U.S . ENVIRONMENTAL PROTECTION AGENCY 

r 

,1040000141 

in the Premanufacture Notice 

. 

. 

PREMANUFACTURE 

NOTICE 

GENERAL INSTRUCTIONS ~ 

~ La ~ i oc.,,~ 

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

not have actual data . 

Make reasonable estimates ifyou do 

Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603). 

If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, your user fee ID number must also appear on your corresponding fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226), P.O . 360399M, Pittsburgh, PA 15251-6399, Attn . TSCA User fee. 

Part 1-GENERAL INFORMATION 

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

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

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

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

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

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

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

submitted . 

Part 11-HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE 

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

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

Part III-LIST OF ATTACHMENTS 

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

each continuation sheet with the corresponding section heading . In Part 111, list these 

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

notice . . 

OPTIONAL INFORMATION 

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

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

pollution prevention and recycling information you may have regarding the new 

substance. 

So-called "binding" boxes are included throughout this form for you to indicate your 

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

production volume, protective equipment . . . This option is intended to reduce delays 

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

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

where certain information provided in such notification is binding on the submitter when 

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

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

chemical identity) reported in the form . 

CONFIDENTIALITY CLAIMS 

You may claim any mformation in this notice as confidential . To assert a claim on the 

form, mark (X) (he 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 notices as confidential you must 

also provide a sanitized version of the notice (including attachments l. For additional 

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

® Mark (e) ifany information in this notice is claimed as confidential . EPA FORM 7710-25 (Rev 5-95) 

TEST DATA AND OTHER DATA 

You are required to submit all test data in your possession or control and to provide a description of all other data known to or reasonably ascertainable by you, if these data are related to the health and environmental effects on the manufacture, processing, distribution 

m commerce, use, or disposal of the new chemical substance. Standard literature citations 

may be submitted for data in the open scientific literature. Complete test data (written in 

English), not summaries of data must be submitted if they do not appear in the open hterature . You should clearly identify whether test data is on the substance or on an 

analog . Also, the chemical composition of the tested material should be characterized . Following are examples of test data and other data . Data should be submitted according to the requirements of §720 .50 of the Premanufacture Notification Rule (40 CFR Part 720) . 

Test Data (Check Below any included in this notice) 

" Environmental fate data 0 Yes " Other data [:] Yes 

" Health effects data 0 Yes Risk assessments 

" Environmental effects data El Yes Structure/activity relationships 

" Physical/Chemical Properties' 0 Yes Test data not in the possession 

or control of the submiuer 

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

TYPE OF NOTICE (Check Only One) 

PMN (Premanufacture Notice) 

INTERMEDIATE PMN (submitted in sequence with final prol'}Adt PMN) 

CZ) 

f'q 

SNUN (Significant New Use Notice) (',i 

TMEA (Test Marketing Exemption Application) 

LVE (Low Volume Exemption) rt 40 CFR 723 .50(cxl) 

I 

C-D ~ 

`) f

n rl 

G3 ; ~ ```-1 

LOREX (Low Release/Low Exposure Exemption) @ 40 CIF5723 .50(c)(2) 

co 

LVE Modification ~ LOREX Modification 

IS THIS A CONSOLIDATED PMN? 1:1 Yes 

# ofchemicals 

(Prenotice Communication # required, enter # on page 3) 

Page 1 Replaces previous editions of EPA Form 7710-25 . 

atE C E l'rpE [l 

03 N 01v 2 1~ ~i'i 2: S2 

`ompany Sanitized 
Public reporting burden for this collection of information is estimated to average 110 hours per response, including time for reviewing 

instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of 

information . Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for 

reducing this burden, to Chief, Information Policy Branch, PM-223, U.S . Environmental Protection Agency, 401 M. St ., S.W., Washington, D.C. 

20460; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C . 20503 . 

CERTIFICATION 

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

1 . The company named in Part 1, 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 possession or control and a description of all other data known to or reasonably ascertainable by me as required by §720.50 of the Premanufacture Notification Rule. 

Additional Certification Statements : 

If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNLTN, check the following user fee certification statement that applies: 

F-1 The Company named in Part I, Section A has remitted the fee of $2500 specified in 40 CFR 700.45(b), or 

The Company named in Part I, Section A has remitted the fee of $1000 for an Intermediate PMN (defined @ 40 CFR 700.43) in accordance with 40 CFR 700.45(b), or 

~ The Company named in Part I Section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b) . 

If you are submitting a low volume exemption (LVE) application in accordance with 40 CFR 723 .50(c)(1) or a Low release and low exposure exemption (LoRex) application in accordance with 40 CFR 723.50(c)(2), check the following certification statements : 

0 The manufacturer submitting this notice intends to manufacture or import the new chemical substance for commercial 

purposes, other than in small quantities solely for research and development, under the terms of 40 CFR 723.50. 

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

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

0 If this application is for an LVE in accordance with 40 CFR 723.50(c)(1), the manufacturer intends to commence 

manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 day review period . 

The accuracy of the statements ,you make in this notice should reflect your best prediction of the anticipated facts regarding the chemical substance described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 USC 1001 . Signature and title of Authorized Official (Original Signature Required) 

Signature of agent - (if applicable) 

Date 

Date 

Confidential 

X 

X 

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

Section A -- SUBMITTER IDENTIFICATION 

Mark (X) the "Confidential" box next to anv subsection you claim as confidential 

1 a. Person Name of authorized official Position 

Submitting 

Notice (in U .S .) 

Company 

Mailing address (number and street) 

City. State, ZIP Code 

b. Agent (if Name of authorized official Position 

applicable) 

X 

Company 

Mailing address (number and street) 

City, State, ZIP Code Telephone Area Code Number 

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

Joi nt Submitter (if Name of authorized official Position 

applicable) 

X 

Company 

Mailing address (number and street) 

City, State, ZIP Code Telephone Area Code Number 

2. Technical Name of authorized official Position 

Contact (in 

U.S .) X 

Company 

Mailing address (number and street) 

City, State, ZIP Code Telephone Area Code Number 

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

and EPA assigned a PC Number to the notice, enter the number . Mark (X) - p. X if none 

4 . If you previously submitted an exemption application for the chemical 

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

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

Mark 

if none 

(X) - 

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

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

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

as i d b EPA s gne y . --~ 

Mark (X) --- 

if none 

6. 

1 . ~ Manufacture 

Type of Notice - Mark (X) 

2. ~ Import 3 . ~ Both 

Only Only 

Binding Option ~ Binding Option 

Mark (X) Mark (X) 

Confidential 

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

Part I -- GENERAL I1Nt+ORMA1'IUN -- Continued 

Section B -- CHEMICAL IDENTITY INFORMATION: You must provide a currently correct Chemical Abstracts (CA) name ofthe substance based on the ninth Collective Index (9Cl) of CA nomenclature rules and conventions . Mark (X) the "Confidential" box next to any item you claim as confidential 

Complete either item 1 (Class I or 2 substances) or 2 (Polymers) as appropriate. Complete all other items. 

If another person will submit chemical identity information for you (for either Item I or 2), mark (X) the box at the right. Confi- Identify the name, company, and address of that person in a continuation sheet. 0 dential I . Class I or 2 chemical substances (for definitions of class 1 and class 2 substances, see the Instructions Manual) 

a. Class of substance - Mark (X) 1 0 Class I or 2 0 Class 2 

b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances . For Class 1 substances a CA Index Name must be provided. For Class 2 substances either a CA Index Name or CA Preferred Name must be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions) . 

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

Method I (CAS Inventory Expert Service - a copy of the Identification 0 Method 2 (Other Source) 

report obtained from the CAS Inventory Expert Services must be 

submitted as an attachment to this notice) 

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

X 

CAS# 

X 

e . For a class I substance, provide a complete and correct chemical structure diagram . For a class 2 substance - (1) List the immediate precursor substances with their respective CAS Registry Numbers . (2) Describe the nature of the reaction or process . (3) Indicate the 

range of composition and the typical composition (where appropriate). (4) Provide a correct representative or partial chemical structure diaQram_ as comnlete as can be known. if one can he reasonablv ascertained. 

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

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

Part I -- Ut;IVh;KAL INFORMATION -- Continued 

Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 

2. Polymers (For a definition of polymer, seethe Instructions Manual .) Confia. Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture. 

dential 

Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) below 500 and below 1,000 absolute molecular weight of that composition. 

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

i) lowest number average molecular weight : - 

ii) maximum weight % below 500 molecular weight : 

iii) maximum weight % below 1000 molecular weight : 

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

b. You must make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the " Confidential " box next to any item you claim as confidential 

(1) - Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the ma nufacture of the polymer. 

(2) - Mark (X) this column if entry in column (1) is confidential . 

(3) - Indicate the typical weight percent of each monomer or other reactant in the polymer. (4) - Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the pol ymer description on the TSCA Chemical Substance Inventory. 

(5) - Mark (X) this column if entries in columns (3) and (4) are confidential . 

(6) - Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for commercial purposes. 

(7) - Mark (X) this column if entry in column (6) is confidential . 

Monomer or other reactant and CAS Registry Number Confi- Typical Identity Confi- Maximum Confidential composition Mark (X) dential residual dential 

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

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

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

Method 1 (CAS Inventory Expert Service - a copy of the identification report ~ Method 2 (other source) 

obtained from CAS Inventory Expert Service must be submitted as 

as attachment to this notice) 

d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers . 

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

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

EPA FORM 7710-25 (Rev . 5-95) Page 5 
rari i -- GENERAL I1NIiOKivIA1'ION -- Continued P~ 5 

Section B -- CHEMICAL IDENTITY INFORMATION -- Continued 

3 . Impurities 

(a) - 

CAS 

Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide the Registry Number if available. If there are unidentified impurities, enter "unidentified." (b) - Estimate the maximum weight 11/o of each impurity . If there are unidentified impurities, estimate their total weight %. 

Impurity and CAS Registry Number 

(a) 

Maximum 

percent 

(b) 

Confidential 

X 

X 

X 

X 

X 

X 

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

X 

4. Synonyms - Enter any chemical synonyms for the new chemical identified in subsection 1 or 2. Confidential 

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

X 

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

Mark (X) this box if you attach a continuation sheet. 71 

6. Generic chemical name - If you claim chemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity of the new chemical substance to the maximum extent possible. Refer to the TSCA Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names. 

Modified amidoamine. 

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

7. Byproducts - 

Number 

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

B yp roduct CAS Registry Number 

(2) 

Confidential 

X 

X 

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

EPA FORM 7710-25 (Rev . 5-95) Page 6 
January 22, 2004 

US Environmental Protection Agency 

EPA East Building 

1201 Constitution Ave, NW 

Washington, DC 20004-3302 

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

RE : Premanufacture Notification P04-141 

Dear Sir or Madam: 

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sw 

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ru 

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9-0 

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

amendment to page 7 of the above-referenced Premanufacture Notice . This amendment 

more accurately reflects the use of this new chemical . 

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

] . Thank you. 

Very truly yours, 

t ] 

[ ] 

Manager, Product Safety 

[ ] 

Ref: 04-0003L .doc 

ornpany Sanitized 

5 ~0 u0 0 ~~0 ~0 ~~!~0 u0 q~luM 

p_-o4- HI q ,<,~ a 7asss 
p. 7 

Part I - GENERAL INFORMAT10N - Continued 

Section C - PBODUCTIOlw IIblPOBT, AND USE IIROBMATI011k 

U/adc 00 fte "CaoBdanfiml' boz next Gamy i1em ym claim as aoaBdaaist 

L Production. vulame-Fstfomabe ft oiodsousa production vdamdunng the first 12 msnfis of production. Al .9o estimate the 

nsxinumt production volume fad' any oonswrtive 12-aWatit period dorft the fin*---,, yeas of production. Estimates douid on 

100% new daentical substance basis . Fare Lwv VeJuwe F.xenpuow 1pLa~timr, if yon ciocae to Irmie yan xolioe teaiesaedat a inorr 

volrrwwthaR I0.000 Jg(yr. spiaofy ft palrrwnasd urk (xJ in the iad'ag box If gnartad, you are biouwd to this aabaer.. 

Maximum first 12-month production (kg/Yr) Maxdmum 12-month production (kg/yr) denuai (1Q0% new diemical substance basis) (1009G new dmmncd substance bow) Mat 

2 Use 7ata®a8m -You must maice aWaeale coa8deatInVtp daims for the dmaiptiae of the "ICY of use, the percent of produdfaa volame 

dewoled b ,Hw 6 dffintneRaubYiaOp,a" d we infoumdoo. Mark 00 the 'Confidentfai"BOIInext lD my item you 

a. (1) - DESadbe eneti ialended cuiegoCp of ose oEfte new amuGd anbefrnoe by Etaeeim and applicadan. 

Q3- Madc pp N~i adune if eo1~y in mroa (1) is coa6daodd boioas iato®afiou K.BQ r-- 

(3) - Ind'iede your wMingsss so have the ia6acaiadoa ptwfded in oolnmn (1) bhuhng- . 

ND - &slbaabe thepeaiaeat af tuhil p~oaue~bw for ti~e Bist Uaee ~eass de~oted eo sch cale®oty aE ax ~ . 

(~ -Madc (70 tl~ e0i1®a If eaEt~ i~1 mll~w (~ is CoaBdmWl bv~s in6oomaUaa (~1). - . 

(A - Eatkaale the paomt af tbe aew aubebaae mtaaualaled m mibdhrei, ~utoaa eundsom aolulkse, or gels : 

a9 mmnafiactured faraamnasdal putposes at aims under yout aanLeal assodaied with eadt ~y of tee. 

(7)-MQic 00 this column if entry in adumn (b, is confidentis! bmikas iafiaamwlim ((3Bp. _ 

(~-LdicaEelG of podW at volume ampeeled tar the ~Ied "u~e" aeclaaa Max* ametlaa me bmc if appropriate. Mark `` ` 

00 Oo ka$ale'vte ndiiiypws to Lave &e me type provided is (8) 6Ldiag. - 

~ -Madc 00 ~ aoLa~ ff ~ w~ aoir4a lq is (~te) aa~o6dmlLl b~eiaees io6am~lim (CBI). -- 

Caftory of we (1) ® W" ii Pto~c- ~ !s~ L M !G of a~ae enpeaed p~irie 

i.ea adisp®ive dyeLor 

_ 

~~ t1aa 9G ~ ~ 

_ 

(g) - ~ . '~! ~ 

iad - C 

Q) C~) (~ 47 (4_ C~l Iimiied aiaoer 

us 

Md 

M11- 

ama¢9d option (9) 

X 4 y~, ~C g6 ~C 

. , 

% 

^ - . . . 

~ 

., y .+q 'v 

% 

'if you have identified a "ooassmee use, please p wide on a ooo- oa sheet a detat'led desQiptionof the use(s) of this chennical 

substance in consumer pvoducls. In addltioa include - & of ti~e aoaaere~eioe of the new ehmdeal subabnce as expected in 

consumer products and describe the dmmical :eactions by which dris substance loses its identity m the consumer product. 

Ma~c p0 tids boac if ran apaeh a amdou~llioa abeet. 

b. Caaa:c If yoa ddnasycoiegayaf uae desaip1ius js subaedioo 2sas ao~Admt~l, enters WmQicdesdpfioa of tdat 

use abegoa~ Aead fl~e ir4aelisas >~d tar aumQks af ~eraic use desaipiio~. 

desaiPtion 

Oil-well addit;ye , 

~ .,j 

+r` .~ 

0 ~ QO ~ booc $ alfadt a ooaRar~flow aheaf. ~ ` :: r-: , 

3. Hasatd bfaosafioa- bdu3e ia ibe nolioe a eop'af aedonade bmiss 'leof any baad wm ft sb knoent labd, maler}d s~dy dw ahee~ 

ar a1~QidasrKaw v,4wdl be b aa, psam avb b aeroaaWy 18Od~r b baer~o~ed b H~is w~baaooe r~ediag 

equ~po~ ec g actioasf0t fite sie ~ , ~aa~ p o~t , m ~ or die p OSd Of 9~e ae w s u6 e l a eoe . Ibt ~ pre t ~ L ml d i a i omat t~~ ; " 

R:a 

PORMFYA791aZ5 (Re+-595) Pa~e7 Gri 

This M.SDS is the one currently befng user! for tlds prodnct before the cthemisal idandqi vras found to be in error 
Part II-- HUMAN EXPOSURE A1N1) ENVIRONMENTAL RELEASE "~ 

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

claim as confidential 

Complete section A for each type of manufacture. processing, or use operation involving the new chemical substance at industrial sites you control. Importers do not have to complete this section for operations outside the U.S ; however, you may still have reporting requirements if there are further industrial processing or use operations after import. You must describe these operations . See instructions manual 

1 . Operation description 

a. Identity -- Enter the identity of the site at which the operation will occur. 

Confidential Name 

X 

Site address (number and street) 

City, County, State, ZIP code 

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

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

production rates or operations, include all the information requested in this section for those 

sites as attachments . 

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

Mark (X) E]Manufacturing E]Processing DUse 

c . Amount and Duration -- Complete I or 2 as a ro riate 

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

chemical substance) 

1 . Batch 

Maximum kg/day (loo^r newchemical Hours/day Days/year 

substance) X 

2. Continuous 

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

(1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g . 5 gallon pails , 55 gallon drum, rail car, tank truck, etc.) . 

(2) Provide the identity , the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting materials and feedstocks (including reactants, solvents, catalysts, etc .), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch .) . 

, (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance . 

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

8 

EPA FORM 7710-25 (Rev . i-95) Page 8 
Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Conti ued 

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

2. Occupational Exposure-- You must make separate confidentiality claims for the description of worker activity, physical form of the new chemical substance , number of works exposed, and duration of activity . Mark (X) the "Confidential" box next to any item you claim as confidential . (1) -- Describe the activities (i .e . bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the substance . (2) --Mark (X) this column if entry in column (1) is confidential business information (CBI). 

(3) -- Describe any protective equipment and engineering controls used to protect workers. 

(4) and (6) -- Indicate your willingness to have the information provided in column (3) or (5) binding. 

(5) -- Indicate the physical form(s) of the new chemical substance (e .g ., solid : crystal, granule, powder, or dust) and % new chemical substance (if part of a mixture) at the time of exposure . 

(7) --Mark (X) this column if entry in column (5) is confidential business information (CBI). 

(8) -- Estimate the maximum number of workers involved in each activity for all sites combined . 

(9) --Mark (X) this column if entry in column (8) is confidential business information (CBI). 

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

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

Physical 

Worker activity 

i b d i f 

CBI Protective Equipment/ Binding forms (s) Binding CBI # of CBI Maximum Duration CBI ( .e ., ag ump ng, illing drums) Engineering Controls Option and % new Option Workers Hrs/day Days/yr Mark (x) substance Mark (x) Exposed 

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (I1) (12) 

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

3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount ofthe new chemical substance released and other release and disposal information. Mark (X) the "Confidential" box next to each item you claim as confidential . (1) -- Enter the number of each release point identified in the process description, part 11, section A, subsection I d(3) . (2) --Estimate the amount ofthe new substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch). (3) --Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI). 

(4) --Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to which the new substance will be released from that release point. 

(5) --a. Describe control technology, if any, and control efficiency that will be used to limit the release of the new substance to the environment. For releases disposed of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet , for each site describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate the amount released to the environment after control technology (in kg/day). 

(6) --Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI). 

(7) --Identify the destination(s) ofreleases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential business information (CBI). 

Release Amount of new substance Media of release 

Number released CBI e.g . stack air Control technology and efficiency (you may wish to o tionall tt h ff i 1 2 

y a ac e ic ency data) CBI ( ) ( a) (2b) (3) (4) (5a) Binding (5b) (6) 

Mark (X) 

(7) Mark (X) the El POTW provide name(s) below: CBI 0 Navigable 0 Other - provide NPDES # CBI destination (s) of releases X waterway Specify to water 

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

EPA FORM 7710-25 (Rev . 5-95) Page 9 
Part II-- HUMAN EXPOSLttr: AND ti;iNVIKUNMENTAL RELEASE -- Continued 

Section B -- INDUSTRIAL SITES CONTROLLED BY OTHERS 

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

B 

for operations outside the U.S ; however, you must report any processing or use activities after import . See the Instructions Manual . Complete n separate section for each type ofprocessing, or use operation involving the new chemical substance. If the same operation is performed at more than one site describe the typical operation common to these sites. Identify additional sites on a continuation sheet. 

l . Operation Description -- To claim information in this section as confidential . circle or bracket the specific information that you claim as confidential . (1) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e.g . 5 gallon pails , 55 gallon drums, rail cars, tank trucks, etc) . On the diagram, identify by letter and briefly describe each worker activity . (2) -- Provide the identity, the approximate weight (by kg/day or kg/batch, on an 100'% new chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all products, recycle streams, and wastes . Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- Identify by number the points of release , including small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the # of sites (remember to identify the locations of these sites on a continuation sheet) : # of sites 

Confidential Business Information Has Been Removed . 

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

2. Worker Exposure/Environmental Release 

(1) --From the diagram above, provide the letter for each worker activity . Complete 2-8 for each worker activity described. (2) --Estimate the number of workers exposed for all sites combined . 

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

(6) --Describe physical form of exposure and % new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to protect workers. 

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

(9) --From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified . (10) -- Estimate the amount of the new substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or kg/batch) . (12) -- Describe media of release i .e . stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration , POTW , or other (specify) and control technology, if any, that will be used to limit the release of the new substance to the environment. (14) -- Identify byproducts which may result from the operation. 

(3), (5),(8),( 11), (13) and (15) --Mark( X) this column if any of the proceedin g entries are confidential business information (CBI). 

Protective Equip. / 

Letter 

of 

iS of 

Workers 

Duration 

of 

Engineering Controls/ 

Physical Form and % 

% in Amount of 

New Media of Release 

Activity Exposed CBI Exposure CBI new substance 

Formulation CBI 

Release 

Number 

Substance 

R l d 

& Control 

(1) (Z) (3) 

e e ase CBI Technology CBI (4a) (4b) (5) (6) (7) (8) (9) (10a) (lob) (11) (12) (13) 

(14) -- Byproducts : P] 

(15) 

X 

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

40 

EPA FORM 7710-25 (Rev . 5-95) Page 10 
p. 11 

OPTIONAL POLLUTION PREVENTION INFORMATION 

To claim information in this section as confidential circle or bracket the specific information that you claim as confidential . In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce 

or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal 

of the PMN substance. Please include new information pertinent to pollution prevention, including source 

reduction, recycling activities and safer processes or products available due to the new chemical substance. 

Source reduction includes the reduction in the amount or toxicity of chemical wastes by technological 

modification, process and procedure modification, product reformulation, raw materials substitution, and/or 

inventory control. Recycling refers to the reclamation of useful chemical components from wastes that would 

otherwise be treated or released as air emissions or water discharges, or land disposal . Descriptions of pollution 

prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance 

with existing regulatory requirements and can be either quantitative or qualitative. The EPA is interested in the 

information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting 

of risks to other environmental media or non-environmental areas (e.g ., occupational or consumer exposure). In 

addition, information on the relative cost or performance characteristics of the PMN substance to potential 

alternatives may be provided. 

All information provided in this section will be taken into consideration during the review of this 

substance. See Instructions Manual and Pollution Prevention Guidance manual for guidance and 

examples. 

Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in the volume manufactured ; (3) a reduction in the generation of waste materials through recycling, source reduction or other means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in the cost of production and/or improved operation efficiency of the new chemical substance in comparison to existing chemical 

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

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

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

EPA FORM 7710-25 (Rev . 5-95) Page 11 
p. 12 

Part III -- LIST OF ATTACHMENTS 

Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and 

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

which it relates, if appropriate. Number consecutively the pages of the attachments . In the column below, enter the inclusive page 

numbers of each attachment. 

Mark (X) the "Confidential" box next to any attachment name you claim as confidential . Read the Instructions Manual for guidance on how to claim any information in an attachment as confidential . You must include with the sanitized copy of the notice form a sanitized version of any attachment in which you claim information as confidential . 

Attachment name Attachment 

pa e number(s) 

Conf9- 

dential 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

X 

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

EPA FORM 7710-25 (Rev . 5-95) Page 12 
p. 13 

r1HxNUAL AN 0 CHEMICAL PROPERTIES WORKSHEET 

To assist EPA's review of physical and chemical properties data, please complete the following worksheet for data you provide and include it in the notice . Identify the property measured, the page of the notice on which the property appears, the value of the property, the units in which the property is measured (as necessary), and whether or not the property is claimed as confidential . !he physical state of the 

neat substance should be provided . These measured properties should be for the neat (100% pure) chemical substance. Properties that are measured for mixtures or formulations should be so noted (°6, PMN substance in __). You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplify review and ensure that confidential information is properly protected. You should submit this worksheet as a supplement to your submission oftest data. This worksheet is not a substitute for 

submission of test data . 

Property Mark Page Value Measured Confi- 

(X) if numbe r or dential 

provide d Estimate Mark (X) 

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

X Physical state of neat substance (s) (1) (9) - 

X Vapor pressure 

@ Temperature 0C 

Torr 

X Density/relative density g/cm3 

Solubility X 

@ Temperature °C 

Solvent g/ 

Solubility in water @ Temperature °C / 

X 

X Melting temperature o 

Boiling / sublimation temperature@ -toff pressure 0C X 

Spectra 

Dissociation constant X 

Particle size distribution 

X 

Octanol / water partition coefficient 

X 

Henry's Law constant X 

Volitalization from water 

X 

Volitalization from soil X 

H @ concentration X 

Flammability X 

Ex lodability X 

Adsorp tion / coefficient X 

Other - Specify X 

X 

X 

EPA FORM 7710-25 (Rev . 5-95) Page 13 Replaces previous editions of EPA Form 7710-25. 
Material Safety Data Sheet 

Date Prepared : 2/20103 Supersedes Date : 11/15/01 

1 . PRODUCT AND COMPANY DESCRIPTION 

Emergency Phone Numbers: 

(800-424-9300 

FOR EMERGENCIES INVOLVING A SPILL, LEAK, FIRE, EXPOSURE OR ACCIDENT ~ONTf~T: CHEMTREC within the United States or 703-527-3887 for international collect calls) o TCAERS (Communication and Emergency Response System) at' ' 

For Product Information : 

Chemical Name or Synonym: 

2. COMPOSITION/INFORMATION ON INGREDIENTS 

Component CAS Reg Number OSHA 

Hazard Percentage 

3. HAZARDS IDENTIFICATION 

A. EMERGENCY OVERVIEW: 

_Physical Appearance and Odor: 

Warning Statements : 

WARNING!! EYE IRRITANT. 

B . POTENTIAL HEALTH EFFECTS: 

1 
p. 15 

Acute Eye : 

Irritant . Can cause redness, irritation, tearing . 

Acute Skin: 

Slightly irritating . May cause redness, irritation . 

Acute Inhalation : 

Inhalation not likely . 

Acute Ingestion : 

Practically non-toxic . 

Chronic Effects : 

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

4. FIRST AID MEASURES 

FIRST AID MEASURES FOR ACCIDENTAL: 

Eye Exposure : 

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

Skin Exposure : 

In 

Remove 

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

Inhalation: 

Inhalation 

air . 

is not an expected route of exposure . If respiratory irritation or distress occurs remove victim to fresh Seek medical attention if respiratory irritation or distress continues. 

Ingestion : 

If victim is conscious and alert, give 1-2 glasses of water to drink. Do not give anything by mouth to an unconscious person. Seek medical attention . Do not leave victim unattended . 

MEDICAL CONDITIONS POSSIBLY AGGRAVATED BY EXPOSURE : Skin contact may aggravate existing skin disease . 

NOTES TO PHYSICIAN : 

All 

be 

treatments 

given 

should be based on observed signs and symptoms of distress in the patient . Consideration should to the possibility that overexposure to materials other than this product may have occurred. 

Treat symptomatically . No specific antidote available . 

5. FIRE FIGHTING MEASURES 

FIRE HAZARD DATA: 

Flash Point: 
p. 16 

Method Used: 

Closed cup 

Flammability Limits (vol/vol°/a) : Lower: Upper: 

No Data No Data 

Extinguishing Media : 

Recommended (small fires) : dry chemical, carbon dioxide, Recommended (large fire) : alcohol foam, universal foam, water spray, Not recommended : water jet (frothing possible) . 

Special Fire Fighting Procedures: 

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

Unusual Fire and Explosion Hazards: 

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

Hazardous Decomposition Materials (Under Fire Conditions): 

oxides of nitrogen 

oxides of sulfur 

oxides of carbon 

6. ACCIDENTAL RELEASE MEASURES 

Evacuation Procedures and Safety : 

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

Containment of Spill: 

Follow procedure described below under Cleanup and Disposal of Spill . 

Cleanup and Disposal of Spill: 

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

Environmental and Regulatory Reporting: 

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

7. HANDLING AND STORAGE 

Minimum/Maximum Storage Temperatures : 

10 to 49 C (50 to 120 F) 

Handling : 

Avoid breathing vapors and mists . Avoid direct or prolonged contact with skin and eyes. DO NOT ALLOW TO FREEZE. If freezing occurs, thaw and remix before using . Frozen material may be thawed in a warm room . Avoid localized overheating . Vent drums while heating . Mix thoroughly to assure homogeneity . 

Storage: 

SHIP AND STORE BETWEEN 50-120 F . Store in tightly closed containers. Store in an area that is dry, well- ventilated, away from incompatible materials (see Section 10. Stability and Reactivity), Expected shelf life if stored 

16 
p. 17 

at recommended temperatures : 12 months. 

8 . EXPOSURE CONTROLS/PERSONAL PROTECTION 

Introductory Remarks: 

These recommendations provide general guidance for handling this product. Because specific work environments and material handling practices vary, safety procedures should be developed for each intended application . While developing safe handling procedures, do not overlook the need to clean equipment and piping systems for maintenance and repairs . Waste resulting from these procedures should be handled in accordance with Section 13 : Disposal Considerations . 

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

Exposure Guidelines: 

No exposure limits were found for this product or any of its ingredients . 

Engineering Controls : 

Where engineering controls are indicated by use conditions or a potential for excessive exposure exists, the following traditional exposure control techniques may be used to effectively minimize employee exposures: general area dilution/exhaust ventilation . 

Respiratory Protection : 

When respirators are required, select NIOSH/MSHA approved equipment based on actual or potential airborne concentrations and in accordance with the appropriate regulatory standards and/or industrial recommendations . 

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

Eye/Face Protection : 

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

Eye contact should be prevented through use of chemical safety glasses with side shields or splash proof goggles . An emergency eye wash must be readily accessible to the work area. 

Skin Protection : 

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

Work Practice Controls : 

Personal hygiene is an important work practice exposure control measure and the following general measures should be taken when working with or handling this material : 

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

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

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

9. PHYSICAL AND CHEMICAL PROPERTIES 

Physical and Chemical properties here represent typical properties of this product. Contact the business area 
using the Product Information phone number in Section 1 for its exact specifications . 

_Physical Appearance: 

Odor: 

pH: 

Specific Gravity : . 

Water Solubility: 

Melting Point Range: 

Freezing Point Range : 

Boiling Point Range : 

Vapor Pressure : 

, Vapor Density : 

Percent Volatiles by Volume: 

10. STABILITY AND REACTIVITY 

Chemical Stability : 

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

Conditions To Be Avoided: 

heat 

open flame 

spark 

Materials/Chemicals To Be Avoided: 

strong acids 

strong oxidizing agents 

The Following Hazardous Decomposition Products Might Be Expected: 

Decomposition Type : thermal 

oxides of nitrogen 

oxides of sulfur 

18 
p. 19 

oxides of carbon 

Hazardous Polymerization Will Not Occur. 

Avoid The Following To Inhibit Hazardous Polymerization : 

not applicable 

11 . TOXICOLOGICAL INFORMATION 

Acute Eye Irritation: 

Toxicological Information and Interpretation : 

eye - eye irritation, rabbit. Moderately irritating . 

Acute Skin Irritation : 

Toxicological Information and Interpretation: 

skin - skin irritation, rabbit . Slightly irritating . 

Acute Dermal Toxicity: 

No test data found for product. 

Acute Respiratory Irritation : 

No test data found for product. 

Acute Inhalation Toxicity : 

No test data found for product. 

Acute Oral Toxicity: 

Toxicological Information and Interpretation : 

LD50 - lethal dose 50% of test species, 8250 mg/kg, rat. 

Chronic Toxicity : 

This product does not contain any substances that are considered by OSHA, NTP, IARC or ACGIH to be "probable" or "suspected" human carcinogens . 

No additional test data found for product. 

12 . ECOLOGICAL INFORMATION 

Ecotoxicological Information: 

Ecotoxological Information and Interpretation : 

LC50 - lethal concentration 50% of test species, 4 .87 mg/I/96 hr, fathead minnow. 

Chemical Fate Information : 

The material is not readily biodegradable (OECD 301 E). 

13 . DISPOSAL CONSIDERATIONS 
p. 20 

Waste Disposal Method : 

Chemical additions, processing or otherwise altering this material may make the waste management information presented in this MSDS incomplete, inaccurate or otherwise inappropriate . Please be advised that state and local requirements for waste disposal may be more restrictive or otherwise different from federal laws and regulations . Consult state and local regulations regarding the proper disposal of this material . 

Container Handling and Disposal : 

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

EPA Hazardous Waste - NO 

14. TRANSPORTATION INFORMATION 

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

The listed Transportation Classification does not address regulatory variations due to changes in package size, mode of shipment or other regulatory descriptors . 

US Department of Transportation 

Shipping Name: 

NOT REGULATED 

15. REGULATORY INFORMATION 

Inventory Status 

Inventory Status 

UNITED STATES (TSCA) Y 

CANADA (DSL) Y 

EUROPE (EINECS/ELINCS) Y 

AUSTRALIA (AICS) Y 

JAPAN (MITI) Y 

SOUTH KOREA (KECL) N 

Y = All ingredients are on the inventory . 

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

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

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

FEDERAL REGULATIONS 

Inventory Issues : 

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

SARA Title III Hazard Classes : 

Fire Hazard - NO 

Reactive Hazard - NO 

Release of Pressure -NO 

Acute Health Hazard - YES 

Chronic Health Hazard - NO 
STATE REGULATIONS : 

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

16. OTHER INFORMATION 

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

2 Health Hazard Rating--Moderate 

1 Flammability Rating--Slight 

0 Instability Rating--Minimal 

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

2 Health Hazard Rating--Moderate 

1 Flammability Rating--Slight 

0 Reactivity Rating--Minimal 

Reason for Revisions : 

Change and/or addition made to Section 12 . 

Key Legend Information : 

ACGIH -American Conference of Governmental Industrial Hygienists 

OSHA - Occupational Safety and Health Administration 

TLV - Threshold Limit Value 

PEL - Permissable Exposure Limit 

TWA - Time Weighted Average 

STEL - Short Term Exposure Limit 

NTP - National Toxicology Program 

IARC - International Agency for Research on Cancer 

ND - Not determined 

Disclaimer: 

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

** End of MSDS Document ** 
p. 22 

CONFIDENTIAL BUSINESS INFORMATION 

Pages 22 through 24 have been removed 

Pages 22 - 24 

A CL 
!TOXICITY DATA 

ACUTE ORAL LDso 

An acute oral LD50 study was conducted using 3 groups of 10 healthy albino mice each dosed once by gavage. Feed and water were provided ad-libitum after dosing and each mouse was observed daily for mortality and other signs of gross toxicity for 5 days. The oral LDr,0 was calculated to be 7.5 mUkg (with 95% confidence limits of 6.5 - 8.7 mUkg). 

Leberco Laboratories, February, 1978 (Ref: PS-1550) 

DERMAL IRRITATION 

Three albino rabbits were evaluated for erythema, eschar and edema formation on abraded and intact skin after the application via patches of 0.5 ml of the test material at 16% solids and pH 7.0 . The patches were removed 24 hours after application and the reactions were noted then and again at 72 hours. The Primary Irritation Index was determined to be 0.83 which classifies the test substance as a slight dermal irritant to rabbit skin under the conditions of the test . 

American Standards Biosciences, March, 1989 (Ref: PS-2662) 

OCULAR IRRITATION 

Three albino rabbits each received 0.1 ml of the test material at 10% solids and pH 7.0 to one eye with the other eye serving as a negative control . Observations were recorded at 24, 48, and 72 hours and again at 4 and 7 days. The Maximum Mean Total Score was 51 .0 (24 hours) and 10.3 (7 days). It was concluded to be a severe irritant to rabbit eyes under the test conditions. 

American Standards Biosciences, May, 1988 (Ref: PS-2658) 

A second study was conducted on an additional 3 rabbits using 0.1 ml of the test substance at 16% solids and pH 7.0 in the manner described above. The Maximum Mean Total Score was 43.7 (24 hours) and 11 .3 (7 days). It was concluded to be a moderate irritant to rabbit eyes under the test conditions. 

American Standards Biosciences, March, 1989 (Ref: PS-2659) 

AQUATIC TOXICITY 

A static aquatic bioassay was run on fathead minnows. Tests were conducted in 1200 ml polypropylene vessels at 22° C with no aeration. Tests were conducted in well water with a pH of 8.0 and total hardness of 270 mg/l. The 96 hour LC50 and 95% confidence intervals were determined to be 4.87 (3.92-6.06) mg/l. The no effect level was determined to be <1 .0 mg/l. 

3M Environmental Labs, November, 1996 (Ref: PS-3440) 

A static aquatic bioassay was run on Daphnia magna. Tests were conducted in 1000 ml glass vessels . The pH, DO and temperature were monitored during the study. The 24-hour EC50 was determined to be 12 ppm, with a 48-hour EC50 of 9.3 ppm. 

RP Industries, March, 1994 (Ref: PS-3536) 

Summary date: February 11, 2003 
PI:Q 24 550 

TrrrrrrrE 

GEBERCO LABORATORIES 

rarrrrrrrrr~rrrrrrrrr~rrrrrrr~rrrsr~rrrraarrrr~rrrrrrrrrrrrrr 

123 HAWTHORNE STREET - ROSELLE PARK, N J 07204 

DIAL 201 245 1933 

February ?3, 1978 

SUBIVIITTED TO : 

ASSAY 'NUMBER : 81971. 

Dr? TE f~ EC--IVFD : December 14, 1977 

?" JST . . :ATERIAL : 

Sli BJECT OF ASSAY: To aetermine tne toxicity, in mice, of the test 

material as submitted . 

'07-THOD OF ASSAY: 

tiormal, healthy CF~~ mice of the Carworth strain, weighing 18 

to 21 grams were used in this study. 

The test material was aoministered orally by means of a rigia stomach 

tube to groups of ten mice . ?rior to feeding the test material was 

ciluted 1 to 5 in water . Following the administration of the test material 

the mice were observ~c :or five :~ay9 . Curing this time they were 

rraintainea in wire cages, 5 to a cage, and had Lab Blox ano water au 

iibitum . 

r i~" I 

. aD 

0 

a~~E'^ 

0 

The method of Litctifield, ') . ~~ . , ana « ~ icoxon, F ., Journal of Pharma-

,~olo?y and Experimental Therapeutics, Vol . 96, page 99, 1949 was usea 

for calculating the oral L D jp . 

This report is submitted for the exclusive use of the person, partnership or corporation to whom it is addressed, and neither the report nor 

the name of these Laboratories nor of any members of its staff, may be used in connection with the advertising or sale of any product or 

process without written authorization . 

26 000024 
p. 25 

LEBERCO LABORATORIES ASSAY NUMBER 81971 

RESULTS : 

Observed 

Ml . /Kilo c 7c 11C Minus 

Mouse Response Observea Txpectea Expected (C. :iI)" 

6 .0 2/10 20 23 3 ~ . 005 

7 . 5 5 / 10 50 ~ 1 1 0 .000 

10 .0 8/10 80 33 ~ ; .020 

0 .25 

N 1 = 30 

ED8,1 = 10 .0 

EDjO - 7 . 5 

ED15 = 5 . 6 

S ED84/ED30 + JD50/ED16 

= 1 . 34 

2 

fED50 = 32 .77 /,iIV1 = 1 .16 

ED50 x f,ED50 = 3 . 7 

ED50/ fED50 = 6 . 3 

The LD,50 was calculatea to be 7 . 5 ml . per xilo mouse with a 19/20 confidence 

of 6 . 3 to 8 . 7 ml . per kilo mouse . 

LEBERC 

\ 

Irving Levenstein, 

Director 

?h . D . 

IL :mr 
AMERICAN STANDARDS BIC~SCIENCES CORPORATION 

PS-2662 

FINAL REPORT 

THE PRIMARY DERMAL IRRITATION STUDY OF 

AT 16$ SOLIDS AND pH 7,0 

ON ABRADED AND NONABRADED SKIN OF 

NEW ZEALAND ALBINO RABBITS 

R .D.9, PO. Box 9021, Reading, PA 19605 (215) 378-7800 

~VJ A Member of the ASTB Companies 28 oo 
FINAL REPORT 

THE PRIMARY DERMAL IRRITATION STUDY OF 

AT 16$ SOLIDS AND pH 7 .0 

ON ABRADED AND NONABRADED SKIN OF 

NEW ZEALAND ALBINO RABBITS 

SPONSOR : 

TESTING FACILITY : AMERICAN STANDARDS BIOSCIENCES 

CORPORATION 

RD 9, BOX 9021 

READING, PA 19605 

STUDY DIRECTOR : York Terrell 

PROJECT NUMBER : 89-164 

STARTING DATE : 2/27/89 

COMPLETION DATE : 3/2/89 

EXPERIMENTAL WORK 

AND REPORT BY : 

3 c 

'A// 

udy Dfrect6r Date 

York Terrell 

APPROVED BY : 

, 

Quality Assurance Date 

Geoffrey St . E . Parke 

page 1 of 9 

/ 
FINAL REPORT 

THE PRIMARY DERMAL IRRITATION STUDY OF 

AT 16$ SOLIDS AND pH 7 .0 

ON ABRADED AND NONABRADED SKIN OF 

NEW ZEALAND ALBINO RABBITS 

QUALITY ASSURANCE UNIT 

INSPECTION STATEMENT 

In accordance with the regulations set forth in the Good 

Laboratory Practice for Nonclinical Laboratory Studies, 40CFR160, 

Federal Register, Vol . 48, November 29, 1983, Part 4, the phase 

of study inspected, along with the date(s) of inspection, are 

shown below . 

PHASE OF STUDY DATE OF INSPECTION 

Observation for dermal irritation 2/28/89, 3/1/89 

Route and Method of Administration 2/27/89 

Notebook entries 3/2/89 

Correlation of notebook entries 

to final report 3/2/89 

COMMENTS : 

At the time of these inspections, all work had been and was being 

performed in a manner consistent with the G .L .P .'s . 

; ---- <-:~.~ 

DATE QAU OFFICER 

Geoffrey St . E . Parke 

page 2 of 9 

, 
FINAL REPORT 

THE PRIMARY DERMAL IRRITATION STUDY OF 

AT 16$ SOLIDS AND pH 7 .0 

ON ABRADED AND NONABRADED SKIN OF 

NEW ZEALAND ALBINO RABBITS 

SUMMARY 

A sample of r- ~AT 16$ SOLIDS AND pH 7 .0 was 

tested for potential dermal irritation in accordance with the 

procedures as outlined in Section 1500 .41 of the Code of Federal 

Regulations . 

A 0 .5 ml portion of the test material was applied to abraded and 

nonabraded skin test sites of three New Zealand Albino rabbits . 

Grading for erythema and edema was performed at 24 and 72 hours, 

Grade one (1) erythema (2/3) and grade two (2) erythema (1/3) as 

well as grade one (1) edema (1/3) was exhibited at the 24 hour 

reading for both abraded and nonabraded skin . All rabbits were 

free of irritation at the 72 hour reading . 

The Primary Dermal Irritation Index was 0 .83 . 
I . OBJECTIVE 

To evaluate the potential dermal irritation ofL 

ISOLIDS AND pH 7 .0 on abraded and non- abraded skin of New Zealand Albino rabbits . 

II . MATERIALS & METHODS 

A. Test Formulation 

r 

A sample ofL 13 was utilized in this study . 

1 . Identification 

}AT 16$ SOLIDS AND pH 7 .0 . 

2 . Dose 

The sample utilized in this study was identified as 

A 0 .5 ml portion of the test material was administered to the abraded and nonabraded skin of each 

rabbit at each test site . 

3 . Method of Administration 

A modification of the method, as described in the 

Code of Federal Regulations, Section 1500 .41, was 

used in this study . Each 0 .5 ml portion of test 

material was applied directly to the abraded and 

nonabraded test site . The material was then 

covered with 1" x 1" surgical gauze and wrapped 

with rubberized cloth . 

4 . Duration of Administration 

The test material was administered once on day 0 of 

the study and left in contact with the test sites 

for 24 hours . 

B . Animal Test System 

l . Justification 

Rabbits are considered the appropriate test systein 

as they are characteristic mammalian system in 

which the dermal response to toxicological agents 

can be evaluated . 

page 4 of 9 

000030 
'2 . Number and Sex 

Three(3) adult New Zealand Albino rabbits, weighing 

2 .37 - 2 .73 kg were utilized in this study . 

3 . Source and Supply 

The rabbits were obtained from Ace Animals, Inc ., 

Boyertown, PA 19512 . 

4 . Housing 

The rabbits were housed individually in stainless 

steel, wire mesh cages in a room at constant 

temperature of 70 (+/-5) degrees F with an 

artificial light cycle of 12 hours . Tap water and 

Purina rabbit pellets were available ad libitum . 

5 . Identification 

Each animal was identified by a numbered ear tag . 

C. Procedure 

Following a 7 day acclimation period, the back and 

flanks of each rabbit were clipped free of hair to expose approx . 10$ of the skin surface . One abraded and 

one nonabraded test site was designated on each side of 

the spinal column . Abrasions were made so as to 

penetrate the stratum corneum but not the dermis . A 20 

guage needle , was used to abrade the skin, a 0 .5 ml 

portion of 7was administered to each test 

site on each animal . Each site was covered by 1 inch 

square gauze pad . The entire test area was then covered 

with rubberized cloth for a period of 24 hours . At the 

end of the exposure period, the rubberized wrapping was 

removed and the skin was wiped free of any test 

material . The test sites were evaluated using the 

Draize scale (Table I) . Evaluations were again made at 

72 hours . 

page 5 of 9 
III . RESULTS 

Individual scores are presented in Table II . 

The Primary Dermal Irritation Index is presented in Table III . 

IV . ORIGINAL DATA STORAGE 
TABLE I 

SCALE FOR GRADING SKIN REACTION 

SKIN REACTION VALUE 

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 slight 

eschar formation (injuries in depth) 4 

Edema Formation : 

No edema 0 

Very slight edema (barely perceptible) 1 

Slight edema (edges of area well-defined by 

definite raising) 2 

Moderate edema (raised approx . lmm) 3 

Severe edema (raised more than lmm and 

extending beyond the area of exposure) 4 

Method for Determining Primary Dermal Irritation Index* 

The Primary Dermal Irritation Index is calculated by adding the 

values for erythema and eschar formation at 24 and 72 hours for 

intact skin to the values on abraded skin at 24 and 72 hours . 

Similarly, the values for edema formation at 24 and 72 hours for 

intact skin and for abraded skin are added . The total of the 8 

values is divided by 4 to give the Primary Dermal Irritation 

Index . 

*Federal Register, Vol . 38, No . 187, September 27, 1973 . 
TABLE II 

INDIVIDUAL SCORES FOR THE EVALUATION OF 

PRIMARY SKIN IRRITATION 

24 HOURS 

ERYTHEMA & ESCHAR EDEMA 

ANIMAL ABRADED NONABRADED ABRADED NONABRADED 

NUMBER right left right left 

8173M 1 1 0 0 

8174M 1 1 0 0 

8175F 2 2 1 1 

AVERAGE 1 .33 1 .33 0 .33 0 .33 

72 HOURS 

ERYTHEMA & ESCHAR EDEMA 

ANIMAL ABRADED NONABRADED ABRADED NONABRADED 

NUMBER right left right left 

8173M 0 0 0 0 

8174M 0 0 0 0 

8175F 0 0 0 0 

AVERAGE 0 0 0 0 
TABLE III 

DETERMINATION OF PRIMARY IRRITATION INDEX 

SKIN EXPOSURE TIME EVALUATION 

REACTION (HOURS) VALUE 

Erythema & Eschar Formation 

Intact skin 24 1 .33 

Intact skin 72 0 .00 

Abraded skin 24 1 .33 

Abraded skin 72 0 .00 

Subtotal 2 .66 

Edema Formation 

Intact skin 24 0 .33 

Intact skin 72 0 .00 

Abraded skin 24 0 .33 

Abraded skin 72 0 .00 

Subtotal 0 .66 

TOTAL 3,32 

Thus, the primary irritation score is 3 .32 divided by 4 = 0 .83, 

page 9 of 9 

37 
p. 36 

AMERICAN STANDARDS BISSCIENCES CORPORATION 

PS-2658 

FINAL REPORT 

. 

THE EFFEJT OF 

pH 7 .0 10% SOLIDS 

ON THE EYE MUCOSA 

OF NEW ZEALAND ALBINO RABBITS 

,,-

5 

R . D.9, P O. Box 9021, Reading, PA 19605 (215) 378-7800 

(6') A Memoer ot the ASTB Companies ~P bG 
FINAL REPORT 

r 

SPONSOR : 

THE EFFECT OF 

)pH 7 .0 10% SOLIDS 

ON THE EYE MUCOSA 

OF NEW ZEALAND ALBINO RABBITS 

TESTING FACILITY : AMERICAN STANDARDS BIOSCIENCES CORP . 

R .D . #9, Box 9021 

Reading, PA 19605 

STUDY DIRECTOR : YORK TERRELL 

STARTING DATE : MAY 12, 1988 

COMPLETION DATE : MAY 19, 1988 

PROJECT NUMBER : 88-329 

EXPERIMENTAL WORK -

AND REPORT BY : 

UUDY-D1KtU1UR DATE 

York Terrell 

APPROVED BY : 

U UNIT 

Geoffrey St . E . Parke 

page 1 of 8 

i . _> ,rc 2-s 11 

DATE 

39 000037 
THE EFFE~T OF 

pH 7 .0 10% SOLIDS 

ON THE EYE MUCOSA OF 

NEW ZEALAND RABBITS 

QUALITY ASSURANCE UNIT 

INSPECTION CERTIFICATE 

In accordance with the regulations set forth in the Good Laboratory Practice for Nonclinical Laboratory Studies, the phase of study inspected along with the date(s) of inspection, are shown below . 

PHASE OF STUDY DATE OF INSPECTION 

Observation for eye irritation 5/11/88 

Notebook Entries 5/17/88 

Correlation of Notebook Entries 

to Final Report 5/19/88 

COMMENTS : 

At the time of this inspection, all work had been and was being performed in a manner consistent with the G .L .P .'s . 

~,z-1 ~ 

DATE QUALr'rY ASSURANCE UNIT 

Geoffrey St . E . Parke 
FINAL REPORT 

THE EFFEC.I OF 

pH 7 .0 10% SOLIDS 

ON THE EYE hTDCOSA OF 

NEW ZEALAND ALBINO RABBITS 

SUMMARY 

Three (3) young adult New Zealand Albino rabbits weighing between 

2 .~-- 2 .9 kg were employed to evaluate the potential irritant effects 

of : 2 sample'~pH 7 .0 

10% Solids on the eye mucosa . 

A measured volume of 0 .1 of test material was administered to the 

conjunctival sac of the right eye of each rabbit . The lids were 

gently held together for 1 second to prevent loss of the test 

material . The eyes were not washed following instillation of the 

test material . 

All three rabbits exhibited positive eye irritation scores at 24 hours 

ranging from grade 2 to grade 4 in the cornea and grade 1 to grade 3 

in the conjunctivae . Grade 2 corneal irritation persisted in one 

animal up to 7 days, but showed reversibility in 2/3 of the animals 

at 4 days . Based on the results obtained in this study, the test 

material is considered to be irritating to the eyes . 
I . OBJECTIVE 

To determine the effects of~ -" 

pH 7 .0 10% Solids on the eye mucosa of New Zealand Albino rabbits . 

II . MATERIALS AND METHODS 

A . Test Compound 

A sample of r ]pH 7 .0 10% Solids was utilized in`~he study . 

1 . Identification 

rIhe test material usedin this study was identified as 

` 

2 . Dose 

H 7 .0 10% Solids . 

A 0 .1 ml sample of was placed in the conjunctival sac of the right eye of each rabbit . 

3 . Method of Administration 

The method employed was a modification of the Code of Federal Regulations 1500-42, 1985 . Each 0 .1 mi 

of the test material was placed in a 1 cc tuberculin 

syringe and then administered into the conjunctival sac of the right eye of each rabbit . Each 0 .1 ml of test 

material was administered as a single administration on 

day 0 . 

B . Animal Test System 

1 . Justification 

Rabbits are considered the appropriate test system as 

they are characteristic mammalian system in which the 

response to toxicological agents can be evaluated . 

C . Procedure 

1 . Animals 

Three(3) young adult New Zealand Albino rabbits 

weighing between 2 .6-2 .9 kg, were used in this study . 

The rabbits were obtained from Ace Animals, Boyertown, 

PA and were conditioned to this laboratory environment 

for a minimum period of seven days . The rabbits were 

housed in suspended wire mesh cages in a room maintainpage 4of8 

000040 
ed at 72, +/- 5 degrees F ., with a light cycle of 12 hours . 

Water and Purina rabbit pellets were available ad libitum . 

2 . Prescreening 

All rabbits used in this study received a pre-screening 

examination designed to detect pre-existing ocular irritation or corneal damage . The rabbits were placed in 

restraining stocks and examined for corneal opacity, iritis, 

conjunctival redness, chemosis or a discharge . In addition, 

the presence or absence of corneal damage was determined by 

placing one drop of 2% ophthalmic sodium fluorescein in the 

eye to be tested . Fifteen seconds after instillation, the 

eye was washed with 0 .9% saline . Following this wash, the 

eye was examined in long-wave ultraviolet light . If present, corneal damage showed up as a bright yellow-green 

fluorescent area on the surface of the cornea . Any rabbit 

showing either corneal damage or an ocular irritation score 

greater than zero, using the grading system presented in 

Table I, was not used in this study . 

3 . Dose Application 

A 0 .1 sample of r IpH 7 .0 10% Solids 

was placed in t~s conjunctival sac of the right eye of each 

rabbit . The left eye served as the control and was not 

treated . The lids of the treated eye were gently held together for 1 second before releasing them to prevent loss of 

the test material . 

4 . Observation 

The ocular reactions were graded at 24, 48, 72 hours, 4 & 7 

days using the grading system presented in Table 1, with the 

same procedures as used for prescreening examinations . 

III . RESULTS 

Individual results are presented in Table II . All three rabbits 

exhibited positive eye irritation scores at 24 hrs . which lasted 

up to 7 days in one animal . Conjuntivae irritation persisted up 

to 7 days in 2 animals while corneal opacity showed reversibility 

in 2/3 animals at 4 days . 

IV . RAW DATA STORAGE 

All raw data is being stored at American Standards Biosciences 

Corp ., R .D .#9, Box 9021, Reading, PA 19605 . 

page 5 of 8 

4 r) 

000041 
TABLE I 

GRADE FOR OCULAR LESIONS 

CORNEA 

Opacity : Degree of density (area most dense taken for reading) 

No ulceration or opacity 0 

Scattered or diffuse areas of opacity (other than slight 

dulling of normal luster), details of iris clearly visible 1* Easily discernible translucent area, details of iris 

slightly obscured 2* 

Nacreous area, no details of iris visible, size of pupil 

barely discernible 3* 

Opaque cornea, iris not discernible through the opacity 4* 

IRIS 

Normal 0 

Markedly deepened rugae, congestion, swelling, moderate 

circumcorneal hyperemia, or injection, any of these or 

combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1* 

No reaction to light, hemorrhage, gross destruction (any or 

all of these) Z* 

CONJUNCTIVAE 

Redness : refers to palpebral and bulbar conjunctivae, cornea & iris 

Blood vessels normal 0 

Some blood vessels definitely hyperemic (injected) 1 

Diffuse, crimson color, individual vessels not easily 

discernible 2* 

Diffuse beefy red 3* 

Chemosis : lids and/or nictating membranes 

No swelling 0 

any swelling above normal 

Obvious swelling with partial eversion of lids 2* 

Swelling with lids about half-closed 3* 

Swelling with lids more than half-closed 4* 

Discharge 

No discharge 0 

Any amount different from normal (does not include small 

amounts observed in inner canthus of normal animals) 1 

Discharge with moistening of the lids and hairs just 

adjacent to lids 

Discharge with moistening of the lids and hairs, and 

considerable area around the eye 3 

*Starred figures indicate positive effect . 

page 6 of 8 44 
(b)(1) An animal shall be considered as exhibiting a positive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stippling), or opacity of the cornea (other than a slight dulling of the normal luster), or inflammation of the iris (other than a slight deepening of the folds (or rugae) 

or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctivae (excluding the cornea and iris) 

an obvious swelling with partial eversion of the lids or a diffuse 

crimson-red with individual vessels not easily discernible . 
TABLE II 

OCULAR RESULTS IN RA~BITS RECEIVING JpH 7 .0 10% SOLIDS 

ANIMAL HOURS DAYS 

NUMBER PARAMETER 0 24 48 72 4 1 

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

7844 Cornea-Opacity 0 2 2 2 2 2 

Area 0 4 3 3 2 1 

Iris-value 0 1 1 1 1 0 

Conjuctivae 

A . Redness 0 2 2 2 1 1 

B . Chemosis 0 2 2 2 1 1 

C . Discharge 0 2 2 1 1 1 

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

7845 Cornea-Opacity 0 2 2 1 0 0 

Area 0 3 1 1 0 0 

Iris-value 0 1 1 1 0 0 

Conjuctivae 

A . Redness 0 2 2 2 1 0 

B . Chemosis 0 3 2 1 1 1 

C . Discharge 0 3 2 1 1 0 

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

7846 Cornea-Opacity 0 2 2 1 0 0 

Area 0 3 1 1 0 0 

Iris-value 0 1 0 0 0 0 

Conjuctivae 

A . Redness 0 2 1 1 1 0 

B . Chemosis 0 2 1 1 1 0 

C . Discharge 0 1 1 1 0 0 

page 8 of 8 
YK13 rl,r=, .ti Q w" ruiu -1-1 

TO : 

RE: 

J 

TOXICOLOGY S'TUDY SUBMT= TO CAP COMMIT'IEE 

Screened for. _j/ 8(e) - 8(d) 

READ INSTRUCTIONS CAREFULLY ' " -

c1,p ID No-~ S -cl2-~r AtC - _j_~-121 

Screen er s namc: ~. - P! 

Drvuion: s 1ML~ Huunesa Unit: 

Location of Study: rTSl. A P1 LL"5 ~JUi IC,~r`A N 

Substance or Monurv Identification. 

Short name _ C:A1 rlo.(t<): . 

Chemtcal name(s): 

Substance or Muturr History (to the eanent lutvwn}: 

- manufactured (includes R&D) - tmponed - processed , dutrtbuted by oat= 

_ manufactured (includes R&D) _ imported - prooesaed - disuibuted bv predecessor. Dates: 

Name of predecessor. 

Substance or Mbnure Use by ' and)or iu customem (check all that apply) 

, R&D - intermediate - aommeraaf distribuuon  pesucide - pharmaoeuucal - food - ooosumer products --- other. 

- other Ex=t of exposure: 

U 

lf you hove checked -only pesucide, pharmaacuuaL or food, do You know that them are no other use of the substance by Rbbae-Pouleac or us 

customers? There am no other uses Don't IMOW if them am OM= U= 

The Information : 

ibe Attached taformataa u: - preiimtnary data ~ a draft report ~! the Gaal re~port - other 

-3ZConducted b%- (C'CGI ~v )L~-t (-C~ ~ 

Type of informauon: 

Reason(s) information abould be aonssdered for 8(e) submns+on : ~ 

,)C)~ c lcx~z rt ~~c ~ i ~1 113 ay) Nrck 

Reasonts) information shoufd be oonsidertd for B(d) submtss+oa : 

Hu LhIs ttudv alrradv beca wbtamtted to tt gwernmeat agency' _ yes 

II yes . name and address o( agency: 

- - J 

don't know Date of submustona 

Reason for submusroo to agencv 

lf this studv u rrponen to EPA awuld there be s oonfLdeatuLtv concern? ` Yes , no 

47 

(Further comments on back- etm 

000045 
p. 46 

TO : 

FROM : 

DATE : September 23, 1992 

PRrvIZOc',ED AND CONFIDENTIAL 

ATTORNEY /CLIENT COMMUNICATION 

SUBJECT : Recommendation regarding toxicological study 

CAP ID _ao . : S-CR-BAK-1421 

Title : 

/American Standar(I`s'Biosciences Corp ID #88-329/The Effect of' pH 7 .0 10% solids on the Eye Mucosa of New Zealand Rabbits 

Attached is the cover sheet for the above-referenced toxicology studies_, -which the screening team found to meet the preliminary screening criteria under' ,Compliance Audit Program (CAP) . The Toxicology Subcommittee has reviewed the study under EPA's current criteria for reporting of studies under TSCA Section 8(.e) . Based on this review, we recommend that the CAP Committee : 

report the study under the CAP . The study appears to be Section 8(e) reportable because ' 

not report the study under the CAP . The study does not appear to be Sectio-X- 8() reportable because, the level of ocular irritation diminished through test termination (Day 7) . The pH of the material as tested was reported to be 7 .0 . See attached report . 

It is not clear whether this study should be reported, because 

The reportability of this study should be discussed by the CAP Committee . 

CAP COMMITTEE DECISION 

_ report ~~ do not report date ; ~~ l - << ? 

REASON : - as above - other (explain below) 
p. 47 

AMERICAN STANDARDS BIC~SCIENCES CORPORATION 

Ps-2659 

FINAL REPORT 

THE EFFECT OF ,.., 

OF NEW ZEALAND ALBINO RABBITS 

AT 16$ SOLIDS AND PH 7,0 

ON THE EYE MUCOSA 

o` '~t " ~; 

`-7 7~, I 

V1n v & 6-C"-A~- 

R . D.9, PO. Box 9021, Reading, PA 19605 (215) 378-7800 

000047 
FINAL REPORT 

THE EFFECT OF 

AT 16$ SOLIDS AND PH 7,0 ~ 

ON THE EYE MUCOSA 

OF NEW ZEALAND ALBINO RABBITS 

SPONSOR: 

TESTING FACILITY : AMERICAN STANDARDS BIOSCIENCES CORP . 

R.D . 9, BOX 9021 

READING, PA 19605 

STUDY DIRECTOR : YORK TERRELL 

STARTING DATE : 2/21/89 

COMPLETION DATE : 2/28/89 

PROJECT NUMBER : 89-163 

EXPERIMENTAL WORK 

AND REPORT BY : 

STUDY DIRECTOR DATE 

York Terrell 

i 

APPROVED BY : 

QUALITY ASSURANCE UNIT DATE 

Geoffrey St, E . Parke 

page 1 of 10 
FINAL REPORT 

r- THE EFFECT OF 

AT 16$ SOLIDS AND pH 7 .0 " 

ON THE EYE MUCOSA OF 

NEW ZEALAND ALBINO RABBITS 

QUALITY ASSURANCE UNIT 

INSPECTION STATEMENT 

In accordance with the regulations set forth in the Good 

Laboratory Practices for Nonclinical Laboratory Studies, 40 CFR160, Federal Register, Vol . 48, Nov . 29, 1983, Part 4, 

the phase of study inspected, along with the date(s) of inspection, are shown below . 

PHASE OF STUDY DATE OF INSPECTION 

Identification 2/23/89 

Protocol 2/23/89 

Observation for eye irritation 2/23/89, 2/24/89, 2/27/89 

Notebook entries 2/23/89 

Correlation of notebook entries 

to final report 2/28/89 

Comments : 

At the time of this inspection, all work had been and was being performed in a manner consistent with the GLP's . 

DATE QUALITY ASSURANCE UNIT 

Geoffrey St . E . Parke 

page 2 of 10 

51 000049 
FINAL REPORT 

THE EFFECT OF 

AT 16% SOLIDS AND pH 7 .0 

ON THE EYE MUCOSA OF 

NEW ZEALAND ALBINO RABBITS 

SUMMARY 

Three (3) young adult New Zealand Albino rabbits, weighing 

between 2 .51-2 .78 kc were employed to evalu4e the potential 

irritant effects of, ~(16% solids and 

pH 7 .0) on the eye mucosa . 

A measured volume of 0 .1 ml of test material was administered 

to the conjunctival sac of the right eye of each rabbit . The lower lids were gently held together for 1 second to prevent 

loss of the test material . The ocular reactions were graded 

at 24, 48 & 72 hours as well as days four (4) & seven (7) . 

Grade two (2) corneal opacity (3/3) was exhibited at the 24, 

48 and 72 hour reading as well as day four (4) . At the seven 

(7) day reading, corneal opacity (grade one (1) (1/3) and two 

(2) (1/3)) was exhibited . Grade one (1) iritis (2/3) was 

exhibited at the 24, 48 and 72 hour reading while grade one 

(1) iritis (1/3) was exhibited at the four (4) and seven (7) 

day reading . Grade one (1), two (2) or three (3) conjunctivae redness, chemosis and discharge (3/3) was exhibited at 

the 24, 48 and 72 hour reading as well as day four (4), while 

grade two (2) or three (3) conjunctivae redness, chemosis and 

discharge (1/3) was exhibited at the seven (7) day reading . 
I . OBJECTIVE 

To determine the effects of'r ~ on the eye mucosa of New Zealan Albino rabbits, 

II . MATERIALS AND METHODS 

A. Test Compound 

A sample of r jwas utilized 

in this study . 

1 . Identification 

The sample used in this 

as '~ 

pH -7 .0 . 

2 . Dose 

was identified 

T 16$ SOLIDS & 

A 0 .1 ml sample of(- 

was placed in the conjunctivae sac of the 

right eye of each rabbit, 

3, Method of Administration 

The method employed was a modification of the 

Code of Federal Regulations 1500-42, 1985 . 

Each O .lml of the test material was placed in 

a lcc tuberculin syringe and then administered 

into the conjunctivae sac of the right eye of 

each rabbit . Each O .lml of the test material 

was administered as a single dose on day 0 . 

B . Animal Test System 

1 . Justification 

Rabbits are considered the appropriate test 

system as they are characteristic mammalian 

system in which the response to toxicological 

agents can be evaluated . 

page 4 of 10 
C . Procedure 

1 . Animals 

Three (3) young adult New Zealand Albino 

rabbits, weighing between 2 .52-2 .78 kg were used in this study . 

The rabbits were obtained from Ace Animals, 

Boyertown, PA and were conditioned to this 

laboratory environment for a minimum period of 

seven days . The rabbits were housed in suspended wire mesh cages in a room maintained at 72, +/- 5, degrees F with a light cycle of 12 

hours . Water and Purina rabbit pellets were 

available ad libitum . 

2 . Prescreening 

All rabbits used in this study received a prescreening examination designed to detect preexisting ocular irritation or corneal damage . 

The rabbits were placed in restraining stocks 

and examined for corneal opacity, iritis, conjunctivae redness, chemosis or discharge . In 

addition, the presence or absence of corneal 

damage was determined by placing one drop of 

2$ ophthalmic sodium flourescein in the eye to 

be tested . Fifteen seconds after 

instillation, the eye was washed with 0 .9$ 

saline . Following this wash, the eye was 

examined in long-wave ultraviolet light . If 

present, corneal damage showed up as a bright 

yellow-green flourescent area on the surface 

of the cornea . Any rabbit showing either 

corneal damage or an ocular irritation score 

greater than zero, using the grading system 

presented in Table I, was not used in this 

study . 

page 5 of 10 
3 . Dose Application 

A O .lml sample of ~ 

was placed in the conjunctivae sac of the 

right eye of each rabbit . The left eye served 

as the control and was not treated . The lids 

of the treated eye were gently held together 

for 1 second to prevent loss of the test 

material . 

4 . Observations 

The ocular reactions were graded at 24, 48 and 

72 hours, 4 & 7 days using the grading system 

presented in Table I, with the same procedure 

as used for prescreening . 

III . RESULTS 

Individual results are presented in Table II . 

IV . ORIGINAL DATA ST0RAGE 
TABLE I - GRADES FOR OCULAR LESIONS 

CORNEA VALUE 

Opacity : deree of density (area most dense taken for reading? 

No ulceration or opacity p 

Scattered or diffuse area of opacity (other than 

slight dulling of normal lustre) ; details of iris 

clearly visible 1* 

Easily discernible translucent area, details of iris 

slightly obscured 2* 

Nacrous area, no details of iris visible, size of 

pupil barely discernible 3* 

Opaque cornea, iris not discernible through the 

opacity 4* 

IRIS 

Normal p 

Markedly deepened rugae, congestion, swelling, 

moderate circumcorneal hyperemia or injection, any of 

these or combination thereof, iris still reacting to 

light (sluggish reaction is positive) 1* 

No reaction to light, hemorrhage, gross destruction 

(any or all of these) 2* 

CONJUNCTIVAE 

Redness (refers to palpebral and bulbar conjunctivae, 

cornea and iris) 

Blood vessels normal 0 

Some blood vessels definitely hyperemic (injected) 1 

Diffuse, crimson color, individual vessels not 

easily discernible 2* 

Diffuse beefy red 3* 

page 7 of 10 

56 
(Table I cont,) 

Chemosis : lids and/or nictating membranes VALUE 

No swelling 0 

Any swelling above normal (includes nictating 

membranes) 1 

Obvious swelling with partial eversion of lids 2* 

Swelling with lids about half closed 3* 

Swelling with lids more than half closed 4* 

DISCHARGE 

No discharge 0 

Any amount different from normal (does not include 

small amounts observed in inner canthus of normal 

animals) 1 

Discharge with moistening of the lids and hairs just 

adjacent to lids 

Discharge with moistening of the lids and hairs, and 

considerable area around the eye 3 

*Starred figures indicate positive effect 

gage 8 of 10 

57 
Interpretation as outlined in Code of Federal Regulations 

1500 .42 . 

(b)(1) An animal shall be considered as exhibiting a positive 

reaction if the test substance produces at any of the 

readings ulceration of the cornea (other than a fine 

stippling), or opacity of the cornea (other than a slight 

dulling of the normal luster), or inflanunation of the iris 

(other than slight deepening of the folds (or rugae) or a 

slight circumcorneal injection of the blood vessels), or if 

such substance produces in the conjunctivae (excluding the 

cornea and iris) an obvious swelling with partial eversion of 

the lids or a diffuse criinson-red with individual vessels not 

easily discernible . 
TABLE II 

RESULTS IN RABBITS RECEIVING 

AT 16% SOLIDS AND PH 7 .0' 

ANIMAL H O U R S DAYS 

NUMBER PARAMETER 0 24 48 72 4 7 

8167M Cornea-Opacity 0 2 2 2 2 2 

Area 0 3 2 2 2 1 

Iris-value 0 1 1 1 1 1 

Conjunctivae 

A . Redness 0 3 3 3 3 3 

B . Chemosis 0 2 2 2 2 2 

C . Discharge 0 3 3 2 2 2 

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

8168M Cornea-Opacity 0 2 2 2 2 1 

Area 0 2 2 1 1 1 

Iris-value 0 1 1 1 0 0 

Conjunctivae 

A . Redness 0 3 3 2 1 0 

B . Chemosis 0 3 2 1 0 0 

C . Discharge 0 3 3 1 0 0 

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

8169F Cornea-Opacity 0 2 2 2 2 0 

Area 0 3 2 1 1 0 

Iris-value 0 0 0 0 0 0 

Conjunctivae 

A . Redness 0 2 2 1 1 0 

B . Chemosis 0 1 1 1 1 0 

C . Discharge 0 3 3 2 1 0 

page 10 of 10 
p. 58 

PRIVILEGED AND COWIDENTIAL 

ATTORNEY / CLIENT C0WfUNICAT ION 

TO : 

FROM : 

DATE : September 23, 1992 

SUBJECT : Recommendation regarding toxicological study 

CAP ID No . : S-CR-BAK-1422 

Title: 

/Americ n Standarc's Biosciences Corp ID #88-163/The Effect of' 

~ at 16% solids and pH 7 .0 on the Eye Mucosa of New Zealand-Rabbits 

Attached is the cover sheet for the above-referenced toxicology studies, which 

the screening team found to meet the preliminary screening criteria under RhonePoulenc's Compliance Audit Program (CAP) . The Toxicology Subcommittee has reviewed the 

study under EPA's current criteria for reporting of studies under TSCA Section 8(e) . 

Based on this review, we recommend that the CAP Committee : 

report the study under the CAP . The study appears to be Section 8(e) 

reportable because 

not report the study under the CAP . The study does not appear to be 

Sectio_X_ 8() reportable because, the level of ocular irritation diminished through test 

termination (Day 7) in 2 (of 3) animals tested . (The remaining animal's scores stayed 

approximately the same throughout the study .) The pH of the material as tested was 

reported to be 7 .0 . See attached report . 

It is not clear whether this study should be reported, because 

The reportability of this study should be discussed by the CAP Committee . 

CAP COMMITTEE DECISION 

report '-"~do not report date 

REASON : - as above - other (explain below) 
PR(V LlJ]4139-i a k .un r u-, ", . ,r 

-1 1; ..r 

RE- TOXICOLOGY SNDY SUBMITTED TO CAP COMMITI'EE 

RPAD iNsTRU=ONs CAREFULLY . . . 

s -~ ~-~A k - 1 y z~--

Saecned for. ~ 8(e) - 8(d) CAP ID No.: 

Screener it name,\ 

Phone: 

Drvuion : 

Lanuon of Study Pf-S L= A P I LC,--S 

Substance or Monure Identification : 

Buameaa Unit : - 

Short name -- (A5 Mo'(s)' -

Chemical name(s): 

Substance or Mixt ure History (to the nnent lutowo): 

manufactured (includes R&D) -_ imported - prvaeased - dixnbttted b!' Dates : 

manufactured (includes R&D) _ imported - proeased - diuributod by prodeco+a" Data: 

Name of predecessor. - 

Substance or Miature Uae by and/or its custotuers : (check all that appty) 

R&D _ intermedtate - eommeraal dutribuuoa ,_ pesticade - pbarm+°euttal - food -- consumer producsa - other. 

other Eneat of eCposurt~ 

[I you hive checked only pesuade. pharmacxuual. or (ooC. do You know that there am no other tssa o( the substance: bv RbBae" Poukac or tu 

Customers? Them am 11o otber tii0 - Don't hatow if them art OIDe! um 

The Information : 

-j-he attacaad tntormattoo is : - ptziimtnm data - s draft report y the Gntl report _ other 

rttl~ ~~~y ~ ~ 4, ~- I h3 - 

Conducted tn'. 

Type of in(otmauon: r~'1^~Ji T 2-- 1 Cr i U .~ 

Reason(s) utlormauoo should be considered for B(e) submustots: 

1-~ 

Reason(s) information should be constdeTevd (or 8(d) submuuon : 

F{as this ctudv rUt:adv be= submitted to a government Agency, _ Yes _ oo / don't lutow Date of subtatssion: 

1f Yes. name and address of sgcncy-. Reason for submtsston to tt6enCy' 

lf this studv a reported to EPA would there be a confideattahtv concerti? - va - no 

(Funher commenta on bsct: - ves 

000059 61 
p. 60 

PS-3440 

3M ENVIRONMENTAL LABORATORY 

ACUTE TOXICITY OF (43 .5% SOLN) TO FATHEAD MINNOW' 

(Pimephales promelas) 

OECD Fish, Acute Toxicity Test, #203 

STUDY COMPLETED: November 12, 1996 

FINAL REPORT COMPLETED : November 13, 1996 

Prepared by : 

Name : Rochelle Robideau 

Laboratory : 3M Environmental 

Laboratory 

Address : Building 2-3E-09 

935 Bush Avenue Env . Lab Request Number P3158 St Paul, MN 55144 

62 0000 
Fathead Minnow Acute Toxicity 

Page 1 

November 13, 1996 - 

SUMMARY 

The purpose of this study was to evaluate the toxic effect ofr ~(43 .5% Soln) on Fathead Minnow (Pimephales promelas) in accordance with the "Fish, Acute Toxicity'T-est", OECD Method No . 203 . exposure. The 

median lethal concentration, 96-hour LC50, was reported as 4 .87 (3.92 - 6.06) mg/L. 

INTRODUCTION 

Acute toxicity tests performed with fish (generally the Fathead minnow) have gained widespread acceptance as 

a means of predicting potential harmful effects of possible environmental contaminants on aquatic vertebrates . The data may also be extrapolated to predict safe and harmful exposure levels for other aquatic species. Three general methodologies currently exist for performing acute toxicity tests with fish : static, static renewal, and flow-through 

procedures . 

The purpose of this study was to evaluate the acute effects of r ~(43 .5% Soln) to Fathead Minnow under static conditions. `' 

MATERIALS AND METHODS 

Test Substance : 

r- 

(43 .5% Soln) Lot DA5D047275 

Composition : Sample labeled as 43.5% solution of''

.- 

J Sample was tested as received . 

Appearance : [ _ _ 

Aqueous Solubility : Complete at concentrations tested . 

Available Physicochemical 

Properties : 

Date Received : 10/14/96 from SCD Lab 

Storage : In the dark at ambient room temperature (22 t 2°C) 

Test Solutions : Common stock solution, 100 mg/L carbon-filtered well water. Each 1 .0 mL = 0 .1 mg of 

test substance. The test concentrations were prepared by addition of the appropriate 

amount of stock solution . Initial pH of stock solution, 8.0 . Initial pH of the highest 

concentration tested, 10 mg/L, 8.0 . 

Reported values : The reported values were based on nominal concentrations or 143.5% 

Soln) in the media at the beginning of the toxicity test . 

L J 

63 000061 
Fathead Minnow Acute Toxicity 

Page 2 

November 13, 1996 _ 

Test Orqanisms 

Species : Fathead Minnow, Pimephales promelas 

Source : Aquatic Biosystems, Inc., Fort Collins, CO. 

Date Received: 10/22/96 

Fish length : 1 .82 ± 0.10 cm 

Fish weight : 0 .034 ± 0 .004 g 

Holding & Acclimation 

Holding : Maintained in lab in carbon-fiftered well water at least 12 days. 

Dissolved Oxygen, mg/L: At least 80% of air saturation value 

pH : 8 .0 

Hardness : 270 mg/L 

Photoperiod : 16-hrs light ; 8-hrs dark daily 

Lighting : Cool-white fluorescent light 

Mortality prior to test : < 10% of the population in 7 days prior to test initiation . 

Feeding : TetraMin flake food daily until 72 hours before test initiation . No feeding 

during the test. 

Test Conditions 

Photoperiod : 16-hrs light ; 8-hrs dark 

Test Vessels: 1200 mL polypropylene beakers 

Test Volume: 1000 mL 

Loading : 10 fish/beaker, 0 .34 g/L 

No. Replicates: Two 

Initial Test Concentrations 

nominal : 1 .0, 2 .5, 5 .0, 7 5, 10.0 mg/L 
Fathead Minnow Acute Toxicity 

Page 3 

November 13, 1996 _ 

Test Conditions (Cont.) 

Limit Test: A range-finding test was performed previously to determine the concentration 

range for use in the definitive test . 

Control & Dilution Water: Carbon-filtered well water. 3M Well No. 2, St. Paul, MN . 

Water aerated 24-hours prior to test initiation . See 

Table 1 for most current water quality analysis on well water. Well water (100%) 

was used for culturing the fish . See Table 2 for selected water quality 

parameters on water used in the toxicity test. 

pH of Control & Dilution Water: 7 .8 

Hardness of Control & Dilution Water: 270 mg/L 

Test Temp., oC : 17.8 - 19.0 °C 

Test Solutions pH : Test solution pH values ranged from 7.8 to 8.2 during the study. 

Exposure Period : 96-hrs 

Effect : No visible movement (e .g. gill movements) and if touching the caudal 

peduncle produces no reaction, fish is considered dead. 

Measurements: Mortality, Temp., pH, & DO. 0, 24, 48, 72, & 96-hrs. 

Visible abnormalities were noted ; erratic swimming and some hemorrhaging. 

Dead fish were removed when observed, and mortality recorded . 

Aeration : None 

Date Test Initiated : 11/08/96 

Date Test Terminated: 11/12/96 

Procedure : The test generally followed the recommendations of the OECD 

Guidelines for Testing of Chemicals (1) . 

CALCULATIONS 

The reported values are based on nominal concentrations in the test media at the beginning of the bioassay . A total of 20 fish were exposed to each concentration. The concentrations tested and the corresponding response data derived from the duplicated toxicity test are used to calculate, if possible . the median lethal concentration, LC50 and 

the 95% confidence interval by standard logistic regression methods (i .e ., Probit Analysis, Trimmed Spearman-Karber) . The LC50 is defined as the concentration estimated to kill 50 percent of the fish after 96 hours exposure . The NOEC 

(no observed effect concentration) and LOEC (lowest observed effect concentration) are also determined from the data, if possible . 

65 000063 
Fathead Minnow Acute Toxicity 

Page 4 

November 13, 1996 

RESULTS 

Percent mortality values obtained after 24, 48, 72 and 96 hours of exposure to~- ~ 43.5% Soln) are summarized in Table 3. ., 

In duplicated measurements, the median lethal concentration (96-hour LC50) foc 143 .5% Soln) was reported as 4 .87 mg/L. The 95% confidence interval were 3.92 to 6.06 mg/L . The NOEC (no observed effect concentration) is <1 .0 mg/L. The LOEC (lowest observed effect concentration) is 1 .0 mg/L. 

ACCEPTABILITY CRITERIA 

This toxicity test meets quality criteria provided in test guidelines : 

1) Not more than 10% of the control fish were dead . 

2) The dissolved oxygen concentrations were greater than 60% of the air saturation value at the temperature tested at the end of the test. 

3) Test temperature did not vary more than 1oC in any 24-hour period. 

4) Copies of the most current reference toxicant test are included in raw data package . 

This test was conducted by Rochelle R . Robideau as requested by Richard Stern of 3M Specialty Chemicals Division Laboratory . 

REFERENCES 

(1) OECD. 1984 . Fish, Acute Toxicity Test, 203 . Guidelines for Testing of Chemicals . Organization for Economic Cooperation and Development, Paris, France. 

(2) OECD . 1981 . Principles of Good Laboratory Practice, Annex 2, C(81) 30 (Final) : 7-28 . OECD Guidelines for Testing of Chemicals. Organization for Economic Cooperation and Development, Paris, France . 
Fathead Minnow Acute Toxicity 

Page 5 

November 13, 1996 

11/12/1996 

TABLE 1 

ENVIRONMENTAL LABORATORY STATUS REPORT 

LAB REQUEST N0 . P2929 

REQUESTOR NAME : RR ROBIDEAU/SAB 

DEPARTMENT : VARY 

PROJECT N0 : VARYING 

DATE RECEIVED : 10/02/1996 

DESC : CARBON-FILTERED WELL WATER (BLDG 

ORIGINAL SOURCE OF WELL WATER; 3M WELL 

Sampling event for October 1996 . 

SAMPLE IS COLLECTED FROM ROOM #4 . 

2-3E) 

#2, ST . 

CONTRACT LAB(S) : PACE 

SPECT 

EXP COMP DATE : 10/31/1996 

DATE COMPLETED : 

PROJECT LEAD : RR ROBIDEAU 

PHONE N0 : 612-778-7065 

3M FAX N0 : 612-778-6176 

PAUL, MINNESOTA . 

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

SAMPLE DATE CODE DESCRIPTION 

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

1 10/03/96 

SPECT COD-LOW 

SPECT TOC 

SPECT TOT-COLIF 

SPECT SOL-F 

SPECT TOT-F 

SPECT TOT-ALK 

SPECT TOT-HARD 

TOT-RES-CL 

SPECT NH3-N 

SPECT PH 

SPECT COND 

SPECT TDS 

SPECT TS 

SPECT TSS 

WELL WATER CARBON FILT . 

*COD (low level method) 

*TOTAL ORGANIC CARBON 

*TOTAL COLIFORM BACTERIA 

*FLUORIDE (PROBE) 

*TOT FLUORIDE (DISTILLED) 

*TOTAL ALKALINITY (PH 4 .5) 

*TOTAL HARDNESS - as CaC03 

TOTAL RESIDUAL CHLORINE 

*AMMONIA NITROGEN - as N 

*pH 

*SPECIFIC CONDUCTANCE 

*TOTAL DISSOLVED SOLIDS 

*TOTAL SOLIDS 

*TOTAL SUSPENDED SOLIDS 

* = CONTRACT LAB DATA 

RESULT MDL or (95$ C .I .) 

<5 MG/L 

3 .4 MG/L 0 .1 

<1 COL/100ML 1 

0 .2 MG/L 0 .1 

0 .2 MG/L 0 .1 

250 MG/L 10 

270 MG/L 10 

<0 .02 MG/L 0 .02 

<0 .1 MG/L 0 .1 

7 .5 UNITS 0 .1 

470 UMHOS/CM 1 

280 MG/L 1 

470 MG/L 10 

<2 MG/L 2 
Fathead Minnow Acute Toxicity TABLE 2 

Page 6 

November 13, 1996 

WATER QUALITY PARAMETERS 

SAMPLE Hardness Alkalinity Conductivity QESC. (1) mg CaCO~LL mg CaCOn/L umhocicm 

Control Water 270 260 570 

Highest Conc . 

Remaining, 280 250 590 

5 .0 mg/L 

(1) Samples removed from test chambers at test termination 
Fathead Minnow Acute Toxicity TABLE 3 

Page 7 

November 13, 1996 

SUMMARY OF ACUTE TOXICITY OF r_ ~(43 .5% SOLN) 

TO FATHEAD MINNOW UNDER STATIC EXPOSURE CONDITIONSO) 

TEST CONC 

PERCENT MORTALITY 

. 

mg/L(2) 24-HOURS 48-HOURS 72-HOURS 96-HOURS 

Blank Control 0 0 0 0 

Blank Control (duplicate) 0 0 0 0 

1 .0 0 10 20 20 

1 .0 (duplicate) 0 1 0 10 20 

2 .5 0 10 10 20 

2 .5 (duplicate) 0 10 20 20 

5 .0 0 30 30 40 

5 .0 (duplicate) 0 30 40 40 

7~5 100 100 100 100 

7 .5 (duplicate) 100 100 100 100 

10 .0 100 100 100 100 

10 .0(duplicate) 100 100 100 100 

EC50, mg/L 6 .12 5 .22 5 .06 4 .87 

95% Confidence interval, mcyL 

Statistical method used, Trimmed Spearman-Karber. 

4 .49 -6 .08 4 .22-6.07 3 .92- 6.06 

NOEC, mg/L 5 .0 <1 .0 <1 .0 <1 .0 LOEC, mg/L 7 .5 1 .0 1 .0 1 .0 

(1) 10 fish per replicate . A total of 20 fish were exposed per concentration . 

(2) Concentration of as received sample, ') (43 .5% Soln) . 

69, 000067 
COPIES OF RAW DATA SHEETS 
p. 69 

ENVIRONMENTAL LABORATORY LR 

96-HR ACUTE TOXICITY TO FATHEAD MINNOW, PIMEPHALES PROMELAS 

TYPE TEST: STATIC X STATIC RENEWAL 

TEST SUBSTANCE: 

r43.5%) Sam le Lot DA5D047275 . Rec'd 10/14/96 from SCD Lab. 

Appears completely mlsclble In well water. 

DILUTION WATER: CARBON-FILTERED WELL WATER (3M WELL #2, ST PAUL, MN) 

TEMP. 16.0°C, pH 1.8 , D.O. q,$ mg/L 

TEST FISH SOURCE: 

-

AQUATIC BIOSYSTEMS, INC. DATE RECEIVED: 10/22/1996 

FORT COLLINS, CO. BATCH 96-4 FISH AGE: 45-46 DAYS AVG. WT. : Q

- ,054±Opb4g AVG. SIZE : I,BZ. ta locm 

NO. OF FISH/TEST CHAMBER: 10 LOADING RATE: 

TEST SOLUTION VOLUME: 1000 mL SIZE OF TEST VESSELS: 1200 mL 

polypropylene DATEINITIATED : 11/$/91,0 IAtS DATE TERMINATED: 

TEST INITIAL TOTAL _ M ORTAL ITY 

VESSEL 

BK1 

CONC. 

mg/L 

CONTROL 

AMOUN 

ADDED* 

- 

24-HR pH D.O. 

mg/L 

48-HR pH D.O. 

mg/L 

72-HR pH D.O. 

mg/L 

96-HR pH D.O. 

mg/L 

BK2 CONTROL - 

1 .1 

1 2 

1 .0 

1 0 

10 

10 

p t a R R `f 

. . 

2.1 

2 2 

2.5 25 0 1, 9 9 K `~ Z RN 

. 2.5 25 -0 1 .0 K 1A 8 2. 5? .7 8 0 

3.1 5.0 So 0 3 ~u Y 

' 

RN 

. 

3 I .2 5.0 50 L R 

4 .1 7~5 75 1 O 

4.2 7 .5 75 - 

5.1 10 .0 100 4 I - - - - 10 - _ 

5 .2 10 .0 100 8 4 - - - _ 

TEMP. 0C 

DATE / ANALYST 

- 

_ _ 

-- 

I .S 

- f 

I $,~- 

3 

, 

- 3 

t 

t 

9~0 

LCSO (95% C.I .) mg/L (,, 1,2.C-) I 22 4Qq _ (y,09) S 010(4 Lz-(i,07) 4 11 19 L - (P-00 

COMMENTS 'mL. Common stock solution, 100 rng/L of carbon-filtered well water. Each 1 . 0 mL - 0. 1 mg. 

Inrtlal pH of stock solution 8.p . Initial pH of highest concentration tested 10 mg/L, 8,0, 

SECONDARY EFFECTS: S = Surfacing ; E = Loss of Equilibrium, Q = Quiescent ; R = Erratic Swimming ; H = Hemorrhaging 

cANALY 

( 1 ooo0s9 
ENVIRONMENTAL LABORATORY PAGE / OF / 

Fi'-,*I ANev~aqe- w~tyh+~~S~~~ 

~ I i nl-rt~ 

li~ n ~, 4 , J I . ~ 

- 

0 ,0;.,; I .ff 

D ,nA 5 -_ I .R 

0 . Q ~Z 

2..0 

a,Q2-9 11-1 

p o 1q I .'1 

0, 0 1-1 

ln, 0Alo I . It 

0,0519 .l . r) 

n oA'7 1 .1 

x = o .-Q a4 X = 1,~2 

DATE 

WORKSHEET ANAL 25 

bI1=t 
TR i MMED SPEFiRIY!Ah,I--I!ARBEF? ME-. fHUL . VERSION L . 

DATE : 11/0_8-12 TEST NUMBER : 1 DURATION : E4 H 

TOXICANT : ]43.5% SOLN 

SPECIES : FATHEAD MINNOW 

RAW DATA : Concentration Number Mortalities 

--- ---- (MG/L) Exposed 

.00 E0 

1 .00 

2.50 

20 0 

20 

5.00 20 

7.50 20 E0 

10 .00 `0 20 

SPEARMAN-KARBER TRIM : 

SPEARMAN-KARRER ESTIMATES : LCOO : 6 .1` 

95'/- CONFIDENCE LIMITS 

ARE NOT RELIABLE . 
TRIMMED SPEARMAN--F!.HRC=.ER METHOD . VERSION 1 .5 

DATE : 11/g8-12 -0 TEST NUMBER : 1 DURATION : 48 H 

TOXICANT 

F& HEAD 

5X SOLN 

SPECIES : FATHEAD MINNOW 

RAW DATA : Concentration Number Mortalities 

--- ---- (MG/L) Exposed 

.00 20 0 

1 .00 E0 E 

2.50 20 G 

5.00 E0 6 

7 .50 

10 .00 20 

20 20 

20 

SPEARMAN-N.ARBER TRIM : 10 .00% 

SPEARMAN-KARBER ESTIMATES : LC50 : 5.EE 

95! LOWER CONFIDENCE : 4.49 

955 UPPER CONFIDENCE : 6 .08 

----------------------------------------------------------------------------- 
FR. f MlYll._J APEF+RMF=iN--KARBI--11 ME fHUD . VEilSLUri l . 

D F i f _ : L L , 0, 1 .=_ ~ T F-3T NL MBL R : l DURATION : 7 2 H TCX ICANT . ~ _143 .5% SOLN 

GPECIES : FATHEAD MINNOW 

RAW DATA : Concentration Number Mortalities 

---- ------ iMi:/Li E<po sed 

.00 20 

1 . 0k.~ 20 , J 

2 .50 

5 .00 20 

20 3 

7 

7 .50 20 E0 

10 .00 E0 E0 

, 5F'EARMAN-N,ARBER TRIM : 15 .00% 

>=F'EARMAN-KARBER ESTIMATES : LCS0 : 1.06 

95'/. LOWER CONFIDENCE : 4.22 

95% UPPER CONFIDENCE : 6 .07 

-------------------------------------------------------------- 
I-r1 (IYIIYII :-D SE-'EEaRMNN-KARPEJi METHOD . 'JCN ._ (Orl L . .~ 

DATE : t ~-~c~~3-l- TEST NUMBER : 1 DURATION : =i6 L_I 

TOXICANT . 143.5% SOLN ., . -

SPECIES : 1=ATHEAD MINNOW 

PAW DATA : Concentration Number Mortal it : o-, 

--- ----- (MG/L) Exposed 

.00 211) Itl 

1 .00 2 iD 4 

2 .50 20 4 

5 .00 `0 8 

7.50 20 20 

10 .00 20 20 

SF'EARMAN-KARBER TRIM : 

SPEARMAN-NARBER ESTIMATES : LC50 : 4.87 

95% LOWER CONFIDENCE : ,:; .9` 

95% UPPER CONFIDENCE : 6 .06 

----------------------------------------------------------------------------- 
p. 75 

ENVIRONMENTAL LABORATORY 

SCREENING TEST 

96-HR ACUTE TOXICITY TO FATHEAD MINNOW, PIMEPHALES PROMELAS 

TYPE TEST: STATIC X STATIC RENEWAL 

LR P 

TEST SUBSTANCE: 143.5% Sample Lot DA5D047275 R ' t t 

_ . ppears completely miscible In well water. 

DILUTION WATER: CARBON-FILTERED WELL WATER (3M WELL #2, ST. PAUL, MN) 

TEMP. I'1,$°C, pH `1 .Iv , D.O . q. Z. mg/L 

TEST FISH SOURCE: -

AQUATIC BIOSYSTEMS, INC. DATE RECEIVED : 10/22/1996 

FORT COLLINS, CO. BATCH 96-4 

FISH AGE: 36-37 DAYS AVG. WT. : O,Om't0.UO5 g AVG. SIZE: t .-icl tp,lefm 

NO. OFFISHITESTCHAMBER: 5 LOADING RATE : to .,qI!j91L_' 

TEST SOLUTION VOLUME : 400 mL SIZE OF TEST VESSELS: 600 mL 

DATE INITIATED : ><p'Z$Jq~, ~~~ DATE TERMINATED: ~~ ~q(p I 

polypropylene 

TEST INITIAL TOTAL M ORTALI TY 

VESSEL 

BK1 

CONC. 

mg/L 

CONTROL 

AMOUN 

ADDED' 

- 

24-HR pH D.O. 

mg/L 

48-HR pH D.O . 

mglL 

72-HR pH D.O. 

mg/L 

96-HR pH D.O. 

mg/L 

BK2 CONTROL I'S 15, ?~ 

1 10 4 

2 10 4 

1 100 40 _ 

2 100 40 

1 500 200 1 's 

2 500 200 

I 

TEMP . °C ~ F3 . 

DATE / ANALYST 

LC50 (95% C.I .) mg/L 410 

COMMENTS 'mg . Individual weights. 

Initial pH of highest concentratio n tested, 7.1p 

SECONDARY EFFF TS S -S,115 acinnF - Loss ot Equilibrium ; Q = Quiescent ; R = Erratic Swimming ; H = Hemorrhaging 

ANALYST; 

( / 

0000"75 
ENVIRONMENTAL LABORATORY PAGE / OF / 

DATE // l/l9~, 

WORKSHEET ANAL" 5 

ll .Zll~ 1 .5( 

~() ;W 2,0 

.nl ;,Ll4 1 .5( 

. O LS L Cr 

nZy ~ . 

i . 5< 

.n34 1,K 

In _3~ 

x= o,o~- ~ x= i,`l9 

±~~n=~,onS .~n_to, i~ 
p. 77 

ENVIRONMENTAL LABORATORY LR 

96-HR ACUTE TOXICITY TO FATHEAD MINNOW, PIMEPHALES PROMELAS 

TYPE TEST: STATIC X STATIC RENEWAL 

TEST SUBSTANCE: NaCl ACS granular, CMS Chempure Brand, Lot 272 KPXA 

DILUTION WATER: CARBON-FILTERED WELL WATER (3M WELL #2, ST. PAUL, MN) 

TEMP . t 8.0°C, pH 1.6 , D.O. q~S mg/L 

TEST FISH SOURCE: AG7UATIC BIOSYSTEMS, INC. DATE RECEIVED : 10/22/1996 

FORT COLLINS, CO. BATCH 96-4 

FISH AGE: 45-46 DAYS AVG. WT. : 010614±10011k AVG. SIZE: I ,gL ±0, t Cm 

NO. OF FISH/TEST CHAMBER: 10 LOADING RATE: 

TEST SOLUTION VOLUME: 1000 mL SIZE OF TEST VESSELS: 1200 mL 

polypropylene 

DATE INITIATED : I I~ t~/q~ 1~3p DATE TERMINATED : tt- /T /q~t~~ 

TEST INITIAL TOTAL MORTALITY 

VESSEL CONC. 

L 

AMOUN 

ADDED' 

24-HR pH D.O. 

mg/L 

48-HR pH D.O. 

mg/L 

72-HR pH D.O. 

mg/L 

96-HR pH D.O. 

mg1L 

SKI CONTROL - 

BK2 CONTROL - 

1 7.5 7.5 e) 9.0 -1A 0 12 .1 9.0 t 

2 7.5 7.5 

1 8.7 8.7 

2 8.7 8 .7 e*) 8-1 1 41; z- 1911 7- 49 . L) 11 .71 ;A I ?- 11 .9 

1 10 10 

2 lo lo I 5t .0 "z' IS .7 U) n S, 2- all 

1 11 .5 11 .5 1 .1 to 2 ,'A .0 1 --' ---- 

2 11 .5 11 .5 / C, in - r - 

1 13.5 13 .5 9.1 - - 1 - - - -- 

2 13.5 13 .5 t 1 11 .11 t O to 10 - - 

TEMP. °C 1$,S 

~DATE / ANALYST It/qJq~"3 ` 

.4 

1~jt0~3 

t .`1 

~ l1/t~~~~~3 ~ llJt719(o~~ 

-- ~ ~ r - ~-

LC50 (95% C. I .) g/L 10 .s ~ ~Q.3-11,Z~ 10 .t --7 -1 

COMMENTS 'g . Individual weights. 

Initia l pH of highest concentration tested, 13 .5 g/L, 13,0 . 

r - ) - 

g,`15~~ .L'1- 10.3~ 9,5A ~9,01- 10,1~ 

SECONDARY EFFECTS: S - Surfacing, E = Loss of Equilibrium, Q = Quiescent, R = Erratic Swimming, H = Hemorrhaging 

ANAL 

7 9, 

000077 
rREMMED SPEOHMAN-KOPOER METHOD . VERSION L .'~ 

DATE : 11/~8-l~_ TEST NUMBER : L DURATION : 14 H TOXICANT : NACL REFERENCE TOXICANT . 

SPECIES : FATHEAD MINNOW 

RAW DATA : Concentration Nymber Mortalities 

(G/L) Exposed 

20 0 

20 0 

.00 

7 .50 

8 .70 

10 .00 20 

20 0 

; 

11 .50 20 15 

13 .50 20 20 

SPEARMAN-KARHER TRIM : ,00y. 

SFEARMAN-F.ARBER ESTIMATES : LC50 : 10 .75 

95% LOWER CONFIDENCE : 

95% UPPER CONFIDENCE : 11 .19 

10 .33 

----------------------------------------------------------------------- 
FOLMiYtiED sr-'ErarrMAN--il,ARBi-R METHOD . VERSION L .'f 

DATE : t1/08-L2 TEIT NUMBER : c DURATION : 48 H TOXICANT : NACL REFERENCE TOXICANT 

SPEi- f 1=S : FArHLAD MINNOW 

RAW DATA : Concentration Number Mortalities 

----- ---- (G/L) Exposed 

.00 20 

7 .50 

8.70 

20 0 

20 , 

10 .00 E0 E, 

11 .50 E0 E0 

13 .50 20 `0 

SPEARMAN-KARHER TRIM : ,00y, 

'CPEARMAN-KARBER ESTIMATES : LCO0 : 10,06 

95% LOWER CONFIDENCE : 9,70 

95% UPPER CONFIDENCE : 10 .44 

-------------------------------------------- 
F RIMMED ':;PEi+Fli=IPi`J--KARBEi? METHOD . VF-R'; fON l . 

DATE : It/08-12 TEST NUMBER : c DURATION : 72 H TOXICANT : NACL REFERENCE TOXICANT 

SPECIES : FATHEAD MINNOW 

RAW DATA : Concentration Number Mortal it iGs 

----- ---- ( i~ / I__ ) Exposed 

.00 20 0 

7 .50 20 -c 

20 4 8.70 

10 .00 20 1 0 

20 20 11 .50 

13 .50 20 E0 

SPEARMAN-KARBER TRIM : 10,00% 

SREARMAN-KARHER ESTIMATES : LC50 : 9 .75 

95% LOWER CONFIDENCE : 9,27 

95'/. UPPER CONFIDENCE : 10 .27 

---------------------------------------------- 
1-RIMMED SPEARirIAN-I<ARBER METHOD . VERSION L . 

DATE : Ll/08--1` TEST NUMBER : c DURATION : '~6 H TOXICANT : NACL REFERENCE TOXICANT . 

'3PEC ( L=C : FPFHEAD MINNOW 

RAW DATA : Concentration Number Mortal it ies 

---- - ---- (a, L) Exposed 

20 0 .00 

7 .50 210 E 

8.70 `0 E, 

10 .00 `0 10 

11 .50 :_0 20 

13 .50 E0 c:0 

SPEARMAN-KARHER TRIM : 10 .00% 

SPEARMAN-KARHER ESTIMATES : LC50 : 9 .58 

95'/. LOWER CONFIDENCE : 9 .07 

95% UPPER CONFIDENCE : 10 .12 

-------------------------------------------------------------------- 
ENVIRONMENTAL LABORATORY 

TOTAL HARDNESS 

Std. Methods for the Examination of Water and Wastewater (18th Edition) 1992. 

Part 2000, Section 2340 Hardness, EDTA Titrimetric Method C pp 2-36 to 2-38. 

Hardness (EDTA) mg CaC03/L = A x B x 1000 

mL sample 

where : 

A = mL titration for sample and 

B = mg CaC03 equivalent to 1 .00 mL EDTA titrant . SAMPLE DESCRIPTION mL SAMPLE A(mL Titrated) RESULT, mg/Las CaC03 COMMENT 

~k /"arrf_i~l~_ - _ _ L.S-- - - - io, 9 'S _ -21 y?5,1. _ 

r 

.~5olu~~dr~ts f'rou~ ~'~yl~'aassay ,b~a~c~ a''i~ f«IL -~wr~rKafibf?, ioo~r,~ .L f'rvru.~dCil 

a~vll cd `C eo~cb/HCv'. L-~ ~3r58 

A 

84 000082 
ENVIRONMENTAL LABORATORY 

TOTAL ALKALINITY 

Std . Methods for the Examination of Water and Wastewater (18th Edition) 1992 . 

Part 2000, Section 2320 Alkalinity, Titration Method B pp 2-26 to 2-28. 

Normality HZSO, Q,.pg,1 

Alkalinity, mg CaC0,/L = A x N x 50000 

mL sample 

where : A = mL standard acid used; N = normality of standard acid 

SAMPLE DESCRIPTION 

11 

. 

mL SAMPLE I A(mL T pH 4 .5) RESULT, mglL as CaC0, 

.a .14d I 

La,&o 

o/u~'o.r5 o.y ~~~it tJioBSady ,~6fftr5 a~ ~tS7` 

Po~hvKCt1, .(.~ 

i'~tirt 

COMMENT 

ibK . /OU M,(, 4vwi PdCff (J'u~~f Co~ 

000083 
p. 84 

ENVIRONMENTAL LABORATORY 

DETERMINATION OF THE CONDUCTIVITY OF AQUEOUS SAMPLES 

Std. Methods for the Examination of Water and Wastewater (18th Edition) 1992. 

Part 2000, Section 2510 Conductivity, Laboratory Method B pp 2-45 to 2-46 . 

Determination of Cell Constant : 

C =(0 .001412)[1+(0 .0191(t-25))j1/Kkcl 

Where : K kcl = measured resistance, ohms; t = observed temperature, °C 

K kct = O. Ghl4lL, ohms, t = 2 s, n °C, C = J, OG 

Standard Solution Used : 80~oi 

Conductivity Calculations : 'E-<f 3 Z 

K=(Km)(C)/1 +0.0191 (t-25) 

Where: K = Conductivity, 4mhos/cm; Km = measured conductivity, 4mhos/cm at t ° C 

.,~olu !/cy( ,~ fro~y-~'~~yr ~blod+ 1Je8ff<r5 ?f ~e~~' ~/~cli%rdfi~y . iou,u(,~rrvnr ea~kGc~rNrt:d~~ ~HwbY%tRy. .C)f,P6b,Sd 

ANAL ,3 

DATE : 8 G) 000084 
ENVIRONMENTAL FATE INFORMATION 

Primary Bio gradability 

~is biodegraded 58.5% using the BODsICOD test. The 5 day Biochemical 

'Oxygen Demand was reported as 440000 mg/l. The Chemical Oxygen Demand was 

determined to be 752000 mg/l. Results are direct measurement of biological oxygen 

consumption occurring as a result of the biodegradation of the test material. The initial 

test medium was prepared using acclimated inoculant from an activated sludge plant . A 

material is considered to be biodegradable if the ratio of 130135 to COD, multiplied by one 

hundred, is greater than or equal to 50. 

Using the River Die Away testc Is biodegraded 35% in 5 days, 59% in 10 

days, 79% in 15 days and 90% in 20 days. Solutions of 20 ppm of test material were 

prepared using samples of water from a river that has biological activity . 

Ref: EF-135 

Ready Biodegradability _ 

Using the Modified OECD Screening Test;,-  ~degraded 38.9% over 28 

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

DOC analysis . Chemicals which reach 70% or greater loss of DOC within 28 days are 

considered readily biodegradable . This level must be reached within 10 days of the 

time at which 10% degradation was seen .~ 7is therefore considered to be 

not readily degradable by this test method'. 

Ref: EF-64 

In the Closed Bottle test, vas found to be degradable. At a test 

concentration of 2 mg/I, the degradation was calculated to be 15.6% (5 days), 75.7% (15 days) and 90.1% (28 days). At 10 mg/l, the rates were 51 .9% (5 days), 72 .8% (15 days) 

and 82 .2% (28 days) . 

Ref: EF-134 

.- -, 

Summary Date: August 4, 1997 
p. 86 

EF-0135 

T`.. C1-T I 1 10I 1 IN C.-',~~ ~ A°R ;2 .6 A" y U 7 

681 MAIN STREET 

BELLEVILLE, NEW JERSEY 07109 

201 - 759~0228 

April 24, 1979 

Dear Mr . Finn : 

Attached is a summary of the results on our biodegradability tests of your r -products . Three samples were submitted : 

I 

Our experiments shpw that all three products are biodegradable ; however, ` ; is on the borderline . 

Two met,liods were used for the determination of the biodegradability of surface active agents : BOD/COD Method and River Die Away Methoc 

If you have any questions, please do not hesitate to contact me . 

Sincerely, 

^ 

, 

Omar Baturay 

Technion Inc . 

Encl . 

OB/dd 

88 0000$6 

CHEMICAL ANAYSIS * RFSEARCH * CONSULTATION 
TEC010H inc . 

681 MAIN STREET 

BELLEVILLE, NEW JERSEY 07109 

201 - 759-0228 

ANALYTICAL REPORT 

CLIENT ~ ~ DATE ADril 24 , 1979 

CLIENT REF . NO. TECHNION REF. NO. 6 17 

BOD/COD Method : 

BOD Mg BOD1~0 Mg COD mg BOD S BOD 

02/kg-~ 02/Kg** 02/kg* COD COD 10 

470,000 664,000 70 .8 

440,000 752,000 58 .5 

610,000 790,000 1,496,000 40 .7 52 .8 

mg of oxygen per Kg of chemipl (as is) ._., 

** BOD10 is determined only for : 

L 

River Die Away Method : 

Percent Degradation 

5 days 10 days 15 days 20 days 

100% 

35% 59% 79% 90$ 

20$ 42% 60% 78$ 
> 

BIODEGRADATION STUDIES 

SPECIALTY CHEMICALS R&D AT ; 

p. 88 

EF-0064 

ubmitter - Mike Finney SBU - Surfactants & Specialties 

ocation 

_ 

- C 

- - i Date Received - 04-12-93 

- 

AS No - ~ Proj . Start Date - 04-12-93 

hemical Name - 

ample ID - 1139 Trade Name - 

- '-. 

iodeg Expt No - 1 Started - 04-12-93 Completed - 05-10-93 

ame of the Test - Ready Biodegradability : Modified OECD Screening Test 

ECD Method - 301E EPA Method - 796 .3240 

iodegradation (%) - 38 .9r Day - 28 Analysis - DOC 

iodegradability Status - Not readily biodegradable . 

omments - Inherent biodegradability testing is suggested. 

)cation of Record - MB/C-0072/189 Result Reported - 05-17-93 

:ientist - Mitchell H . Berman Manager - Mitchell H . Berman 141 

004088 

CONFIDENTIAL DATA FOR INTERNAL r 

9 ~UOF 'AIN APPROPRIATE AUTHORIZATION FOR DISC ~OSURE OU,4 

NLY 
.-~ ~'rOJ!'! 

Z 

O 

Q 

O W 

0 2 4 6 8 1012 1416182022242628 

DAYS 

Data star" 4-1$-M 

Date c.amPh"& e-lo-U 

7CHiodevs"Uoat - 30.9 

Dm. r.oo.u.o~: MB/c-oM/iea 
f' ` JJ ~I (~ 

ECM 

environmental compliance monitoring 

October 10, 1989 

p 90 

EF-0134 

r..Analysis of-the three samples identified 

^eceived September 5, 1989 has~een asoand completed . Analysis 

by ~Fe closed bottle test (40 CFR 796) indicates all samples are readily 

biodegradable . 

The results of analysis and an invoice are enclosed . If you have any 

questions, please contact me . 

Sincerely, 

EnvironmWal Compliance Monitoring, Inc . 

JW/cm 

Enclosure 

#1004/1060 

John Wnek 

Technical Manager 

92 

000090 

PO Box 427 Neahanic Station, New Jersey 08863 
Ready Biodegradability : Closed Bottle Test 

Sample : 

Start Date : September 10, 1989 

Theoretical Test Concentration : 2 mg/L and 10 mg/L 

Inoculum : "lixed Culture 

Analysis : Oxygen Electrode 

Temperature of dilution water after aeration : 21°C 

Dissolved oxygen content of aerated distilled 

water prior to start of test : 8 .5 mg 02/L 

mg 02/L After X Oays 

Culture Media Sample 0 5 15 28 

Mineral nutrient solution without Cl 8 .2 8 .5 8 .0 7 .5 

test material and without inoculum C2 8 .2 8 .5 7 .8 7 .3 

C3 8 .2 8 .5 7 .9 7 .7 

CAvg, 8 .2 8 .5 7 .9 7 .5 

Mineral nutrient solution without B1 8 .4 8 .2 7 .9 -

test material but with inoculum B2 8 .4 8 .0 7 .9 7 .3 

B3 8 .4 8 .2 8 .0 7 .2 

BAvg . 8 .4 8 .13 7 .93 7 .25 

Mineral nutrient solution with test 2 mg/L 8 .4 8 .1 7 .4 6 .3 

material and with inoculum 2 mg/L 8 .4 8 .1 7 .4 6 .6 

2 mg/L 8 .4 7 .8 7 .1 6 .6 

2 mg/L Avg . 8 .4 8 .0 7 .3 6 .5 

10 mg/L 8 .4 6 .0 4 .9 3 .9 

10 mg/L 8 .4 5 .8 4 .9 3 .9 

10 mg/L 8 .4 6 .1 4 .9 3 .7 

10 mg/L Avg . 8 .4 5 .97 4 .9 3 .83 

000091 

erwkonnonftl compYance monitorlnQ 

93 ECM 
p. 92 

2- 

Ready Biodegradability : Closed Bottle Test (continued) 

Sample : ; ` 

TOD or COD of Test Material : 416,000 mg COD/Kg 

Test Period in Days 

5 15 28 

Oxygen Depletions After X Days 2 mg/L 0 .13 0 .63 0 .75 

10 mg/L 2 .16 3 .03 3 .42 

Percent Biodegradability 2 mg/L 15 .6 75 .7 90 .1 

10 mg/L 51 .9 72 .8 82 .2 

Conclusion : The sample is considered readily biodegradable according 

to the test criteria of a minimum 60% degradation in a 

28 day period (40 CFR 796 .3200) . 

000092 

ernrkonmon"l compH4nce monitorinV 

ECM 94 
Ready Biodegradability : Closed Bottle Test 

Sample : Glucose/Glutamic Acid (Known Degradable Material) 

Start Date : September 10, 1989 

Theoretical Test Concentration : 2 mg/L and 10 mg/L 

Inoculum : Mixed Culture 

Analysis : Oxygen Electrode 

Temperature of dilution water after aeration : 21oC 

Dissolved oxygen content of aerated distilled 

water prior to start of test : 8 .5 mg 02/L 

mg _ OZ/L After X Days 

Culture Media Sample_ 0 5 15 28 

Mineral nutrient solution without Cl 8 .2 8 .5 8 .0 7 .5 

test material and without inoculum C2 8,2 8 .5 7 .8 7 .3 

C3 8 .2 8 .5 7 .9 7 .7 

CAvg, 8 .2 8 .5 7 .9 7 .5 

Mineral nutrient solution without B1 8 .4 8 .2 7 .9 -

test material but with inoculum B2 8 .4 8 .0 7 .9 7 .3 

B3 8 .4 8 .2 8 .0 7 .2 

8 Avg . 8 .4 8 .13 7 .93 7 .25 

Mineral nutrient solution with test 2 mg/L 8 .4 7 .2 6 .5 6 .0 

material and with inoculum 2 mg/L 8 .4 7 .5 6 .4 6 .0 

2 mg/L 8 .4 7 .5 6 .4 6 .0 

2 mg/L Avg . 8 .4 7 .4 6 .43 6 .0 

10 mg/L 8 .4 2 .7 <1 (1 

10 mg/L 8 .4 2 .6 <1 <1 

10 mg/L 8 .4 2 .7 ~1 <1 

10 mg/L Avg . 8 .4 2 .67 cl 0 

000093 

erwhorxnental compilence monkorkV 

95 ECM 
p. 94 

-2- 

Ready Biodegradability : Closed Bottle Test (continued) 

Sample : Glucose Glutamic Acid (Known Degradable Material) 

TOD or COD of Test Material : 1,024,000 mg TOD/Kg 

Test Period in Days 

5 15 28 

Oxygen Depletions After X Days 2 mg/L 0 .73 1 .5 1 .25 

10 mg/L 5 .46 >6 .93 >6 .25 

Percent Biodegradability 2 mg/L 35 .6 73 .2 61 .0 

10 mg/L 53 .3 >69 >63 

Conclusion : The sample is considered readily biodegradable according 

to the test criteria of a minimum 60% degradation in a 

28 day period (40 CFR 796 .3200) . 
p. 95 

RALPH 

McELRoy TRANSLATION 

COM ['ANY 

October 2, 2003 

Re : 6705-94996 

To Whom It May Concern: 

This is to certify that a professional translator on our staff who is skilled 

in the French language translated the enclosed internal document 

concerning L Irom French into English . 

We certify that the attached English translation conforms essentially to 

the original French language . 

Kim Vitray 

Operatinns Manager 

Subscribed and sworn to before rne this `_ day of -, 2003 . 

2; ti., . .o. TINA WUELFiNG 

.'~ Notary Pubhc, State of Texas \J

--- 

~ 

My Commission Expires Tina Wuelfing 

"";foi ;,," December 08 . 2003 Notary Public 

My commission expires : December 8, 2003 

910 WEs-r AvE . 

AUS"riN . TEXAS 78701 

EXCEI.LENCE WITH A SENSE OF URGfNLY'' 

w~rw. mcelroytranstation .corn 

(512) 472-6753 

1-800-531-9977 

FAX (512) 472-4591 

9~ 000095 
[Internal document concernin~ J 

Job No. : 6705-94996 

Translated from French by the Ralph McElroy Translation Company 

910 West Avenue, Austin, Texas 78701 USA 

98 oo00-9+s 
T/SE/MES/ECOTOXICOLOGY 

EVALUATION OF THE "POTENTIAL FINAL" AEROBIC BIODEGRADABILITY IN 

AQUEOUS MEDIUM OF 

, 

ACCORDING TO DIRECTIVE 133/99 PUBLISHED 1N THE OFFICIAL JOURNAL OF 

EUROPEAN COMMUNITIES ON MAY 30, 1988 

(ZAHN AND WELLENS TEST) 

Measurements of Dissolved Organic Carbon (DOC) provided by the Zahn and Wellens method 

were carried out at time zero and at the end of the test . In addition, measurements of carbon 

dioxide released were carried out throughout the incubation period . 

REPORT OF THE BD 93 STUDY 

Study carried out according to the Good Laboratory Practices of the OECD. 

By Frederic Baud-Grasset Director of the Study 

Dominique Gebski Achievement of the Study 

Roger Sternalski Achievement of the Study 

and preparation of the report 

I, the undersigned, declare that the present work was carried out under my control, in agreement 

with the procedures that are described, and that this report forms an exact and faithful report of 

the results obtained. 
Decines, on March 23, 1995 

Director of the Study: 

Frederic Baud-Grasset 

[signature] 

This report includes 13 pages 

[footer] 

[header, same on pages 2/13 through 13/13] 

RE/ECOTOX/BD 93 STUDY 2/13 

Proof of Quality Assurance 

TITLE OF THE STUDY: Evaluation of the "potential final" aerobic biodegradability in 

aqueous medium of: 

According to directive 133/99 published in the Official Journal of the European Communities of 

May 30, 1988 (Zahn and Wellens test) 

REFERENCE NUMBER OF THE STUDY REPORT: BD 93 

Audited and dated 

phases 

Date of the audit 

report 

Dates of receipt of the audit report by: 

Director of the stud Director of installation 

Protocol 10/3/94 10/3/94 10/6/94 10/4/94 

Study in progress 

Final report 2/23/95 2/24/95 3/10/95 2/24/95 
The audits carried out during this study have not revealed any deviations related to Good 

Laboratory Practices which could bring into question the quality or integrity of the study. 

Date: March 17, 1995 [signature] 

Quality Assurance Stamp: 

Andre Vessot 

IP 3 002 - rev . 2 - page 1/1 Document for attachment: 3 AO 004 

1 - GENERALITIES 

1 .1 Requester of the study : 

1 .2 Characteristics of the product studied 

Reference., ~ lot No. DAF018242, received in the laboratory on September 15, 

1993 CAS No . 70851-08-0 

r -. 

_J 

Site and conditions of storage: at room temperature, in ventilated cupboard (Office 111 building 

M 26) reserved for products in studies. 

Properties : at 20°C, the product is presented in the form of a~ 

The product is miscible with water at room temperature. 

1 .3 Goal of the study 

To evaluate the "final" biodegradability of[ -j that is the level of biodegradation 

reached when the carbon part of this product submitted to the test at a given concentration, under 

the action of aerobic microorganisms, is totally removed by producing carbon dioxide, water, 

mineral salts and new microbial cellular components (biomass). 

1 .4 Site of carrying out the study c 
1 .5 Schedule of the study 

- Stabilization period of the sludge : from October 4 to 18, 1994 

- Start of the test : October 18, 1994 

- End of the test : November 15, 1994 

1 .6 Site for archiving documents related to the study 

In a cabinet reserved for "B .P .L." studies and located in office 138, building M 26. 

2 - CONDUCTING THE STUDY 

2.1 Principle of the method 

The activated sludge and the test medium were introduced into test containers, then the mixture 

was stirred and aerated. 

After a stabilization period for endogenous respiration of the sludge equivalent to 13 days, the 

product was added to obtain an organic carbon concentration near 300 mg/kg. 

The degradation was followed by periodically determining the amount of carbon dioxide 

released and trapped in the form of barium carbonate. The total amount of C02 released was 

determined and the biodegradation expressed in theoretical % of CO2, evaluated after 28 days of 

incubation . 

The results of analysis of the DOC at the beginning and at the end of the test are presented and 

commented upon. 

2.2 Reagents 

2.2 .1 . Chemical reagents 

All the chemical reagents used were of analytical quality. 

The double-distilled water for the preparation of the solutions had a dissolved organic carbon 

content < 4 mg/kg. 

2.2 .2 Biological reagent 

The activated sludge used for the test was sampled in the aeration tank of the treatment plant of 

St. Germain at Mont d'Or on September 30, 1994 in the morning. It was stabilized for 4 days by 

bubbling air into the sampling container under a hood at room temperature (time necessary for 

degradation of the endogenous organic carbon). 

Before its use, the sludge was washed by two successive centrifugations and the bacterial residue 

washed with test medium (2 .2 .3). Its content of material in suspension, determined by weighing 

of the dry extract was: 2190 mg/L. 

The final content of the dry material per kg of test solution was adjusted to: 

104. 000100 
0.3 g per kg. 

2 .2 .3 Test medium 

Composition* : 

KH2P04 85,000 m g 

K2HPOQ 217,5(}0 mg 

NH4C1 5,000 Mg 

Na2HP04, 2H20 334,000 mg 

MgS04, 7 H20 22,500 mg 

Ca012, 2 H20 36,400 mg 

FaG13, 6 H20 0,250 mg 

Double-distilled water 1000 g 

2.3 Test device 

It is outlined in the following figure : it allows trapping of the carbon dioxide. 

(2) 

(1) Entrance of air 

(2) Flow rate regulator 

(3) Guard flask 

(4) Rehumidification of the air (barium oxide solution) 

(5) Incubation container 

(6) Magnetic stirrer 

(7) Unit for trapping COZ produced (barium oxide solution) 

[In tables, commas in number represent decimal points .] 

ioJ ooosOJL 
The incubation containers (5-L glass Erlenmeyers) and the glassware used were previously 

cleaned of any trace of organic material or toxic substance for microorganisms (treatment with 

sulfochromic [acid]). 

2 .4 Test progress 

The test was carried out according to the Operating Procedures in force in the laboratory. 

2.4 .1 Solution : Study product 

An amount of product corresponding to an average concentration of organic carbon of 

300 mg/kg was introduced into the test medium (2.2 .3). 

2 .4 .2 Solution : Reference substance 

The reference substance (analytical grade ethylene glycol with known biodegradability) was 

diluted in the test medium (2.2 .3) to obtain a theoretical concentration of organic carbon of 

300 mg/kg. 

2.4 .3 Solution : Study product + reference substance 

The product and the reference substance were brought into the test medium (2 .2 .3) to obtain a 

theoretical concentration of organic carbon of 300 mg/kg for each of the compounds. 

2.4 .4 Environment of the test 

The test was carried out in the dark, in ventilated cell 130, office free of toxic vapors . The 

temperature recorded continuously during the trial varied between 20.1 °C and 22.6°C. 

2 .4 .5 Components of the test 

It included: 

- two test containers for the study product FE1 and FE2 

- two control test containers FBI and FB2 

- a test container for monitoring the activity 

of the inoculum (reference substance) FC 

- a test container for monitoring the abiotic 

degradability FA 

- a test container for monitoring the inhibition FI 

2.4 .6 Setting up the test 

Each incubation container contained 2500 g of test medium. 

104 000102 
The contents of each container are achieved according to the following table : 

r6t8rence 

r6cipient 

1 d'essai 

milieu 

mirOral 

Q) 

2.2 .3 

substance 

r6t6rence 

(3) 

2 .4 .2 

produit 

+(9) 

r4fkence 

2 .4.3 

produit 

en Otude 

~ 

2 .4 .1 

rdactit 

btologique 

© 

2.2 .2 

solution 

NaN3 

Ail 0 gfkg. 

Q 

F81 x x 

FS 2 x x 

FE 1 x x x 

FE 2 x _ x x I 

FC x x 

X ~ f ;, I 

FA x x x 

(1) Biological reagent: volume of biological reagent (2.2 .2) corresponding to 0.3 g/kg of 

MES in the test solution (or 42.1 mL). 

(2) Sodium nitride solution: 1 % of the amount of test solution 

Key: 1 Test container reference number 

2 Mineral medium 

3 Reference substance 

4 Product + reference 

5 Study product 

6 Biological reagent(l) 

7 NaN3 solution (2) at 10 g/kg 

2 .4 .7 Measurement of the dissolved organic carbon "DOC" 

Samples were taken from all the test containers at the beginning of the test (time 0) and at the 

end of the test before acidification, for the determination of the DOC concentration. 

The measurement of the DOC was carried out on the supernatant of a sample (approximately 

6 mL) of test solutions, centrifuged for 20 min at 6000 rpm and at 6°C. 

The DOC was measured with the help of a Dohrmann DC 190 carbon analyzer with oxidation at 

900°C. 
2.4 .8 Measurement with the barium oxide traps 

The amount of carbon dioxide released and trapped in the barium oxide flasks was measured 

after visual estimation of the amount of precipitate formed, in comparison with the traps located 

downstream in the same series . 

The last day of the test, all the test containers were acidified with 1 mL concentrated 

hydrochloric acid in order to decompose the carbonates and bicarbonates . 

Aeration was continued for 24 h, and then a final measurement carried out on all the barium 

oxide traps. 

3 - CALCULATIONS AND EXPRESSION OF THE RESULTS 

3 .1 Calculation of the concentrations of dissolved organic carbon 

In the FE, FC and FI containers, the concentrations of dissolved organic carbon were calculated 

according to the formula: 

DOCt= DOCFEt- (DOCFBIt + DOCFS2t)/2 

DOCt: Concentration of Dissolved Organic Carbon at time t in mg/kg 

DOCFEt : Concentration of Dissolved Organic Carbon in mg/kg in test containers FE 1 or FE2, FC 

and FI at time t. 

DOCFBIt: Concentration of Dissolved Organic Carbon in mg/kg in test container FB 1 at time t. 

DOCFB2t : Concentration of Dissolved Organic Carbon in mg/kg in test container FB2 at time t. 

In container FA the concentrations of Dissolved Organic Carbon were calculated according to 

the formula: 

DOCt = DOCFAt 

DOCFAt: Concentration of Dissolved Organic Carbon in mg/kg in test container FA at time t. 

3 .2 Calculation of the theoretical amount of carbon dioxide released 

The theoretical amount, expressed in mg, of carbon dioxide released by the study product (or 

reference substance) was calculated by using the following formula: 

CO2Tmg = C X P X 44/12 

C: concentration of the study product (or reference substance) expressed in mg of carbon per kg 

of suspension or test solution 

P: final weight of the test 

44/12: molecular weight of carbon dioxide/carbon 
3 .3 Calculation of the % degradation according to the amount of COz released 

The % degradation after tdays of incubation was calculated for each test container according to the 

formula: 

% degradation = [(COZ F ,o to t - C02 FBto to t)/COZT] x 100 

C02 F to to t : Total amount of carbon dioxide expressed in mg, released in each test container FE, 

Fl and FC between the start of the incubation to and time t. 

COZ FBro to t : Mean of the total amount of carbon dioxide expressed in mg, released in test 

containers FB between the start of the incubation to and time t. 

C02T: Theoretical amount of carbon dioxide expressed in mg (3 .2) expected in FE I, FE2, Fl and 

FC, respectively . 

3 .4 Calculation of the % abiotic degradation according to the C02 released 

The % degradation after tdays of incubation was calculated for the test container according to the 

formula: 

% degradation = (COZ F to tot /C02T) x 100 

C02 F to to t : Total amount of carbon dioxide expressed in mg, released in test container FA 

between the start of the incubation to and time t. 

C02T: Theoretical amount of carbon dioxide expressed in mg (3 .2) expected in test container 

FA. 

4 - RESULTS 

The amounts of dissolved organic carbon measured at time zero and at the end of the test are 

presented in Table 3 . 

The amounts of carbon dioxide produced by the biodegradation of the study product and 

reference product measured over time are presented in Table 1 . 

The percentages of degradation calculated according to the amount of C02 released according to 

incubation time are presented in Table 2 . They are equal to 56 and 64% in the two test containers 

of the product after 28 days of incubation . 

For the container for monitoring abiotic degradability, 46 .20 mg of COZ were measured over 28 

days, which corresponds to a degradation equivalent equal to 2%. 

The degradation curves over time are presented in Figure 1 . 
5 - VALIDITY OF THE RESULTS 

- The difference between the values of the percentage of biodegradation of the two test 

containers is less than 20% at the end of the test (8% on the 281' day) . 

- The % biodegradation in the test container for monitoring the activity of the inoculum (FC) is 

>_ 60% on the 14t' day (69% on the 10`h day) 

- The % biodegradation in the test container for monitoring the inhibition (FI) is _>25% on the 

14th day (65% on the 10'h day) 

- The amount of C02 released at the end of the test in each control test container (FB) is 

<_70 mg/L (53 .2 and 55.2 mg/L on the 28th day). 

Therefore, the test is considered to be valid. 

6 - CONCLUSIONS 

Product De adatio me Mean percentage biode adation 

r- -i 

~ 28 da s __7~ 60% 
Table No. 1 

Production of carbon dioxide in mg as a function of time 

Product: L 

Method: Publication of the Official Journal 

of European Communities of May 30, 1988 

T.inc . O 

en jours 

_ 

C02 dans 

(FBI +FB~l 

2 

C02 dans 

FE1 

C02 darls 

FE2(Z 

C02 darts 

FC Q) 

C02 dans 

F1 O 

C02 dans 

FA (Z 

0 0 0 0 0 0 0 

1 15,84 26,18 23,32 18,92 25,30 0,00 

2 26,02 146,85 108,57 49,94 290,84 0,00 

3 36,52 488,51 475,31 200,64 988,24 0,00 

6 57,97 773,41 841,39 1448,59 2943,05 0,00 

7 68,53 857,45 935,55 1666,39 3202 .43 15,18 

10 82,45 1029,71 1139,71 1985,83 3638,14 15,18 

17 100,05 1251,25 1460,47 2395,69 4057,02 27,94 

2 i i 12.59 1 ^' 1 4 ^ . o~ V'I 

.~-. . , 1 J 

., 1 J I 1 ~ L

~~1 75.33 i e,20069 ~ 39 

23 118,97 1568,60 1813,13 2512,73 4292,86 32,12 

28 135,58 1677,39 1905,97 2579 .72 4444,66 46,20 

Quan:itd th6oriqu® 

(3) de C02 ariendue (mg) 2758 .81 2752,41-- 2757-3 5505 .51 275d,4 ~ 

FE1 and FE2: test containers for the study product 

FBI and FB2: control test containers 

FC: test container for monitoring the activity 

of the inoculum (reference substance) 

FA : test container for monitoring the abiotic 

degradability 

Fl : test container for monitoring the inhibition 

Key: 1 Time inclusive in days 

2 COZ in 

3 Theoretical amount of C02 expected (mg) 
Table No. 2 

Percentages of degradation as a function of time (from measurements of C02) 

ProductE 

J 

Method: Publication of the Official Journal 

of European Communities of May 30, 1988 

uuree 

d'incubation 

en 'ours 

0 

Pourcentages de ddgradation 

FE1 FE2 FC Ff FA 

0 

: 

0 

t 

0 0 0 0 

1 0 0 u u ir 

2 4 3 1 5 0 

3 16 16 6 17 0 

6 26 28 50 52 0 

7 29 f 32 ~ 58 ~ 57 1 

10 34 38 i 69 I 65 

i 

! 1 J 

1 

1 7 42- 49 83 1 c 

; ~ 

21 48 53 86 74 1 

23 53 62 87 76 1 

28 56 64 89 78 2 

FE 1 and FE2: test containers for the study product 

FC: test container for monitoring the activity 

of the inoculum (reference substance) 

FA: test container for monitoring the abiotic 

degradability 

Fl: test container for monitoring the inhibition 

Key: 1 Duration of incubation in days 

2 Percentages of degradation 
Table No . 3 

Production of dissolved organic carbon in mg/L as a function of time 

Productc 

Method: Publication of the Official Journal 

of European Communities of May 30, 1988 

R6iBrence COD mesur6 COD mesurd Dftradation 

r6cipient en mg/! en mg/) % 

cfessai ~ au temps au temps d 

z6ro (2) 28 jours 28 jours 

OO a0 

FB 1 3,93 3,42 

FB 2 4,84 3 .83 

FE 1 298,14 78,18 75 

FE 2 289 .02 i 81 .21 73 

: f 357.00 ~ 4,40 ' 100 

F1 632,40 91,05 86 

FA i 296,16 f 282,24 f 5 

Key: 1 Test container reference number 

2 DOC measured in mg/L at time zero 

3 DOC measured in mg/L at time 28 days 

4 % Degradation at 28 days 
Figure No. 1 

Degradation curves as a function of time (from measurements of COz) 

ProductiMethod: Publication of the Official Journal 

of European Communities of May 30, 1988 

a° 

z 

0 

Ea 

a 

a 

w 0 

O 

. FC 

FA 

1-4 

3 5 10 15 20 25 30 

TEMPS EN JOURS 

" --------- T-. -.--T 

Key: 1 % degradation 

2 Time in days 

FE 1 and FE2: test containers for the study product 

FC : test container for monitoring the activity 

of the inoculum (reference substance) 

FA: test container for monitoring the abiotic 

degradability 

Fl : test container for monitoring the inhibition 
CERTIFICATE 

OF ANALYSIS 

wiwn, ro THIS AWU,Y= covIAs OUR "n,40,Y TO 

8ATlPI,$ ZrT'R858 

1101 Pilo"" ew-MxzT 

Box 581 

W95T POINT 

GA 31833-1779 

i 

1 

I 
CRCirNthtIE (°A^-DTE 

FCOTOXICOLOGICA1, SUMMARY 

1 - crtleperataa) - i 

INHERENT BIODEGRADABILM 

Th ~ 'has been tested for inherent biodegrddahility. The assay wa.s cacried 

out in accotdarice ;Mth the 871302.rELC Directive (Zahn-Wellens test) and the 06CD 

Ciuidclines (OECD 3{l2tl) . The Principles of Good Laboratory Practice were follo%,ed, 

The conditions of the Zaltn-Vl+cllcns test were fulfilled but the apparatus was modified to 

allow for (-'02 measuretttcnts during the test . The biode&r-adation was calculated ftom the 

C02 released ate ;uurcmcnt4 compared to the theoretical arnount of CC)2 fix completc 

minernJizration of the chemical. The Dissolved Organic Carbon (p()(-) mesiyttrtat7enis as 

descriltod in thc Zahtt-V4'eilens lnethtxi, were also performed at the beginning and the end 

of tln. testr- Thc: _tbiodegradation calculatcd »~ith the CU2 measurements ovas 60 °k 

within 28 days. !hc positive control was degraded to 69 °lo 8vithin 10 days which is a 

guarantee of the inoculum activity nnd no inhibition was detected with the toxicity control . 

With the 1XK ntcasarenwnts, die ~ 

I biodegradation was confirmed- A 

'viodct;radattion of 74"io was obtained wtthin 23 days. - 

On the basis of these Tcsults, the 

in tbix inherent text- 3 i4 considered as totally hiodcRradablc 

Ref. : Crit-Decines - Evaluation of the "final potential" aerobic biodegradation of the~ 

~- Report of study B 93 - March 23, 1995 
[box] Laboratory accredited by the National Network of Tests under No . 51 .87/01 [logo] 

T/SE/MES/ECOTOXICOLOGY 

DETERMINATION OF THE ACUTE ECOTOXICITY AFTER 24 HOURS AND 48 HOURS 

OF EXPOSURE OF 

WITH RESPECT TO Daphnia magna 

ACCORDING TO THE METHOD PUBLISHED IN THE OFFICIAL JOURNAL OF 

EUROPEAN COMMUNITIES ON DECEMBER 29, 1992 

(STATISTICAL TEST) 

REPORT OF STUDY D 218 

Study carried out according to Good Laboratory Practices of the OECD. 

By Robert Bazin Director of the Study 

Gilles Moreau and Achievement of the Study 

Monique Saugues 

With the participation of: 

Michel Argoud Preparation of the animals 

Gilles Moreau Preparation of the report 
1, the undersigned, declare that the present work was carried out under my control, in agreement 

with the procedures that are described, and that this report forms an exact and faithful report of 

the results obtained. 

Decines, on March 15, 1994 

Director of the Study: 

Robert Bazin 

[signature] 

The reproduction of this study report is only authorized 

in the form of complete photographic facsimile 

It includes 8 pages and 1 appendix 

The RNE accreditation only certifies the technical competence of the laboratories for tests 

covered by the accreditation . 

[footer] 

[header for pages 2/8 through 8/8] 

RE/ECOTOX/ STUDY D 218 2/8 

Proof of Quality Assurance 

TITLE OF THE STUDY: Determination of the acute ecotoxicity after 24 h and 48 h of 

exposure of: 

with respect to Daphnia magna according to the method published in the Official Journal of 

European Communities on December 29, 1992 (statistical test) 

REFERENCE NUMBER OF THE STUDY REPORT : D 218 
p. 115 

19 

Audited and dated 

_phases 

Date of the audit 

report 

Dates of receipt of the audit report by: 

Director of the stud Director of installation 

Protocol 11/25/93 11/25/93 11/26/93 11/26/93 

Study in progress 

Final report 2/10/94 2/10/94 2/24/94 2/24/94 

The audits carried out during this study have not revealed any deviations related to Good 

Laboratory Practices which could bring into question the quality or integrity of the study. 

Date: February 28, 1994 [signature] 

Quality Assurance Stamp: 

Cecile Mazot 

[footer] 

IP 3 002 -rev. 2 -page 1/1 Document for attachment : 3 AO 004 

1 - GENERALITIES 

1 .1 Requester of the study : 

1 .2 Goal of the study 

To evaluate the acute ecotoxicity of with respect to daphnia: Daphnia magna 

(IRCHA strain - Research center - BP 1 - 91710 V ert le Petit), originating from the 

Ecotoxicology Laboratory of CRIT/D and for which the sensitivity has been determined in study 

D225 (report in Appendix 1) 

1 .3 Characteristics of the product studied 

Reference :, ~eceived in the laboratory week 37/1993 
p. 116 

20 

Site and conditions of storage: at room temperature, in ventilated cupboard (Office 111, building 

M 26) reserved for products in studies. 

Properties: The product in its commercial form is a stable aqueous solution with the active 

material, pale yellow in color. 

1 .4 Schedule of the study 

- Preliminary test : starts December 1, 1993 

- Final test : starts December 8, 1993 

1 .5 Site for archiving documents related to the study 

In a cabinet reserved for "B.P .L." studies and located in office 138, building M 26. 

2 - CONDUCTING THE STUDY 

2.1 Principle 

Determinations of the initial concentrations of the product which, after 24 h and 48 h, have 

immobilized 50% of the daphnia used in the experimentation. 

These concentrations, called effective, initial, inhibitory concentrations are designated by: EC 

50-24 or 48 h. 

The concentrations are expressed in ppm (weight/weight) . 

The test was conducted in two steps : 

- a preliminary test designed to give an approximate indication of the EC50 and to determine the 

range of concentrations for the final test, 

- a final test, only the results of which have been kept. 

2 .2 Reagents 

2.2 .1 Chemical reagents 

All the chemical reagents used were of analytical quality. 

Double-distilled water was used for the preparation of the solutions . 

2.2 .2 Biological reagent 

Daphnia magna Strauss 1820 (Cladocera Crustacea) commonly called daphnia (IRCHA strain) 

obtained in the rearing of the Ecotoxicology laboratory of C.R.I .T./D. 

The daphnia used were of a size such that they pass through a screen with mesh opening of 

800 ~tm, but were retained on a screen with mesh opening of 560 pm. 

118 000116 
p. 117 

21 

2 .2 .3 Test medium 

The test medium was prepared with double-distilled water with a conductivity of 0 .95 p6-cm-I . 

Its composition is the following: 

CaCl2, 2HO0 0,297 g11 

MgCi2, 6 H20 0,167 gI1 

0,200 g/1 

K2S04 0,026 g1l 

The test medium was aerated with compressed air. At the time of its preparation for the final test, 

its pH was 8 .0 at 21'C, and its oxygen concentration at 100% saturation . 

2.3 Test solutions 

Before each preliminary or final test, product (1 .3) and test medium (2.2 .3) were introduced into 

a container in order to obtain a mother solution of 100 ppm (weight/weight). 

The test solutions were prepared by direct dilution of the mother solution with the test medium 

(2.2 .3) in order to obtain the necessary concentrations . 

The concentrations of the test solutions are expressed in ppm (weight/weight). 

At the end of the test the test solutions were discharged directly with the effluents from 

C.R.I .T./D. 

2.4 Reference substance 

Analytical grade potassium dichromate (I{2CrZ07). 

2.5 Test containers 

The test was carried out in 100-mL Pyrex beakers. 

2.6 Environment of the test 
p. 118 

CERTIFICATE 

OF ANALYSIS 

MAIL TO 

r 

;Ac+aCT ~ :C6 Fa~ '.9T^flER P!t(.'MU --,X9P" 

it5i Lt?l~ild" jR;i~ 

--- ` 

PfOALY!~Yj 

10097365 bA2G019393 

yYtl" If O.""{IIL., . 

' 

I I 

50 

THIS ANALYSIS COVERS OUR SHIPMENT TO 

SAMPLE EXPRESS 

1101 PITTMAM STREET 

Box 591 

WEST POINT 

GA 31833-1779 

^.9T(,'MEF ^Pl~I! PfQ 

221 

FLAW C69MR LOt h0. ,. J 

FINAL PRODUCT ANALYSIS 

1101401 
[box] Laboratory accredited by the National Network of Tests under No. 51 .87/01 

T/SE/MES/ECOTOXICOLOGY 

APPENDIX 1 TO REPORT D 218 

DETERMINATION OF THE ACUTE ECOTOXICITY 

AFTER 24 HOURS OF EXPOSURE OF 

POTASSIUM DICHROMATE 

(reference product) 

WITH RESPECT TO Daphnia magna 

ACCORDING TO THE METHOD PUBLISHED IN THE OFFICIAL JOURNAL OF 

EUROPEAN COMMUNITIES ON DECEMBER 29, 1992 

Report of Study D 225 

(reference study for study D 218) 

Study carried out according to Good Laboratory Practices of the OECD. 

By Robert Bazin Director of the Study 

Monique Saugues and 

Gilles Moreau Achievement of the Studv 

With the participation of 

Michel Argoud Preparation of the animals 

Gilles Moreau Preparation of the report 

I, the undersigned, declare that the present work was carried out under my control, in agreement 

with the procedures that are described, and that this report forms an exact and faithful report of 

the results obtained . 
p. 120 

28 

Decines, on March 15, 1994 

Director of the Study : 

Robert Bazin 

[signature] 

The reproduction of this study report is only authorized 

in the form of complete photographic facsimile 

It includes 6 pages 

The RNE accreditation only certifies the technical competence of the laboratories for tests 

covered by the accreditation. 

[footer] 

[header on pages 2/6 through 6/6] 

RE/ECOTOX STUDY D 225 2/6 

1 - GENERALITIES 

1 .1 Requester of the study: 

Ecotoxicology Laboratory Methods and tests department 

1 .2 Goal of the study 

To evaluate the sensitivity of the population of daphnia sampled on December 8, 1993 (Daphnia 

magna, IRCHA strain - Research center - BP 1 - 91710 Vert le Petit), originating from the 

rearing of the Ecotoxicology Laboratory of CRIT/D by determination of the acute toxicity of the 

reference product: potassium dichromate. 

1 .3 Product studied 

Potassium dichromate, RP Normapur, Prolabo, lot 90002, stored in the laboratory at room 

temperature. 

1 .4 Schedule of the study 

test starts December 8, 1993 

ends December 9, 1993 

iz0 000120 
p. 121 

29 

1 .6 Site for archiving documents related to the study 

In a cabinet reserved for "B.P .L." studies and located in office 138, building M 26 . 

2 - CONDUCTING THE STUDY 

2 .1 Principle 

Determination of the initial concentrations of the product which, after 24 h, has immobilized 

50% of the daphnia used in the experimentation. 

This concentration, expressed in ppm (weight/weight), called effective, initial, inhibitory 

concentration, is designated by: EC 50-24 h. 

The test was conducted in a single step, the EC 50-24 h of potassium dichromate having to be 

located between 0.9 ppm and 2.0 ppm (weight/weight). 

2.2 Reagents 

2 .2 .1 Chemical reagents 

All the chemical reagents used were of analytical quality. Double-distilled water was used for the 

preparation of the solutions. 

2 .2 .2 Biological reagent 

Daphnia magna Strauss 1820 (Cladocera Crustacea) commonly called daphnia (IRCHA strain) 

obtained in the rearing of the Ecotoxicology laboratory of CRIT/D . 

The daphnia used were of a size such that they passed through a screen with mesh opening of 

800 um, but were retained on a screen with mesh opening of 560 ~im. 

2.2 .3 Test medium 

The test medium was prepared with double-distilled water with a conductivity of 0 .95 [6-cm-' . 

Its composition is the following: 

cacl,.2Kzo 0,297 911 

M902. 6 H20 0,167 9ll 

N8F003 0.209 g14 

K-2SO4 0,026 p11 
p. 122 

30 

The test medium was aerated with compressed air. At the time of its use, its pH was 8 .0 at 21 °C, 

and its oxygen concentration at 100% saturation . 

2 .3 Test solutions 

- A potassium dichromate solution was prepared at 100 ppm (weight/weight) in double-distilled 

water. 

- A solution at 10 ppm (weight/weight) in double-distilled water was obtained by diluting the 

100-ppm mother solution 10-fold . 

At the end of the test, the test solutions were discharged directly with the effluents from CRIT/D. 

2.4 Test containers 

The test was carried out in 100-mL Pyrex beakers . 

2.5 Environment of the test 

The test was carried out in sites reserved for this purpose and temperature-controlled . The 

temperature recorded continuously during the test, in the incubation cabinet, varied between 

20.0°C and 21 .0°C. 

These values conform to the conditions (temperature between 18°C and 22°C at f 1 °C) required 

by the test method. 

The incubation was done in the dark. 

2.6 Progress of the test 

9 test solutions (2 .3) of the product (1 .3) were made at the following concentrations 0.60 - 0 .80 -

0.95 - 1 .1 - 1 .4 - 1 .7 - 2.1 - 2 .5 and 3 .0 ppm (weight/weight). 

On December 8, 40 g of each of the test solutions (2.3) were introduced into 1 test container 

(2 .4) per concentration, and 40 mg of test medium (2.2 .3) into another test container (control 

container). 

20 daphnia were added to each container (in 10 min for all the containers) . 

Twenty-four hours after the introduction of the daphnia, on December 9, 1993, the daphnia 

incapable of moving in each test container were counted. 

Immediately after the counting, the concentration of dissolved oxygen was measured for the test 

solution corresponding to the lowest concentration in which 100% of the daphnia were 

immobilized. 

3 - RESULTS 

3 .1 Physicochemical parameters and percentages of immobilization 

124 000122 
p. 123 

31 

The physicochemical parameters measured and the percentages of immobilization obtained are 

reported in Table No. l . 

3 .2 Determination of the EC 50-24 h 

The EC 50-24 h of the potassium dichromate and its 95% confidence limits were determined by 

the probit method (original software from C. E. Stephan). 

The approached value at two significant figures is 

EC 50-24 h 1 .3 ppm (weight/weight) . 

The 95% confidence interval limits are 1 .2 ppm and 1 .5 ppm (weight/weight). 

4 - CONCLUSION 

On December 9, 1993 the EC 50-24 h of potassium dichromate (reference product) on daphnia 

(Daphnia magna) originating from the rearing of the Ecotoxicology laboratory of CRIT/D is 

1 .3 ppm (weight/weight). 

This value is between 0 .9 ppm and 2 .0 ppm, validity conditions required by the method 

published in the Official Journal of the European Communities on December 29, 1992 . 
Physicochemical parameters and % immobilization 

1 

Table No. 1 

Organism: Daphnia magna 

Product : potassium dichromate 

Method: Method published in the Official Journal 

of European Communities on December 29, 1992 

Concentrations Immobilisation 02 

an ppM enombre120 % 96 (polds!poisJs) 

1 ® T.- m, y.:i ~ V 

V 

- 

1 1 1 1 I 

O .ED ~ 0 i 

0 .80 i t I 

a .95 - ! 1 I 

I-i,l 

--- 

Y ?.0 , 

I I 

f 

~ ~ , 5 5 t 

1 1 '7 I ~ n 1 1 / 

, I 

, 

7 

1 1 1 1 

I I 1 1 J 1 

20 100 

__ 3 .0 ~ 20 I 100 I - i 

Key: 1 Concentration in ppm (weight/weight) 

2 Immobilization 

3 Number/20 

4 Reference 
p. 125 

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