Document Control Office 

Office of Pollution Prevention and Toxic 

Substances, 7407 

U.S. EPA 

1201Constitution Ave., NW 

Washington, DC 20460 

February 13, 2004 

RE: Premanufacture Notice TS-04ASK1 

Dear Sir or Madam: 

On behalf of the [ 

] is hereby submitting in accordance with 40 CFR Section 

720.50 the attached Premanufacture Notice (PMN) TS-04ASK1 for review. 

In accordance with 40 CFR Section 700.45(b ), the fee of $2,500.00 has 

been submitted (see attached copy of check). 

This PMN notification contains confidential business infonnation (CBI). 

Accordingly, in addition to the submission of the original notification and two 

copies, a single sanitized copy is also provided. 

Finally, the PMN fom1 used is an electronic version purchased from CMA. 

The document showing EPA approval ofthe fom1 is attached. 

If there are any questions regarding this submission, please do not hesitate 

to contact me at [ ] . 

tncerely, ) 

Attachments 

Co 

.. 

c..rz 

-

.·:_ .. -- .:~~ ;· .. ·;· 
Fom1 A roved. O.M.B. No. 2070-0012. Approval Expires I 0-31-96. 

U.S. ENVIRONMENTAL PROTECTION AGENCY AGENCY USE ONLY 

--- ·- -· ................. v~ yu.o'"'"' 

in the Premanufacture Notice 

PREMANUFACTURE 

NOTICE 

( 54 

GENERAL INSTRUCTIONS 

Datt: of receipt 

I' 

You must provide all information requested in this fom1 to the extent that it is known to or reasonably ascenainable by you. Make reasonable estimates if you do not 

have actual data. 

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

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

!fa 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. 

Pan 1-GENERAL INFORMATION 

You must provide the currently correct Chemical Abstracts (CA) Name of the new 

chemical substance, even if you claim the identity as confidential. You may authorize 

another person to submit chemical identity inforrnation for you, but your submission will 

not be complete and the review will not begin until EPA receives this information. A 

letter in suppon of your submission should reference your TS user fee identification 

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

If you claimed any infom1ation as confidential, a single sanitized copy must also be 

submitted. 

Pan 11- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

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

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

Pan Ill- LIST OF ATTACHMENTS 

Attach additional sheets if there is not enough space to answer a question fully. Label 

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

attachments, any test data or other data and any optional infomJJtion included in the 

notice. 

OPTIONAL INFORMATION 

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

substance. On page II of this limn, space has been provided for you to described 

pollution prevention and recycling information you may have regarding the new 

substance. 

So-called "binding" boxes arc included throughout this fonn for you to indicate your 

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 

that routinely accompany the development of consent orders or Significant New Use 

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

where certain infom1ation provided in such notification is binding on the submitter \\·hen 

the Agency approves the exemption applicatiott, checking a binding box in this notice 

does not by itself prohibit the submitter from later deviating from the infom1ation (except 

chemical identity) reponed in the form. 

CONFIDENTIALITY CLAIMS 

You may claim any information in this notice as confidential. To assen a claim on the 

fom1, mark (X) the confidential box next to the infomtation that you claim as 

confidential. To assert a claim in an attachment, circle or bracket the infom1ation you 

claim as confidential. If you claim information in the notices as confidential. you must 

also provide a sanitized version oft he notice (including attachments). For additional 

instructions on claiming infom1ation as confidential, read the Instructions Manual. 

Mark (x) if any infonnation in this notice is claimed as confidential. 

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

TEST DATA AND OTHER DATA 

You are required to submit all test data in your possession or control and to provide a 

description of all other data known to or reasonably ascenainable by you, if these 

data are related to the health and environmental effects on the manufacture, 

processing, distribution in commerce, use, or disposal of the new chemical 

substance. Standard literature citations may be submitted for data in the open 

scientific literature. Complete test data (written in English), not summmies of data. 

must be submitted if they do not appear in the open 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 to the requirements 

of §720.50 of the Premanufacture Notification Rule (40 CFR Pan 720). 

Test Data (Check Below any included in this notice) 

Environmental fate data 0 Yes Other data 0 Yes 

Health effects data 12.1 Yes Risk assessments 

Environmental effects data 12.1 Yes Structure/activity relationships 

PhysicaL'Chemical Propenies• 12.1 Yes Test data not in the possession 

or control ofth~ submitter 

A physical and chemical properties worksheet is located on the last page of this form. 

TYPE OF NOTICE (Check Only One) 

D 

D 

D 

P:VIN (?remanufacture Notice) 

INTERMEDIATE PMN (submitted in sequence with final product PMN) 

SNul\ (Significant New Use Notice) 

TMEA (Test Marketing Exemption Application) 

L VE (Low Volume Exemption)@ 40 CFR 723.50(c)(l) 

0 LOREX (Low Release/Low Exposure Exemption)@ 40 CFR 723.50(c)(2) 

0 L VE Modification 

IS THIS A CONSOLIDATED PMN? 

# of chemicals 

D 

D 

LOREX Modification 

Yes 

(Prcnotice Communication# required. enter# on page 3) 

Replaces previous editions of EPA Form 7710-25. 

' 
Public reporting burden for this collection of information is estimated to average II 0 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 Ia 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: 

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

0 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 

0 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 (L VE) 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: 

0 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. 

0 The manufacturer is familiar with the terms of this section and will comply with those terms; and 

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

0 If this application is for an LVE in accordance with 40 CFR 723.50(c)(l), 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 a_ccuracy of the statements you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical substance 

descnbed herein. Any knowing and willful misinterpretation is subject to criminal penaltv pursuant to t8 USC tOOt. 

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

Signature of agent -(if applicable) Date 

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

Confidential 

X 

X 
Part I --GENERAL INFORMATION 

Ia. Person 

Submitting 

Notice (in U.S.) 

b. Agent (if 

applicable) 

City, State, ZIP Code 

Name of authorized official 

Company 

address (number and 

ty, State, ZIP Code 

c: If you are submitting this notice as part 

Joint Submitter (if 

applicable) 

Name of authorized official 

Company 

Mailing address (number and street) 

City, State, ZIP Code 

2. Technical 

Contact (in 

U.S.) 

Name of authorized official 

3. 

4. 

5. 

6. 

Company 

Mailing address (number street) 

City, State, ZIP Code 

you have had a prenotice communication concerning 

and EPA assigned a PC Number to the notice, enter the number. 

you submitted an exemption app,tJcauon 

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

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

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

If you submitted a fide to manufacture or · 

for the chemical substance covered by this notice, enter the notice number 

assigned by EPA. 

Type of Notice - Mark (X) I. 

D 

Manufacture 

Only 

Binding Option 

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

this box. 

2. 

Telephone 

Telephone 

Telephone 

Import 

Only 

Area Code 

Area Code 

Mark (X) 

if none 

Mark (X) 

if none 

Mark (X) 

if none 

D Binding Option 

Page 3 

X 

3. 0 Both 
I. Class I or 2 chemical >uc•>•a"'"'", 

a. Class of substance- Mark (X) or 2 

Instructions Manual) 

Class 2 

b. name (Currently correct Chemical Abstracts (CA) Name that is 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 orCA Preferred Name must 

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

c. Please identity which method you used to develop or · the specified chemical identity nformation reported in this notice: 

~ 0 Method 2 (Other Source) 

d. exists for the substance) 

CAS# 

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

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

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

diaQram. a<; comnlete a<; can he known. if one can he rea<;onahlv ascertained. 

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

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

substance based on 

Confidential 

X 

X 

X 

X 

X 
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 D Other 0: (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 attach a continuation sheet. 

b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual in . 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 (I) 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 

d. 

commercial purposes. 

Mark this column if 

ContiX 

X 

X 

which method you used to develop or 

Method I (CAS Inventory Expert Service- a copy of the identification report 

obtained from CAS Inventory Expert Service must be submitted as 

as attachment to this no 

currently correct Chemical Abstracts (CA) name for the polymer that is consistent v.ith 

Typical 

% 

% X 

% X 

% X 

% 

% 

% 

this notice (check one). 

Inventory listings for similar polymers. 

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

attach a continutation sheet. 

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

% 

% X 

% X 

% X 

% 

% 

% 
3. ~~~ . . (a) _ Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial pu11JOSe. 

CAS Registry Number if available. If there are unidentified irnpurities,_enter "unidentified:" . 

Estimate the maximum %of each If there are umdentified estimate their total %. 

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

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

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

Maximum 

percent 

% 

% 

% 

% 

% 

% 

% 

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

Polyoxyether salt 

Mark (X) this box if 

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, 

attach a continuation sheet 

Provide the 

Confi-

'dential 

X 

Confidential 

X 

7. Byproducts- Describe any byproducts resulting from the manufacture, processing, use, or disposal of the new chemical substance, Provide the CAS Registry 

Number ifavailabk 

CAS Number 

EPA FORM 7710-25 (Rev. 5-95) Page 6 

Confidential 

X 

X 

X 

X 
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. 

l. 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 I 00% new chemical 

substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than I 0,000 

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

Maximum first 12-month production (kg/yr) Maximum 12-month production (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. (I)-- Describe each intended category of use of the new chemical substance by function and application .. 

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

(3) -- Indicate your willingness to have the information provided in column (I) 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 (I) CBI Binding Produc- CBI %in CBI %of substance expected per use CBI 

Option tion% Form- (8) 

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

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

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 mclude esttmates 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. 

0Mark (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 generic use descriptions. 

description 

polymerization additive 

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

3. Hazard Infor~atio~ Includ: in the notice a copy ofreasonable facsimile of any hazard warning statement, label, material safety data sheet, or other Binding 

mformat10n whtch wtll be provtded to a~y person who IS reasonably likely to be exposed to this substance regarding protective equipment or practices Option 

for the safe handmg, transport, use, or dtsposal of the new substance. Ltst m part III hazard information you include. Mark (x) 

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

EPAFO RM 7710 -25 (Rev. 5 -95) Page 7 
rt 11-- HUMAN 

Section A-- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER you 

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

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

there are further industrial or use · ons after · . You must describe these . See instructions manual 

I. 

of the site at which the ·on will occur. 

Name 

Not applicable because PMN substance will be imported 

(number and street) 

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. 

b. 

I. Batch 

2. Continuous 

sheet. 

Maximum kg/batch (100% new chemical 

substance) 

Contidential 

Use 

Batches/year 

Batches/year 

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

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

drum, rail car, tank truck, etc.). 

(2) Provide the identity, the approximate weight (by kg/day or kg/batch on a I 00% 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. 

Not applicable because PMN substance will be imported 

this box if you attach a continuation sheet. 

EPA FORM 7710-25 (Rev. 5-95) Page 8 
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 activ~ty, 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. 

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

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

(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 (CBl). 

(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 (CBl). 

(10) and (II)-- 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 (I I) are confidential business information (CBI). 

Worker activity CBI Protective Equipment! Binding Physical forms(s) Binding CBI #of CBI Maximu duration CB! 

m 

(i.e., bag dumping, tilling drums) Engineering Controls Option and% new Op1ion Worker Hrs/day Daysiyr 

Mark(x) substance Mark (x) s 

(I) (2) (3) (4) (5) (6) (7) Expose (9) {10) {II) (12) 

d 

(8) 

Not applicable, PMN 

substance will be imoorted 

D 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. 

(I) --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 (I) and (2) are confidential business information (CBl). 

(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 ofRCRA 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 CBl Media of Control technology and efficiency (you may wish to optionally attach efficiency data) CBI 

Number released release 

(I) (2a) (2b) c.gSiackair Binding 

(3) (4) (Sa) Mark (X) (5b) (6) 

Not applicable because PMN substance 

will be imported 

(7) Mark (X) the 0 POTW provide name(s) below: CBI 0 Navigable 0 Other- SpecifY provide NPDES # CBl 

r--- destination(s) of waterway releases to water. 

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

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

Section B --INDUSTRIAL SITES CONTROLLED BY OTHERS 

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

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

section B for each type 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 additional sites on a continuation sheet. 

I. Operation Description --To claim information in this section as confidential, circle or bracket the speci fie 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 oft he new chemical substance. (4) Please enter the# of sites (remember to identify the locations of 

these sites on a continuation sheet): 

____u_ 

# of sites 

[ 

] 

See page 10a 

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

2. Worker Exposure/Environmental Release 

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

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

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

(6) --Describe physical fom1 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) -- Esti~te the amount of the new substan~e released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/hatch). 

(12) -- Descnbe media of release 1.e. stack atr, fugtttve atr (optional-see Instructions Manual), surface water, on-site or oft:site land or incineration, POTW, or other 

(spectfy) 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 (X) this column if any of the proceeding entries are confidential business information (CBI). 

Letler #of CBI Duration CBI Protective Equip. I 0

toin CBI Release A moun! of CBI Media of Release CBI of V..'orkers of Engineering Controls/ Fom1· Number New & Control Acl· Exposed Exposure Physical Form and % ulation Substance Technology ivity new substance Released 

(I) (2) (3) (4a) (4b) (5) (6) (7) (8) (9) (lOa) I lOb) (II) (P) ( 13) 

X X X X X 

(14) -- Byproducts: (I5) none 

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

EPA FORM 7710-25 (Rev. 5-95) Page 10 
Page lOa 
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 infonnation 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 

infonnation 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. 

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

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

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

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

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

Attachment name Attachment Confipage number(s) dential 

48-52 

Material Safetv Data Sheet (J\1SDS) 

Physical & chemical properties worksheet 13 

NMR spectrum 14 

GPC data 15-19 

Acute Toxicity Test in Fish 20-22 

Skin Sensitization Study in the Guinea Pig 23-33 

Mutagenicity Study with Bacterial Reverse Mutation Assay 34-45 

CASIES Report 46 

PMN fee documentation 47 

CMA electronic PMN form documentation 53 

Use and exposure information 10a 

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

EPA FORM 7710-25 (Rev. 5-95) Page 12 
PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET 

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

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

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

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

Properties that are measured for mixtures or formulations should be so noted(% PMN substance in ). 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 

infom1ation 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 data. 

Property Mark Page Value 

(X) if number 

(80'Y., aqueous solution) (a) provided (b) (c) 

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

Vapor pressure 

(ii) Temperature oc Torr 

Density/relative density@ 20°c X 50 1.027 glml 

Solubility 

@ Temperature oc 

Solvent: ethanol, acetone, isopropanol; xylene X 50 soluble; insoluble 

Solubility in water@ Temperature oc X 50 soluble 

Melting temperature X 0 oc 

Boiling I sublimation temperature@ torr pressure oc 

Spectra 

Dissociation constant 

Particle size distribution 

Octanol I water partition coefficient 

Henry's Law constant 

Volitalization from water 

Volitalization from soil 

pH@ concentration 2% solution X 50 7.0-8.0 

Flammability: 

Explodability 

Adsorption I coefficient 

Other - Specify 

Mt.!asured o ConfiEstimate denuai 

Mark (X) 

(l\1 or E) (d) 

M 

M 

E 

E 

M 

M 

ATTACHMENT 

PAGE 13 
·-ooo1.4 

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00016 

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00017 
noo1.s 
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~-J 
J 

ACUTE TOXICITY OF 

TO JAPANESE KILLIFISH(Oryzias latipes) 

TESTING FACILITY 

L 

TEST OPERATOR 

MAIKO SUZUKI, M.Sc. 

STUDY DIRECTOR 

NAOHIRO NISHIYAMA, Ph.D. 

TEST METHOD 

OECD Guidelines for testing of Chemicals No.203(1992) 

TEST SPECIES 

Japanese killifish (Oryzias latipes) 

Fish were obtained from a fish breeder in Japan, and maintained in-house with dechlorinated water at a 

temperature of approximately 25oC. 

TEST SUBSTANCE 

Test material 

Chemical name: 

Purity 

Description :clear liquid 

Lot. No. : 030304 

METHOD OF PREPARATION 

An amount of test material (l.Og or 4.0g) was directly dissolved in purified water. And the volume 

adjusted to lOOmL to give lOg/Land 40g/L stock solutions respectively. The stock solutions were then 

further dissolved in a final volume of 2liters of dechlorinated tap water to give the test concentrations. 

00020 
TEST CONCENTRATION 

5.0, 10, 20, 40, 80 mg/L (active concentration) 

PROCEDURES 

Eight fishes were exposed to the solution of test substance for 96 hours. The test media was renewed 

at 48 hours after the exposure initiated. Mortality was recorded at 3,6,24,48,72 and 96 hours after the 

start of exposure. 

TEST PERIOD 

Exposure initiated 10/14/2003 

Exposure completed: 10118/2003 

RESULTS 

Cumulative mortality data in eight fishes at each observation time was shown in Tab!~ 1. 

According to OECD Guideline, the test is considered valid if the mortality in the control group does 

not exceed 10%(or one fish if less than ten are used) at the end of the test. So the results of this test are 

thought to be reliable although the death of one fish was observed in 5.0 and 10mg/L. 

Table 1 

Nominal Cumulative mortality (number) (Initial population: 8) 

concentration 

( m g/L) 3 hr 6 hr 24 hr 48 hr 72 hr 96 hr 

Control 0 0 0 0 0 0 

5.0 0 0 0 0 1 1 

10 0 0 0 1 1 1 

20 0 0 0 0 0 0 

40 0 0 1 1 2 3 

80 0 0 2 8 8 8 

Analysis of the mortality by the Probit method (Ecotox·Statics released by the Japanese society of 

environmental toxicology) based on the nominal test concentrations gave the following results (Table 2). 

The 96hr LC5o value of [ )s active was 38mg/L. 

Table 2 

Time (hr) LC50 (mg/L) 95% Confidence Limits (mg/L) 

24 62 43-104 

48 47 31-93 

72 43 25-115 

96 38 23-85 

D0021 
The temperature and pH of the test solutions were maintained at 23-24oC and 6.0-8.2 respectively 

throughout the test. Dissolved oxygen concentrations were not less than 60% of the air saturation value 

within the period of the test. 

AUTHENTICATION 

00022 
JBS-03-GPAG-0496-007 

Final report 

Skin sensitization study of [ 

]in guinea pigs 

(GPMTmethod) 

Start of experiments: April 14, 2003 

May 25,2003 

January 15, 2004 

End of experiments: 

Final report: 

Study director: /c?tdu{:; J ~A.{,~ 

JWI~<-Y ;.5/ ~t?f t1 

JBS Inc. 

00023 

;.if.:('' - 1 - -
JBS-03-GPAG-0496-007 

Materials and methods 

1. Test article 

c 

]CLot No.: 030304, supplied as water solution, concentration of an active 

ingredient: 20%, amount received: 228 g (gross weight)), used as a test article, was provided 

by l J and stored at room temperature protected from light. 

2. Animals 

Sixteen females guinea pigs (Std:Hartley, 4 weeks old) were purchased from Japan 

SLC. Inc. for the main study. The animals were acclimated for 1 week, and weighed twice 

(on the next day of the arrival and at group allocation (1 day before start of dosing)). The 

animals (5 weeks old) without no abnormalities in clinical signs during the ac_climatization 

period were allocated randomly to groups using an adequate stratification method according 

to body weight on the day of group allocation and random numbers generated by a computer. 

Body weight range was 333 - 369 g at group allocation. The animals were identified 

individually with cage cards. For the preliminary study, additional 8 guinea pigs (5 weeks 

old) were purchased. 

3. Animal husbandry 

The animals were housed m stainless steel wire-hanger cages (36 cmDx25 cmWx 

18 cmH) in an animal room (Area I), set temperature at 20 - 26°C, relative humidity of 40 -

70%, ventilation of 12 - 18 times/hour and illumination for 12 hours (7:00 - 19:00). 

Commercial chow diet (Labo RG-RO, Nihon Nosan Kogyo K.K.) and tap water (Kaizu-cho, 

Kaizu-gun, Gifu) were provided ad libitum. 

4. Preparation of dosing formulations 

FCA emulsion of physiological saline was prepared by mixing and emulsifying an 

equal volume of physiological saline and FCA. Physiological saline solutions of the test 

article were prepared by diluting an appropriate amount of the test article with physiological 

saline to get solutions of 1, 0.6, 0.2, 0.1, 0.06, 0.02, 0.01, 0.006, 0.002 and 0.001% (for the 

preliminary study) or 0.6% (for the main study), FCA emulsion of the test article (0.6%) 

was prepared by mixing and emulsifying an equal weight of FCA and 1.2% test article 

solution in physiological saline. 

Test article solutions for topical application were prepared by diluting an appropriate 

amount of the test article with water for injection to get 20% (as supplied), 10, 5, 3, 1 and 

0.5% (for the preliminary study), 20% (as supplied, for topical application in induction in the 

main study), or 10, 5, 3, 1, 0.5 and 0.3% (for challenge in the main study), 

Concentration of the test article is presented in weight percentage of the active 

ingredient. 

UOOZ4 

,.... - 2 -
JBS-03-GPAG-0496-007 

5. Preliminary study 

The test article solutions (0.1 mL) in physiological saline (1, 0.6, 0.2, 0.1, 0.06, 0.02, 

0.01, 0.006, 0.002 and 0.001 %) were injected intradermally in the back of 4 guinea pigs, and 

the injection sites were observed at 24, 48 and 72 hours after the injection. Darkening, ulcer 

or necrosis was observed at concentration of I%, moderate erythema at 0.6%, and slight 

erythema at 0.2 and 0.1 %. No changes were, however, observed at concentration of 0.06% 

or less. From the results, concentration in intradermal injection in the main study was set at 

0.6%. 

A preliminary study determining concentrations for topical application in induction 

and challenge was performed using 4 guinea pigs, which had been pretreated with intradermal 

injection of FCA emulsion of physiological saline (each 0.1 mL) in 4 sites of the dorsal neck 

(Fig. 1, illustrated with broken lines) 1 week before the topical application. The test article 

solution (0.06 mL), as supplied (20%) or its diluted solution in water for injection (10, 5, 3, 1 

or 0.5%) was soaked into a piece oflint (1.5x 1.5 em), and the lint was occlusively applied for 

24 hours in the same method as done at challenge, and changes in the skin were observed. 

Very slight to well defined erythema with very slight edema was observed at 20%. Very 

slight to well defmed erythema without edema and very slight erythema were observed at 10 

and 5%, respectively. On the other hand, no erythema nor edema was observed at 3% or less. 

From these results, concentration for topical application in induction was set at 20%, and 

concentrations for challenge were set at 10, 5, 3, 1, 0.5 and 0.3%. 

6. Main study 

T bl 1 G a e roup composihon3 

Induction by topical Challenge Group Induction by intradermal injection (day 0) application (day 7) (day 21) 

Test (I) FCA emulsion of physiological saline 

article (2) 0.6% test articleh) 20% test article 10, 5, 3, I, 0.5 

(3) FCA emulsion of0.6% test article 

(1) FCA emulsion ofphysiological saline 

and 0.3% test 

Vehicle articlec) 

control (2) Physiological saline Water for injection 

(3) FCA emulsion of physiological saline 

a): Concentration of the test article IS presented m weight percentage of active mgred:ent. 

b): Solution in physiological saline 

c): Solutions in water for injection 

6.1 Induction by intradermal injection 

Number 

of 

animals 

10 

5 

On I day before the intradermal injection (day -1 ), induction site in the dorsal neck 

(Fig. 1, illustrated with broken lines) and its around were clipped and shaved with electric 

clippers and an electric shaver. On the next day (day 0), the followings, each 0.1 mL, were 

intradermally injected in pairs of the sites (1), (2) and (3) illustrated in Fig. 1. 

00025 

Mit 

- 3 -
JBS-03-GP AG-0496-007 

FCA emulsion of physiological saline was injected in the sites (1) of all animals in 

both groups. Physiological saline solution of 0.6% test article and FCA emulsion of 0.6% 

test article were injected in the sites (2) and (3), respectively, of the test article group. In the 

vehicle control group, physiological saline and FCA emulsion of physiological saline were 

injected in the sites (2) and (3), respectively. 

6.2 Induction by topical application 

On day 6, the induction site (Fig. 1, illustrated with broken lines) and its around were 

clipped and shaved with electric clippers and an electric shaver. 

On day 7, followings (each 0.2 mL) were soaked into pieces oflint (2x4 em); 20% test 

article solution in the test article group and water for injection in the vehicle control group. 

The lint was applied in the induction site, wrapped with a dental damp-proof rubber sheet, and 

fixed by wrapping with an adhesive elastic bandage. The occlusive application was 

continued for 48 hours. 

D 

D 

D 

D 

D 

D 

Induction sites 

(1) (2) (3): Intradennal injection sites (0.1 mL in 

each site) 

Area surrounded with broken line: Topical 

application site (2x4 em, 0.2 mL) 

Challenge sites 

Areas surrounded with solid line ( 1 - 6 

sites in each animal) 

(1.5x1.5 em in each site, 0.06 mL) 

Fig. 1. Induction and challenge sites in the guinea pig Maximization test 

6.3 Challenge 

On day 20, the back of the animals was clipped and shaved with electric clippers and 

an electric shaver. On the next day (day 21), 0.06 mL of the test article solutions in water 

for injection (10, 5, 3, 1, 0.5 and 0.3%) were soaked into pieces of lint (1.5xl.5 em) and the 

pieces of lint were patched in the challenge sites in the back (Fig. 1, illustrated with solid 

lines) of the test article and vehicle control groups. The pieces of lint were wrapped with 

dental damp-proof rubber sheets, and fixed by wrapping with an adhesive elastic bandage. 

The occlusive application was continued for 24 hours. The sites were rotated among the 

animals to avoid deviation by the position of the sites. 

~··ooozs 
JBS-03-GPAG-0496-007 

7. Observations and judgement 

The skin was observed at 24, 48 and 72 hours after removal of the application for the 

challenge, and skin reactions were evaluated according to the Draize criteria listed in Table 2. 

Mean score (total score of the reaction/number of animals in each group) of the skin reaction 

was calculated in each group and in each observation. Photographs of all animals were 

taken. 

Table 2. Draize criteria of skin reaction I) 

A. Erythema and eschar formation Score 

Noerythema 0 

Very slight erythema (barely perceptible) 

Well defmed erythema 2 

Moderate to severe erythema 3 

Severe erythema (beet redness) to slight eschar formation (injures in depth) 4 

B. Edema formation Score 

No edema 0 

Very slight edema (barely perceptible) 

Slight edema (edges of area well defmed by defmite raising) 2 

Moderate edema (area raised approximately I mm) 3 

Severe edema (raised more than 1 mm, and extending beyond area of 4 

exposure) 

Total score of the reaction= A+ B 

Results 

Skin sensitization potential of [ 

Jwas investigated in guinea pigs (GPMT method) 

according to Table I. 

By challenging with 10% test article, very slight erythema was observed in 6 out of 

I 0 animals of the test article group. However, similar very slight erythema was observed in 

3 out of 5 animals of the vehicle control group. 

The change in the skin of the test article group was considered to be due to primary 

skin irritation potential of the test article but not to be due to skin sensitization, because 

similar change was observed in the vehicle control group. 

From these results, skin sensitization potential of the test article was judged to be 

negatiye under the conditions used in this study. 

00027 
JBS-03-GPAG-0496-007 

Individual data of skin sensitization study of test article a) (GPMT method) 

10% 5% 3% 1% 0.5% 0.3% 

er for inlection Water for injection Water for injection Water for injection Water for injection Water for injection 

48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 

Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 f 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I 

6 0 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 .0 0 0 0 0 0 0 0 0 ,.----,:-- --

6 4 _ _Q_ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

---- r----- -· ·-·--

6 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0.6-r-ox- -0.0 ----,----·---·-·--.--- 

0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 -o:o"·· 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

2 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

---

2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

02 

- ---- --

0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 

---- - - --- - -··- -

f Draize) _ . J 

_ 

rticle are presented in weight percentage of active ingredient. 

-l:00028 

I 
J BS-03-G PAG-0496-007 

Individual data of preliminary study to set concentration of test article a) 

0.6% 0.2% 0.1% 0.06% 0.02% 

ne Physiological saline Physiological saline Physiological saline Physiological saline Physiological saline 

2hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 

2 2 2 1 1 1 0 0 0 0 0 0 0 0 0 0 

3 2 2 1 1 0 0 1 0 0 0 0 0 0 0 0 I I 

2 1 1 0 1 1 0 1 0 0 0 0 0 0 0 0 

3 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 I I 

0.006% 0.002% 0.001% 

ne Physiological saline Physiological saline Physiological saline 

2hr 24hr I 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 

0 0 

I 

0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

0 0 0 0 0 0 0 0 0 0 

t 

0 0 I ' 0 0 0 0 0 0 0 0 

ythema, 2; moderate erythema, 3; darkening in the injection site, ulcer or 

-· ·- -- ·-··-· ·v

10% 5% 3% 1% 0.5% 

Water for injection Water for injection Water for inlection Water for injection Water for injection 

2hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 24hr 48hr 72hr 

 E Er E I Er E Er E Er E Er E Er E Er E Er E Er E Er E Er E E Er E Er 1:::. Er E' 

0 1 0 2 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 01 

0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

- -

f Draize) . 

a· ire- .in a(aetiv·a· .i.ngredien? 

-7-

··'00029 
JBS-03-GPAG-0496-007 

Reference photographs 

Twenty four hours after removal of topical application (No.705) 

Left Right 

3% test article (0/0) Upper 1% test article (0/0) 

0.5% test article (0/0) Middle 0.3% test article (0/0) 

10% test article (1/0) Lower 5% test article (0/0) 

( ): score (erythema/edema) 
JBS-03-GPAG-049~-007 

Twenty four hours after removal of topical application (No.715) 

Left Right 

3% test article (0/0) Upper 1% test article (0/0) 

0.5% test article (0/0) Middle 0.3% test article (0/0) 

10% test article (1/0) Lower 5% test article (0/0) 

( ): score(erytherna/edema) 
JBS-03-GP AG-049!)-007 

Preliminary study to set concentration for intradermal injection 

(72 hours after injection, No. 724) 

0.006% test article (0) 0.002% test article (0) 

0.001% test article (0) 1% test article (3) 

0.6% test article (1) 0.2% test article (0) 

0.1% test article (0) 0.06% test article (0) 

0.02% test article (0) 0.01% test article (0) 

( ): score 

. 00032 

~~· ·.· . ... -.. .,, . .. - 10 -
JBS-03-GPAG-0496-007 

Preliminary study to set concentration for topical application 

(24 hours after removal of topical application, No. 731) 

Left Right 

20% test article (2/1) Upper 1 0% test article (1/0) 

5% test article (1/0) Middle 3% test article (0/0) 

1% test article (0/0) Lower 0.5% test article (0/0) 

( ): score (erythema/edema) 

00033 

-11-· .._, 
Final Report 

Mutagenicity Study of 

l 

with the Bacterial Reverse Mutation Assay 

(Study Number 8640) 

BML, INC. 

00034 

.-. 
Study number: 8640 

Title: Mutagenicity study of [ 

}ith the bacterial reverse mutation assay 

Objective of the study: To assess the effect of the test substance by the reverse mutation test in bacteria. 

Sponsor 

Name 

Address 

Testing facility 

Name 

Address 

Date of study 

Initiation 

Completion 

Persons in charge 

Study Director 

Persons in charge of study 

Section in the company 

General Laboratory, BML, INC. 

1361-1, Matoba, Kawagoe-shi, Saitama 350-1101, Japan 

June 18, 2003 

July 3, 2003 

Yoshihiro Oguma 

Miko Sarada, Atsuko Takano, Yukino Fujiwara 

] 

Section of Safety Evaluation, Division of Safety Evaluation & Reagent 

Name of the person who prepared the final report, and date of preparation 

t;~~ Title: Study Director 

Date: J0..11 , f 2 0 0 (/= I 

0003~ 
1. Summary 

Mutagenicity potential of. [ 

)was assessed with Salmonella typhimurium TA100, TA98; 

In this study, neither increase in the number of revertant colonies more than twice in comparison with that of the 

negative control nor dose-related response was observed in any strains of base-pair substitution type or frame-shift 

type, with or without metabolic activation. 

From the above,( 

no mutagenicity forward to bacteria under the described study conditions. 

2. Date of test 

Initiation of the dose-finding test 

Initiation of the main test 

Completion of the main test 

Initiation of the confirmatory test 

Completion of the confirmatory test 

3. Test substance 

(1) Name 

(2) BML-CODE 

(3) Lot No. 

(4) Purity 

(5) Appearance at room temperature 

(6) Solubility 

June 18, 2003 

June 23, 2003 

June 26, 2003 

June 30, 2003 

July 3, 2003 

[ 

BML-6774 

030304 

20% 

Liquid 

Water : 50% 

(7) Condition of storage Room temperature in the dark 

The above information on the test substance was obtained from the sponsor. 

4. Tester strains 

(1) Strains used l), 2) 

The following two strains were used. 

Base-pair substitution type : Salmonella typhimurium TAlOO 

Frame-shift type : Salmonella typhimurium TA98 

-2-

00036 

.. ,, 

' . 

]las 

J 
(2) Supplier and date of receipt of strains 

S. typhimurium TA100 

S. typhimurium TA98 

(3) Characterization date 

S. typhimurium TA100 

S. typhimurium TA98 

(4) Reason for choice 

: The Division of Mutagenesis, National Institute of Hygienic Sciences, 

Japan (The Division of Genetics and Mutagenesis, Biological Safety 

Research Center, National Institute of Health Sciences, Japan at present); 

April15, 1982 

: Dr. Ames, U.C. Berkeley, CA, U.S.A.; January 20, 1988 

: March 27, 2003 

: March 27, 2003 

These strains are very sensitive to mutagens and are the most commonly used in bacterial reverse mutation 

assay. 

(5) Condition of storage 

The cell suspension and DMSO (spectrophotometric grade) were mixed in a ratio of 0.8 mL to 0.07 mL. The 

mixture was subdivided into 0.3 mL aliquots, and then frozen and stored at -80'C. 

5. Control compounds 

(1) Negative control 

Negative control plates were treated with only distilled water for injection that was used to prepare the 

solution of the test substance. 

(2) Positive controls 

Strain 

TA100 

TA98 

Without S9 (uglplate) 

AF-2 

AF-2 

(0.01) 

(0.1 ) 

AF-2 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide 

With S9 (uglplate) 

B[a]P 

B[a]P 

(5.0) 

(5.0) 

(Wako Pure Chemical Industries, Ltd.; Lot No. WTII1046; Special grade of JIS; Purity, more 

than 95%) 

B [a ]P Benzo [a ]pyrene 

(Wako Pure Chemical Industries, Ltd.; Lot No. DWF7715; Special grade of JIS; Purity, more 

than 95%) . 

00037 

.. 
1) Solvents 

AF-2, and B[a]P were dissolved in DMSO(Wako Pure Chemical Industries, Ltd.; ·Lot No. WAH4660). 

These solutions were subdivided, stored at less than -20'C and thawed just prior to use. 

2) Reason for choice of the positive control compounds 

These compounds were chosen in accordance with the "Guidelines for the Industrial Safety and Health 

Law." 

6. Materials 

(1) S9 mix 

1) S9 

Name 

Manufacturer 

Lot No. 

Manufacture date 

Purchase date 

Species and strain 

Sex 

Age 

Weight 

S9 

ORIENTAL YEAST, CO., LTD. 

03031413 

March 14, 2003 

April 10, 2003 

Sprague-Dawley rat 

Male 

7 weeks 

223.4±8.1g 

Inducing substance 

Administration route 

Dose 

Phenobarbital(PB) and 5,6-benzoflavone(BF) 

Intraperitoneal injection 

PB=30+60+60+60 mg/kg (4 days); BF=80 mg!kg(at the third day) 

Storage Stored below -80'C 

2) Cofactor 

Name 

Manufacturer 

Lot No. 

Storage 

Cofactor 

ORIENTAL YEAST, CO., LTD. 

999302 

Stored below 5'C 

3) Composition of S9 mix (per 1mL) 

Water 0.9 mL 

0.1 mL 

8.0 ,umol 

S9 

MgCh 

KCI 

G-6-P 

NADPH 

NADH 

Na-Phosphate buffer (pH 7.4) 

33.0 ,umol 

5.0 ,umol 

4.0 ,umol 

4.0 ,umol 

100.0 ,umol 

(2) Top agar 

Used agar 

Name 

Manufacturer 

Lot No. 

BACI'O-AGAR 

DIFCO LABORATORIES 

2289929 

- 4 - 00038 

.. 
(3) Minimal glucose agar plate 

Name 

Manufacturer 

Lot No. 

Manufacture date 

Purchase date 

Storage 

7. Method 

(1) Solvent 

Name 

Manufacturer 

Lot No. 

Tesmedia AN 

ORIENTAL YEAST, CO., LTD. 

ANI270DS 

April 3, 2003 

May 23, 2003 

Stored at room temperature 

Distilled water for injection (iapanese Pharmacopoeia) 

Hikari Pharmaceutical Co., Ltd. 

A31TS1 

(2) Preparation of the test substance solution 

Based on the information from the sponsor, distilled water for injection was used as the solvent for the test 

substance. The test was carried out with the weight converted by multiplying measured weight by 0.200 because 

the purity of the test substance was 20%. Preparation of the test solution was carried out just prior to use under 

lamp with ultraviolet absorbent filter. 

(3) Condition of pre-culture 

1) Nutrient Broth 

Name 

Manufacturer 

Lot No. 

2) Incubator 

Model 

Manufacturer 

3) Pre-culture procedure 

Nutrient Broth No. 2 

OXOID LIMITED 

261002 

COOL BATH SHAKER ML-10 

TAITEC CORPORATION 

A bacterial suspension of each strain (20,uL) was inoculated into an L-form culture tube (35 mL capacity) 

containing 10 mL of Nutrient Broth. This culture tube was left at 4'C for 7 hours and 45 minutes and then 

incubated while shaking (100 rpm) in a water bath at 37'C for 8 hours. After incubation, the optical density 

was measured. The bacterial cultures were stored at room temperature and used within 2 hours after 

incubation. 

-s- 00039 

.....-

·~ 
4) Number of bacteria at the end of pre-culture 

The number of bacteria in the culture was estimated from the optical density at the end of the pre-culture. 

S. typhimurium TAlOO 

S. typhimurium T A98 

(4) Dose selection 

Dose-finding test 

2.06x10 9 /mL 

2.64x10 9 /mL 

Main test 

2.34xl09 /mL 

2.68xl09 /mL 

Confirmatory test 

2.64xl09 /mL 

The dose range for the main test was determined from the dose-finding test using the following five dose 

levels: 20, 78, 313, 1250 and SOOO,ug/plate. 

In the dose-finding test, the growth inhibition by the test substance was observed at 1250,ug/plate and more 

in S. typhimurium TA98 with metabolic activation, at 5000,ug/plate in S. typhimurium TA100 without 

metabolic activation. And the number of revertant colonies in S. typhimurium TA98 without metabolic 

activation increased more than one and a half times in comparison with that of the negative control. And the 

precipitate of the test substance on the plate was not observed either with or without metabolic activation. 

Therefore, as the highest dose level of the test substance in the main test, the 1250,ug/plate dose was selected 

for S. typhimurium TA98 with metabolic activation, the 5000,ug/plate dose was selected ~or S. typhimurium 

TA100 both with and without metabolic activation and S. typhimurium TA98 without metabolic activation. 

These highest doses were diluted 4 times (using a common ratio of 2) to provide a total of 5 dose levels for 

S. typhimurium TAlOO with metabolic activation and 5 times (using a common ratio of 2) to provide a total of 

6 dose levels for S. typhimurium TA100 without metabolic activation and S. typhimurium TA98 with metabolic 

activation and 6 times (using a common ratio of 2) to provide a total of 7 dose levels for S. typhimurium T A98 

without metabolic activation in confirmation of mutagenicity at low doses. 

(5) Test procedures (the pre-incubation method) J), 4

), s), 6

) 

For the tests without metabolic activation, 0.5 mL of 0.1M Na-phosphate buffer (pH 7.4) and 0.1 rnL of each 

fresh bacterial culture were added to each tube containing 0.1 mL of the test substance solution. For the tests 

with metabolic activation, 0.5 mL of the S9 mix was added to each tube instead of the O.lM Na-phosphate 

buffer. The mixture was pre-incubated in a water bath at 37"C for 20 minutes while shaking horizontally, and 

then 2.0 mL of top agar were added to the mixture, and the contents of each tube were poured over the surface 

of the minimal glucose agar plate. These operations were conducted under lamp with ultraviolet absorbent 

filter. 

All plates were incubated at 37"C for 48 hours, and the number of revertant colonies was counted. 

Afterwards, growth inhibition of the test strains was checked using a stereoscopic microscope. As top agar, a 

soft agar solution (0.6% Agar and 0.5% NaCl) with 1/10 by volume of the solution of 0.5 mM biotin-0.5 mM 

L-histidine, respectively. One minimal glucose agar plate was used for each dose level in the dose-finding test 

and two minimal glucose agar plates were used for each dose level in the main test and the confirmatory test. 

00040 

"' ........ 

~ 
(6) Counting procedure 

The number of revertant colonies was counted with colony counter. 

1) Measuring instrument 

Model 

Manufacturer 

Colony Analyzer CA-7 II 

System Science Co., Ltd. 

2) 

3) 

Correction 

Correction with the coefficient 

Coefficient 

1 - 100 colonies : xl.ll 

101 - 400 colonies : xl.16 

401 - colonies : xl.25 

8. Criteria for judgment S) 

In the tests, if the number of revertant colonies on the test plates increased significantly in comparison with that 

on the control plates (based on twice as many as that of the negative control), and dose-response and 

reproducibility were also observed, the test substance was to be judged positive. Statistical analysis was not done. 

9. Results and discussion 

The results are shown in Tables 1 to 3. 

In the dose-finding test and the main test, neither an increase in the number of revertant colonies (more than 

twice as many as that of the negative control) at any doses in any strains of base-pair substitution type or 

frame-shift type, with or without metabolic activation, nor dose-related response was observed. Furthermore, the 

confirmatory test was carried out at the doses that a few increases were observed. As a result, an increase in the 

number of revertant colonies was not observed. 

The revertant colonies of the positive controls showed an increase of more than twice that of the negative 

controls, indicating that this study was performed correctly. 

From these results, the mutagenicity of the test substance was judged negative. 

The growth inhibition of the test strains by the test substance was observed at doses marked with" * "in the 

Tables, and the precipitate on the plates was not observed either with or without metabolic activation. 

10. Conclusion 

From the results described above, it is concluded that [ 

) is not mutagenic in the bacterial reverse mutation assay carried out under 

the experimental conditions. 

-7- 00041 

~ 
11. References 

1) B.N. Ames, F.D. Lee, and W.E. Durston: An Improved Bacterial Test System for the Detection and 

Classification of Mutagens and Carcinogens, Proc. Natl. Acad. Sci. USA Vo1.70, No.3, pp.782-786, March 

1973 

2) J. McCann, N. E. Spingarn, J. Kobori and B.N. Ames: Detection of Carcinogens as Mutagens: Bacterial Tester 

Strains with R Factor Plasmids, Proc. Natl. Acad. Sci. USA Vol.72, No.3, pp.979-983, March 1975 

3) T.Yahagi, M. Nagao, Y. Seino, T.Matsushima, T.Sugimura and M.Okada: Mutagenicities of N-nitrosamines on 

Salmonella, Mutation Res. Vol.48, pp.121-130, 1977 

4) D.M. Maron and B.N. Ames: Revised Methods for the Salmonella Mutagenicity Test, Mutation Res. Vol.113, 

pp.173-215, 1983 

5) A guidebook for Mutagenicity Studies using Bacteria, New Edition, Ed. by Chemical Substances 

Investigation Division, Industrial Safety and Health Department, Ministry of Labor, Japan Industrial Safety and 

Health Association, 1986 

6) Testing Methods for Environmental Mutagens: Ed. by Tajima, Kada, Kondo and Tamura, Koudan-sha Co., 

pp.56-68, 1980 ' 

-8- 00042 

......... 

·~ 
Table 

Table of Dose-f nd ng Test Results 

Name of test substance : L J 

No.8640 

A term of test June 18, 2003 - June 21' 2003 

Test substance Number of revertant colonies/plate 

With or without concentration Base-pair substitution type Frame-shift type S9mix 

(p.g/plate) TA100 TA98 

Solvent Control 139 17 (Water) 

20 133 11 

78 145 27 

-S9mix 

313 110 22 

1250 110 10 

5000 123* 15 

Solvent Control 140 29 (Water) 

20 126 39 

78 135 27 

+S9mix 

313 119 36 

1250 110 21* 

5000 91 26* 

Positive Name AF-2 AF-2 

control Concentration 

not (.u.g/plate) 0. 01 0. 1 

requiring Number of 561 597 S9mix colonies/plate 

Positive Name B [a] P B [a] P 

control Concentration 

requiring (tLg/pl ate) 5.0 5.0 

S9m ix Number of 812 196 colonies/plate 

AF-2 : 2- (2-Fury I) -3- (5-n it ro-2-fu ry I) ac ry I ami de 

B[a]P : Benzo[a]pyrene 

Notes 

*:The growth inhibition of the tested bacterium by the test substance was observed. 

- 9 - 00043 

... 
Table 2 

Tab I e 0 f Ma n T e s t Result·s 

Name of test substance:[ 

No.8640 

A term of test June 23, 2003 - June 26, 2003 

Test substance Number of revertant colonies/plate 

w i t h or without 

cone en t ration Base-pair substitution type Frame-shift type S9mix 

(tLg/plate) TAtOO TA98 

Solvent Control 122 22 

(Water) 122 ( 1 2 2) 27 ( 2 5) 

78 37 

NT 27 ( 32) 

156 143 37 

114 ( 12 9) 37 ( 37) 

313 122 36 

- S9mix 131 ( 127) 28 ( 3 2) 

625 109 24 

97 ( 10 3) 27 ( 26) 

1250 95 27 

108 ( 10 2) 30 ( 2 9) 

2500 100 28 

127 ( 114) 22 ( 25) 

5000 IOH 26 

98* ( 1 03)* 23 ( 2 5) 

Solvent Control 156 34 

(Water) 147 ( 152) 40 ( 37) 

39 27 

NT 33 ( 30) 

78 37 

NT 27 ( 3 2) 

156 42 

NT 48 ( 45) 

+S9mix 313 106 34 

121 ( 114) 38 ( 36) 

625 122 44 

120 ( 121) 44 ( 44) 

12 50 91 32* 

105 ( 98) 3H( 35)* 

2500 89 

96 ( 93) NT 

5000 76 

85 ( 81) NT 

Positive Name AF-2 AF-2 

control Concentration 

not (t.t.g/plate) 0. 01 0. 1 

requiring Number of 525 515 

S9mix colonies/plate 571 ( 548) 578 ( 547) 

Positive Name B [a] P B [a) P 

control Concentration 

requiring (t.t.g/plate) 5.0 5.0 

S9mix Number of 897 214 

colonies/plate 878 ( 888) 219 ( 217) 

AF-2 : 2-(2-Furyl)-3-(5-ni tro-2-furyl)acrylamide 

B [a) P : Benzo [a] py rene 

Notes 

*:The growth inhibition of the tested bacterium by the test substance was observed. 

NT : Not tested 

The average number of colonies of two plates at each concentration is shown in the ( ). 

-lQ- '00044 

..,. 
Table 3 

Table of Conf rmatory Test Results 

Name of test substance:[ ) 

No.8640 

A term of test June 30, 2003 - Ju I y 3, 2003 

Test substance Number of revertant colonies/plate 

with or without concentration Frame-shift type S9m i x 

(JLg/plate) TA98 

Solvent Control 18 

(Water) 21 ( 20) 

39 16 

13 ( 15) 

78 23 

30 ( 27) 

117 28 

21 ( 25) 

-S9mix 156 24 

13 ( 19) 

195 19 

29 ( 24) 

234 23 

17 ( 20) 

273 22 

21 ( 22) 

313 14 

20 ( 17) 

Positive Name AF-2 

control Concentration 

not {J.Lg/plate) 0. 1 

requiring Number of 590 

S9mix colonies/plate 565 ( 578) 

AF-2 : 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide 

Notes 

. The average number of colonies of two plates at each concentration is shown 

in the ( ) . 

-u- '00045 
:ccs InventorY_ Expert .Service 

A division of the American Chemical Society 

Phone: 800~63 1-1884, 614-447-3870 

Fax: 614-447-3747 

E-mail: answers@cas.org 

Internet http://www.cas.org/Support/client.html 

INVENTORY EXPERT SERVICE REPORT 

IES-ORDER NUMBER: 76913 

REGISTRY NUMBER: [ J 

CA INDEX NAME 

l J 

Please print the above CA Index Name on the appropriate page of your PMN. 

~If this box is checked, CAS has made correction(s} marked in red to 

~ your IES order. Please make the same correction(s} to your PMN before 

submitting it to the EPA. 

00046 

2540 Olentangy River Road P.O. Box 3343 { •. '\ It • io 43210-0334 
--

I L Rll nFL LJXEBUSINESSFOFIMS 1 +ll(D-32B-Q304 

oooo'flll-
KCDS-No. 102169-02 [ J Revised Date 

Set Up Date 

1 I 5 

January 28, 2004 

July 29, 2003 

MATERIAL SAFETY DATA SHEET 

KCDS-No. 

[1.PRODUCT AND COMPANY IDENTIFICATION] 

PRODUCT NAME 

SUPPLIER 

ADDRESS 

DIVISION 

TELEPHONE NUMBER : 

FAX NUMBER 

EMERGENCY 

TELEPHONE NUMBER 

[2.COMPOSITION/INFORMATION ON INGREDIENTS] 

SUBSTANCE OR PREPARATION : Preparation 

INGREDIENTS AND CONCENTRATION RANGE 

Ingredients Concentration Range(%} CASRN 

[ J 

INGREDIENTS CONTRIBUTING TO None 

THE HAZARD(JAPAN) 

[3.HAZARDS IDENTIFICATION] 

MOST IMPORT ANT HAZARDS 

ADVERSE HUMAN HEALTH 

EFFECTS 

ENVIRONMENTAL EFFECTS 

PHYSICAL AND CHEMICAL 

HAZARDS 

CLASS NAME FOR MSDS IN 

JAPAN. 

[4.FIRST-AID MEASURES] 

IN CASE OF INHALATION 

IN CASE OF SKIN CONTACT 

IN CASE OF EYE CONTACT 

IN CASE OF INGESTION 

[5. FIRE-FIGHTING MEASURES] 

: To the best of our investigation, no special hazards have to be 

mentioned. 

: To the best of our investigation, no information about adverse effect in 

the environment available. 

: This material is not dangerous in case of usual handling. 

: Not applicable 

Remove person to fresh air. If necessary seek medical attention. 

Wash material off the skin with plenty of water and soap. If necessary 

seek medical attention. 

Immediately hold eyelids open and flush with a stream of water for at 

least 15 minutes. If necessary seek medical attention. 

Seek medical attention. Never give anything by mouth to an unconscious 

person. If possible, rinse out mouth and give one or two glasses of water 

or milk to drink. 

000048 

• 
KCDS-No. 102169-02 2 I 5 [ ] Revised Date January 28, 2004 

EXTINGUISHING MEDIA 

NOT SUITABLE EXTINGUISHING 

MEDIA 

SPECIFIC HAZARDS 

SPECIFIC METHODS 

PROTECTION OF FIREFIGHTERS 

[6.ACCIDENTAL RELEASE MEASURES] 

PERSONAL PRECAUTIONS 

Powder, alcohol-resistant foam, water spray, carbon dioxide,sand 

No information available 

May produce irritating or toxic gases in a fire. 

Keep away from sources of ignition and use appropriate extinguishing 

media. Fight fire from upwind position if possible. 

Product itself is non-combustible. 

Use goggles in combination with dust mask, and another protections as 

appropriate to situation. 

Use goggles and protective gloves. 

Large spills : Remove person to safety. 

Ensure adequate ventilation. 

ENVIRONMENTAL PRECAUTIONS : Do not discharge into the drains, surface waters or ground water directly. 

METHODS FOR CLEANING UP 

PREVENTION OF SECONDARY 

HAZARDS 

[?.HANDLING AND STORAGE] 

HANDLING 

TECHNICAL MEASURES 

PRECAUTIONS 

SAFE HANDLING ADVICE 

STORAGE 

STORAGE CONDITIONS 

PACKAGING MATERIALS 

Small spills: Absorb spills with sand, inert absorbent, waste cloth or 

sawdust. Then wipe up remainder in waste cloth. 

Large spill: Dike spills and dispose of in safe area. 

: No information available 

Facilities storing or utilizing this material should be equipped with an 

eyewash facility and a safety shower. 

No information available 

Handle in well-ventilated areas. . 

Use safety glasses and protective gloves as appropriate to situation. 

Wash hands and face and gargle after handling. 

Keep container tightly closed. 

Protect from sun. Store in a dark and well-ventilated place. 

No information available 

[B.EXPOSURE CONTROLS/PERSONAL PROTECTION] 

ENGINEERING MEASURES Facilities storing or utilizing this material should be equipped with an 

LIMIT VALUES 

ACGIH(TLV) 

OSHA(PEL) 

eyewash facility and a safety shower. 

Use an adequate ventilation. 

Not established 

Not established 

PERSONAL PROTECTIVE EQUIPMENT 

RESPIRATORY PROTECTION Use as appropriate to situation. 

00 
KCDS-No. 102169-02 

HAND PROTECTION 

EYE PROTECTION 

SKIN AND BODY 

PROTECTION 

HYGIENE MEASURES 

: Rubber gloves 

: Safety glasses 

: Full-body suit 

: No information available 

[9.PHYSICAL AND CHEMICAL PROPERTIES] 

PHYSICAL STATES 

: Liquid 

: Light yellow to yellow 

: Slightly characteristic odour 

] 

FORM 

COLOUR 

ODOUR 

pH 7.0 - 8.0 ( 2% solution ) 

3 I 5 

Revised Date January 28, 2004 

SPECIFIC TEMPERATURESfTEMPERATURE RANGES AT WHICH CHANGES IN PHYSICAL STATE OCCUR 

BOILING POINT 

MELTING POINT 

DECOMPOSITION 

TEMPERATURE 

FLASH POINT 

: No data available 

: No data available 

: No data available 

: Not applicable 

AUTOIGNITION TEMPERATURE : No data available 

EXPLOSION PROPERTIES 

EXPLOSION 

VAPOUR PRESSURE 

VAPOUR DENSITY 

DENSITY 

SOLUBILITY 

: UPPER LIMIT : No data available 

: No data available 

: No data available 

1.027 g/mL 

1.018 g/mL 

1.008 g/mL 

: Soluble 

20 oc ) 

40 oc ) 

60 oc ) 

LOWER LIMIT: No data available 

WATER SOLUBILITY 

SOLVENT SOLUBILITY : Soluble in ethanol, acetone and isopropanol. 

OCTANOLJWATER PARTITION 

COEFFICIENT 

OTHER DATA 

[10.STABILITY AND REACTIVITY] 

STABILITY 

HAZARDOUS REACTIONS 

CONDITIONS TO AVOID 

MATERIALS TO AVOID 

Insoluble in xylene. 

No data available 

No data available 

: Stable in general. 

: Stable in general. 

: No information available 

No information available 

000050 

... _~' 

....... 
KCDS-No. 102169-02 4 I 5 [ J Revised Date January 28, 2004 

HAZARDOUS DECOMPOSITION 

PRODUCTS 

OTHERS 

(11.TOXICOLOGICAL INFORMATION] 

ACUTE TOXICITY 

LOCAL EFFECTS 

No information available 

No information available 

No information available 

CORROSIVITY No information available 

SKIN IRRITATION No information available 

EYE IRRITATION No information available 

SENSITIZATION Guinea pig, Guinea Pig Maximization Test: 

Negative (Data on active component) 

CHRONIC TOXICITY/LONG TERM No information available 

TOXICITY 

CARCINOGENICITY No information available 

IARC Not established 

NTP Not established 

OSHA Not established 

MUTAGENICITY : Ames test (TA98,TA100): Negative (Data on active component) 

TERATOGENICITY No information available 

REPRODUCTION TOXICITY No information available 

OTHER DATA No information available 

[12.ECOLOGICAL INFORMATION] 

MOBILITY No information available 

PERSISTENCE/ No information available 

DEGRADABILITY 

BIOACCUMULATION No information available 

ECOTOXICITY 

AQUATIC TOXICITY 

OTHER DATA 

[13.DISPOSAL CONSIDERATIONS] 

Red killifish, 96h, LC50 : 38 mg/L (Data on active component) 

No information available 

Review "HANDLING AND STORAGE (Section 7)". 

Passed to a licensed waste contractor. 

Incinerate with little portions. 

Risk of producing harmful gases such as carbon monoxide and nitrogen 

oxides. 

Dispose of waste in accordance with local,state and federal regulations. 

(14.TRANSPORT INFORMATION] 

Follow all regulations in your country or region 

UN CLASS/UN NUMBER : Not applicable 

00~ 
... KCDS-No. 102169-02 

PRECAUTIONS 

5 I 5 

[ J Revised Date January 28, 2004 

Review "ACCIDENTAL RELEASE MEASURES (Section 6)". 

Review "HANDLING AND STORAGE (Section 7)". 

Ensure containers without breakage or leakage. 

Ensure containers tightly fixed. 

Follow all regulations in your country or region. 

[15.REGULATORY INFORMATION] 

Follow all regulations in your country or region 

INVENTORIES : ENCS(Japan) Yes 

TSCA(USA) No 

EINECS(EU) Yes(Polymer) 

AICS(Australia) Not evaluated 

DSL(Canada) Not evaluated 

ECL(Korea) Not evaluated 

PICCS(Philippines) Not evaluated 

[ ]s not able to check up the regulatory information in regard to the substances in your country or 

region,therefore,we request this matter would be filled by your responsibility. 

[16.0THER INFORMATION] 

REFERENCE -Safety data sheet for chemical products - Part 1: Content and order of 

sections( ISO 11014-1) 

-International Chemical Safety Cards(ICSC) (Compiler's Guide)(1994) 

To the best of the manufacturer's knowledge, the information contained herein is accurate. However, neither the 

manufacturer, nor any of its affiliates, make any representations or warranties (expressed or implied), nor assumes 

any liability(including liability for any direct, incidental, consequential, or other damages) with respect to the accuracy 

or completeness of the information contained herein. Such information may be (without limitation) invalid if the 

specified material is used in combination with another ,in a particular process, or under unusual conditions. 

Determination of suitability of any material for any given purpose is the sole responsibility of the user who assumes all 

risk and responsibility therefore. All materials may present unknown hazards and should be used with appropriate 

caution. The manufacturer cannot and does not guarantee that the hazards described herein are the only ones that 

exist. 

000052 
I 

PreManufacture Notice and 

Notice of Commencement Forms 

~PA.Form 7710-25 (Rev. 5-95) 

EPA Form 7710-56 (Rev. -96) 

Installation and Use Instructions 

MS Word 6.0for·Windows 

COMPLIAN 

ASSISTANCE 

T 0 0 L S 

U.S. EPA Approved December 12, 1996 

by Anthony Cheatham 

TSCA Data Administration Section 

• 

l ~ Responsible Care· ' r A Public Commitment 

0000 ••