0
p. 27

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p. 28

STANDARD PROTOCO L

(1) TITLE . Acute Oral Toxicity . (FHSA)

(2) OBJECTIVE . To obtain data concerning the acute toxicity of

the test material by oral ingestion .

(3) SPECIES . Sprague-Dawley derived albino rats .

(4) SEX AND AGE . Young adult males and females 200-300 grams .

(5) HOUSING . All animals will be individually housed in stainless steel cages and offered food and water ad li bitum .

(6) TREATMENT LEVELS AND NUMBERS OF ANIMALS . Initial testinq

with 5 males and 5 females will be performed at a dose

level of 5 gm/kg . If mortality does not exceed 50% at

this dose level, no further dose levels will be tested .

If mortality is produced, additional dose levels will he

performed to obtain data for calculation of the acute

oral lethal dosage (LD50)

'

~7) FASTING . All test animals will be fasted overnight prior

to dosing .

(8) DOSI NG . All animals will be dosed by oral gavage with the

test material as is (if liquid), or in a suitable inert

solvent (for solid or semi-solids) . The volume of the dosing

solution will not exceed 4-5 milliliters per animal .

(9) OBSERVATIONS AND DURATION OF TESTING . All test animals will

be observed daily for 14 days following dosing for any toxic

or deleterious effects . The weight of each animal will be

determined prior to dosing, at death, or at the end of 14 days .

(10) SACRIFICE AND NECROPSY . All test animals living at the en d

of the observation period will be sacrificed by carbon dioxide

asphyxiation . Gross necropsy will be conducted on all animals

sacrificed at the end of the 14 days .

(11) DATA REPORTING AND EVALUATION . At the end of the observation

period, calculation of the LD50 and 95% confidence limits are

performed by the method of moving averages, using the tables

constructed by Weil (Weil, C .S . : Fables for Convenient Calculation of Median Effective Dose (1:,D and rD50) and instruction

in Their Use . Biometrics, 8, 249 (H52) .
p. 29

Tox Monitor Laboratories, Inc .

33 West Chicago Avenue

Oak Park, Illinois 60302

(312) 345-697 0

REPORT NO . TM 90-62

CLIENT :

SAMPLE :

TESTS PERFORMED :

Eye Irritatio n

Primary Skin Irritation

Acute Oral Toxicity

Acute Dermal Toxicity

METHODS AND RESULTS :

See attached pages for methods, tables of results,

and tables for scoring on irritation tests .

SUMMARY AND CONCLUSION :

was tested for eye irritation,

primary skin irritation, acute oral toxicity, and acute

dermal toxicity .

Instillation of sample into the eyes of rabbits produced

a maximum mean irritation score of 28 .7/110 .0 in unwashed

eyes, classifying the sample as being moderatel y

irritation to the eyes .

Application of sample to intact and abraded skin of

rabbits produced a primary skin irritation score of

4 .59, classifying the sample as being moderately

irritating to the skin .

The acute oral LD 50 of sample was found to be greater

than 5 gm/kg body weight .

The acute dermal LD of sample was found to be greater

than 2 gm/kg body weight ight .

April 12, 1990 TOX MONITOR LABORATORIES, INC .

u=P V:.~ ,

Michael Kukulinski

Study Director

Robert F . Lock e

~ ~ Quality Assurance Unit
PSL'?343

TOX MONITOR LABORATORIES, INC .

REPORT NO . TM 90-62 CLIENT :

ACUTE DERMAL TOXICITY

SAMPLE :

SAMPLE PREPARATION : Dosed nee t

Initial 14 Day

Rabbit Body Weight Dose Dose in Body Weigh t

Number Sex (grams) Gm/Kg grams (grams) Fate

169 F 2519 2 .0 5 .04 2749 Survived

170 F 2317 4.63 2742 Survived

171 F 2028 4.06 2461 Survived

172 F 2101 " 4.20 2359 Survived

173 F 2271 4.54 2780 Survived

187 M 2036 4.07 2400 Survived

188 M 2011 " 4.02 2434 Survived

189 M 2100 4.20 2473 Survived

190 M 2021 4.04 2264 Survived

191 M 2081 4.16 2288 Survived

CAP Reviewed for Sec, a (e )

ComO" Program

On ti, 'By-
p.31

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p. 32

TOX MONTIOR LABORATORIES, INC .

REPORT NO . TM 90-62 CLIENT :

NECROPSY FINDING S

Rabbit # Sex Findings

169 F No gross changes observed

170 F No gross changes observed

171 F No gross changes observed

172 F No gross changes observed

173 F No gross changes observed

187 M No gross changes observed

188 M No gross changes observed

189 M No gross changes observed

190 M No gross changes observed

191 M No gross changes observed.

~1
p. 33

TCX M(-)NITOR LABORATORIES, INC .

STANDARD PROTOCOL

(1) T ITLE . Acute Dermal Toxicity .

(2) OBJECTIVE . To obtain data concerning the acute toxicity

of the test material by dermal application .

(3) SPECIES . New Zealand Albino Rabbits .

(4) SEX AND AGE . Young adult males and females .

(5) HOUSING . All animals will be individually housed in

stainless steel cages and offered food and wate r

ad libitum .

(6) TREATMENT LEVELS AND NUM?3ERS OF nN1MALS . Initial testing

with 5 males and 5 females will 'performed at a dose I)e

level of 2 gm/kg . If mortality does not exceed 50% at

this dose leve .l, no further dose levels will be tested .

If mortality is produced, additional dose levels will be

performed to obtain data for calculation of the acute

dermal lethal dosage (LD50)

'

(7) ANIMAL PREPARATION . Twenty-four hours before application

of the test material, the trunk of the rabbit is st,aved .

The 24-hour period between shaving and application of the

test material allows recovery of the stratum corneum from

the disturbance caused by the shaving .

(8) DOSING . All animals are weighed on the day of dosing .

Based upon the animal's body weight, the test material is

applied and a sleeve of plastic sheeting is fitted over

the shaven trunk of the animal and secured in place with

adhesive tape . The test material remains in contact with

the skin for a 24 hour period after which time the wraE,

is removed and any remaining test article wiped off .

(9) OBSERVATIONS AND DURATION OF TESTING . All test ananimals

will he observed da .Lly for 1 days Following dosing for any

toxic or deleterious effects. The weight of each animal

will be determined prior to dosing, at death, or at the end

of the 14 days.

(10) DATA REPORTING AND EVALUATION . At the end of the observation

period , calculation of the LD~O and 95% confidence limits are

performed by the method of moving averages, using the tables

constructed by Weil (Weil, C .S . : Tables for 'Convenient Ca .l .-

culation of Median Effective Dose (LDh and ED ) and Instruct .i ;-)r i in Their Use 50 . Biometrics, 8, 249 (1959) .

r1 r )

J ~.
p. 34

Tox Monitor Laboratories, Inc .

33 West Chicago Avenue

Oak Park, Illinois 60302

(312) 345-6970

REPORT NO . TM 90-62

CLIENT :

SAMPLE :

.TESTS PERFORMED :

Eye Irritatio n

Primary Skin Irritation

Acute Oral Toxicity

Acute Dermal Toxicity

METHODS AND RESULTS :

See attached pages for methods, tables of results,

and tables for scoring on irritation tests .

SUMMARY AND CONCLUSION :

was tested for eye irritation,

primary skin irritation, acute oral toxicity, and acute

dermal toxicity .

Instillation of sample into the eyes of rabbits produced

a maximum mean irritation score of 28 .7/110 .0 in unwashed

eyes, classifying the sample as being moderatel y

irritation to the eyes .

Application of sample to intact and abraded skin of

rabbits produced a primary skin irritation score of

4 .59, classifying the sample as being moderately

irritating to the skin .

The acute oral LD SO of sample was found to be greater

than 5 gm/kg body weight .

The acute dermal LD of sample was found to be greater

than 2 gm/kg body we0 ight .

April 12, 1990 TOX MONITOR LABORATORIES, INC .

t~ P ► ~ . , .

Michael Kukulinski

Study Director

Robert F . Locke

Quality Assurance Uni t r n

3J
p. 35

PS-1341

TOX MONITOR LABORATORIES, INC .

R EPORT NO . TM 90-62 CLIENT :

PRIMARY SKIN IRRITATION

SAMPLE :

24 HOURS 72 HOURS

UNABRADED ABRADED UNABRADED ABRADED

Rabbi t

Number Erythema Edema Erythema Edema Erythema Edema Erythema Edema

1 2 3 2 3 3 2 3 2

2 2 3 3 3 3 2 3 3

3 2 3 2 3 2 2 3 2

4 2 2 2 2 2 2 2 2

5 2 2 2 2 2 2 3 2

6 2 2 2 2 2 2 2 2

AVE : 2 .0 2 .5 2.17 2 .5 2 .33 2 .0 2 .67 2 .17

PRIMARY SKIN IRRITATION SCORE : 4 .5 9

OBSERVATIONS : Blanching at 24 hours .

Some eschar & fissuring at 72 hours .

CAPIpNo:s cie - o A k- 0 1o y

Cwvftw

br(e)

pmow I

O 4r 1 l Ci

34
p. 36

TOX MONITO R LABORATORIES, INC .

STANDARD PROTOCOL

(1) TITLE : Primary Skin Irritation (FHSA/CPSC )

(2) OBJECTIVE : To obtain data concerning the primary skin

irritation potential of the test material .

(3) S PECIES : New Zealand Albi.no Rabbits .

(4) SEX & AGE : Young Adult Males & Females 1500-2500 gms body weight .

(5) HOUSING : All animals will be individually housed in stainless

steel cages & offered food & water ad libitum .

(6) TREATMENT & NUMBER OF ANIMALS : Primary skin irritation to the

skin is measured by a patch-test technique . The hair is clipped

from the abdomen of six albino rabbits ; and four areas of the

abdomen, approximately ten centimeters apart, are designated for

the application of the patches . Two one-square inch sites on

the right side are abraded while similar sites on the left side

remain unabraded .

(7) DOSING : The test sample* is placed on the skin under a one-inch

square piece of cotton gauze which is held in place with adhesive

tape . The entire trunk of the animal is then wrapped with a

rubberized cloth and remains for a 24 hour exposurc period .

* 0 .5 milliliter in the case of liquid s

* 0 .5 grams in the case of solids or semisolid s

(8) OBSERVAT IONS & DURATION OF TEST ING : Ai ter 24 hours the patches

are removed, and the skin is examined for signs of irritation

(erythema and or/edema) . The skin is examined again at the

end of 72 hours .

(9) DATA REPORTING & EVALUATION : Average values for erythema and

eschar formation at 24 hours and 72 hours for intact skin are

added to values on abraded skin at 24 hours and 72 hour s

(4 values) . Similaily, values for edema iormation at 24 hours

and 72 hours for intact and abraded skin are added (4 values) .

The total of the 9 values is d ividEd by 4 to give the primary

irritation score .

A primary skin irritant is a substance which results in an

empirical primary irritation score of 5 or more .

3~
p. 37

TO}: MONITOR LABORATORI ES, INC .

(2)

(10) EVALUATION OF SKIN REACTIONS

Value* A . Erythema and Eschar Formatio n

Very slight erythema (barely perceptible) . . . . . . . 1

Well defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Moderate to severe erythema . . . . . . . . . . . . . . . . . . . . . 3

Severe erythema (bcet redness) to sligh t

eschar formation (injuries in depth) . . . . . . . 4

B . Edema Formation

Very slight edema (barely percaptiblc) . . . . . . . . . . 1

Slight edema (edges of area well defined by

definite raisings) . . . . . . . . . . . . . . . . . . . . . . . . . 2

Moderate edema (area raised approx . 1 mm) . . . . . . .3

Severe edema (raised more than 1 mm and

extending beyond area of exposure) . . . . . . . . . 4

*The value recorded for each reading is

the average value of the animals subject

to the test .

36
p. 38

TOX MONITOR LABORATORIES, INC .

PRIMARY S K I N IRRITATION DESCRIPTIVE RATING

Mean Primary Irritation Scor e

(values) Descriptive Rating

0 rJon-irritating

0 .1 - 0 .5 Minimally Trritating

0 .6 - 1 .5 Slightly Irritating

1 .6 - 3 .0 Mildly Irritating

3 .1 - 5 .0 Moderately Irritating

5 .1 - 6 .5 Severely Irritating

6 .6 - 8 .0 Extremely Irritating

37
p. 39

Tox Monitor Laboratories, Inc .

33 West Chicago Avenue

Oak Park, Illinois 60302

(312) 345-6970

REPORT NO . TM 90-62

CLIENT :

SAMPLE :

TESTS PERFORMED :

Eye Irritatio n

Primary Skin Irritation

Acute Oral Toxicity

Acute Dermal Toxicity

METHODS AND RESULTS :

See attached pages for methods, tables of results,

and tables for scoring on irritation tests .

SUMMARY AND CONCLUSION :

was tested for eye irritation,

primary skin irritation, acute oral toxicity, and acute

dermal toxicity .

Instillation of sample into the eyes of rabbits produced

a maximum mean irritation score of 28 .7/110 .0 in unwashed

eyes, classifying the sample as being moderatel y

irritation to the eyes .

Application of sample to intact and abraded skin of

rabbits produced a primary skin irritation score of

4 .59, classifying the sample as being moderately

irritating to the skin .

The acute oral LD 50 of sample was found to be greater

than 5 gm/kg body weight .

The acute dermal LD of sample was found to be greater

than 2 gm/kg body weight ight .

April 12, 1990 TOX MONITOR LABORATORIES, INC .

Ll~ P

Michael Kukulinski

Studv Director

~C~~►.►+L.Y'

Robert F . Locke

Quality Assurance Unit

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p. 42

TO'S MONITOR L.IDORII`i'ORILS, INC .

RABBIT EYE TIMITATION METHO D

Albino rabbits of the New Zealand strain were used as test

animals for evaluating the eye irritation potential-, of the

test materials .

The test sample was instilled into the conjunctival sac of

the right eye of each rabbit in accordance with the procedure

listed in the Table of Eye Irritation Results under Corm Administered, with the left eye -serving as the control . The

general technic of evaluation follcwed that of J . 11 . Drai2e+ .

At each scoring interval the cornea, iris, and palpebral

conjunctivae were examined and graded for irritation and injury

in accordance with the Draize scoring system . See attachnd

pages for the Appendix for Eye Irritation Test, Grades for

Ocular Lesions . in this scoring system special emphasis is

placed upon irritation or damage to the cornea, while less

emphasis is placed upQn irritation to the iris or conjunctivae .

A rating is obtained by selecting the maximum mean irritation

score at 1, 24 ,48 or 72 hours after instillation of samp] a .

If the rate of dissipation of the injury did not meet the

requirements defined for the descriptive rating appropriate

for a particular numerical score, the descriptive rating is

raised by one or more levels . See the attached pages for the

Descriptive Rating System .

*J . 11 . Draize : Dermal Toxicity, "Appraisal of the

Safety of Chemicals in rooels, Drugs and Cosmetics",

Association of :'oocl and f)ruc, Oi f icirtls of th a U . S . ,

L 9 5 9, 1~<~.~►-9 -!;1 ---._.

..

._.__--__._ .

4 1
TOY MONITO_Z LABORATOP.IES, INC . p.43

APPENDIX FOR EYE IRRITATION TES T

GRADES FOR OCULAR LESIONS

CORNEA

Opacity (D) - Degree of densit y

Scattered or diffuse area, details of iris clearly visible . . .1

Easily discernible translucent areas, details of iris ~

slightly obscured . . .

Opalescent areas, not details of iris visible, size o . . 2f

pupil barely discernible

Opaque, iris not visible

. . . . . . . . . . . . . . . . . . . . . . . . . ,3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Area of Cornea Involved (A )

One quarter (or less) but not zero . . . . . . . . . . . . . . . . . . ,1

Greater than one quarter but less than one half . . . . . . . . . . . . . . . . 2

Greater than one half but less than three quarters . . . . . . . . . . . . . 3 Greater than three quarters, up to whole area . . . . . . . . . . . . . . . . . . 4

Score Equals D x A x 5 Total Maximum = 8 0

IRIS

Values

Folds above normal, congestion, swelling, circumcorneal

injection (any or all of these or a combination of any

thereof), iris still reacting to light (sluggis h

reaction is positive) . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . ,

No reaction to light, hemorrhage, gross destruction (an y

or all of these) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Score equals Value x 5 Total Maximum = 10

CONJUNCTIVA

Redness (R) - refers to palpebral conjunctiva onle

Vessels definitely injected above normal . . . . . . . . . . . . . ,l

More diffuse, deeper crimson red, individual vessels ~

not easily discernible

Diffuse beefy red . . . . .

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

.

. .

. .

.

.

.

.

.

.

.

.

.

.

.

. . . . . ,2

. . . . . . . . . . . . . . . . . . . . . . . . . 3

Che mosi s

Any swelling above normal (includes nictating membrane) . . . . . . . . 1

Obvious swelling with partial eversion of the lids . . . . . . . . . . . . .2

Swelling with lids about half closed . . . . . . . . . . . . ,3

Swelling with lids about half closed to completely closed . . . . . . 4

Dis charge

Any amount different from normal (dose not include smal l

amount observed in .inner canthus of normal animals . . . . . . . . . . . . . 1

Discharge with moistening of lids and hairs adjacent to lids . . .2

Discharge with moistening of lids and hairs and considerable

area around eye . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Score equals (R+S+D) x2 Total Maximum = 20

The maximum total score is the sum of all scores obtained from the

cornea, iris, and conjunctiva . 40

If-
p. 44

Tc)X MONITOR LABORA'1'ORIFS, INC .

EYE IRRITATION TEST UR :l (2R1r'7'I17): RATING SYST ;; M

(~

Classification Range Definition

Non-irritating 0 .0 - 0 .5 To maintain this rating, all scores

at the 24--hour reading must be zero ;

otherwise, increase rating one level .

Practically Greater than To maintain this rating, all scores

Non-irritating 0 .5 - 2 .5 at the 24-hour reaaincl must be zero ;

otherwise, increase rating one levol .

Minimally Greater than To maintain this rating, all ,cores

Irritating 2 .5 - 15 .0 at the 72-hour reading must he zero ;

otherwise, increase rating one level .

Mildly Greater than To maintain this ratincl, all, scores

Irritating 15 .0 - 25 .0 at the 7-clay reading InklSt be 7(-1.0 ;

otherwise, increase rating one level .

Moderately Greater than To maintain this r.atin(l, scores at

Irritating 25 .0 - 50 .0 7 days must be less than or equal to

10 for 60'6 or more of the animals.

Also, mean 7-day scores must he less

than or equal to 20 . If 7-day mean

score is less than or equal to 20

but less than 10, then no animal

among those showing scores greater

than 10 can exceod a score of 30 if

rating is to be nnai ntn i nec] ;otlierwise, increase rating one level .

Severely Greater than To maintain this ratin(a, scores at

Irritating 50.0 - 80 .0 7 day,; 11111st be less t!<<z~~ or equa l

to 30 for 60's or more of the animals .

Also, me,tn 7-clay scores- must be lef~s

than or equal to 40 . if 7-day mean

score is less than or equal Lo 40,

but less than or equal to 30, then

no animal among those showing scores

greater than 30 can exceed a score

of 60 if rating is to be maintained ;

otherwise, increase rating by one

level .

Extremely Greater than

irritating 80 .0 - 110 .0

4 ".3
p. 45

R

Tox Monitor Laboratories, Inc .

33 West Chicago Avenue

Oak Park, Illinois 60302

(312) 345-6970

REPORT NO . TM 90-62

CLIENT :

SAMPLE :

TESTS PERFORMED :

Eye Irritatio n

Primary Skin Irritation

Acute Oral Toxicity

Acute Dermal Toxicity

METHODS AND RESULTS :

See attached pages for methods, tables of results,

and tables for scoring on irritation tests .

SUMMARY AND CONCLUSION :

was tested for eye irritation,

primary skin irritation, acute oral toxicity, and acute

dermal toxicity .

Instillation of sample into the eyes of rabbits produced

a maximum mean irritation score of 28 .7/110 .0 in unwashed

eyes, classifying the sample as being moderatel y

irritation to the eyes .

Application of sample to intact and abraded skin of

rabbits produced a primary skin irritation score of

4 .59, classifying the sample as being moderately

irritating to the skin .

The acute oral LD 50 of sample was found to be greater

than 5 gm/kg body weight .

The acute dermal LD of sample was found to be greater

than 2 gm/kg body weight ight ..

April 12, 1990 TOX MONITOR LABORATORIES, INC .

Michael Kukulinsk i

Study Director

I ~.TC~~►r~G-y

Robert F . Locke

Quality Assurance Unit

44
p. 46

ENVIRONMENTAL FATE INFORMATIO N

Inherent Biodegradability

Using the Modified Zahn-Wellens test, degraded 91 .6% in 28

days . This die-away test uses activated sludge suspended in a mineral medium . A

relatively high concentration of test compound is utilized in this method . Compounds

which show greater than 20% removal of DOC are regarded as inherentl y

biodegradable while those showing greater than 70% removal of DOC are considered

ultimately biodegradable is therefore considered ultimately

biodegradable by this test method . Ref: EF-451

Ready Biodegradabilit y

Using the Modified OECD Screening Test degraded 71.5% over

28 days. This is an open shake-flask test which measures the degree of

biodegradation by DOC analysis . Chemicals which reach 70% or greater loss of DOC

within 28 days are considered readily biodegradable . This level must be reached within

10 days of the time at which 10% degradation was seen . This time limit was not met .

is therefore considered to be not readily degradable by this test

method .

Ref: EF-453

Summary Date : October 10, 1997

4%5
p. 47

EF-045 1

Applicability

7/21/97

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Inherent Biodegradability : Modified Zahn-Wellens Test

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»: .: 302B 796.3360

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Ultimately biodegradable

Ready biodegradability testing will be run upon request

MB/C-0677 9/3/97

CONFIDENTIAL DATA FOR J(ISE ONLY

OBTAIN APPROPRIATE AUTHORIZATION FOR DISCLOSURE OUTSIDE O F

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F-0453

BIODEGRADATION STUDIES

NORTH AMERICAN CHEMICALS

CRANBURY ANALYTICAL

&

MICROBIOLOGICAL SERVICES

= Applicability

7/21/97

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Read Biodegradability: Modified OECD Screening Test

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71 .5 ; 28 DOC

Not readily biodegradable

-~~•.~•~. .:;.; . A biodegradation level of 71 .5% was reached on da 28 y , OECD guidelines . However

::'::3 Stl 1 level of >70/o% u ate that the pass ~n 10 t be reachedwith' days of 0 mus exceeding 10% . As

such, this , as readily biodegradable not be classified b .

~rn.~ ► 1€`~~evx~ :. >; :: NIB/C-0677 Wi>i :-Rfy:© 10/6/97

CONFIDENTIAL DATA FOR INTERNAL USE ONLY

OBTAIN APPROPRIATE AUTHORIZATION FOR DISCLOSURE OUTSIDE O F

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CONFIDENTIAL BUSINESS INFORMATION

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Page 50 - 57

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