### 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 MStreet, 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) 628·1000 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 Enterthetotal numberofpages inthe Premanufacture Notice 

### 46 

### GENERAL INSTRUCTIONS You must provide all information requested inthisform tothe extentthat it is known to or reasonably ascertainable by you. Make reasonable estimates ifyou donot 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 identityofthe new chemical substance, even ifyou claim the identity as confidential. You may authorize another person to submitthe identityforyou, butyour submission will not be complete and review will notbegin until EPA receives this information. Part II. HUMAN EXPOSUREAND ENVIRONMENTAL RELEASE You may need additional copies of part II, sectionsA and B ifthere are several

**manufa~ture,** processing, or use operationsthatyou will describe in the notice. You should reproduce these sections as needed. Part Ill. LIST OF ATTACHMENTS You should attach additional sheets ifyou do not have enough space on the form to answer a question fully. Inpart Ill, listthese attachments, anytest data orotherdata, and anyoptional information thatyou include in the notice. OPTIONAL INFORMATION You may include inthe noticeany informationthatyou want EPA to consider in evaluating the new substance. The Instructions Manual identifies categories ofoptional informationthat you may want EPA to review. CONFIDENTIALITY CLAIMS You may claim any information inthis notice as confidential. To assert a claim on theform, mark (Xl theconfidential box nextto the informationthatyou claim as confidential. Toasserta claim in an attachment, circle or bracketthe informationyou claim as confidential. Ifyou claim information in the notice as confidential, you must provide asanitized version ofthe notice, including attachments, to EPA withyoursubmission. For additional instructionson claiming information as confidential, read the Instructions Manual. Indicate belowthe 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 andto provide adescriptionofall other data knownto or reasonably ascertainable by you ifthese data are related tothe health and environmental effects ofthe manufacture, processing, distribution in commerce, use, ordisposal ofthe newchemical substance. Standard literature citations may be submitted for data inthe open scientificliterature. Completetest data, notsummaries ofdata, must be submitted ifthey do notappear in the open literature. Following are examples oftest data and otherdata. You should submitthese data according tothe requirements of §720.50ofthe 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 afunction 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 planttoxicity (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 inthe possession or control of the submitter 3-3-86

### SANITIZED COPY 

### PMN-H-PC-52 

# "'

.. CERTIFICATION .,..

**~.** I certify that tothe best of my knowledge and belief: 1 . The company named inpart I, sectionA, subsection 1 aofthis notice form intendsto manufactureorimport for a commercial purpose. otherthan in small quantities solelyfor research and development, the substance identified in part I, section B. · · 2. All information provided in this notice is complete and truthful asofthe date ofsubmission. 3. I am submittingwiththis noticeall testdata in my PQssession orcontrol and adescriptionofall otherdata known to or reasonably ascertainable by meas required by §720.50ofthe Premanufacture Notification Rule. <It Contidential Signature of authorized official 

# c2 Date 

# _dL 9- -)I 

# r-? ""-""'

### - Signature Of agent - (ifapplicable} (/ Date 

### Part 1- GENERAL INFORMATION



## ~ Section A - SUBMITTER IDENTIFICATION Confidential Mark (XJ the "Confidential"boxnextto anysubsection you claim as confidential. 1a. Person Name of authorized official Title submitting 

### James 

# s. Lee Vice President, Coatings notice Company

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

### Henkel Corporation 

## I·:•. ' t,.-... Mailing address (number andstreet)



# Y~6~ 300 Brookside Ave. City, State, ZIP code 

### Ambler, PA 

## 1 900? b. Agent(if Name ofauthorized official Title applicable} Company 

# I/:·········



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

### > 1{'. City, State, ZIP code



## r.~ 

## > .

.c. Ifyou are submitting this noticeaspart ofajointsubmission, mark (XJthis box. 

## D 2. Technical Name 

### Geogi Rauscher Title 

### Manager, Regulatory Affairs contact 

### Inez Kowalski Analyst, Regulatory Affairs Company .................... 

### Henkel Corporation Mailingaddress (number and street) ••••••••• 

### 300Brookside Avenue 19002 City, State, ZIP code 1Area code : Numbe'628...

### 1342 

### Ambler, PA Telephone : 

### 215 I f\?Q_l

**~LJ.l;** 3. Ifyou have had a prenotice communication (PC) concerning this notice and EPA Mark IXJ assigned a PC Numbertothe notice, enterthe number ifnone 

### ----+

### lXJ 4. If you have submitted atest-marketing exemption ITMEI application forthe chemical

**~ark** (XJ substance covered bythis notice, enter theTME number assigned by EPA ifnone 

### ----+

### 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 ifnone ----+

### 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" boxnext to anyitem you claim as confidential. Completeeither Item 1 or2 ••appropriate. Completeell otherItems. Ifanother person will submitchemical identity informationfor you, mark (X) the box atthe right.-----+

## 0 Identifythe name, company, and address ofthat person inacontinuation sheet. 1 .Cleaa 1 or2 chemlcelaubatancea !fordefinitionsof class 1 and class 2 substances, see the Instructions Menuell

e. Class ofsubstance - 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~s**

c. Molecularformula 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 astructural diagram. Foraclass 2 substance - (1 lUstthe immediateprecursorsubstances withtheir X

respective CAS Registry Numbers. 12) Describethe natureofthe reaction or process. (3) Indicatethe range ofcomposition and the typical composition (where appropriate). (4) Provide a representative structural diagram (ifpossible).



### 0 Mark IX! this boxifyouattach a continuation sheet. FORM EPA 7710·25

**~4·26·831** Page 3SANITIZED 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. Indicatethe lowest number-average molecular weight composition ofthe polymer you intendto manufacture. Indicatethe maximum

weight percent of low molecular weight species below 500and below t.000absolute molecular weightofthatcomposition. Describe dential the methods of measurement or the bases foryour estimates. 

### Not Applicable 

### 0 Mark"tXrtrm:

**oo~if"V'du"attach** a continuationshee,.



### - b. You must make separate confidentialityclaims for monomerorother reactant identity, composition information, and residual

information. Mark {XI the "Confidential" box nexttoany itemyou claim as confidential. ( 1 l - Providethe chemical name and CAS Registry Numberofeach monomerorother reactant used in the manufactureofthe polymer. (21 - Indicatethetypical weight percent ofeach monomerorother reactant inthe polymer. (31 - Mark (X} the identity column ifyou wanta monomerorother reactant used attwoweight percentor lesstobe listed as part ofthe polymerdescription ontheTSCA Chemical Substance Inventory. (4} - Indicate the maximum weight percent ofeach monomerorother reactantthat maybe present as a residual inthe polymeras manufactured for commercial purposes. Monomerorother 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 boxifyou attach a continuation sheet. c. Provide a representative structural diagram ofthe polymer, ifpossible. 

### Nut Applicaf>le



### 0 Mark {X) this box ifyou 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 IDENTITYINFORMATION -Continued

3. Impuritlee faI - Identify each impurity that may be reasonably anticipatedto be present in the chemical substance as manufactured for commercial purposes. Provide the CAS Registry Number if available. Ifthere are unidentified impurities, enter "unidentified." fbi - Estimate the maximumweight percent of each impurity. Ifthere are unidentified impurities, estimate theirtotal weight percent. Impurity and CAS Registry Number Maximum Confi- percent dential IaI (b) % 

### X % 

### X % 

### X % 

### X % 

### X % % 

### D Mark lXI this boxifyou attach a continuation sheet. 4. Synonym• - Enter any synonymsforthe new chemical substance identified in subsection 1 or 2. Contidential 

### 1,6 

### Hexanediol diglycidyl ether D Mark lXI this boKifyou attacha continuation sheet. 5. Trade Identification - List trade names forthe new chemical substance identified in subsection 1 or 2. 

### Photomer 1017 

### D Mark lXI this boKifyou attach a continuation sheet. ···.·.·. 6. Generic chemical name -Ifyou claim chemical identity as confidential, enterthe generic chemical name thatyou developed with EPA during prenotice communication. Ifyou have notdeveloped a generic name with EPA, provide a generic name that reveals the specific chemical identity ofthe new chemical substance to the maximum extent possible. Read the TSCA Chemical Substance Inventory, Initial Inventory, Volume Ifor guidance on developing generic names.



### Aliphatic epoxy monomer D Mark lXI this boKifyou attacha continuation sheet. 7. Byproduct•- Describe any byproducts resulting from the manufacture. processing, use, ordisposal ofthe new chemical substance at sites you control. Provide the CAS Registry Number ifavailable. Byproduct CAS Registry Number Conti- (11 121 dantial 

### X 

### X X 

### D Mark lXI this boKifyou attach a continuation sheet. FORM EPA 7710.25 14·26·831 Page 5SANITIZED COPY PMN-H-PC-52 Part 1- GENERAL INFORMATION- Continued Section C- PRODUCTION, IMPORT, AND USE INFORMATION 1 . Productionvolume
- Estimatethemaximum production volume during the first 12 months of production. Also estimate the maximum production volume for any consecutive 12-monthperiod during the first three years of production. Confi- **~-------------------------------------------------------,----------------------~----------------------------------4dential**

2. Use Information You must make separate confidentiality claims forthe description ofthe category of use, the percent ofproduction volume devoted to eachcategory, the formulation ofthe newsubstance, and other use information. Mark(XI the "Confidential" box nextto any item you claim as confidential. a. (1I - Describe each intended category of use ofthe new chemical substance byfunction and application. {2) - Estimatethe percent of total production for the first threeyears devoted to eachcategory of use. (3) - Estimatethe percent ofthe newsubstance as formulated in mixtures, suspensions, emulsions. solutions, orgels as manufactured for commercial purposes at sites underyour control associated with each categoryof use. (4) - Mark (XI whetherthe use is site-limited, industrial, commercial, or consumer. Mark morethan one column ifappropriate. Read the InstructionsManual for examples. Category of use (1)



### 0 Mark (XI this boxifyou attach a continuation sheet. b. Generic use description Ifyou claim any category of use description in subsection 2a as confidential, entera genericdescriptionofthat category. Read theInstructions Manualfor examples ofgeneric usedescriptions. 

### 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 providedto any person regarding protective equipmentorpractices 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 ifyou attach hazardinformation. FORM EPA·7710·2514·26-831 Page 6 X

### ... SANITIZED r.nPV PMN-J.I-Pr.-52 ' 

### Part II - HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE



### ~ SectionA - INDUSTRIALSITESCONTROLLED BYTHE SUBMITTER CcamllleteMOtionAforNOhtypeofmenufecture,proceeelng,orueeoperationlnvolvlntthe- chemical

**su~Mm~noe**etlndultrllllaltayoucontrol. 

## .

. Mark tXJ the "Confidential"boxnextto anyitem you claim as confidential. 1•Operedon d•crlpdon Confl·

•· Identity- Enterthe identityofthe site atwhichthe operationwill occur. dentlel Name 

### Henkel Corooration Siteeddreu (number and street) i> 

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

### Charlotte. Mecklenbura North Carolina 28217 i Ifthesame operationwilloccuratmorethanonesite, enterthe numberofsites. I I Identifytheadditional sites on acontinuationsheet. I 

### 0 Mark tXJthis boxifyouattacha continuationsheer. t:· .:,:,, i/• b. TypeMark tXJ 1 

### Ill Manufacturing 2

### 0 Processing 

### 30 Use c. Amountend Duration - Complete 1or2as appropriate Maximum kg/batch I Hours/batch I Batches/year 1. Batch I I X 1 I Maximum kg/day I Hours/day I Days/year 2. Continuous I I I I d. Process description X (1) Diagramthe majorunitoperation steps and chemical conversions. t21 Provide the identity,theapproximate weight lby kg/deyorkg/batch). end entrypointofall feedstocks (including reactants. solvents, and catalysts). t3t Identify by numberthe points ofrelease tothe environment ofthe newchemical substance.



### 0 Mark IX/this boxifyouattacha continuation sheet. FORM EPA-7710-25 14·26·831 Page 7

## SANITIZED COPY PMN-H-P>C- 52 Part II - HUMAN EXPOSUREAND ENVIRONMENTAL RELEASE - Continued



## ~ SectionA - INDUSTRIALSITESCONTROLLED BYTHE SUBMITTER - Continued

2 •Occup.ftlonat Exposure You must make separate confidentiality claims forthe descriptionofworkeractivity, physicalformofthe newchemical substance, number ofworkers exposed, and durationofactivity. Mark(XI the "Confidential" box nexttoanyitemyou claim as confidential. I1I - Describe the activities in which workers may be exposed tothe newchemical substance. Include activities in which workers wear protectiveequipment. (2) - Indicatethe physical formIs) ofthe newchemical substance atthetime ofexposure. (3) - Estimatethe maximum number of workers involved ineach activity. 14) and (51 - Estimatethe maximum duration ofthe activityforanyworker inhours perdayand 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 boxifyouattacha continuation sheet. 3. Envn--mem.t R.... aeand Disposal You mustmakeseparate confidentiality claims forthe release numberandtheamountofthenewchemicalsubstance released and otherrelease and disposal information. Mark (XI the "Confidential" box nexttoeach itemyou claimasconfidential. ( 1I - Emerthe numberofeach release point identified intheprocessdescription, partII, sectionA,subsection 1 d(3). (21 - Estimatetheamountofthe newchemicalsubstance released directlytotheenvironmentorintocontroltechnology (inkg/dayorkglbatch). (31 - ldemifythe media (air. land, orwater)towhichthe newsubstance willbe released fromthatrelease point. (41 -Describecontroltechnology, ifany,thatwill be usedtolimitthe release ofthe newsubstancetotheenvironment. For releases disposed ofon land, characterizethe disposal method. (51 - Identifythedestination(s) of releases towater. Release Amountof newsubstance Confl· Media of Control technology Conti- Number released release

(1) 121 dentlal (31 (41 dential 

### X X 

### X 

### X X X

(51 MarklXI the 1

**~** POTW (publicly owned treatment works) 3 

### 0 Other - spacitr.; destination(s) of releases to water. 2 

### 0 Navigable waterway 

### 0 Mark tX/this box ifyou 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 - INDUSTRIALSITES CONTROLLED BYOTHERS CompleteMCtion B foreachtypeofproc:aalntor UHoperlltioninvolvingthe newchemic.......,__

# lit.,... youdonotcontrol. Toclaim information in this sectionasconfidential. circle orbracket

**the~** informationthatyou dBimasconfidential. Operation description Describethe

**ty~?ical** proct:ssing or useoperation. Identifythe unitoperation stepswhich mayoccurduringtheoperation. Estimate the numberofsttes at whtch the operation is likelytooccur. Identifysituations inwhichworkerexposuretoand/orenvironmental release ofthe newchemical substance may occur. Estimatethe percentof newchemicalsubstanceasformulated inproducts manufacturedforcommercial purposes intheoperation oras used intheoperation. Estimatethe numberofworttersexposedand thedurationofexposure. Identify controlswhich limitworkerexposure and environmental release Iftypicallyused. Identify byproducts which may resultfromthe 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 fallunder 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 ofthe form and test data and otherdata (including physical/chemical properties and 

### '"'"" structure/activity information), and optional information afterthis page. Clearly identifythe attachment and the section ofthe form to which it relates, ifappropriate. Number consecutively the pages ofthe attachments. In the column below, enterthe inclusive page numbers of each attachment. Mark (X) the "Confidential" box nextto any attachment nameyou claim as confidential. Read the Instructions Manual for guidance on howto claim any information in an attachment as confidential. You must include withthe sanitized copy ofthe 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 & 

### DRisk Assessment 9 

### Infrared Spectra 10 

### Primary Dermal Irritation Study 11-35 

### Label 36

**-c#,'ll~.**

,cw.'" 

### 0 Mark IX) this box ifyou attach a continuation sheet. Enterthe attachmentname andnumber.

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 (H20=1) Not Available Vapor Pressure Not Available Solubility in H 20, % 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. 

# 11

1 

# ..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. EyeChemical 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 CONFIDENTIALSANITIZED 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



# ~2 

# ·r: 

# g.

jame 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

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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



### 1 

### 1-3

1 

### 1 

### 1-2

2 2 2 3 3 3 3 

### 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

# I 

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## PMN-H-PC-52 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


### Amean 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 

# I I I I 

# I I 

# I I 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 

# II I 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: 

### I-2 Date: 

# /o/:J3/07 

# ' bate: 10/l/87

# I I I I I I 

# I I I I I 

# I I SANITIZED COPY PMN-H-PC-52 

### 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 

### I-3

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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 discarded. 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.


### I-4 20

### '. 

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### 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.


### I-5 

# 3\.

### ' SANITIZED COPY PMN-H-PC-52 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.

1-6

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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 CONPI 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: 

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# £///? 

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**$'<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 

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### PMN-H-PC-52 Attachment page 26 CONFIDENTIAL
Primary Skin Irritation Score Sheet
- Rabbits 

### FDRL Material I.

### D. No.: 

# 47-

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### No. : 

# %?J'C Time Dosed: ___ ... 

# 9_;;;;..~---:------- Dosed by: ___ 

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

4 Intact Edema 7 Intact Formation 

### 10 Intact 

### 14 

# I Intact 

# I Comments:



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### COMMENTS **PM~l~H~PC~52** 

### · Attachment page 27 

### CONFIDENTIAL study No. :__ 

## ""'""95?3-.~C;;;;..... __ _ Date Dosed: 

# 11£$1

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### FDRL Study



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## 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.

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## ~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. Net Wt. Net Wt. 

## 0 C. S. 

### to ---- ml with diluent 

## 0 Adcied __ ml of diluent QAdded __ g 

### of diluent Tare \oit. ___ 

### Tare 

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### Wt. Gross 

### Wt. 

## 0 Other: see additional notes Test Mixture Was: c:JStirred; 

# 0 Blended at _ speed; 

# 0 Sonicated; 0Beated to _ 

## •c in 

### a water bath; 

## Oother: Dosing Information L!vel Coefficient• 

# <-alka> (g/kg) 

### pB and Demsity 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



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# =Dose {ml). 

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# • •

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### Appendix III **P~1N-H-PC-** 52 

### Attachment page31 CONFIDENTIAL 

### FDRL Study No. 9598C

FDRL Personnel Responsibilities

III-l



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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



### III-2

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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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# ___"_' SANITIZED COPY **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 INSPECTIONSCHECUUE (ACUTIE8) INSPECTION OATES TYPE TEST DATE lltESUL. TS lltEIDORTEC TO MANAGEMENT 

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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



### IV-3**~ -~**  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 SPillS

NITH VACUUH TRUCK. SOAK UP SHAll

SPillS WITH ABSORBENT HATERIAL

AND PLACE IN LABELED HASTE

CONTAINER FOR DISPOSAL. WEAR

ADEQUATE PERSONAL PROTECTIVE

CLOTHING AND EQUIPHENT. DISPOSAL= DISPOSE OF PRODUCT IN AN APPROVED

CHEHICAL WASTE lANDFill OR INCI-

NERATE IN ACCORDANCE NITH APPLI-

CABLE FEDERAL, STATE AND LOCAL

REGULATIONS. STORACE RNO HANDLING=

HAY CONGEAL OR STRATIFY IF COLD.

ALLOW TO WARH TO ROOH TEMPERA-

TURE. HIX WILL BEFORE USING.

STORE IN A COOL, SHADED, WELL

VENTILATED. DRY PLACE AWAY FROH

DIRECT HEAT AND SUNLIGHT. STORE

AWAY FROH FOODSTUFFS, ALKALINE

SUBSTANCES AND HATERIALS LIKELY

TO INITIATE POLYHERIZATION.

NET **~T.** LBS LOT 1••mwmmmmmmmmmmmmmmmmmm1

- **-~··:.::=.....____.:-::;::·::::::::.-.::::.;..:.;...·:_·_:::..::.:.·.** ::_·:.:.:::.::::;:::-::_-.-··_ ··-- **--~** ··--""' FIRST RID= EYES: FLUSH AT ONCE WITH LARGE AHOUNTS

OF WATER FOR AT LEAST 15 HINUTES

HOLDING EYELIDS APART. HASHING

WITHIN ONE HINOTE IS ESSENTIAL TC

ACHIEVE HAXIKUH EFFECTIVENESS.

GET HEDICAL ATTENTION. SKIN: WASH THOROUGHLY WITH SOAP & WATER

REHOVE CONTAKINATED CLOTHING AND

FOOTWEAR. NASH CLOTHING BEFORE

REUSE. DISCARD FOOTWEAR THAT HAS

BEEN CONTAMINATED ON THE INNER

SURFACES. GET HEDICAL ATTENTION

IRRITATION SHOULD DEVELOP. INHALATION: REKOVE TO FRESH AIR. ADMINISTER

OXYGEN IF AVAILABLE GET HEDICAL

ATTENTION. INGESTION: DO NOT INDUCE VOMITING. IF VOMIT-

ING SHOULD OCCUR SPONTANEOUSLY

KEEP AIRWAY CLEAR. GET HEDICAL

ATTENTION. NEVER GIVE ANYTHING BY

HOUTH TO AN UNCONSCIOUS PERSON. =- 001 (./') ):o """0
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