U .S. ENVIRONMENTAL PROTECTION AGENCY



# r ,1040000141 in the Premanufacture Notice

.

. 

## PREMANUFACTURE NOTICE

GENERAL INSTR

UCTIONS ~ ~ La ~ i oc.,,~ You must provide all information requested in this formto the extent that it is known to or reasonably ascertainable by you. not have actual data. Make reasonable estimates ifyou do Before you completethis form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available fromthe Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603) . Ifa user fee has been remitted for this notice (40CFR700 .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, HQAccounting 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 ifyou claimthe 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 yoursubmission should reference your TS user fee identification number. You must submit an original and two copies ofthis notice including all test data. Ifyou 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 ofthis 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 ofthis 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 formfor 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 ofconsent 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 fromthe information (except chemical identity) reported in the form . CONFIDENTIALITY CLAIMS You may claimany mformation in this notice as confidential . To assert a claim on the form, mark (X) (he confidential box next to the information that you claimas confidential . To assert a claimin an attachment, circle or bracket the information you claimas confidential . Ifyou 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 ANDOTHER DATA Youare required to submit all test data in your possession or control and to provide a description ofall other data known to or reasonably ascertainable by you, ifthese data are related to the health and environmental effects on the manufacture, processing, distribution m commerce, use, ordisposal ofthe new chemical substance

. Standard literature citations may be submitted fordata in the open scientific literature. Complete test data (written in English), not summaries ofdata must be submitted ifthey do not appear in the open hterature. Youshould clearly identify whether test data is on the substance or on an analog. Also, the chemical composition ofthe tested material should be characterized. Following are examples oftest 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 NewUse Notice) (',i TMEA (Test Marketing Exemption Application) LVE (LowVolume Exemption) rt 40 CFR 723.50(cxl) I C-D ~ n `) f rl G3 ;~```-1 LOREX (Low

Release/LowExposure 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 EPAForm7710-25. atE C El'rpE[l 

## 03 N 01v 21~ ~i'i 2: S2 `ompany SanitizedPublic 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 ofthis 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 ofmy knowledge and belief: 1 . The company named in Part 1, section A, subsection 1 a ofthis notice formintends 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 ofthe 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 §720.50ofthe Premanufacture Notification Rule. Additional Certification Statements: If youare 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 Ahas remitted the fee of $2500specified in 40 CFR700 .45(b), or The Company named in Part I, SectionAhas 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 SectionAis a small business concern under 40 CFR 700 .43 and has remitted a fee of $100 in accordance with 40 CFR 700 .45(b) . Ifyou are submitting a low volume exemption (LVE) application in accordance with 40 CFR723.50(c)(1) or a Low release and low exposure exemption (LoRex) application in accordance with 40 CFR723.50(c)(2), check the followingcertification statements: 0The 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 . 0The 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 ofthe date ofthe expiration of the 30 day reviewperiod. 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 ofAuthorized Official (Original Signature Required)

Signature ofagent - (if applicable) Date

Date Confidential X

X

EPA FORM7710-25 (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 andstreet) City. State, ZIPCode b. Agent (if Name ofauthorized official Position applicable) X

Company Mailing address (number and street) City, State, ZIP Code Telephone Area Code Number

c. Ifyou are submitting this notice as part of ajoint submission, mark (X) this box. Joint Submitter (if Name ofauthorized 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, ZIPCode Telephone Area Code Number 3. Ifyou 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 ifnone 4. Ifyou previously submitted an exemption application for the chemical substance covered by this notice, enter the exemption number assigned by Mark (X) - EPA . If you previously submitted a PMN for this substance enter the if none PMN number assigned by EPA(i .e. withdrawn or incomplete) . - " 5 . Ifyou 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 Mark (X) --- s gne y . --~ 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

EPAFORM

7710-25 (Rev. 5-95) Page 3p. 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 itemyou claimas confidential Complete either item 1 (Class I or 2 substances) or 2 (Polymers) as appropriate. Complete all other items . Ifanother 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 p erson in a continuation sheet. 0 dential I . Class I or 2 chemical substances (for definitions ofclass 1 and class 2 substances, see the Instructions Manual) a . Class ofsubstance - 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 CA9CI 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 fromthe CAS Inventory Expert Services must be submitted as an attachment to this notice) d. Molecular formula and CAS Registry Number (ifa 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 ofcomposition 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 .

Mar k (X) this box if you attach a continuation sheet. EPA FORM

7710-25 (Rev. 5-95) Page 4p. 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 ofthe polymer you intend to manufacture. dential Indicate maximum

weight percent of lowmolecular weight species (not including residual monomers, reactants, or solvents) below500 and below1,000absolute molecular weight ofthat 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 %

below1000 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 itemyou claimas 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 ifentry in column (1) is confidential . (3) - Indicate the typical weight percent ofeach monomer or other reactant in the polymer. (4) - Mark (X) the identity column ifyou want a monomeror other reactant used at two weight percent or less to be listed as part ofthe polymer

description on the TSCA Chemical Substance Inventory . (5) - Mark (X) this column ifentries in columns (3) and (4) are confidential . (6) - Indicate the maximum weight percent ofeach 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 ifyouattach 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 ofthe identification report ~ Method 2(other source)

obtained fromCAS 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) - Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose . Provide the CAS Registry Number if available. Ifthere are unidentified impurities, enter "unidentified." (b) - Estimate the maximum weight 11/o of each impurity. Ifthere 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 claimchemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity ofthe 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 ifyou attach a continuation sheet. 7. Byproducts - Describe any byproducts resulting fromthe manufacture, processing, use, or disposal of the new chemical substance

. Provide the CAS Registry Number ifavailable. B roduct yp CAS Registry Number (2) Confidential X X X 

# Mark(X)thisboxifyouattachacontinuationsheet X EPA FORM7710-25 (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), Room6428 RE: Premanufacture Notification P04-141 Dear Sir or Madam

: .~ L ®sw 0 ru 

### r.) 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 

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### Part I -GENERAL INFORMAT10N-Continued SectionC- PBODUCTIOlw IIblPOBT,ANDUSE IIROBMATI011k U/adc 00

fte"CaoBdanfiml' boznext Gamyi1em ym claim asaoaBdaaist L Production.vulame-Fstfomabeftoiodsousa productionvdamdunngthefirst 12msnfisofproduction. Al .9oestimate the nsxinumtproductionvolume fad'anyoonswrtive12-aWatit period dorftthefin*---,, yeas ofproduction. Estimates douid on 100%new

daenticalsubstancebasis. FareLwvVeJuwe F .xenpuow 1pLa~timr,ifyonciocae toIrmieyanxolioe teaiesaedat a inorr volrrwwthaR I0

.000Jg(yr .spiaofy ft palrrwnasdurk(xJ in theiad'agbox Ifgnartad, youarebiouwd to this aabaer.. Maximum

first 12-monthproduction (kg/Yr) Maxdmum 12-month production (kg/yr) denuai (1Q0%new

diemical substance basis) (1009G new dmmncd substance bow) Mat

2 Use 7ata®a8m

- YoumustmaiceaWaealecoa8deatInVtpdaimsforthedmaiptiae of the "ICYofuse, the percentofprodudfaa volame dewoled b ,Hw 6 dffintneRaubYiaOp,a" d we infoumdoo. Mark 00 the 'Confidentfai"BOIInext lDmy item you a . (1) -DESadbeeneti ialendedcuiegoCp of oseoEftenew amuGdanbefrnoe by Etaeeim and applicadan. Q3- Madc pp N~iadune ifeo1~yin mroa (1)iscoa6daodd boioasiato®afiou K .BQ r-- (3) -Ind'iede your wMingssssohave theia6acaiadoaptwfdedin oolnmn (1) bhuhng- .

. ND - &slbaabe thepeaiaeataftuhil p~oaue~bw forti~e Bist Uaee ~eassde~oted eoschcale®otyaE ax ~ (~ -Madc (70tl~e0i1®a IfeaEt~i~1 mll~w (~isCoaBdmWl bv~sin6oomaUaa (~1) . - . (A - Eatkaale thepaomtaftbeaew aubebaae mtaaualaled m mibdhrei, ~utoaa eundsom aolulkse, or :

gels a9mmnafiacturedfaraamnasdal putposes ataims under yout aanLeal assodaied witheadt ~yoftee . (7)-MQic 00thiscolumn ifentry in adumn (b, isconfidentis! bmikas iafiaamwlim ((3Bp . _ `` (~-LdicaEelGof `

podW atvolumeampeeled tarthe ~Ied "u~e"aeclaaa Max*ametlaa me bmc ifappropriate. Mark 00Ooka$ale'vte ndiiiypwstoLave&e metype providedis (8)6Ldiag . - ~ -Madc 00 ~aoLa~ ff ~ w~ aoir4a lqis(~te)aa~o6dmlLl b~eiaees io6am~lim(CBI) . -- Caftoryof we (1) ® ii W" Pto~c- ~ !s~ L M !Gofa~aeenpeaedp~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

% 'ifyouhaveidentified a "ooassmee use, please p wideonaooo- oa sheet adetat'leddesQiptionoftheuse(s) of thischennical substance inconsumer pvoducls. In addltioa include - & ofti~eaoaaere~eioe ofthenew ehmdeal subabnceasexpected in consumerproductsanddescribe thedmmical :eactionsbywhichdris substanceloses its identity m theconsumer product. Ma~c p0tidsboacifran apaehaamdou~llioaabeet. b . Caaa:c Ifyoaddnasycoiegayaf uaedesaip1iusjs subaedioo2sasao~Admt~l, enters WmQicdesdpfioa oftdat

abegoa~ Aeadfl~eir4aelisas >~d taraumQksaf ~eraicusedesaipiio~ . use desaiPtion Oil-well addit;ye ,

~ .,j +r` .~ 0 ~QO ~booc$ alfadt aooaRar~flow aheaf. ~ `: : r-: , 3 . Hasatd bfaosafioa- bdu3eiaibenolioea eop'afaedonade bmiss 'leofany baad wm

ftsbknoentlabd, maler}ds~dy dw ahee~ ara1~QidasrKaw v,4wdl be b aa,psam

avb b aeroaaWy 18Od~r b baer~o~ed b

H~isw~baaooe r~ediag equ~po~ec actioasf0tfitesie ~ ~aa~ o~t mordie OSdOf 9~eae u6 eoe l Ibt ~ t ~ L di i t~~ g , p , ~ p w s . e a pre ml a omat " ; R :a PORMFYA791aZ5 (Re+-595) Pa~e7 Gri

This M .SDS is the one currently befng user! for tlds prodnct before the cthemisal idandqivras found to be in error

### Part II-- HUMANEXPOSURE A1N1) ENVIRONMENTAL RELEASE "~

Section A-- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER Mark (X) the "Confidential" box next to any itemyou claimas confidential Complete section Afor 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 maystill have reporting requirements ifthere 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 ofthe site at which the operation will occur. Confidential Name X Site address (number and street) City, County, State, ZIP code Ifthe same operation will occur at more than one site, enter the number ofsites. Identify the additional sites on a continuation sheet, and if any ofthe 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 ifyou attach a continuation sheet. b. Type -- Mark (X) E]Manufacturing E]Processing DUse c. Amount and Duration -- Com plete I or 2 as a ro riate Maximumkg/batch (100% new Hours/batch Batches/year chemical substance) 1 . Batch Maximumkg/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) Diagramthe major unit operation steps and chemical conversions. Include interimstorage and transport containers (specify- e.g. 5gallon 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%newchemical substance basis), and entry point ofall 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 ofthe newchemical substance.

~Mark (X) this box if you attach a continuation sheet 8

EPAFORM

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 formof the new chemical substance, number of works exposed, and duration of activity. Mark (X) the "Confidential" box next to any itemyou 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 (ifpart of a mixture) at the time of exposure. (7) --Mark (X) this column ifentry in column (5) is confidential business information (CBI) . (8) -- Estimate the maximum number ofworkers involved in each activity for all sites combined. (9) --Mark (X) this column ifentry 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 ifyou 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 itemyou claimas 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 ifentries 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, ifany, and control efficiency that will be used to limit the release ofthe new substance to the environment . For releases disposed ofon land, characterize the disposal method andstate 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 ifentries 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 ofrelease Number released CBI e.g. stack air Control technology and efficiency (you maywish to o tionall tt h ff i 1 2 ya 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) ofreleases X waterway Specify to water Mark (X) this box ifyou attach a continuation sheet. EPA FORM

7710-25 (Rev. 5-95) Page 9

### Part II-- HUMANEXPOSLttr: ANDti ;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 for operations outside the U .S ; however, you must report any processing or use activities after import . See the Instructions Manual . Complete nseparate section B for each type ofprocessing, or use operation involving the new chemical substance

. Ifthe 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 claiminformation in this section as confidential . circle or bracket the specific information that you claimas confidential

. (1) -- Diagramthe major unit operation steps and chemical conversions, including interimstorage and transport containers (specify - e .g. 5gallon 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 ofrelease , 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) : # ofsites



### Confidential Business Information Has Been Removed.

Mark (X) this box ifyouattach a continuation sheet. 2 . Worker Exposure/Environmental Release (1) --From

the diagramabove, provide the letter for each worker activity. Complete 2-8 for each worker activity described. (2) --Estimate the number ofworkers exposed for all sites combined. (4) -- Estimate the typical duration ofexposure per worker in (a) hours per day and (b) days per year . (6) --Describe physical formof exposure and % new chemical substance (if in mixture), and any protective equipment and engineering controls, ifany, used to protect workers. (7) -- Estimate the percent of the new substance as formulated when packaged or used as a final product. (9) --Fromthe process diagram above, enter the number ofeach release point. Complete 9-13 for each release point identified. (10) -- Estimate the amount ofthe 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, ifany, that will be used to limit the release ofthe new substance to the environment . (14) -- Identify byproducts which may result fromthe operation. (3), (5),(8),(11), (13) and (15) --Mark(X) this column if any ofthe p roceeding 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 ease CBI Technology CBI (4a) (4b) (5) (6) (7) (8) (9) (10a) (lob) (11) (12) (13)

P] (14) -- Byproducts : (15) X Mark (X) this box if you attach a continuation sheet, 40

EPA FORM

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

## OPTIONAL POLLUTION PREVENTION INFORMATION To claiminformation in this section as confidential circle or bracket the specific information that you claimas confidential . 

### In this section you may provide information not reported elsewhere in this formregarding your efforts to reduce or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal of the PMNsubstance. 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 fromwastes 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 EPAis interested in the information to assess overall net reductions in toxicity or environmental releases and exposures, not the shifting ofrisks 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 PMNsubstance to potential alternatives maybe provided. All information provided in this section will be taken into consideration during the reviewof this substance. See Instructions Manual and Pollution Prevention Guidance manual for guidance and exam ples. 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 ofthe 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 FORM7710-25 (Rev. 5-95) Page 11p. 12 

## Part III -- LIST OF ATTACHMENTS Attach continuation sheets for sections of the formand 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 formto 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 claimas confidential . Read the Instructions Manual for guidance on how to claimany information in an attachment as confidential . You must include with the sanitized copy ofthe notice forma sanitized version of any attachment in which you claiminformation 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 ifyou attach a continuation sheet . Enter the attachment name and number .

EPA FORM

7710-25 (Rev. 5-95) Page 12p. 13 r1HxNUAL AN0 CHEMICAL PROPERTIES WORKSHEET To assist EPA's reviewof 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), andwhether 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, PMNsubstance in __) . You are not required to submit this worksheet ; however, EPAstrongly 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 number or dential provided Estimate Mark (X) (a) (b) (c) (M or E) (d) X Physical state of neat substance (s) (1) (9) - X Vapor pressure @ Tem perature 0C Torr X Density/relative density g/cm3 X Solubility @ Temperature °C Solvent g/ Solubility in water @

Temperature °C / X X Melting temperature o Boiling / sublimation temperature@ - toff pressure 0C X S p ectra X Dissociation constant 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 Adsorption / coefficient X Other - Specify X X X

EPA FORM

7710-25 (Rev. 5-95) Page 13 Replaces previous editions of EPA Form7710-25.

# Material Safety Data Sheet

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

## 1 . PRODUCT ANDCOMPANY DESCRIPTION

Emergency Phone Numbers: FOR EMERGENCIES INVOLVINGA SPILL, LEAK, FIRE, EXPOSURE ORACCIDENT ~ONTf~T: CHEMTREC (800-424-9300 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: 1p. 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 FORACCIDENTAL: Eye Exposure: Hold eyelids open and flush with a steady, gentle streamof water for at least 15 minutes . Seek medical attention. Skin Exposure: In case of contact, immediately wash with plenty of soap and water for at least 5 minutes . Seek medical attention. Remove contaminated clothing and shoes . Clean contaminated clothing and shoes before re-use. Inhalation: Inhalation is not an expected route of exposure. If respiratory irritation or distress occurs remove victimto fresh air. Seek medical attention if respiratory irritation or distress continues. Ingestion: If victim is conscious and alert, give 1-2 glasses of water to drink. Do not give anything by mouth to an unconscious person. Seek medical attention. Do not leave victimunattended . MEDICAL CONDITIONS POSSIBLY AGGRAVATED BY EXPOSURE: Skin contact may aggravate existing skin disease. NOTES TO PHYSICIAN: All treatments should be based on observed signs and symptoms of distress in the patient . Consideration should be given to the possibility that overexposure to materials other than this product may have occurred. Treat symptomatically. No specific antidote available. 

## 5. FIRE FIGHTING MEASURES FIRE HAZARD DATA

: Flash Point :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 : waterjet (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 : Followprocedure 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 bywashing 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. HANDLINGANDSTORAGE Minimum/MaximumStorage Temperatures : 10to 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, thawand remix before using. Frozen material may be thawed in a warmroom . 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 fromincompatible materials (see Section 10 . Stability and Reactivity), Expected shelf life if stored 

# 16p. 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 fromthese 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 ANDCHEMICAL PROPERTIES Physical and Chemical properties here represent typical properties of this product . Contact the business areausing 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 

# 18p. 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 CONSIDERATIONSp. 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 fromfederal 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 belowprovide 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 fromlisting. 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 fromlisting. N = Not determined or one or more ingredients are not on the inventory and are not exempt fromlisting . FEDERAL REGULATIONS Inventory Issues : All functional components of this product are listed on the TSCA Inventory. SARATitle III Hazard Classes : Fire Hazard - NO Reactive Hazard - NO Release of Pressure -NO Acute Health Hazard - YES Chronic Health Hazard - NOSTATE 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 TermExposure 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 ACL

## !TOXICITY DATA

ACUTE ORAL LDso An acute oral LD50study was conducted using 3 groups of 10 healthy albino mice each dosed once by gavage. Feed and water were provided ad-libitumafter dosing and each mouse was observed daily for mortality and other signs of gross toxicity for 5 days. The oral LDr,0was 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 MaximumMean 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) Asecond 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 MaximumMean 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) 

### AQUATICTOXICITY A static aquatic bioassay was run on fathead minnows. Tests were conducted in 1200 ml polypropylene vessels at 22° Cwith 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, DOand temperature were monitored during the study. The 24-hour EC50was determined to be 12 ppm, with a 48-hour EC50of 9.3 ppm . RP Industries, March, 1994 (Ref: PS-3536) Summary date: February 11, 2003

## PI:Q24550

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 whomit 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 000024p. 25 LEBERCO LABORATORIES ASSAY NUMBER 81971

RESULTS : Observed c 7c 11C Minus Ml . /Kilo 

### 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 N1 = 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 NEWZEALAND ALBINO RABBITS

R.D.9, PO

. Box 9021, Reading, PA 19605 (215) 378-7800

~VJ A Member of the ASTB Companies 28 ooFINAL REPORT THE PRIMARY DERMAL IRRITATION STUDY OF

AT 16$ SOLIDS AND pH 7 .0 ON ABRADED AND NONABRADED SKIN OF NEWZEALAND 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 NEWZEALAND 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 NEWZEALAND 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 9III . RESULTS

Individual scores are presented in Table II . The Primary Dermal Irritation Index is presented in Table III . IV. ORIGINAL DATA STORAGETABLE 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 0TABLE 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 

# 37p. 36 

# AMERICAN STANDARDS BISSCIENCES CORPORATION PS-2658



### FINAL REPORT

. THE EFFEJT OF pH 7 .0 10% SOLIDS ON THE EYE MUCOSA OF NEWZEALAND 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 D ATE York Terrell APPROVED BY: U UNIT Geoffrey St . E . Parke

page 1 of 8

i. _> ,rc2-s 11



### DATE



# 39 000037

### THE EFFE~T OF pH 7 .0 10% SOLIDS ON THE EYE MUCOSA OF NEWZEALAND 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 ASSUR ANCE 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 Albinorabbits . 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 . RAWDATA 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



# J pH 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 8YK13 .ti rl,r=, 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 knowthat themare no other use of the substance by Rbbae-Pouleac or us customers? There amno other uses Don't IMOWif themamOM= 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 

# 000045p. 46

TO: FROM : DATE : September 23, 1992 

### PRrvIZOc',ED AND CONFIDENTIAL ATTORNEY/CLIENTCOMMUNICATION

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 NEWZEALAND ALBINO RABBITS AT 16$ SOLIDS AND PH 7,0 ON THE EYE MUCOSA

o` '~t " ~; `-7 7~, I 

## V1nv &

6-C"-A~-

R. D.9, PO

. Box 9021, Reading, PA 19605 (215) 378-7800 

# 000047FINAL REPORT THE EFFECT OF AT 16$ SOLIDS AND PH 7,0 ~ ON THE EYE MUCOSA OF NEWZEALAND 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 10FINAL REPORT r- THE EFFECT OF AT 16$ SOLIDS AND pH 7 .0 " ON THE EYE MUCOSA OF NEWZEALAND 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 000049FINAL REPORT THE EFFECT OF AT 16% SOLIDS AND pH 7 .0 ON THE EYE MUCOSA OF NEWZEALAND 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 10C. 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 ST0RAGETABLE 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 

### 57Interpretation 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 10p. 58

PRIVILEGED AND COWIDENTIAL ATTORNEY / CLIENTC0WfUNICATION 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 -~~-~Ak - 1 yz~-- Saecned for

. ~ 8(e) - 8(d) CAP ID No.: Screener it name,\ Phone : Drvuion: Lanuon of Study Pf-S L=A PI 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 knowthat there amno other tssa o( the substance : bv RbBae

" Poukac or tu Customers? Themam11o otber tii0 - Don't hatowif them art OIDe! um The Information: -j-he attacaad tntormattoo is: - ptziimtnmdata - 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

3MENVIRONMENTAL 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 0000Fathead MinnowAcute 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 fromSCD Lab Storage : In the dark at ambient roomtemperature (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 pHof 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 000061Fathead MinnowAcute 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/LFathead MinnowAcute 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 pHvalues ranged from7.8 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 fromthe 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 fromthe data, if possible . 

# 65 000063Fathead MinnowAcute 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. OECDGuidelines 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 2Fathead 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 fromtest chambers at test terminationFathead MinnowAcute Toxicity TABLE 3

Page 7 November 13, 1996

SUMMARY OF ACUTE TOXICITY OF r_ ~(43.5% SOLN) TO FATHEAD MINNOWUNDER 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 20fish were exposed per concentration. (2) Concentration of as received sample, ') (43 .5%Soln) . 

# 69, 000067

# COPIES OF RAW DATA SHEETSp. 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 fromSCD 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 ORTALITY 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 0

8 3.1 5.0 So 0 3 ~u Y ' RN . I 3.2 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 84 - - - _

TEMP. 0C DATE / ANALYST -

_ _ -- I .S - fI $,~- 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, 100rng/L of carbon-filtered well water. Each 1 . 0mL - 0 . 1 mg. Inrtlal pH of stock solution 8.p . Initial pH of highest concentration tested 10 m g/L, 8,0, SECONDARY EFFECTS: S = Surfacing ; E = Loss of Equilibrium, Q = Quiescent ; R = Erratic Swimming; H = HemorrhagingcANALY ( 1 

# ooo0s9ENVIRONMENTAL LABORATORY PAGE / OF / 

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

~ I inl-rt~ li~n ~, 4 , J I . ~ - 0 ,0; .,; I .ff D ,nA5 -_ I .R 0 . Q~Z 2..0 a,Q2- 9 11-1 p o 1q I .'1 0, 01-1 ln, 0Alo I . It 

## 0,0519 .l.r) 1 .1 n oA'7 

### x = o .-Qa4 X= 1,~2 DATE 

### WORKSHEET ANAL 

## 25

bI1=tTR 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 Fi 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 2iD 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 TOFATHEAD 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

. BATCH96-4 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 ORTALITY 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 concentration tested, 7.1p SECOND

ARY EFFF TS S -S,115 acinnF - Loss ot Equilibrium; Q = Quiescent ; R = Erratic Swimming; H = Hemorrhaging ANALYST; ( / 

## 0000"75ENVIRONMENTAL 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,`l 9 ±~~n=~,onS .~n_to, i~p. 77 ENVIRONMENTAL LABORATORY LR 96-HR ACUTE TOXICITY TOFATHEAD 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/TESTCHAMBER: 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*) 8-1 141; z- 1911 7- 49 . L) 11 .71 ;AI ?- 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.

Initial 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 Bx 1000 mL sample where: A = mL titration for sample and B = mg CaC03 equivalent to 1 .00 mL EDTA titrant . 

### SAMPLE DESCRIPTION m L SAMPLE A(mL Titrated) RESULT, m g /Las CaC03 COMMENT ~k /"arrf_i~l~_ - _ _ L.S-- - - - io, 9 'S _ -21y?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~vllcd`C eo~cb/HCv' . L-~ ~3r58 A 

# 84 

# 000082ENVIRONMENTAL 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 Nx 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. /OUM,(, 4vwi PdCff (J'u~~f Co~



## 000083p. 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 = 2s, n °C, C = J, OG Standard Solution Used: 80~oi Conductivity Calculations: 'E-<f3Z

K=(Km)(C)/1 +0 .0191 (t-25) Where: K = Conductivity, 4mhos/cm ; Km = measured conductivity, 4mhos/cmat 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: 

# 8G) 

# 000084

# ENVIRONMENTAL FATE INFORMATION

Primary Bio gradability

~is biodegraded 58.5%using the BODsICOD test. The 5day 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 mediumwas prepared using acclimated inoculant froman 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 15days and 90%in 20 days. Solutions of 20ppmof test material were prepared using samples ofwater froma river that has biological activity. Ref: EF-135 Ready Biodegradability _ Using the Modified OECDScreening Test ;,- ~degraded 38.9%over 28 days. This is an open shake-flask test which measures the degree of biodegradation by DOCanalysis. Chemicals which reach 70%or greater loss of DOCwithin 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 degradationwas 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%(28days) . Ref: EF-134 .- -,

Summary Date: August 4, 1997p. 86 EF-0135 

# T

` .. C1-TI 1 10I 1 IN

# C.-',~~ ~ A°R ;2.6 A" y U7 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 1 7 BOD/COD Method : BOD Mg BOD1~0 Mg COD mg BODS BOD 02/kg-~ 02/Kg** 02/kg* COD COD10 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 Date Received - 04-12-93

_ - - i

- 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/ieaf' ` JJ ~I (~ 

# ECM environmental compliance monitoring

October 10, 1989 p 90 EF-0134



### r..Analysis of-the three samples identified asoand

^eceived September 5, 1989 has~een 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, NewJersey 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 

# ECMp. 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 

# ECM 95p. 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 WhomIt 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 IromFrench into English . We certify that the attached English translation conforms essentially to the original French language.

KimVitray Operatinns Manager Subscribed and sworn to before rne this `_ day of -, 2003. 2 ; ti., . .o. TINA WUELFiNG \J ~ .'~ Notary Pubhc, State of Texas ---

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 fromFrench by the Ralph McElroy Translation Company 910West Avenue, Austin, Texas 78701 USA 

# 98 oo00-9+s

### T/SE/MES/ECOTOXICOLOGY

EVALUATION OF THE "POTENTIAL FINAL" AEROBIC BIODEGRADABILITY IN AQUEOUS MEDIUM OF

, ACCORDINGTO DIRECTIVE 133/99 PUBLISHED 1N THE OFFICIAL JOURNAL OF

EUROPEANCOMMUNITIES ON MAY 30, 1988

(ZAHNANDWELLENS TEST) Measurements ofDissolved 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 Proofof Quality Assurance TITLE OF THE STUDY : Evaluation ofthe "potential final" aerobic biodegradability in aqueous mediumof: 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 rep ort Dates ofreceipt of the audit report by: Director of the stud Director ofinstallation 

### 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 AO004 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 ofstorage: 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 formof a~ The product is miscible with water at room temperature. 

### 1 .3 Goal ofthe study To evaluate the "final" biodegradability of[ -j that is the level ofbiodegradation 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: fromOctober 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 - CONDUCTINGTHE STUDY 2 .1 Principle of the method The activated sludge and the test mediumwere 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 formof bariumcarbonate. 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 DOCat the beginning and at the end ofthe 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 < 4mg/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 roomtemperature (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 ofthe 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 300mg/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 300mg/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 oforganic carbon of 300mg/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 °Cand 22.6°C. 2.4.5 Components ofthe 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 oftest 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 oftest 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 fromall 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 DOCconcentration. The measurement of the DOCwas carried out on the supernatant of a sample (approximately 6mL) of test solutions, centrifuged for 20 min at 6000 rpm and at 6°C. The DOCwas 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 bariumoxide flasks was measured after visual estimation of the amount of precipitate formed, in comparison with the traps located downstreamin 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 ANDEXPRESSION OF THE RESULTS 3.1 Calculation of the concentrations of dissolved organic carbon In the FE, FC and FI containers, the concentrations ofdissolved 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 FE1 or FE2, FC and FI at time t. DOCFBIt: Concentration of Dissolved Organic Carbon in mg/kg in test container FB1 at time t. DOCFB2t : Concentration of Dissolved Organic Carbon in mg/kg in test container FB2 at time t. In container FAthe 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 FAat 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 = CXPX 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 tot - C02FBto tot)/COZT] x 100 C02 F to to t: Total amount of carbon dioxide expressed in mg, released in each test container FE, Fl and FCbetween the start of the incubation to and time t. COZFBroto 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 tot: 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 ofthe 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 C02released 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 p ercentag e 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

_ C02dans (FBI +FB~l 2 C02dans

FE1 C02darls

FE2(Z C02darts

FC Q) C02dans

F1 

## O C02dans



### 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

ofthe 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 C02expected (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 CODmesur6 CODmesurd 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 DOCmeasured in mg/L at time zero 3 DOCmeasured 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 0Ea a a w 0 O . FC



## FA 1-4 5 10 15 20 25 30 3 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 inhibitionCERTIFICATE 

## 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 ICRCirNthtIE (°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 allowfor (-'02 measuretttcnts during the test . The biode&r-adation was calculated ftomthe 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 inoculumactivity 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 23days. - On the basis of these Tcsults, the in tbix inherent text- 3i4 considered as totally hiodcRradablc 

### Ref . : Crit-Decines - Evaluation of the "final potential" aerobic biodegradation of the~

~- Report ofstudy B 93 - March23, 1995

### [box] Laboratory accredited by the National Network of Tests under No. 51 .87/01 [logo]

T/SE/MES/ECOTOXICOLOGY DETERMINATIONOF THE ACUTE ECOTOXICITYAFTER24 HOURS AND48 HOURS OF EXPOSURE OF WITH RESPECT TODaphnia magna ACCORDINGTOTHE METHOD PUBLISHED IN THE OFFICIAL JOURNAL OF

EUROPEAN COMMUNITIES ON DECEMBER29, 1992

(STATISTICAL TEST) REPORT OF STUDY D218 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 formof 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 D218 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: D218p. 115 19 Audited and dated _phases Date of the audit rep ort Dates ofreceipt of the audit report by: Director ofthe 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 AO004 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 Vert le Petit), originating fromthe 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 37/1993p. 116

### 20

Site and conditions ofstorage: at room temperature, in ventilated cupboard (Office 111, building M 26) reserved for products in studies. Properties: The product in its commercial formis 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 ofthe 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 50-24or 48 h. The concentrations are expressed in ppm(weight/weight) . The test was conducted in twosteps: - a preliminary test designed to give an approximate indication of the EC50and 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 ofthe 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 000116p. 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 100ppm(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 ofthe test solutions are expressed in ppm(weight/weight) . At the end ofthe 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 testp. 118 

## CERTIFICATE OF ANALYSIS MAIL TO



## r

;Ac+aCT ~:C6Fa~ '.9T^flERP!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 LOth0

. ,. J FINAL PRODUCT ANALYSIS



### 1101401

### [box] Laboratory accredited by the National Network ofTests under No. 51 .87/01

T/SE/MES/ECOTOXICOLOGY APPENDIX 1 TOREPORT D218

DETERMINATIONOF THE ACUTE ECOTOXICITY AFTER24 HOURS OF EXPOSURE OF POTASSIUM

DICHROMATE (reference product) WITH RESPECT TODaphnia magna ACCORDINGTOTHE METHOD PUBLISHED IN THE OFFICIAL JOURNAL OF

EUROPEAN COMMUNITIES ON DECEMBER 29, 1992

Report of Study D225 (reference study for study D218) 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 formof 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 D225 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, IRCHAstrain - Research center - BP 1 - 91710Vert le Petit), originating fromthe rearing ofthe Ecotoxicology Laboratory of CRIT/D by determination of the acute toxicity of the reference product: potassium dichromate. 1 .3 Product studied Potassiumdichromate, RP Normapur, Prolabo, lot 90002, stored in the laboratory at room temperature. 1 .4 Schedule ofthe study test starts December 8, 1993 ends December 9, 1993 

# iz0 000120p. 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 - CONDUCTINGTHE STUDY 2.1 Principle Determination of the initial concentrations ofthe 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 ofanalytical 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 p11p. 122

### 30

The test medium

was aerated with compressed air. At the time of its use, its pHwas 8.0 at 21 °C, and its oxygen concentration at 100%saturation. 2.3 Test solutions

- A potassiumdichromate solution was prepared at 100 ppm (weight/weight) in double-distilled water . 

### - Asolution 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 fromCRIT/D . 2.4 Test containers The test was carried out in 100-mL Pyrex beakers. 2.5 Environment ofthe 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 conformto the conditions (temperature between 18°Cand 22°C at f1 °C) required by the test method. The incubation was done in the dark. 2.6 Progress of the test 9test 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 oftest medium(2.2.3) into another test container (control container) . 20daphnia 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 000122p. 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 potassiumdichromate and its 95% confidence limits were determined by the probit method (original software fromC . 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 potassiumdichromate (reference product) on daphnia (Daphnia magna) originating fromthe rearing ofthe 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 : potassiumdichromate 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 J I I 1 1 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 CONFIDENTIAL BUSINESS INFORMATION 

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# 0003 .25 Pages 127 - 134