SANITIZED COPY 

September 22, 1988 

Document Control Officer 

Office of T~ic Substances (TS-790) 

U.S. Environmental Protection Agency 

Henkel Corporation 

ORGANIC PRODUCTS 

401 M Street, S.W. 

Washington, DC 20460 

Re: PMN SUBMISSIONS 

Dear Sir or Madam: 

§I -8~ c;;;r;;O -;j J1f 

p -$" ?' ~ :;;.;1f 

Enclosed are five Premanufacture Notices (PMN) for new chemical subtances. 

We have assigned our internal code PMN-H-PC 49, 52, 53, 54, 55 to these 

submissions. Since these PMH s contain CONFIDENTIAL BUSINESS INFORMATION, 

a saniti7ed copy of each PMN is attached for the public record. 

Please direct all ouestions and correspondence relating to these PMH's to 

Geogi Rauscher at 215-628-1342 or myself at 215-628-1345. 

Very truly yours, 

~or~L lne7 J. Kowalski, Analyst 

Regulatory Affairs Department 

Federal Exoress No. 8980311690 

Enclosures: 

IK/dmf 

300 Brookside Avenue, Ambler, PA 19002 (215) 628·1 000 Telex: 6B51092AMCHM UW 
&EPA 

SANITIZED COPY 

United States 

Environmental Protection 

Agency 

PMN-H-PC-52 O.M.B. No. 2070-0012: Approval Ex 

AGENCY USE 

Date of receipt 

PREMANUFACTURE NOTICE 

FOR NEW CHEMICAL SUBSTANCES 

DOCUMENT CONTROL OFFICER When 

completed 

send this 

form to: 

OFFICE OF TOXIC SUBSTANCES, TS-793 

U.S. E.P.A. 

401 M STREET, SW 

WASHINGTON, D.C. 20460 

Enter the total number of pages 

in the Premanufacture Notice 46 

GENERAL INSTRUCTIONS 

You must provide all information requested in this form to the extent that it is known to or reasonably 

ascertainable by you. Make reasonable estimates if you do not have actual data. 

Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" 

(Instructions Manual). 

Part I. GENERAL INFORMATION 

You must provide the chemical identity of the new chemical 

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

authorize another person to submit the identity for you, but your 

submission will not be complete and review will not begin until 

EPA receives this information. 

Part II. HUMAN EXPOSURE AND ENVIRONMENTAL 

RELEASE 

You may need additional copies of part II, sections A and B if there 

are several manufa~ture, processing, or use operations that you 

will describe in the notice. You should reproduce these sections 

as needed. 

Part Ill. LIST OF ATTACHMENTS 

You should attach additional sheets if you do not have enough 

space on the form to answer a question fully. In part Ill, list these 

attachments, any test data or other data, and any optional 

information that you include in the notice. 

OPTIONAL INFORMATION 

You may include in the notice any information that you want EPA 

to consider in evaluating the new substance. The Instructions 

Manual identifies categories of optional information that you may 

want EPA to review. 

CONFIDENTIALITY CLAIMS 

You may claim any information in this notice as confidential. To 

assert a claim on the form, mark (Xl 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 claim as 

confidential. If you claim information in the notice as confidential, 

you must provide a sanitized version of the notice, including attachments, to EPA with your submission. For additional 

instructions on claiming information as confidential, read the 

Instructions Manual. 

Indicate below the categories of information you have claimed as confidential in the notice. 

1 0 SUBMITTER IDENTITY 

2 0 CHEMICAL IDENTITY 

3 [X! PRODUCTION VOLUME 

4 [X! USE INFORMATION 

5 [X! PROCESS INFORMATION 

6 0 PORTIONS OF A MIXTURE 

7 1]1 OTHER INFORMATION 

EPA Form 7710-25 (4-26-831 

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 

ascertainable by you if these data are related to the health and 

environmental effects of 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, not summaries of data, 

must be submitted if they do not appear in the open literature. 

Following are examples of test data and other data. You should 

submit these data according to the requirements of §720.50 of the 

Premanufacture Notification Rule (40 CFR Part 720). 

Test data 

• Environmental fate data 

Spectra (UV, visible, and infrared) 

Density of liquids and solids 

Water solubility 

Melting point/melting range 

Boiling point/boiling range 

Vapor pressure 

Partition coefficient, n-octanollwater 

Biodegradation 

Hydrolysis (as a function of pH) 

Photochemical degradation 

Adsorption/desorption to soil types 

Dissociation constant 

Other physical/chemical properties 

• Heahh affects data 

Mutagenicity 

Carcinogenicity 

Teratogenicity 

Acute toxicity 

Repeated dose toxicity 

Metabolism studies 

Sensitization 

Irritation 

• Environmental effects data 

Microbial and algal toxicity 

Terrestrial vascular plant toxicity (e.g., seed germination studies, growth inhibition) 

Acute and chronic toxicity to animals (e.g., fish, birds. 

mammals, invertebrates) 

Other data 

• Risk assessments 

• Structure/activity relationships 

• Test data not in the possession or control of the submitter 

3-3-86 
SANITIZED COPY PMN-H-PC-52 

.,.. .. "' CERTIFICATION 

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

1 . The company named in part I, section A, subsection 1 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 PQssession 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. 

<It 

Contidential 

Signature of authorized official 

c2 

Date 

_dL 9- -)I ""-""' - r-? 

Signature Of agent - (if applicable} (/ Date 

Part 1- GENERAL INFORMATION 

~ Section A - SUBMITTER IDENTIFICATION Confidential Mark (XJ the "Confidential" box next to any subsection you claim as confidential. 

1a. Person Name of authorized official Title 

submitting James s. Lee Vice President, Coatings notice 

Company 

••••••••••••••••••••••••••••••••••••• 

Henkel Corporation 

t,.-... Mailing address (number and street) I·:•. ' 

Y~6~ 300 Brookside Ave. 

City, State, ZIP code 

Ambler, PA 1 900? 

b. Agent(if Name of authorized official Title 

applicable} 

Company I /:········· 

Mailing address (number and street) ~~~~,,;· > 

1{'. 

City, State, ZIP code r.~ > . 

. c. If you are submitting this notice as part of a joint submission, mark (XJ this box . D 

2. Technical Name Geogi Rauscher Title Manager, Regulatory Affairs contact Inez Kowalski Analyst, Regulatory Affairs 

Company .................... 

Henkel Corporation 

Mailing address (number and street) ••••••••• 300Brookside Avenue 19002 

City, State, ZIP code 1 Area code : Numbe'628 ... 1342 Ambler, PA Telephone : 21 5 I f\?Q_l ~LJ.l; 

3. If you have had a prenotice communication (PC) concerning this notice and EPA Mark IXJ assigned a PC Number to the notice, enter the number if none ----+ lXJ 

4. If you have submitted a test-marketing exemption ITMEI application for the chemical ~ark (XJ 

substance covered by this notice, enter the TME number assigned by EPA if none ----+ fXJ ,._ 

If you have submitted a bona fide request for the chemical substance covered by Mark (X) this notice, enter the bona fide request number assigned by EPA if none ----+ D y 

6. Type of Notice -Mark IX) 1 ~ Manufacture 2 D Import 

FORM EPA-7710·25 (4·26·831 Page 2 
SANITIZED COPY PMN-H-PC-52 

Part I- GENERALINFORM;\TION- Continued 

~ Section 8- CHEMICAL IDENTITY INFORMATION 

Mark lXI the "Confidential" box next to any item you claim as confidential. 

Complete either Item 1 or 2 •• appropriate. Complete ell other Items. 

If another person will submit chemical identity information for you, mark (X) the box at the right.-----+ 0 

Identify the name, company, and address of that person in a continuation sheet. 

1 . Cleaa 1 or 2 chemlcelaubatancea !for definitions of class 1 and class 2 substances, see the Instructions Menuell 

e. Class of substance - Mark IX) 1 lXl Class 1 2 0 Class 2 

b. Chemical name (preferably CAS or IUPAC nomenclature) 

Oxirane, 2,2'-(1,6-hexanediylbis(oxymethylene))b~sc. Molecular formula and CAS Registry Number (if known) 

Molecular Formul~: 12 H, 0~ 

CAS Registry Number: 16096-31-4 

Confidential 

d. For a class 1 substance, provide a structural diagram. For a class 2 substance - (1 lUst the immediate precursor substances with their X respective CAS Registry Numbers. 12) Describe the nature of the reaction or process. (3) Indicate the range of composition and the typical composition (where appropriate). (4) Provide a representative structural diagram (if possible). 

0 Mark IX! this box if you attach a continuation sheet. 

FORM EPA 7710·25 ~4·26·831 Page 3 
SANITIZED COPY PMN-H:PC-52 

Part I - GENERAL INFORMATION - Continued 

~ Section 8- CHEMICAL IDENTITY INFORMATION- Continued 

2 • Polymers (For a definition of polymer, see the Instructions Manual. l Confia. Indicate the lowest number-average molecular weight composition of the polymer you intend to manufacture. Indicate the maximum weight percent of low molecular weight species below 500 and below t .000 absolute molecular weight of that composition. Describe 

dential 

the methods of measurement or the bases for your estimates. 

Not Applicable 

0 Mark"tXrtrm: oo~if"V'du"attach a continuation shee,. - b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark {XI the "Confidential" box next to any item you claim as confidential. 

( 1 l - Provide the chemical name and CAS Registry Number of each monomer or other reactant used in the manufacture of the polymer. (21 - Indicate the typical weight percent of each monomer or other reactant in the polymer. 

(31 - 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. 

(4} - 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. 

Monomer or other reactant and CAS Registry Number Conti- Ty.pical Identity Confi· Maximum Contidential composition Mark IXJ dential residual dential ( 1} (2} (3} ' (4} 

% % 

Not Applicable· % % 

% % 

% % 

% % 

% % 

% % 

0 Mark IXJ this box if you attach a continuation sheet. 

c. Provide a representative structural diagram of the polymer, if possible. 

Nut Applicaf>le 

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

FORM EPA-7710-25 !4-26-831 Page 4 
SANITIZED COPY PMN-H-PC-52 • 

Part I -GENERAL INFORMATION -Continued 

~ Section B -CHEMICAL IDENTITY INFORMATION -Continued 

3. I mpuritlee 

fa I - Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for 

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

fbi - Estimate the maximum weight percent of each impurity. If there are unidentified impurities, estimate their total weight percent. 

Impurity and CAS Registry Number Maximum Confi- percent dential 

Ia I (b) 

% X 

% X 

% X 

% X 

% X 

% 

% 

D Mark lXI this box if you attach a continuation sheet. 

4. Synonym• - Enter any synonyms for the new chemical substance identified in subsection 1 or 2. Contidential 

1,6 Hexanediol diglycidyl ether 

D Mark lXI this boK if you attach a continuation sheet. 

5. Trade Identification - List trade names for the new chemical substance identified in subsection 1 or 2. 

Photomer 1017 

D Mark lXI this boK if you attach a continuation sheet. ···.·.·. 

6. Generic chemical name -If you claim chemical identity as confidential, enterthe generic chemical name that you developed with EPA 

during prenotice communication. If you have not developed a generic name with EPA, provide a generic name 

that reveals the specific chemical identity of the new chemical substance to the maximum extent possible. 

Read the TSCA Chemical Substance Inventory, Initial Inventory, Volume I for guidance on developing generic names. 

Aliphatic epoxy monomer 

D Mark lXI this boK if you attach a continuation sheet. 

7. Byproduct•- Describe any byproducts resulting from the manufacture. processing, use, or disposal of the new chemical substance at sites you control. Provide the CAS Registry Number if available. 

Byproduct CAS Registry Number Conti-

( 11 121 dantial 

X 

X 

X 

D Mark lXI this boK if you attach a continuation sheet. 

FORM EPA 7710.25 14·26·831 Page 5 
SANITIZED COPY PMN-H-PC-52 

Part 1- GENERAL INFORMATION- Continued 

Section C- PRODUCTION, IMPORT, AND USE INFORMATION 

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. Confi- ~-------------------------------------------------------,----------------------~----------------------------------4dential 

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 (XI the "Confidential" box next to any item you claim as confidential. 

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

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

(3) - 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. 

(4) - Mark (XI whether the use is site-limited, industrial, commercial, or consumer. Mark more than one column if appropriate. 

Read the Instructions Manual for examples. 

Category of use 

(1) 

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

b. Generic 

use 

description 

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. 

Coatings 

-Include in the notice a copy or reasonable facsimile of any hazard warning statement, label. material safety data sheet. or other information which will be provided to any person regarding protective equipment or practices for the safe handling. 

transport, use. or disposal of the new chemical substance. List in part Ill any hazard information you include. 

Mark (XI this box if you attach hazard information. 

FORM EPA·7710·2514·26-831 Page 6 

X 
... SANITIZED r.nPV PMN-J.I-Pr.-52 

' Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

~ Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER 

Ccamlllete MOtion A for NOh type of menufecture, proceeelng, or uee operation lnvolvlnt the- chemical su~Mm~noe etlndultrllll alta you control. 

. 

. 

Mark tXJ the "Confidential" box next to any item you claim as confidential. 

1 • Operedon d•crlpdon 

Confl· 

•· Identity- Enter the identity of the site at which the operation will occur. dentlel 

Name 

Henkel Corooration 

Site eddreu (number and street) i> 

3300WestinQhouse Blvd. ; > City, County. State, ZIP code 

Charlotte. Mecklenbura North Carolina 28217 i 

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

Identify the additional sites on a continuation sheet. I 

I 

0 Mark tXJ this box if you attach a continuation sheer. t:· .:,:,, 

i/• 

b. TypeMark tXJ 

1 Ill Manufacturing 2 0 Processing 30 Use 

c. Amount end Duration - Complete 1 or 2 as appropriate 

Maximum kg/batch I Hours/batch I Batches/year 

1. Batch I I 

1 X I 

Maximum kg/day I Hours/day I Days/year 

2. Continuous I I 

I I 

d. Process description 

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

t21 Provide the identity, the approximate weight lby kg/dey or kg/batch). end entry point of all feedstocks (including reactants. solvents, and catalysts). t3t Identify by number the points of release to the environment of the new chemical substance. 

0 Mark IX/ this box if you attach a continuation sheet. 

FORM EPA-7710-25 14·26·831 Page 7 
SANITIZED COPY PMN-H-P>C- 52 

Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued 

~ Section A - INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER - Continued 

2 • Occup.ftlonat Exposure 

You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance, number of workers exposed, and duration of activity. Mark (XI the "Confidential" box next to any item you claim as confidential. I 1 I - Describe the activities in which workers may be exposed to the new chemical substance. Include activities in which workers wear protective equipment. (2) - Indicate the physical form Is) of the new chemical substance at the time of exposure. (3) - Estimate the maximum number of workers involved in each activity. 

14) and (51 - Estimate the maximum duration of the activity for any worker in hours per day and days per year. 

Physical Maximum Maximum duration Worker activity ~fl· Conti· =I Confi· ntlal form(sl 

~· number Hrslday Days/yr dential 111 121 (31 (4) (51 

X liquid X X 

X Liquid X X 

X liquid X X 

X Liquid X X 

X Liquid X X 

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

3. Envn--mem.t R .... ae 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 (XI the "Confidential" box next to each item you claim as confidential. 

( 1 I - Emer the number ofeach release point identified in the process description, part II, section A, subsection 1 d(3). (21 - Estimate the amount of the new chemical substance released directly to the environment or into control technology (in kg/day or kglbatch). (31 - ldemify the media (air. land, or water) to which the new substance will be released from that release point. (41 -Describe control technology, if any, 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. 

(51 - Identify the destination(s) of releases to water. 

Release Amount of new substance Confl· Media of 

Number released release Control technology Conti-

(1) 121 dentlal (31 (41 dential 

X 

X 

X 

X 

X X 

(51 Mark lXI the 

destination(s) of 1 ~ POTW (publicly owned treatment works) 3 0 Other - spacitr.; 

releases to water. 2 0 Navigable waterway 

0 Mark tX/ this box if you attach a continuation sheet. 

FORM EPA-7710·25 1<1·26-831 PageS 
SANITIZED COPY PMN-H-PC-52 

Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -Continued 

~ Section B - INDUSTRIAL SITES CONTROLLED BY OTHERS 

Complete MCtion B for each type of proc:aalnt or UH operlltion involving the new chemic .. .....,__ lit.,. .. you do not control. 

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

Operation description 

Describe the ty~?ical proct:ssing or use operation. Identify the unit operation steps which may occur during the operation. Estimate the number of sttes at whtch the operation is likely to occur. Identify situations in which worker exposure to and/or environmental release of the new chemical substance may occur. Estimate the percent of new chemical substance as formulated in products manufactured for commercial purposes in the operation or as used in the operation. Estimate the number of wortters exposed and the duration of exposure. Identify controls which limit worker exposure and environmental release If typically used. Identify byproducts which may result from the operation. 

The PMN substance will be sold to industrial formulators and processors who sell 

their coatings mainly for industrial/commercial uses such as metal deco/can 

exteriors, but could also be used for certain plastic 11heet/containers and 

paper/paperboard applications. The above mentioned applications would fall under 

the area of curable coatings. The types of printing methods used could 

include: lithography, flexography, gravure, screen and curtain applications. 

In formulator mixes our PMN substance with other ingredients to 

form the coatings. Our material is used as a diluent or modifier in standard 

systems and thus is used in small quantities. A typical formulation is shown 

below: 

Ingredients 

Pigment (fillers etc.) 

Resin (epoxy) 

"Diluent" (PMN Substance) 

(may be one or more) 

Catalyst 

Additives (flow modifiers) 

CURABLE COATINGS 

Typical 

0-15 

5Q-60 

5-15 

2-15 

1-5 

Typical use levels of these reactive epoxy diluents 

are in the vicinity of 5-15% in the final coating. 

The curable coatings can be reacted or polymerized to the final inert coating or 

binder by several means including ultraviolet radiation (most common method), electron beam and infrared exposure. The reactive diluents collectively react with 

the resin in the formulation, yielding the inert final cured (cross-linked) 

polymer. 

It is expected that sites will use the PMN substance at. the 

formulator level and sites at the final user level. Formulators 

and users are aware of epoxy compounds and precautions are taken to limit exposure 

to these materials including adequate ventilation and use oi protective clothing. With use of proper precuations, all exposures should be negligible. The majority of the formulating process is mechanical with the material being transfered from 

drums to the blending equipment which consists of mechanical mixing or milling, and 

packaging of finished formulation. It is expected per site are 

[X] Arwl~~'fMtxtqFvou attaJ?,9J'Hi/hinb£\.JOnlDA-~fng and packaging operations per batch, 

FORM EPA·7710·25 t•·26-S31 PageS 
SANITIZED COPY PMN-H-PC-52 

\ ' Part Ill- 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 Contipage number(sl dential 

Page ~ Con't 1 

Summary of Physical and Chemical Properties 2 

Risk Assessment 3-4 

MSDS 5-R 

R & D Risk Assessment 9 

Infrared Spectra 10 

Primary Dermal Irritation Study 11-35 

Label 36 

-c#,'ll~. 

,cw.'" 

0 Mark IX) this box if you attach a continuation sheet. Enter the attachment name and number. 

FORM EPA-7710-25 (4-26-83! Page 10 
Page 9 Con't SANITIZED COPY PMN-H-PC-52 

Attachment Page 1 

CONFIDENTIAL 

however precautions will be taken to limit exposure. It is estimated that 

At ihe user will be working with a system containing the 

PMN substance , anywhere Any potential 

exposure should be very limited since the coating will be applied mechanically and 

levels of the substance will • Ventilation is provided and 

safety glasses, long gloves, aprons or other suitable protective gear is worn to 

protect workers from contact with the PMN substance and other chemicals used in the 

working place. No by products are expected as a result of the operations. 

The PMN substance may enter the environment in a controlled manner as a result of 

container disposal and clean up. If incineration is used, the PMN substance would 

be destroyed. Accidental spills or leaks will be contained and absorbed, then 

disposed of in accordance with all applicable Federal, state and local regulations. 

\ \ 
SANITIZED COPY PMN-H-PC-52 

Attachment Page 2 

CONFIDENTIAL 

SUMMARY OF PHYSICAL AND CHEMICAL PROPERTIES 

Appearance Pale yellow liquid 

Viscosity @ 25°C 20-30 cps 

Moisture <O. 2% 

Flash Point 

l~ 
SANITIZED COPY 

RISK ASSESSMENT AND DISCUSSION 

The PMN substance is a diglycidyl ether the result of reacting 

PMN-H-PC-52 

Attachment page3 

CONFIDENTIAL 

In comparison with the starting 

materials, the toxicity of the final product is expected to be lower. Residual 

epichlorohydrin is expected to be <20 ppm after being removed by distillation. 

This PMN substance will be used in various types of ultraviolet, electron beam 

or infrared curable coating formulations. 

The product is expected to be mildly irritating to the skin and eyes. Toxicity 

data for Primary Dermal Irritation resulted in a Draize score of 1.11/8.00, see 

attachment pages 11-35. Significant irritation of the eyes, skin or respiratory 

tract under normal use is not expected as long as proper handling procedures 

are followed. Diglycidyl ethers as a group seem to cause some skin sensitization 

on prolonged and repeated use if not handled properly. If misting occurs under 

unusual circumstances, however, the PMN. substance could be irritating to the 

mucous membranes and respiratory tract. Concerns exist with regard to health 

effects of these ethers. It is our understanding that many products of this 

type show positive Ames results. Furthermore, carcinogenicity bioassays have 

yielded negative results for a number of such compounds. In any event, we 

believe that proper handling precautions and information on our MSDS's will 

allow these products to be used safely. 

Manufacturing personnel are experienced and aware of proper handling procedures 

for chemicals and wear safety glasses, gloves and other suitable protective 

clothing when contact with chemicals is anticipated. It is anticipated that 

people may be working at different operations during the manufacturing phase of 

the PMN substance for hours for days per year. Most of the 

manufacturing activity takes place in a closed system and adequate ventilation 

is provided. 

Formulators using the PMN substance in curable coating formulations may be 

exposed to the PMN substance during its addition to the high shear mixing 

vessel. Levels of the PMN substance in the coatings generally is not expected 

to exceed 30%. Typically workers at sites will be 

involved in the mixing operation for for packaging per batch. 

It is anticipated that batches per year per site would be made on the 

average. Workers would wear appropriate protective clothing and gloves to 

insure safety. Processors are familiar with the hazards of epoxy compounds and 

these procedures will be performed where adequate ventilation is available. At 

the user level workers per site, , will be working 

with a system using the PMN substance about hours per day, anywhere from 

days per year. The coating is applied mechanically at ambient temperature 

either by curtain or a transfer coater or rolled on in a controlled and 

ventilated area. Due to its nature as a reactive diluent, the PMN substance is 

expected to react completely upon cure. If any PMN substance were to enter the 

air it should be contained when typical ventilating systems are used. 

Discharges to water or land should also be controlled. The PMN substnce is a 

liquid and it is expected that during the manufacturing phase, tank washings, 
Risk Assessment Con't 

POTW. The 

SANITIZED COPY PMN-H-PC-52 

Attachment Page 4 

CONFIDENTIAL 

clean-out will contain some PMN material. 

be sent out to a chemical waste landfill. Empty 

drums from a processor are expected to be washed and then sent to a drum 

reclaimer. 

As with any chemical substance, accidental leaks or spills may occur. The 

material will be contained with an absorbent and disposed of in accordance with 

local, state and Federal government regulations. 

This PMN substance, a reactive "diluent", exhibits the following improved 

characteristics over standard "reactive diluents" presently being used in the 

industry segment. 
SANITIZED COPY PMN-H-PC-52 

Attachment page 5 

::G:~r-I i)Li;TIAL 

Henkel Process Chemicals, Inc. 

350 Mt. Kemble Avenue, CN 1931 

Morristown, New Jersey 07960-1931 

MATERIAL SAFETY DATA SHEET 

l Slight Health Hazard 1 Slightly Combustible 1 Slightly ~eactive 

Ratings based on NIOSH Identification System for Occupationally Hazardous Materials 1974. 

Complies with 29 CFR 1910.1200 OSHA Hazard Communication Standard. 

DEPARTMENT OF TRANSPORTATION INFORMATION 

PROPER SHIPPING NAME: 

Not Applicable 

I PRODUCT IDENTIFICATION 

Manufacturer's Name 

HENKEL PROCESS CHEMICALS, INC. 

Address 

350 Mt. Kemble Avenue, CN 1931 

Morristown, New Jersey 07960-1931 

Product NamE( ) 

PHOTOMER R 1017 

Synonyms 

Diglycidyl Ether of 1,6-Hexanediol 

II HAZARDOUS INGREDIENTS 

Material or component 

Diglycidyl Ether of 

1,6-Hexanediol 

Traces of epichlorohydrin (106-89-8) 

are present in this product. 

PEL = OSHA Permissible Exposure Limit 

III PHYSICAL DATA 

Boiling Point, 760 rnrn Hg 

Not Available 

Specific Gravity (H2

0=1) 

Not Available 

Vapor Pressure 

Not Available 

Solubility in H2

0, % by WT. 

Insoluble 

Evaporation Rate (Butyl Acetate = 1) 

Not Available 

HAZARD CLASS: 

Not Applicable 

Regular Telephone No. 201/540-9888 

24 Hour Emergency Phone No. 201/267-1000 

% 

100 

Hazard Data 

PEL: None Established 

PEL: 2 ppm, skin, 8-hr TWA (ACGIH) 

5 ppm, skin, 8-hr TWA (OSHA) 

Melting Point 

Not Applicable 

Freezing Point 

Not Available 

Vapor Density (Air = 1) 

Not Available 

% Volatiles by Vol. 

Nil 1-. 

. 00 Dens~ty at 2 C 

Not Available 
SANITIZED COPY PMN-H-PC-52 

Attachment page 6 

CONFIDENTIAL 

Appearance and Odor 

Light yellow, almost water-white 

liquid; slight odor. 

Viscosity 

23 cp Brookfield 

IV FIRE AND EXPLOSION DATA 

Flash Point (Test Method) 

> 200°F (93°C) PMCC 

Flammable Limits in Air, %by Vol. 

Extinguishing Media 

Water spray, C02 , dry chemical. 

Special"Fire Fighting Procedures 

pH 

Not Available 

DEVELOP EMERGENCY ACTION PLAN 

Autoignition Temperature 

Not Available 

Lower Upper 

Not Available Not Available 

Cool exposed containers with water spray. Self-contained breathing apparatus in 

confined areas. 

Unusual Fire and Explosion Hazard 

Product may polymerize at high temperatures. Polymerization is a highly exothermic 

reaction and may produce sufficient heat to cause thermal decomposition and/or rupture 

of containers. Thermal decomposition can lead to the evolution of irritant vapors or 

gases and/or fires. 

V HEALTH HAZARD INFORMATION 

Health Hazard Data 

Product may contain traces of epichlorohydrin which, based on animal studies, is listed 

in the International Agency for Research on Cancer Annual Report. 

Routes of Exposure 

Inhalation 

Not expected to present a hazard due to low volatility at room temperature. 

Inhalation of mist or vapor may cause irritation of respiratory tract. 

Skin Contact 

May cause irritation. May be a sensitizer. 

Skin Absorption 

No data. 

Eye Contact 

May cause irritation. 

Ingestion 

Considered slightly toxic. 

Effects of Overexposure 

Acute Overexposure 

May cause skin and eye irritation. Inhalation of mist may cause irritation of 

respiratory tract. 

I~ 
Chronic Overexposure 

No data. 

SANITIZED COPY 

Emergency and First Aid Procedures 

Eyes: 

PMN-H-PC-52 

Attachment page 7 

CONFI':'ENTIAL 

Flush at once with large amounts of water for at least 15 minutes holding lids apart. 

Washing within one minute is essential to achieve maximum effectiveness. Get medical 

attention. 

Skin: 

Wash thoroughly at once 

clothing and footwear. 

decontaminated on inner 

develop. 

Inhalation: 

Remove to fresh air. 

Ingestion: 

DO NOT induce vomiting. 

Get medical attention. 

Notes to Physician 

None 

VI REACTIVITY DATA 

with large amounts of soap and water. Remove contaminated 

Wash clothing before reuse. Discard footwear that cannot be 

surfaces. Get medical attention if irritation should 

If vomiting should occur spontaneously, keep airway clear. 

Never give anything by mouth to an unconscious person. 

Conditions Contributing to Instability 

Heat; organic or inorganic free radical producing initiators; exposure to sunlight, 

ultraviolet light or other ionizing radiation; contamination with alkaline substances; 

trace metals. 

Incompatibility 

Primary and secondary amines, acids, alkalies, free radical producing initiators. 

Hazardous Decomposition Products 

CO and co2 • 

Conditions Contributing to Hazardous Polymerization 

Direct heating, dirt or chemical contamination, sunlight, ultraviolet light or ionizing 

radiation. When it is required to warm product, a controlled temperature not exceeding 

45°C may be used for limited periods. 

VII SPILL OR LEAK PROCEDURES 

Steps to be Taken if Material is Released or Spilled 

Stop leaks. Large spills should be cleaned up immediately by vacuum truck. Small 

spills should be soaked-up with absorbent materials and placed in labeled waste 

container for disposal. Wear adequate personal protective clothing and equipment. 

Waste Disposal Method 

Dispose of in an approved chemical waste landfill or incinerate in accordance with 

applicable Federal, State, and local regulations. Storage of waste material for greater 

than 90 days must meet the requirements of the Resources Conservation and Recovery Act. 

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SANITIZED COPY 

VIII INDUSTRIAL HYGIENE CONTROL MEASURES 

Ventilation Requirements 

Local exhaust ventilation. 

Specific Personal Protective Equipment 

Respiratory {Specify in Detail) 

PMN-H-PC-52 

Attachment page 8 

CONFIDENTIAL 

None required under normal use. NIOSH/MSHA approved respirator if necessary. 

Follow manufacturer's recommendations. 

Eye 

Chemical splash goggles or face shield. 

Gloves 

Gauntlet gloves of polyethylene or PVC lined polyethylene liners with frequent 

disposal. 

Other Clothing and Equipment 

Barrier creams, disposable coveralls. 

IX SPECIAL PRECAUTIONS 

Precautionary Statements 

CAUTION! MAY CAUSE IRRITATION 

Avoid contact with eyes, skin and clothing. 

Avoid breathing mist or vapor. 

Wear chemical splash goggles, gloves and protective clothing when handling. 

Use with adequate ventilation and employ respiratory protection where spray 

or mist may be generated. 

Wash thoroughly after handling. 

Avoid contact with amines, acids, alkalies and free-radical initiators to prevent 

decomposition. 

Avoid contact with heat, dirt, chemicals and radiation to prevent hazardous 

polymerization. 

Keep container closed. 

FOR INDUSTRIAL USE ONLY 

Other Handling and Storage Requirements 

Product may congeal or stratify if subjec~·ed to below freezing temperatures. Allow to 

warm to room temperature and mix well before using. DoE£! heat above 90°F (32°C). 

Store in a cool, shaded, well-ventilated, dry area away from direct heat and sunlight. 

Store away from foodstuffs, organic peroxides or other materials likely to initiate 

polymerization. 

Prepared by: William J. Meyers DATE: January 31, 1986 

All information recommendations and sug.gestions appearing herein concerning our product are 

based upon tests and data believed to be reliable. However, it is the user's 

responsibility to determine the safety, toxicity, and suitability for his own use of the 

product_described herein. Since the actual use by others is beyond our control, no 

guarantee, expressed or implied, is made by Henkel Process Chemicals, Inc. as to the 

effects of such use, the results to be obtained, or the safety and toxicity of the product 

nor does Henkel Process Chemicals, Inc. assume any liability arising out of use, by others, 

of the product referred to herein. The information herein is not to be construed as 

absolutely complete since additional information may be necessary or desirable when 

particular or exceptional conditions or circumstances exist or because of applicable laws 

or government regulations. 

_., 
SANITIZED COPY PMN-H-PC-52 

Attachment Page 9 

CONFIDENTIAL 
SANITIZED COPY PMN-H-PC-52 

Attactvuent Page 10 

CONFIDENTIAL 
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FOOD & DRUG RESEARCH LABORATORIES, INC. 

ROUTE 17C. P. 0. BOX 107, WAVERLY. NY 14192·0107 607 565·8131 

PRIMARY DERMAL IRRITATION STUDY 

OF 

PHOTOMER 1017 · 

IN 

NEW ZEALAND WHITE RABBITS 

PMN-H-PC-52 

Attachment page 11 

CONFII)ENTIAL 

FDRL Study No. 9598C 

et • , Submitted to : Henkel · Corporation Morristown, NJ 07960 

As ciate Toxicologis 

Date: November 25, 1987 

S~y Dir:cto~ 

c jame ~2 ·r: g. LaVeg i .. , Vice President 

Director of Toxicology 

Tllis report Is •nte4 fer the erclusiYe use tl the t~trson, t~~rtllershlp, If arp~ntion II.._ It Is.,....., ... ee1t11tr lit-".., lit-tf 1111se 

la~oraleries .. r tf 111J ••bers ef Its staff. IIIIJ lie IBed In CllllleCiion with the ~ ., \e tf 11J IINMt tr 1nCf! ' .. ,. ''tell lllllerlratfell. 

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table of Contents 

Contents 

ABSTRACT •• 

INTRODUCTION • . 

MATERIALS AND METHODS. 

Protocol . • • • . . Test Article and Preparation • 

AnimHls and Animal Husbandry Dose Administration .••.••••• 

Test Site Evaluation . . • • • 

Observations and Body Weights. Data Evaluation-Dermal Irritation Scores • 

RESULTS Ah~ CONCLUSION 

Deraal Irritation .• 

REFERENCE. 

Appendices 

I Protocol •• 

II Raw Data. 

III FDRL Personnel Responsibilities • 

PHN-1-1-PC-52 

Attachment page 12 

CONFIDn!TIAL 

FDRL Study No. 9598c 

Page Nos. 

ii 

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1-3 

1 

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1-2 

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1-7 

1-7 

IV Quality Assurance Unit and GLP Coapliance Statements. 

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ABSTRACT 

PMN-H-PC-52 

Attachment page 13 

CONFIDENTIAL 

FDRL Study No. 9598c 

Pbotomer lOli was evaluated for potential primary_ dermal irritation using 

six New Zealand White rabbits. Each rabbit was administered 0.5 al of the 

test article to one intact test site. Each test site was semi-occluded for 

four hours following dose administration. Dermal irritation was scored at 

0.5, 24, 48, i2 hours, 4, i, 10 and 14 days after patch removal according to 

the Draize method. 

The test article produced dermal irritation characterized by very slight 

to well-defined erythema. One rabbit exhibited very slight edema 24 hours 

after patch removal. Test article application also caused dry skin in two of 

six rabbits. No dermal irritation was noted ten days after dose 

administration. Based on the 24, 48 and i2 hour readings, the sean primary 

dermal irritation score was determined to be 1.11. 

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Ih"TRRDUCTIOt\ 

P~1N-H- PC- 52 

Attachment page 14 

CONFIDE~TIAL 

FDRL Study No. 9598c 

The purpose of this study was to evaluate the potential pri•ary der.aal 

irritation of Photomer 1017 when administered to New Zealand White rabbits. 

The study was authorized by W. Monroe Atkinson, Senior Analyst, Regulatory 

Affairs Department, Henkel Process Chemicals, Inc., Morristown, New Jersey on 

October 1, 198i. The study was conducted from Nove.ber 3 to November 17, 1987 

in accordance with the regulations for Good Laboratory Practice as described 

by the FDA (21 CFR Part 58) and EPA (40 CFR Part 792), the Toxic Substances 

Control Act, Health Effects Test Guidelines (1982) and FDRL Standard Operating 

Procedures. All data and pertinent records have been retained by FDRL and are 

available to the Sponsor upon request. 

MATERIALS AND METHODS 

Protocol 

The Study Protocol is given in Appendix I. 

Test Article and Preparation 

The test article was received at FDRL on October 23, 1987. It was 

described as Photamer 1017 by the Sponsor and assigned FDRL Identification 

Number 87-G433. The test article was dispensed as received. 

yillals and Aniaal Husbandry 

Young adult New Zealand White rabbits (Ace Aniaals, Inc., )oyertGWD, 

PA) were acclillated to the laboratory envinmJ~ent for a ainillua of 6 daya. 

They were observed daily during the acclt.ation period to assure their 

suitability as test animals. All housing and care conforwed to the ~ttiiDdarda 

established in "Guide for the Care and Use of Laboratory Aniaals" DREW 

Publication No. (NIH) 85-23. The anima~• were housed individually in 

wir.-.esh cages and identified by ear tag and cage card. Food (NIH 09 Rabbit 
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Attachment page 15 

CONFIDENTIAL 

FDRL Stucly No. 9598c 

Ration, Zeigler Brothers, Inc., Gardners, PA) and fresh tap water were 

supplied ,gg libitum. Six animals weighing between two and three kiloarwere aelected randomly from the acclt.ated colony and assianed to the t .. t 

1roup. 

Dose Administration 

The back of each rabbit was clipped with an electric clipper on the 

day prior to dosing. The ·test article was topically applied to one intact 

test site per rabbit. Immediately after doee administration, each test site 

was semi-occluded with a gauze patch held ·in. place with Micropore® tape. In 

addition, the animals were fitted with circular collars to prevent patch 

removal. The patches and collars were re.oved four hours after application 

and the exposure sites gently wiped with gauze to reiiOVe as IIUch non-absorbed 

test article as possible. 

Test Site Evaluation 

Dermal irritation was evaluated at 0.5, 24, 48, 72 hours, 4, 7, 10 

and 14 days after patch re.oval. Erytbe.a and eel-. were scored aeparately 

according to the Draize .ethod given in Appendix I. 

Gbservations and Body Weilhts 

.'l'he anU.ls were observed twice daily for 110rtali ty at leut 6 haara 

apart. Body weights ~re obtained on atud)' ·day 1 prior to dose 

I adllini8tration. At study teraination, the Dmals were wthlmi&ed by 

intracardiac injection of sodiua pentobarbital and discarded. 

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Data Evaluation-Dermal Irritation Scores 

Pt~N-H-PC-52 

Attachment page 16 CONFIDENTI.A~ 

FDRL Study No. 959Sc 

A mean primary dermal irritation score was calculated for the test 

animals. Six individual animal scores were calculated· from dermal irritation 

readings taken at 24, 48 and 72 hours following patch removal. Individual 

animal scores were obtained by adding the total erythema and eschar for.ation 

score to the total edema formation score and dividing by three. The aean of 

the six individual animal scores represents the aean primary irritation score. 

RESULTS AND CONCLUSION 

Dermal Irritation 

Individual dennal irritation score data is given in Appendix II. The 

test article produced dermal irritation characterized by very slight to 

~''"'""""' well-defined erythema. One rabbit exhibited very slight edema. 24 hours after 

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patch reaoval. Test article application also caused dry akin in two of six 

rabbits. No dermal irritation was noted ten days after dose administration. 

Based on the 24, 48 and 72 hour readings, the ~ prt.ary dermal irritation 

score was determined to be 1.11. 

REFERENCE 

Draize, J. H., 1965. Appraisal of the Safety of Chemicals in Foods, Drugs ud Coaaetics. Association of Food ud Drug Officials of the Uaited 

States, Topeka, Kansas. 
P~"J-H-PC-52 

'~ SANITIZED COPY Attachment page 17 

CONFIDENTIAL 

/''"~') FDIU. Study No. 9598c 

II 

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I Appendix I 

I Protocol 

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Study Title: Primary Dermal Irritation Study 

in Rabbits (EPA/TSCA) 

P~N-H-PC-52 

Attachment page 18 

CONFIDENTIAL 

FDJU. Protocol t;o. 408 

1/87 

Paae 1 of 5 

Testing Facility: Food and Drug Research Laborator:les, Inc. 

Waverly, ~ew lork 14892 

S~onsor and Address: Henkel Corporation 

Morristown, NJ 07960 

Sponsor's Representative: Monroe Atkinson 

FDRL Study ho: 959SC 

Test Article 

Sponsor ID: Photomer 1017 

FDRL ID: 87-0433 

Vehicle: Not applicable 

Schedule 

Proposed Start Date: 10/30/87 

Proposed Completion Date: ll/13/87 

Proposed Final Report Date: 12/4/87 

Approval of Protocol 

Study Director: 

Sponsor: 

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bate: 10/l/87 
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Attachment page 19 

CONFIDENTIAL 

Pase 2 of .5 

A. Purpose - To evaluate the primary dermal irritation of the test 

article when administered to New Zealand White z·abbits. 

B. Choice of Test System and Route of Administration of Test Material 

New Zealand White rabbits have been shown to be sensitive to the 

toxic effects of a variety of chemicals and have been used extensively. Dermal dosins corresponds to a likely route of human 

exposure. 

c. Test Article - Sufficient quantity of the test article-from th~ · · 

same batch or lot should be provided to complete the study. __ The 

Sponsor is responsible for maintainins records of the test article 

purity, source and other data required by 21 CFR Part .58.10.5. 

Storase conditions and safety precautions will be provided by the 

Sponsor. 

D. Animals and Animal Husbandry -All houlins and care shall conform 

to the standards established in •Guide for the Care and Uae of Laboratory Animals• DREW Publication No. (NIB) 8.5-23. 

1. Species/Strain: New Zealand White rabbits. 

2. Source: . ~ FDIU. and USDA approved supplier. 

3. Age at Initiation: Youns adult. 

4. Number: 6 

5. Identification: Ear tas, color coded caae taa. 

6. Housing: Individually houaed in vire-.esh bottom caaes • 

.. 7. Food: NIH 09 Rabbit lation, ad libitum, supplied fresh daily. No known contaminants are expected to be present in the basal diet that would interfere with the conduct of this atudy. 

8. Water: Tap water, ad libitum. Water is .onitored for contaminant~at periodic intervals accordins to FDRL Standard Operatins Procedures 

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Attachment page CONFIDENTIAL 

Page 3 of 5 

9. Environment: All animals will be housed in environment-controlled rooms as per "Guide for the Care and Use 

of Laboratory Animals". A 12-hour li&ht-dark 

cycle will be maintained. 

10. Quarantine: Minimum of 5 days. Durin& this conditioning 

period, the rabbits will be observed for any 

clinical signs of disease. All rabbits with any 

evidence of disease or physical abnormalities will 

be dis carded. 

E. Dosing- Dosing will be done via dermal application. 

F. Experimental Design 

No. of 

Animals 

6 

Test Article 

Level 

0.5 ml if liquid; 0.5 g if eolid 

or semi-solid, moistened with 

0.5 ml physiological sa!ine 

1. Animals will be weighed prior to the initiation of the study. 

2. On the day prior to dosing, the fur shall be clipped from the 

back and flanks of each animal. 

3. The test article will be applied to one intact site per animal. 

All sites will have an area of one square inch. 

4. Each test site shall be aemi-occluded with a one square inch 

gauze patch, two single layers thick, held on with surgical 

tape. Collars will be placed around the animals' neck to 

prevent removal of patches during period of exposure. 

5. The patches will be left on the animals for 4 hours following 

application of the test article. After 4 hours, the patches 

will be removed and the te1t aites aently wiped using a 1oft 

clean gauze. 

6. Skin lites will be examined at o.s, 24, 48 and 72 hours 

following patch removal. Erythema and edema will be acored 

individually and evaluated according to the method of Draize, 

1965 (see Attachment I for Draize 1corina method). the aites 

will be examined and acored on day 4, 1, 10 and. 14 if 

irritation persists. 

G. Terminal Studies - After the end of the observation period all 

animals will be euthanized with sodium pentobarbital and discarded. 

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Attachment page 21 

CONFIDENTIAL 

Page 4 of 5 

H. Analysis of Data - The scores for ~rythema, eschar formation and 

edema at 24, 48 and 72 hours will be added. The six values are 

then divided by 3 yielding 6 individual animal scores. The mean of 

the 6 individual animal irritation scores represents the mean 

primary irritation score. 

I. Final Report - Two copies of the final report will be submitted to 

the Sponsor. The final report will include all information necessary to provide a complete.and accurate description and evaluation 

of the test procedures and results. The report will contain all 

procedures used for the study. 

J. Retention of Data - All data including reports from this study will 

be retained in accordance with the pertinent sovernment resulations. In any case, the Sponsor will be contacted prior to disposition of these materials. 

K. Compliance with Government Regulations - The study will be conducted according to the Good Laboratory Practice regulations aa described by the FDA (21 CFR Part 58), the EPA (40 CFR Part 792), FDRL 

Standard Operating Procedures and the Toxic Substances Control Act, 

Health Effects Test Guidelines (1982, NTIS Publication No. PB-82-

232984 and 1983, NTIS Publication No. PB-83-257691). Cbanses in 

the protocol will not be made without the specific written request 

or consent of the Sponsor. In the event that the Sponsor authorizes a protocol chanse verbally, auch change will be honored by 

FDRl. However, it then becomes the responsibility of the Sponsor 

to follow such verbal change with a written verification. 

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Attachment page 22 

CONFIDENTIAL 

Page 5 of 5 

lf departure otherwise occurs·from this protocol or the GLP 

regulations, this will tmmediately be brought to the attention of 

the Sponsor. 

L. Quality Assurance - This study will be inspected and the final 

report reviewed by FDRL's Quality Assurance Section in accordance 

with FDRL's Standard Operating Procedures alons with the pertinent 

government regulations. 

M. Reference 

Draize, J .H., 1965. Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Association of Food and Drug Officials of 

the United States, Topeka, Kansas. 

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AttachiDent 1 

Erythema and eschar formation: 

No erythema •• . . . • • • • • • • • • 0 

Very slight erythema (barely perceptible). • 1 

Well-defined erythema ••••• . . . . . 2 

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

Severe erythema (beet redness) to sli&ht 

eschar formations (injuries in depth). • 4 

Edema formation: 

No edema •• . . . . . . . . . . . . . • • • 0 

Very slight edema (barely perceptible) • . . 1 

Slight edema (edges of area well defined 

by definite raisin&) • • • • • • • • • • 2 

Moderate edema (raised approximately l mm) • 3 

Severe edema (raised more than l mm and 

extending beyond the area of exposure) • • 4 

1-7 ~·~. 

P~N-H-PC-52 

Attachment page 23 

CON PI DENTIAL 

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~'"' Data 

Primary Skin Irritation Score Sheet - Rabbits 

PMN-H-PC-52 

Attachment page 25 

CONFIDENTIAL 

FDRL Test Article I.D. No.: 1?- p/j3 FDRL Study No.: 9:J9lC. Tirne Dosed: £·,;;La UAJ..,'"f f.l:>~ 11/~tl .Date: tl!:i/32 Dosed by: · if~ Dos.age (per site) : t> . .S ,.._I 

Study 'Design: £///? 7:!C.A 

"l'ech. 

Scoring 

Erythema 

and 

Observation 

after patch 

removal 

(hours) Skin 

$'<o~;rt '" 

0 .S I ;so Intact 

24 

Eschar 

Fo~tion~~~~~~~----~-----~~~~~~~~~~~~~~--~~~ 

Edema 

Formation 

0.5 Intact 

Intact 

48 Intact 

72 Intact 0 

(B) Edetn!. Sub-total 0 

(C) OVerall total • (A+B) I U I~ I / J 7 L.? IJ J 

Mean Score / 

(D f 6) • I I 

Reviewed and Calculated by: _.fvi.J.f:. ____ _ Date: 11//)/[] 

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Ra"'' Data 

PMN-H-PC-52 

Attachment page 26 

CONFIDENTIAL 

Primary Skin Irritation Score Sheet - Rabbits 

FDRL Material I. D. No.: 47- olo :> FDRL Study No. : %?J' C 

Time Dosed: ___ ... 9_;;;;..~---:-------

Dosed by: ___ ..:;.j;;...__....-..;::;J_;t/____ _ 

Date: 1161/3'7 I 

Dosa9e (per site): (),S ~ 

~/1 ---j, <./' A Study Desi9n: __ ...::!;;!Z::;;;...:fi;...__.;......;;J-;._I"t___ _ 

Observation 

Scoring Tech. Date Skin 

Erythema Intact 

and Intact 

Eschar Intact :orma~ionl_.~~~~~~r--~~-~~~~~~~r-~~~~~--+-~-+~~~ 

Intact 

4 Intact 

Edema 7 Intact 

Formation 10 Intact 

14 I Intact I 

Comments: FOo~..f.c..~ - see- C4C.-..~f e;kee,/. 

Reviewed and Calculated by: -Jt~t..-=----- oate = _f.! /tz/!7 

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COMMENTS 

PM~l~H~PC~52 · 

Attachment page 27 

CONFIDENTIAL 

study No. : __ ""'""95?3-.~C;;;;..... __ _ 

Date Dosed: 11£$1 --~~~------

f' ~l·~-,,·"" rlrc.~ :C\ r:.d\ . tF Itt 

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Study Title: _ ___..fy~_f _____ _ 

FDRL Identification No.: !?- 0{03 

Date 

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Balance Calibration 

and Work Log 

Weioht (k_g) I 

Appliec Read ! Difference 

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CONFIDENTIAL 

FDRL Study No.: f.:)f!'t. 

Scale i Technician 

No. I Initials 

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Note: Scales not complying with SOP specifications are not to be used. Report to study directors. 

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Body Weight Sheet 

Type o! Test: 

PMN-H-PC-52 

Attactvnent page 29 

CONFIDENTIAL 

FDRL Study l~o. : ?t5?Jc, 

Initiation Date: lt/a/'37 

Animal Number Ini'tial 

and Sex Body Weight 

(kg) 

J'J- LJ2&_i'>'- I :;.s·~ 

:17- ff114~ I ~~.~b 

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I 37- ~9~ ,._ ~· 5'5 

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M- "h/r? Date: erl I 

comments: Received from Ace~Animals, Inc1 on 1oJ'? ,qh~. 

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Attachment page 30 CONFtDENHAL 

TEST ARTICLE PREPARATION DATA 

Study Title:C;Jt,../j?t/-'------------- FDRL Study No.: tf:>fJY(?~ -·- Species: · · . 

Test Article I. D. No.: J7--(Jfl2 

Diluent (if app.: lot•/exp.date): 

----~~~DN~t~~---------

Prepared Cone. t./.A r/l r. w/v,w/w, v/v 

Total Allount Dispensed -?c ; aa@ 

Prepared Physical state:tb.Ts {kt~.t~ d) 

Other .aterials: 

Procedures and Measurements: 

~st article dispensed undiluted; c:Jrest article around.in a mortar: 

c:Jrest article sieved (no. __ sereen);E:]Test article heated in water bath 

( •c); r:Jrest article diluted as follows: 

0Weiahed _ mg, am of test article 

0 Measured _ 11l, ml of test article 

Calibration 

Balance No. _ Balance No. 

0 C. S. to ---- ml with diluent Net Wt. Net Wt. 0 Adcied __ ml of diluent 

QAdded __ g of diluent 

Tare \oit. ___ Tare Wt. __ 

Gross Wt. Gross Wt. 

0 Other: see additional notes 

Test Mixture Was: c:J Stirred; 0 Blended at _ speed; 0 Sonicated; 

0Beated to _ •c in a water bath; Oother: 

Dosing Information 

L!vel Coefficient• <-alka> (g/kg) 

pB and Demsi ty 

petenpinations 

- pH of lOr. w/v aqueous •ixture 

- Teat article ~ensity: ' 

Additiopal Notes:---------------------------------------------------

--------------------------------------------·-----------------------

Initial and Date: Calc~lations Jf!tt/111/11 Preparation lftt/¢:1 Review j_t:' tt?rZ/J7 

,/ ec,..I.L.I I d~ \~I • Coefficient x BWt {kg) = Dose {ml). 

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Appendix III 

P~1N-H-PC- 52 

Attachment page 31 

CONFIDENTIAL 

FDRL Study No. 9598C 

FDRL Personnel Responsibilities 

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Personnel 

J.A. Biesemeier, B.S. 

J.G. Laveglia, Ph.D. 

F.F. Paul, B.S. 

E. L. Reagan, A.A.S. 

D.A. Webster 

---·----------

·SANITIZED COPY 

FDRL Personnel Responsibilities 

Job Title 

President 

PMN-H-PC-52 

Attachment page 32 

CONFIDENTIAL 

FDRL Study No. 9598C 

Vice President/Director of 

Toxicoloay 

Manager of Ouali ty Assurance 

and Archiving Functions 

Associate Toxicoloaist 

Coordinator of Toxicolo&y 

Technical Services 

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Appendix IV 

Quality Assurance Unit and 

GLP Compliance Statements 

IV-1 

~3 

P~1N-1-1-PC-5?. 

Attachment page33 

CONFIDENTIAL 

FDRI. Study No. 9598C 

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P~N-H-PC-52 

Attachment page 34 

CONFIDENTIAL 

FDRL Study No. 9598C 

This final report was reviewed as required by Good Laboratory 

Practice Regulations for non-clinical laboratory. studies, 21 CF:R 

Part 58~ 40 CFR Part 792 and the study protocol. lDapectiontl were 

acca.plished as noted, and reported to the study director and 

.anagement t.mediately following their ca.pletion. Baaed on these 

iDapections and the review of the report, this study was conducted 

and reported in conformance with the Good Laboratory Practice 

reaulations. 

STUCY NO . . 9.5.9. K QAU INSPECTION SCHECUUE (ACUTIE8) 

INSPECTION OATES TYPE TEST 

DATE lltESUL. TS lltEIDORTEC TO MANAGEMENT 

,4 PSI ~- _, ...... --~ ... - J Nl· ..... Jt/! A 

(I 

13 J)5.I: ~-· " J. _._.~-

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GLP COMPLIANCE STATEMENT 

PMN-H-PC-52 . . 

Attachment page 35 

CONFIDENTIAL 

FDRL Study No. 9598c 

I hereby certify that this study was performed in compliance with 

regulations for Good Laboratory Practice (GLP) as described by the EPA (40 

CFR Part 160 and 792) and FDA (21 CFR Part 58). 

[Jb~ &-- Study Director ~ 

Date 

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PHD TOMER® 

1017 

S lABEl COMPLIES WITH THE OSHA FEDERAL HAZARD HUNICATION STANDARD, 29 CFR 1910. 1200. 

Warranty and limitation of Damages: Seiier warr(lnts that t/l!S m.:~tcnal contarms lo its chcrn!ca! descr:p!1\.ln ana to seller's wutten specJfJcallon~ SEllER MAKES NO OTHER E~PRESS OR IMPLIED WARRANTY. INCLUDING ANY OTHER EXPRESS OR IMPLIED WARRANTY Of FITNESS OR Of MERCKANTASILITY. ANO NO AGENT Of SELLER !S AUTHOR!Z£0 TO oo SO EXCEPT IN WRITING WITH A SPECifiC REFERENCE TO THIS WARRANTY. In no event shall seller'~ !jabthty for an~ breach of warranty C¥.C€.t!d (t\e purdtasc pr1cc of the material as to wh•rll a claim IS madf' 

CAUTION! 

HAY CAUSE IRRITATION. HAY CAUSE AllERGIC SKIN REACTION. AVOID CONTACT WITH EYES, SKIN, AND CLOTHING. 

AVOID BREATHING HIST OR VAPOR. WEAR CHEHICAL SPLASH GOGGLES, GLOVES AND PROTECTIVE CLOTHING WHEN HANDliNG. 

USE WITH ADEQUATE VENTILATION AND EHPLOY RESPIRATORY PROTEC- TION WHERE HIST OR VAPOR HAY BE GENERATED. 

NASH THOROUGHLY AFTER HANDLING. KEEP CONTAINER CLOSED WHEN NOT IN USE. 

FOR INDUSTRIAL USE ONLY. SEE HATERIAL SAFETY SHEET FOR ADDITIONAL INFORMATION. 

REGULATED INCREDIENTCSl= 

l.b-HEXANEDIOL DIGLYCIDYL ETHER 

TARGET ORGANS:SKIN,EYES,LUNGS. 

HtUS RATING: 

2H IF IR 

SPILLS RND LEAKS= 

STOP LEAKS. CLEAN UP lARGE S

NITH VACUUH TRUCK. SOAK UP SH

SPillS WITH ABSORBENT HATERIA

AND PLACE IN LABELED HASTE CONTAINER FOR DISPOSAL. WEAR ADEQUATE PERSONAL PROTECTIVE CLOTHING AND EQUIPHENT. 

DISPOSAL= 

DISPOSE OF PRODUCT IN AN APPRO

CHEHICAL WASTE lANDFill OR IN

NERATE IN ACCORDANCE NITH APP

CABLE FEDERAL, STATE AND LOCAL REGULATIONS. 

STORACE RNO HANDLING= HAY CONGEAL OR STRATIFY IF COL

ALLOW TO WARH TO ROOH TEMPERA- TURE. HIX WILL BEFORE USING. STORE IN A COOL, SHADED, WELL VENTILATED. DRY PLACE AWAY FRO

DIRECT HEAT AND SUNLIGHT. STOR

AWAY FROH FOODSTUFFS, ALKALINE SUBSTANCES AND HATERIALS LIKEL

TO INITIATE POLYHERIZATION. NET 

~T. LBS LOT 1••mwmmmmmmmmmmmmmmmmmm1 -

-~··:.::=.....____.:-::;::·::::::::.-.::::.;..:.;...·:_·_:::..::.:.·. ::_·:.:.:::.::::;:::-::_-.-··_ ··-- --~ ··--""'