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## CERTIFICAllON
I , 

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## tor purpaaee wtthiD 1,

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### of

### the

### ecpit'IIdaa 

### gfthe

30**day~period.** 

### ' '



# . '

"



## ,....

## Part I - GENERAL INFORMAnON COllfi­ 

### Section A
M**Su~g _~s;.;u~**  

## ________ ____________**~~** 

## ________________________ _____ - SUBMIt!ER IDENI'IfICAllON dential liL Person Notioe (In 

## u.s.)
Cty, Si:ate. ZIP Code 

### Henderson, NV 89015 Name ofauthorized. official b. Agent (If applicable)

Oty,

(!. Uyou 11ftsumiUtt:Ing tIWI 

### nottce.pertofajcUlt

### subm.l.akm. mark 00**~** Jolat Name 

### of aulh«Jzedolftdal Submitter

# ~~cab~**-C~;;--~--------------~~~--------------------~-------** Malling ad.drIIi (number and street) aty, State, ZIP CQde 

## ,­ 2. Technical Name Contact 

### Dr. George S. 

## an U.s.) Company 

### Regulatory**Assista~ce** 

### Corporation MailIng addrtII (numbes: and meet) 

### 17 C1earview Circle Oly/State,. ZIP**~** 

### Hopewell Junction, New York 

### 12533

Mark 00 

# --....... fiJ IlDOM. 5. Uyou havesubmitted • notiCe of

### Boaa fide Intentto 

### manufacture or Import for the chemh::allUbetaDce 

### covenct by thJa notICIe, 

### entli: the notice number aaalgnect. byEPA. " .... i. TypeoiNotice-MarkOO '1. 

# D =ufacture 2.

# D'~ Option 

# D 'Va1ence Inc.

Telephoae I I bolL**-.-;..--.------------:::~** PoRtioa \

Telephone PoRtion



### President

Ifyouhave had a

### prenot:lce,c:ammuDicati.aa (PC) COl\cmUngtIWI notke and EPA assigned a PC N\pII.ber to the

### lUIdce. mtar the number. ' Te1epbaae I I' 

### 845 ' 

### 896-4340

FORM EPA 7J1O.2S (Rev. 5-95)

## Part I - GENERAL INFORMATION
- Continued S ti ' 

### B r-'U'"l:n.

### rrCAL IDt::1II.l'T"I"'I"V INFORMATION You 

### m .. provide II c:un'IJlI.tly comtCt QIemkal Abltrada (CA) !ImIiI of the 

### subetllnce 

### ec on - '-4l.J:O.I.'V.u. loa" ... U. I
. : based on the nlnthConedive Index (9(l) of CAnomiInclatun ruleund conventioN. item you claim as Cctmplete eitheritem 1 (ClaM 1 or 1ltlbllances) or 1 (Polymers) 

## a. appropriate. Complete an other item.. Ifanother

### person will submit chemicalidentity information for you (lor either item 1or 2), mark 00 the box at the risJ:!t. address of that ' ..... 1. 

### eta.. 1 or 1 chemicaisubmncel (for

### definitions ofclass 1 and class 2 substano!s, see theIn.truc:tloD. ManWll) a. Class of substance Mark 00 1 

# 0 Oass 1 

## or 2 

# 0 au. 2 . b. Otemicalname**(C~tly** correct OtemicalAbstrac:ts (CA) Name that is consistent with TSCA Inventory listings for IIimilar sublstan,Q:1S. For Class 1 substances a CA Index Name must be provided. For Case 2 substances either a CA Index Name or CA Preferred Name be provided, whichever is appropriate buedon CA 9Cnomenclature rules and conventions.). '

c. Please identify which method you

## usea to deVelOp 01' obtain the spedfled.chemicalindentityinformaUoo reported. in thia notice:

(check oneh . 

## [!] Method 1 (CAS InventcryExpert Service
- a copy of the Identifk:atlon 

# OMethod 2 (Other Source) report obtained &om the CAS Inventory Expert Service IlWItbe submitted as an attechment to thiI notice) d.. Mo1ecul4r formula and CAS Registry Number (ifa number already exUbI for the II.lbetmce)

e. Po.. a cluI1 sublltance, provide a COQ\plete andcorrect.cbemic:al strudurediagram. For a clue2aubltance
- (1) u.t the immediate

precurscr sub8tanc:ea withtheir respectlve CAS Registry Numbca. (2) DeIcribe the.tureofthe 

### r-=tt.aa or**pr~** (3) Ind.kate the range ofoompoilltlon and. the typical campoilltion (whereapp.ropriate). (4) Providea cmrectrep:_tatlveor partlal chemical strud:ure diagram, as COIJ'I'pleie .. can be known.Jforie can bef'IIUCIIably ac:ertIIined.



### Mark (X) thls box if you attach a FORM EPA 771()"1S . 

### <RaY. 5-95) Pap.

# I Part I - GENERAL INFORMAnON
­ 

## Continued

## ~ Section B - CHEMICAL IDENTITY INFORMATION
- Continued 2.**Pol~mers** (Fo: a definition ofpolymer, see the Instruction. Manual) Confidential a. Indicate the number-average weight ofthe lowest molecular Weight compoetion of the polymer you intend tomanufacture.

. Indicate maximum Weight percent oflowmolecular weight species (not induding residual monomers, reactanbl, or solvents) below

SOO and below 1,000 absolute molecular weight ofthat composition. 

# • Describe the method. ofmeUUl'ement orthe basil for youre.timatea: GPC 

# 0 OtherD : (SpecIfy) I) lowest number average moI8(Ularweight: til maximum weight '!Io below 500 molecular weight tiD maximum weight'!lo below 1000 molecular weight 

# o Mark (X) this box ifyou attach a continuation sheet.

b. You mustmake separate confidentiality daimsfor monomer orotherreactant identity, composition information, and residual information. Mark (X) the "Confidential" box next to anyitem you daim as confidential. (1)
- Provide the specific chemical name and CAS Registry Number (ifa number exists)·of each monomer or other reactant usedin the 

# • manufacture of thepolymer. . . (2)
- Mark (X) thiscolumn ifentry in column (1) isconfidential (3)
- Indicate the typical weight perc:ent of each monomer orotherreactant in the polymer. (4)
- Mark (X) the identity column If you want. monomer or other reactaDtlured at two weightpercent or leuto be IDted

# a. partofthe polymer de.crlptioD on the TSCA Chemical Sublltance Inventory. (5)
- Mark (X) thiscolumn ifentries in colWlUll (3) and (4) area:mfidentlal. . (6)
­ Indicate the l1'IUimum weight perc:ent ofeach mOJ)omer or other reactant that may be present u • residualin thepolymer as manufactured for commerdal 

### pu.rpoaes. (1)
- Mark (X) this column if entry in column (6) is' confidential Monomer or otherreactant andCAS Registry Number Coa1I­ 

### Typical Identity Coaft. Maximum 

# =. dmtial Mark00 dmtial residual (1) (2) '(3) (4) (5) (6) • (7) 

# " " ." ." 

# " " 

# " 

# " 

# " "


# .. GI!. 

# " " 

# o Mark (X) thisbox ifyouattach a continuatiaiillheet. Co Please Identify which method you uaedtodMopor obtaID theapedfled chemic:ll identity Informatfi:m reported in thie notke. (check one). 

# . o Method 1 (CAS Inventory

# = Service**~** a copy ofthe idenI:lflcatklD report 

# 0 Method 2 (otbar SIOUlC8) . obtained from Inventory Expert Service mUllt be IUI:Imittedas . I-­ an attachmmt to thia notice)

d. The currently c:otTect OtemicalAbstracts (00name for the polymerthat Is conaiItent with TSCA Inventory lIstfngs for!dmilar polymera.

e. Provide a correct representative or partial chem1cal structurediagram. u complete ..can be known. if OMcan be reasoI\Ilbly .....tainecL



# -


# .

, 

# o Mark

# 00 thisbox if you attach a continuaticm sheet. Page 5 

# . FORM EPA 771 (}.2S (Rev.5-95)

## Part I - GENERAL INFORMATION- Continued**~.** Section B - CHEMICAL IDENTITY INFORMATION
- Continued 3. IrnPllrltla

(al...., Identify e.adl implUity tllat may be _ubI,. anltdp;lted to be pnseat In tile chemiCIIl1lbltaaa! •**_~** for Q)1BJII.erc:i.al P1UpOMI.

. Providethe CAS Kep.uy NlUIlber If &Yallable. .IftIIel'e _wei_tified Irnpmlfet.eater "uldC!lltl.fied.· (b)**-EatlDl~** 

### u..e maxim.1UIl weipt 'Jro ofeada Implldty. If there_uid_tIfied iDlpmu.,eItbuletheirtotal weialll'Jro, Maximum Impurity and CAS Registry Number CoDfI.. percent dentlaJ. (a) (b) 

# X " % % 

# " % " I·

..

# ­ 

# " 

# o Mark (X) this box ifyouattach • amtinuallon sheet. 4. Synonym.
- 

### Enter any chemI.cal synQl'l)'DII for thenew dlemical subetancekle.ntiBed.1n subIed1Q1'1l (]I'l. 

# . 

# :1 

# o Mark (X) this box ifyou attacb • amtinuatkm sheet. 5, Trade W_tiB.catiQl'l
- Uat trId.e namesfor theflew IUllet.mce klenti8ad ill lOll. 

# o Mark 

### 00 this box if you attadl • c:ontinuatiQl'l sheet. 6. Generic dlemical name - Uyou claim dlem1calld.entity .. 

### CCIIIfldeDIiai. you anutprovide• pnerkchemical namefor your substance

. that l1MI8Ia the spectfk: dlemblidentityof thenew chemical subItance In the maXimum extent poaaible. Refer In theTSCA QemicalSubstlmcelnwnlDr}', 1985 Edltkla, AppmdtxBfor guidance QI'I**~elDplnlJ.** genericnames.. . 

# . Lithium Metal Phosphate 

# 0 Mark 00 thisbox if you attach • amtinuallClli sheet. 7. Byprodlldl-- an,. ;.'" reIUltIng frc:m the mmu.fllcture, proc:esIing, UI!Iet (]I' ofthenew chemiallsubItanc:a Provld.e CAS n '. Ifavailable. .**.~-.** CAS RepayNum_ Byproduct Conti· clenijal (2) 0> 

# -. 

# X .)«

, 

# b{ 0

. Mark

### 00 tlWI box If**yo~** attacb a amtinuatioa sheet.

... FORM EPA mO-25 (Key,5-95) Pap

### 6

## Part I - GENERAL INFORMAnON
­ 

## Continued**~** 

### SectionC - PRODUCTION, Il\iPORT, AND USE INFORMATION: Mark 00 the "Confidentiar box next to any item you dalm as confidential. . L Production volume
- Estimate the maximum production volume during the first 12 months ofproduction. Also estimate the maximum production volume £arany consecutive 12-month period during the first three years ofproduction. Estimates should beon 100% new chemical substance basis. For a Low Volume Exemption application, 

### ifyou choose to have your noticereviewed at a lower product?-on volume than 10,000 kg/yr, specify the volume and mark (x) in thebinding box. 

### Ifgranted, you are bound to this volume. Maximumfirst 12-monthproduction (kg/yr) Maximum 12-month production 

### (kg/yr) Confi.. lbadfq dentlal Optioa (100% new chemical substance basis) (100% newchemical substance basis) MakW 

# J><

2. Use. Information
- You must makeseparate confidentiality

# claims for the deeaiption of thecategory ofuse, the percent ofpfodUdion volume devoted to each category, theformulatlcm of the new substance, and other use lnfarmatlOil. Mark00 the "Confidential" Box nextto any itemyou claim as oonfidentl.al. a. (1)
- Desatbe each intendedcategory Of use ofthenewc:he.mkal substance by fund10n and application. (2)
- Mark 00 this column ifentry incoJumnO) Is confidential busin_**~tiOll** (CBI). (3)
­ Indicate

# your**wlllin~** 10 have the information providedIn colUDID

# m btncUng. (4)
- Estlmate thepercent 

### c:ttotal produdioa for the first three}'8UI devoted Io..ch of WIll. (5)
­ Mark 00 this cohmin ifentry

### 'in colUDID (4) II confidential bustn_information ( . (6)
­ Estimate thepercent ofthe new subatanceas formulated inmixturel, su.spenIiona, emullliana, IIOlutlona, or**g~**

. as manufactured. for commerdal purposes at sites under your contnll..,..t·tedwUh each category of WIll.



# m- Marlc: 00this column ifentry in column (6) Is confidential busin_information (CBl). . . (8)
- IncUcate I)(, ofproductvolume expected for the Uated.**~UM"IIdcn.** Markmore than OMbox if 

### appoprlJite. Mark 

## . (X) to indicate your willlnsn_1ohave theuse type provided In (8) 

### bIncfIns. (9)
- Marlc: 00 this column ifent:ry6es) incolumn (8) Is (are) caa.6d.entlal buslneallnformatiOll (CBI). Category of use (1) 

### em Blacliq Procb:IIC<­ CBI I)(, In CBI " ofsubltance expectedper use**~I** (byfunction and application ie. a dispeniw dyefor 0pti0II tion I)(, Form.­ (8) MMk6rl uladon finishing polyester flben) Istte­ 

### 1Uln-· lnc:b»- Com­**~iDdiDl** (2) (3) (4) (5) (6) (7) llmited 1!UD\eS' trial merdal Optkm (9) 

# D< 9r. 

# lX % 

# X 1)<**~** % 

# [X %

# X 

# X 9r. % % 9r. .. 

# . % 9r.

- % 9r.

., 9r. 9r. 

### ·Ifyou haveidentified, a**"consumer~** U8e, pleuepmvideon a continuation 

### sheet a detaned description 

### ofthe use(s) ofthis 

### chemiCal substance in consumer products. 

### Inaddition include eatimatet

### oftheconcentration 

### ofthe

## new chemical substance as expected in consumer products and describe the chemical reactions 

### by which this 

### .ubstance

### loies it.identityinthe consumer product. 

# o Mark 00 this box ifyou attach a COIItinWll:iOll ebeet. b. Generic Ifyou claim 

# .:l category ofusedllatptlCa lD IUbIed:Iort 2a
.. 

### ClXlfldential" en_a geMri.c cIeIcriptkIa ofthat use category. the IDltI'IlctloD. Mamaal for exampl_of pncicUII
. de!lcription 

# . Electrode material

.. 

# o Mark OOtlUa box ifyouattadlacmdnuat1cnllheet. 3. 

### Huud Informatloll- Induct. Inthe l'lOIica a copy ofnIIIClNbIe facIdmile ollllYhuudWIl'DIng sbItaneIIt" 

### label. matariallafety data

### eheet.

or other Infcnnatkla which will be

# = 10 Illy perDl whoIs reuoaably Ilbly 10 be expceed 10 1:hia!lUbttanc:e regarding protective 

# n equipment or practic=- for the ufe transport. WIe. ordJapoeal ofthe new subetanc& 

### u.tIn

### pmm 

### hazard.1nformati9n you indude.



### . IMar!( 00 thiabox if YOU attach hazard • .. . FORM EPA 1710-25 (Rev. 5-95) 

# .Pa.'

## Part II ...;. HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE UllnttaerlllLa.t boxlIext to any item you Complete section A for each type ofmanufacture, proceuing, orUM operation involving the new chemicalsubltaDce at industrlal Rtel you control.**Impo~eft** do not have 10 complete thia .ection for opel'lltion. ou.tlide the V.S. ; however, you may .a.Uhavereporting requirement. ifthere are

b. Type..,.

Mark (X) 

# o Manufactw:tng 

# o Use further indu.trt.il proceuing or UM OP8l'lltion. after import. You mUlt deacribe theM opel'lltionL See inatraction. manual. of the site at which the willoo:ur.

SUe address atld City, County, State. ZIP Code If the sameoperation will occur atmore than one site, enter the number of sites. Identify the

. addlti.onal sites on a continuation sheet, and ifany ofthe sites have significantly different . .,... produCition rates or operations, include all the Information requested.in this eed:Ion for those 

### attach. sheet:

1. Batch HOUl"I/day

(1) Diagram themajor unitoperation stepe and chemical a:mYC'IIclIIL Includeinterim storage andtransportcontainel'll (tpe!d.fy-e.g. 5 gallon pails, 55

. gallon drum, 

### ran car, tank truck,' etc). . . .' ' (2) Provide the identity, the approximate weigtlt (by kg! day or kg/batch on • 100" newchemic:al1Ubltancebasis), andentrypoint ofan starling materials andfeedstoclaI (indud:lngreaclanlll.lOlvents,. and catalyats, etc), and01 an produd:II, rtcydeIII:reIIn18. and wutes. Indude cleaning chemicals (nolie frequency ifnot used daily or per batch.). (3) Identify by number the points of release, including

### JINll orinte:nrdltant rei..., 10 theenvironmentofthe newchemical substance.



# o Mark 

### 00 thisbox ifyou attach. conttnUllica\ sheet. FORM EPA 1710-25 (Rev. 5-95) PageS

# I Part II
- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
- Continued**~** Section A ­ INDUSTRIAL SITES CONTROLLED BY THE SUBMI 11EK
­ Continued 2. Occupational Expoeu.re
­ You must make separate oonfidentiality cla.ima for the description of worker activity, physical form ofthe new chemical substance, number of workers expoeed. andduration ofactivity. Mark 00 the ·Confidential" boxnext to any item you claim as confident1al. (1)
­ Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) Inwhich workers may be exposed to the substance. (2)
­ Mark 00 thia column ifentry in oolumn (1) is oonfidential businesainformation (CBD. (3)
­ Describe an)! protectiveequipment andengineering controls used to protect workers. (4) and (6)
- Indlcate you wUlingnessto have the in.fprmation provided. in ooiumn (3) or (5) binding. (5)
- Indlcate thephysical formes) and new chem1calsubstance (if In mixture)of the new chemical substance at the time of exposure (i.e., solJd: crystal, granule, powder, or dust) and 'lI. new chemical substance (if Inmixture). . .' (!) ­ Mark (X) thia column ifentry in column (5) is confidential businessinformation (CBD. (8) -- Estimate the lllIIXimum number of workers involved. in eac:h activity for all sites combined.. (9) ­ Mark (X) thia column ifentry incolumn (8) is oonfidential business information (CBD. (10) and (11)
­ Estimate the maximUlnduration

# o!. actiY.'!r for any worker In hours per day anddays J)eJ' year. (12)
­ Mark (X) thia column ifentries in columns \10J and \11J are oonfident1al business information CBb. Worker activity , CBl Protective Equipu1entl BlDdla, Physical formes BtAclIal CDI . #I of (i.e.. bag dumping, filling drums) EngineuinaControia Optioa and" new Optioa Worken CBt MaximUll duratioit CDI**~/day** Days/yr Mark W substance Mark W Expoaed (1) (2) (3) (4) (5) (6) 

## m (8) (9) (10) (11) (12)



# o Mark 00 thia box ifyou attach a oontinuatlon sheaL 

# X 3. En'VirODmental 'R.eleue and DUpoai- YoumUltmakeseparate c:anfldentlality cIaiIM fcx the releue numba' and. the amowItofthe

## new c:llemlal substancereleased. and other releaM I1'Id. dtIpoeallnformatlon. Mark 00 the ·Con.fldentlal* box next to e.c:b item you cl.aim • confidential. (1)**~** 

### Enter thenumber of each releaM pciDt identlfled.ln the clelc:r.l.ption., partII. sec:tioD A. subeectian Id(3).

. (2)
- Estimate the IIIl\01DI.t of the substance releued (a) directly tothe envtraamer\t 01' (b)into amtroltechnology (Inkg/day oi:'**~/bIltc.h)** •

. (3)
- Mark 00 this column if entries In colUXlUl8 (1) and a) are cxmfldential 'butdJ:ieiN tnrormatlon (CBI). (4)
- Idenlify tbemed1a (stackair, fugitlve air (optional-eee InItructIon Manual), Niacawater, OIHlteOl' off-efte!aDd or Inc:ineratlan. 

### P01W, or

. other (specify» towhich the new substance w111·be releuedfroiD that rel
.... pc:Ud.
. . (5) - a. Desa:ibe coittrol technology, ifany,,and amtrol ef8dencythat

## wm be used tolimit the r..... ofthenewsubltance to theenvirOnment. For releuesdisposed. ofon land, charac:teri.ze the dJspoIIal methodandstate wbetber it is approved. tOl' dispoeal 01 RCRA hazardous waite. On a continuation sheet , for each site desaibe any additional dispoIIal methods that wIJl beusedand whether the waateis subject to secondary or tertiaryOIHIlte tre8tmerlt. 

### J:I. BttImate the amount released totheenvironment after oontrol technology (Inkg/day). (6)
- Mark 00 this column ifentries IncolUDll'lS (4) and (S) areoonfidentialbullDel!llllnfonnatlan (CBI). (!) - ldenlify the destlnlltlon(s) 01releueI to waWr'. PIeQe supplyNPOPS (Naliollal Pollutant DIIcbarge EHm1natIon SystEm) numbers fcx d1rect

. dischargers 01' NPDPS numbers01 tbePOIW (PubUdy 0wDed Tre8lm.cltWorb). Mark (X) ifthePOIW DameorNPDPS • is confidential businese information (CBn. . Release AmoUnt ofnewsubetance Number _t. (l)**~** (2b) CBI**I:~** Control techDology and. efflc:ilN:y (youmay wiab to optianaIly attach effidenc:ydata) CBI**~~*****T~** . (3) (4) (Sa) , : Wadt(x) (Sb) (6)

t I . I
(7) Mark (X) the 

# 0 Porwprovicle name(s)below: 

# 0 NavIpbJe destlnatkm(s) 01 ,...-­ waterway 

# o Other - Specify provide 

### NPDES. CBI releases to water. 

# o Mark 00 thisbox ifyou attach a continuation sheet. 

# x FORM EPA 771()'2S (Rev. 5-95) Pllgd

## Part II
- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
- Continued • Section B ­ INDUSTRIAL SITES CONTROLLED BY OTIfERS Complete section Bfor typical processing Or use operations involving the new chemical substance at sites you do not oontrol. Optional for typical manufacturlnJ or processing oper!'ltions involving the new chemical substance at sites outside the U.s. that you do not control-see Instructions Manual Complete a separate section Bfor ea= ofprocessing, or use operation**invo1~** thenew chemical substance. Uthe same operation Is performed atmore than one site desc:ribe the cal operation common to these sites. Iden additional sites on a continUation sheet. Optional for sites outside the United States.- See Instructions Manu8L 1. Operation DelCl'il?tion
- To claim information in this section as confidential. dl'cle or braclcet the sped.f.k: information that you claim IIconB.dentIaL (l)
.... 

## Diagram the major unitoperation stepand chemical conversions, including interim storage andtransport containers (spec:l.fy-5 gallon pails, 55 gallon diums, rail cars, tank trucb, etc). On the diagram. identify byletter and. briefly describe each worker activity. (2)
­ Provide the identity, the approximate weight (by kglday or kg/batcll. l00'lli new chemical substance basis), andentry point ofallfeedstoc:ks (includingreactants, solvents andcatal}'llts, etc) and of allproducts, recycle streams, and wastes. Include deanlng chemicals (note

### frequency Ifnot used. daily orper batch). (3)
­ Identify by number the points ofrelease, including smaJl orintermittent releases, to the environment ofthe new chemical substance.
. Enter

### t of sUet



### .



# . 

# o Mark 

### 00 tbja. box iiyou attach •

## ~tinuali<m sheet. 1.**WCll'kIr~_ta11l1l** .... (1)
­ Fromthe cilagrmnbov .. pIOVIde the letter for each worka' dvity. Complete 2-8 for each worker ac:tlvtty deec:ribed. (2)
- Fatimate the number ofworkenI expoeed.forall

## _lies amblned.
. (4) -Esl:bDatethe typicaldUl'llllcn 01 expoaure perwtll'ka' In (a)houri perday ad (b) dayI per yee. (6)
- Deaaibe ph,...callorm ofexposure and. 'lIi DJ!W c:hemtcalllUbllance (Ifinmixture), and. anyprotective equipment and. engineering controls, Ifany used to.prolact worbnL . . (7)- Fatimate thepercent 01 the newsubetulce _formulated when pecbgecIor UIIed II. ftnal'prod:uct. (9) ­ From the diagram above, enter the number ofeadlreleuepoint. Complete9-13 for -=b releIIe

### pcmt identified. (10)
­ Estimate the amount oJ. the newsubstancereJ.eued. (a) direc:dy to the mvironment ell.' (b) intocontrol technology to the envlronment

. (in kg/day orkg/batch). •.. . (12)
- DeaaibeU'Mldia ofrei
... (staclC air, fusitlw 

### m (optional-BeeInstrw::t:tcas Manu.J), surface W1lter, 0l'Hite ell.' olf-site land. 01'indneratl.on, P01W, orother (sped.fy» and. CQIltrol 

### technolOgy, Ifany, that

### wm be used. to Umit the releIIe01 the new II1.1bstanceto'theenvlronment. (14)
­ Identify byproducta which mayresult &am the operatiCll'l. . . (3), (5), (8), (11), (13) and (15). Mark 

### 00 this 

### CXIluDm if my01 theproceeding IIftI:rleI arecaafidential buIdneIIinformal1oa (CBl).

. Letter 'of CBI Duratloa CBI Protd.veEquip. 

### I

## ~~~ CBI 

## .rw... Amount of CBI Control CBI of Worken 01 Ji.aglDeeriDg 

### Contro1al 

### Number New Tedmology Act- Expoaed. Expcwre Pb}'licalFarmIDd " ulal10n SubttmCllt lvity DeW IIUbItII'IcI RAiIeaIed I 001) : (1Ob) 0) (2) (3) (4a) I C4b} (5) (6) (7) (8) (9) 01 (12) (13) 

# : I I I I I 

## • I I I 

### I· I I


# . I I 

# :**~** I 

### t I 

### I I 

# . I (14)
­ Byproduc:ts: (15) 

# o Mark (X) this box ifyou attach a continuation sheet. 

### FORM EPA mo.2S (Rev. 5-95) 

### Pap10 .

## OPTIONAL POLLUTION PREVENTION INFORMAnON To claim information inthis section as confidential circle orbraclcetthe specific information that you claim as confidential. 

## In 

## this section you may provide information not reported elsewhere in this fofll,. regarding your efforts toreduce or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal of the P!dN substance. Please include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes orproducts available due to the new chemical substance. Source reduction includes the reductionin the amount or toxicity ofchemical wastes by technological ' modification, process and procedure modification, product reformulation, raw materials substitutionJ 

## and/orinventory control. Recycling refers to the reclamation.ofuseful chemical components from wastes that would otherwise

## be treated or released as air emissions or water discharges, orland disposal. DescriptionS of pollution prevention, source reduction and recycling should emphasize potential risk reduction subsequent to compliance with existing regulatory requirements and can

## beeither quantitative or qualitative. The EPA is interested in this information to assess overall net reductions in toxicity orenvironmental releases and exposures, not the shifting of risks to other environmental med.iaor non-environmental areas <e.g., occupational or consumer exposure). In 

## addition, informationontherelative cost or performance characteristics of the PMN substance to potential alternatives may 

## be provided. 

## All information provided in this section 

## wlll be 

## taken into consideration during the review ofthis substance. See Instructions Manualand Pollution Prevention Guidance manual for
. 

## guidance and examples. .Describe tbe 

### expected net benefits, such Ii (1) an overall rec:luction inriskto humanhealth or

### the environment; (2.) a rec:lUdion 

### in thevolumemanufactured; (3) a rec:luction 

### in the generation 

### ofwaste materials through 

### recycling.. soun:e rec:luction or other meanSi (4) a reduction'in potential toxicity 

### athuman 

### expoeure and/or envtrorunental reieue; (5) an 

### inaeue inproduct performance, a decreasein the cost ofproduction and/or improved operation

### efficiency of

### the neW cbemical substance in comparisonto existingchemical substancesused in simi1ar applkatiol\l; or (6) 

### the extent

### to which

### tbe new cbemical substarice may bea substitute for an existing substancethat poses a greateroverall riskto human health ortheenvironment.



# .

.

-

• 

# ·0 Mark (X) this 

### boX if you attach a continuation sheeL 

# '.

Palin- 

## Part III
- LIST OF ATIACHMENTS
'. Attach continuation sheets for !ledions ofthe form and lest data andother data (includingphysical/chemiC:aJ. properties and structure/ac:tivity information), and optional Information after this

### page. Oearlyidentify the attachmentand the Hdion ofthe form 10 whichitrelatel$, ifappropriate. Number consecutively the pages ofthe attadunents. In the columnbelow, enter theinclWII.ve 

### page numbers ofeach attachment. . . Marlc (X) the "Confidenlial8 box next to any attachmentname youdalm asconfidential. Read the IMtracticxl. Mamlai fer guidance on how to daimanyinformation In an attachment as amfldentiaL You must Include with the sanitized copy ofthenotice form a sanitized version of any attachment In which youclaim information asconfidential Attachment name " Attachment 

### piag8 number(s) Confldential 

## Material Safety Data Sheet (MSDS) 14
- 17 

# 1'>< 18

# .~ 19
- 49 

# lX 50
- 52 

# Ix 53- 57 

# rx' 58
- 64 

# )(

.

.

.

.



# -



# . 0 MlIl'kOO this box if you attach a amUnuation 1Ibeet..inter theattac:bment namead. number. FORM EPA 111()'2S (Rev. 5-95) Page 12YH

### rSlCAL AND CHEMICAL PROPERTIES WORKSHEET



# . To assist EPA's review of physical and chemical prOperties data. please complete the following worksheet for data 

### you provide and include it in thenolice. Identify the property measured. the page of the notice on which the property appears, the value 

### . ofthe property, the units in which the property Is measured (as nea!!ISa1j'), and whether or not the Is claimed as confidential The physical state of the neat substanceshould be provided. These measured propertlell "be for the neat**(1~** pure)cltemical substance. Properties that are measund for mixtures or formulations should be sonoted ('!(. PMN substanceIn _).You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as itwill simplify review and ensure that amfidenlial information is properly 

### protected. Yau should submit this worksheet as a supplement to your submission oftest 

# • data. This worksheet is not a substil:ule for submission of test data. Property Page Value M
__ ConfI- Mark (X) If or dential provided number IItiINiII (a) (b)**(~)** Mark(X) , (MorE) (d) Physical state ofneat substance _ (s)_(I)_uv Vaporpressure "C Torr 

# • @ Temperature Density/relative density g/an3 Solubility "C.

@ Temperature

Solvent giL Solubility inwater • Temperature "C '''C Melting**ten'I~ture** "C Boiling/sublimation tem-perature 

# • torr prellUl'e Spectra Dissociation amstant

, " Partide sizedistribution " Octanol/water partition coeffk:lent 

## . " Henry'. Law COl'IStant Volitallzation from water Vol1taJization fram IIOil pH • concentration Flammability Explodabmty i\dsorptionlcoe:fftdmt
, 

### ., Other Sped.fy ./

# CONFIDENTIAL



# YQqe:s I

# t-) - 

# toY CONFIDENTIAL 

# I¥

### 1 Full Notification Report:

### ~
4.0.00 TOXICOLOGICAL STUDIES Number: 1 4.1.10 Acute Toxicity: Administered orally - acute oral Number: 1 given below and in with the criteria given in Annex 

### VI of the ctive, the substance should be: classified as very toxic classified as toxic classified as harmful not classified 

### X test [ 

### X 1 

### > 2000 mg/kg
95% confidence limits:

sex

M F the dose-mortality curve: /strain: HanErl: Wist (SPF)

200 200300 (PEG 300)

of onset and duration: number of

clinical signs were noted during the course of the study ,Effect on organs (related to dose level):

No macroscopy


### 96/54 423) were observed at necropsy

ible for test: L.....**,~** ___ _____ _2 

### Full Notification Report:**~~**

ENGL 

### 4452 ::TINGEN

The test substance does not require any labelling3 

### Full Notification Report:**~**
4.1.12 Acute Toxicity:Fixed dose toxicity procedure 

### Number: 1 the basis of the test results given below and in conformity with the criteria given in Annex VI of the IDirective, the substance should be: classified as very toxic classified as toxic classified as harmful not classified scriminating dose mg/kg ENGL**Prelimina~y** 

### sighting study ,Number of animals: 

## o male 

## o female 

# Is '/ ' I 

### peCles straln:



# "'1'74 

### Full Notification Report:
4.1.12 Acute Toxicity:Fixed dose toxicity procedure 

### Number: 1 

### administered (mg/kg) Evident toxicity Mortal 2000

500

50

5 

### <5 doses administered:

ENGL 

### Study:
I 

### INUmber of animals: male female Species/strain: used:



# /1

### 5 Full Notification
4.1.12 Acute Toxicity:Fixed dose toxicity procedure Number: 1 [Results of initial 

### (I) and further (F) dosing !Sex Dose Type Dose (mg/kg) Animals Evident toxic Deaths ENGL IObservations: ! I ENGL ISigns of toxicity, onset and duration, deaths: ENGL 

### i ,Effects in the organs (related to treatment) : 

# iMethOd' ENGL

!BOdY responsible for test: ! 

# Icomments, I ENGL



# 116 

### Full Notification Report:

### ~.~
4.1.20 Acute toxicity: Administered by inhalation 

### Number: :. iOn the basis of the test results given below and in Iconformity with the criteria given in Annex VI of the lDirective, the substance should be: i 

### classified as very toxic classified as toxic classified as harmful not classified 

## x ILimit test 

## x ] I 

## o : > 

### 5,415 mg/l confidence limits: 95% :Slope of the concentration-mortality curve: i

### !Species/strain: I 

### Rat, HanBrl:Wist (SPF) I

### Exposure period: 4 hours ,Method of exposure: 

## I Nose only 4 hour exposure gas liquid solid aerosol aerosol Physical form of substance [ ] [ X 

### J 

### IMass median aerodynamic diameter (for liquid and solid

aerosols) : Impactor :. 2.68 mcm (2.45 GSD) Impactor 2 2.6:' mcm (2.44 GSD)Full Notification Report:

### ~ 7
4.1. 20 Acute toxicity: Administered by inhalation Number: 1

sex concentration (mg/l) number of animals number of deaths
M F 5,415 5,415 5 5 of toxicity related to concentration, of onset and duration: 

## o o

Mortal No deaths occurred during the study. All animals were sacrificed as scheduled on day 15. Clinical signs No clinical signs were observed during the 15 observation period Body weights There were no relevant adverse effects on body weight development of male and female animals during the I5-day observation period. Transient retardation in body weight gain was occasional seen in some animals. However, these minor effects on body weight were transient and may have been related to slight physical stress during restraint in the exposure tubes and/or incidental. Consequently they were not considered to be toxi ffect in organs (related to on) : Macrocopical findings At necropsy all animals showed red brown discoloration of the lung due to the test item treatment.
403) responsible for test: RCC, RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN
ENGL 

### s: The test substance does not require any labelling

### 8 Full Notification Report:
4.1. 30 Acute Toxicity: Administered cutaneously Number: 1 given in Annex 

### VI of the Directive, the substance should be: classified as very toxic classified as toxic classified as harmful not classified 

### x test [ X 

### I > 2000 mg/kg confidence limits: ENGL of the dose-mortality curve:

od: (SPF) 24 hours

sex occlusive Glycol (PEG

dose (mg/kg) semi-occlusive [ 

### X ]

number of

animals number of deaths
M 2000 5 

## o F 20CO 5 

## o9 

### Full Notification
4.1. 30 Acute Toxicity: Administered cutaneously 

### Number: 1 of toxicity related to dose level used, of onset and duration: localscales on the back were noted in two males and one females at different times. No further clinical were observed during the observation period. signs were noted during the observation period.

on organs (related to dose level) : macroscopic findings were observed at necropsy. 402) 

### responsible for test: RCC I 

### RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN

The test substance does not require any labelling ENGL
ENGL



# 10

### 10 Full Notification

### Report:f~
4.1.50 Acute Toxicity: Skin irritation 

### Number: 1 IOn the basis of the test results given below and in conformity with the criteria given in Annex VI of the Directive, the substance should be: classified as not classifiedirritant classified as corrosive X White (SPF)11 Full Notification Report:
4.1. 50 Aoute Toxioity: Skin irritation Number: 1 

### ENGL of substance: 500

dressing: occlusive semi-occlusive [ X 

### 1
water ibility of any observed effect: Changes fully reversible within days Changes not fully reversible within an observation of days Results (showing mean scores if >3 animals) : culated on the basis of the scores for each animal 24, 48 and 72 hours

1 

### / 2 3 M score

0,33 0,33 0,33 maximum value

0,33 maximum duration of any effect

24 maximum value at the end of the observation period

0,33 

## I 1 

## o loedema 2 

## o I 3 

## o M 

## o o ENGL Other observations:

Coloration: a light black coloured staining was evident at the test site of all animals from 1 to 24 hours after treatment Corrosion : no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin Body weight : within the normal range of variability EEC Directive 92/69 Method EEC B.4 (OECD 404)
RCC, RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN



# ................... ;;l.S**~**12 Full Notification Report:

substance does not require any label

### 13 Full Notification Report:
4.1. 60 Acute Toxicity: Eye Irritation 

### Number: 1 test results given below and in criteria given in Annex 

### VI of the rective, the substance should be: classified as irritant not classified X IspeCieS!strain: 

# i Rabbit, New Zealand White (SPF) lNumber of animals: 3 INature of substance:

solid 

## I IAmount of substance: 100 MG 

## I Reversibili of any observed effects: 

# 1- Changes fully reversible within days : Changes not fully reversible within an observation period of days (showing individual scores if**<~** 

### 3 animals) on the basis of the scores for each animal at 72 hours Results and 

### if score maximum maximum maximum value at value duration the end of the of any observation effect period (in hours) 1 1, 

### 33 2 0,33 3 1,33 M 

### 1,33 72 1 0 2 0 3 

### 0 M 0 

### 1 0 

### 2 0 

### s

3 M 

### 0 0

I 

### liris 1 2 3 M 

### 0 0 0 014 Full Noti ion Report: of the treated eyes by the test Corrosion : no corrosion of the cornea was observed at any of the reading times item was observed

Directive 92/69 Method EEC 

### B.5 (OECD 

### 405) responsible for test: RCC , RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN
ENGL substance does not re labell15 ,f '**1,'l'.1!~·** IfI A" ",'" ,/' Full Notification
4.1. 70 Acute Toxicity: Skin sensitization Number: 1 On the basis of the test results given below ana ln :conformity with the criteria given in Annex 

### VI of the

, the substance should be: classified as irritant not classified X

, Ibm:GOHI, SPF-quality animals in test group: 10 of animals in negative control group: 5

concentration not giving rise to irritating effects prel test: 10 of test material and vehicle used at each induction:

in Freund's Adjuvant for intradermal induction in PEG 

### 300 for the topical induction

of irritation during induction: material and vehicle used at each

Number of animals showing skin reactions after



### 3 

## o o control group
of sensitization at each challenge None of the control and test animals showed skin reaction after the treatment with,... at 

### 3% (w/w) in PEG 

### 300 .IOther observations

No deaths occurred

### 16 Full Notification Report:

### ~ (type of test) : Directive 96/54 B.6 

### (OECD 406) 

### responsible for test: 

### RCC f 

### RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN

not have to be classified and labelled as a skin sensitiser



# 11 

# 30

### 1

not

or observed: /strain:

cle: Full Notification Report:**~**
4.2.10 Sub-acute/sub-chronic toxicity (28/90 day test) Number: l ENGL of test: 28 days of the criteria substance should

the below and in basis

ty with Annex VI of the

f the classified as toxic classified as harmful classified 

## x N concentration at which no toxic effects 150 mg/kg/day OR mg/l per h/day Rat. RanBrl: WIST (SPF) of administration:

of administration or of exposure:
PEG 300 aerodynamic diameter (for liquid and solid

exposure per day (inhalation or dermal) : hours regime (5 or 7 days/week) : 7
Number of animals
5 

### 5 5 5 5 5 

### 5 5 Dose/concentration


## o 30 150 450 

## o 30 150 450 (in relation to dose levels/concentration)2 

### Full Notification Report:

## ~ All animals treated with 30, 150 and 450 mg/kg/day survived until scheduled necropsy. Clinical signs No clinical signs of toxicology relevance were noted during daily observation or weekly observation. Funtional Observation No clinical signs of toxicology relevance were noted i 

### f'J.nctional observation (week 4) . Strength No test item related differences in fore-or hindlimb strength were noted at any dose. Locomotor activity No test item-related differences in locomotor activity were noted at any dose level. Food Consumption The mean daily food consumption of the test item-treated groups were unaffected. Body weight Transient reductions of mean body weight were noted in males and females treated with 450 mg/kg/day. These findings were most clearly expressed on treatment day 15 and were considered to be test item-related. The body weight development of the rats treated with 30 and 150 mg/ were similar to those of the controls. ) Laboratory findings: Hematology Test item-related in the hematology parameters of the rats treated with 450 mg/kg/day included reduced hemoglobin and hematocrit (males only), "left-shift" in the reticulocyte maturity indices (males only), increased absolute and relative reticulocyte counts (females only) and increased absolute and relative monocyte counts (females only). These changes were considered to be test item-related changes of compensated anemia accompanied by different stages of reticulocytosis. The rats treated with 30 and 150 mg/kg/day were considered unaffected. Clinical biochemistry Test item-related in clinical biochemi parameters of the rats treated with 450 mg/kg/day included elevated urea (males only), increased activities of alanine aminotransferase, increased alkaline phosphatase levels (females), decreased sodium and potassium levels (both sexes), increased c phosphorus (females) and decreased globulin levels (both sexes). Decreased sodium and sium in females treated with 150 mg/kg/day were also considered to be test item-related effects. The rats treated with 30 mg/kg/day were considered to be unaffected.

13) 

### Effect in organs: I 

### Organ weight3 

### Full Notification Report: No test organ weights were noted at any dose level. Macroscopic findings No test item-related macroscopic findings were evident at necropsy. Microscopic findings Test item-related histopathological chamges were noted in kidney, spleen and femoral bone marrow of rats. In the cortex of the kidney, minimal or moderate hyperplasia and hypertrophy with luminal dilatation of the tubular epithelium of the medullary rays were noted in some rats treated with 450 mg/kg/day. This finding was considered to be of adverse character. In the spleen, a minimal increase in splenic hemosiderin storage was recorded in some animals treated with 450 mg/kg/day. This change is generally considered to be a sign of increased erythrocytic turnover. Minimally increased erythropoiesis together with a decreased myel s, which is also indicative of an increased regeneration of erythrocytes, was noted in the femoral bone marrow of some animals treated with 450 mg/kg/day. The changes recorded in spleen and bone marrow were regarded as an ) Dose possibly primary and have therefore the value of adverse effect. or concentration at which no effect was observed 30 mg/kg/day OR
EEC Directive 96/54 B. 7 (GECD 407)

4452 ITINGEN COMPANY AG

highest dose of 450 mg/kg/day was selected in a second time on the basis of the results seen at a first highest dose of 750 mg/kg/day during the study running. Marked clinical s were noted in the rats treated with 750 mg/kg/day. Food consumption was reduced and a loss of body weight was noted. Because of the poor conditions of these animals and for ethical reasons, it was decided to sacrifice these animals on day 9 of treatment. The missing group was then replaced by the new 450 mg/kg/day group of 10 animals (5M + 

### SF). Preliminary Dose Range finding study. The dose of 30, 150 and 750 mg/kg of the main study was selected on the basis of a preliminary DOSE RANGE FINDING STUDY performed on the same strain of rats at the following doses : 200, 600 and 1000 mg/kg, 2 anima's roup/sex for five days.

### 4



### compared Full Notification Report: Clinical signs : dark feces in rats treated at 600 and 1000 from day 2 and in 200 mg/kg rat from day 3 from treatment. This effect was not considered test item-related but a passive effect. On day 5 test item-related ruffled fur and emaciation was noted in animals at 1000 mg/kg. Food consUr.llption Test item related marked decrease of mean absolute and relative food consumption was noted in animals at 1000 mg/kg. Weights A test item-related loss of body weight was noted during 3 5 from treatment in both sexes at 1000 mg/kg when to controls. weight Test item-related increase in kidney relative weight and decrease in spleen relative weight were noted in animals at 1000 mg/kg. Based on these preliminary results the final doses for the main 28-day study were set at 30, 150 and 750 mg/kg.1 Full Notification Report:
4.3.10 Mutagenicity: Bacteriological test Number: 1 ENGL IType of bacteria/strain:

S. Thyphimurium TA1535, TA 1537, TA 98, TA100 IE. Coli WP2 uvrA , IConcentration range in the main test (micrograms/plate) ! with metabolic activation: 33 5000 without metabolic activation: 33 5000 !concentration of test substance observed to be toxic 'Ito bacteria (micrograms/plate) I a) In a preliminary test I with metabolic activation: 5000 ! without metabolic activation: 5000 b) In the main test with metabolic without metabolic activation: activation: 5000 2500 Solvent:

DSMO Iconcentration of the test substance resulting in !precipi tat ion : 333 microgr/plate I IMetabolic activation system: 

### i S9 fraction prepared from adult male Wistar Hanlbm rats I induced by i.p. application of Phenobarbitale and Beta 

### i Naphthoflavone p.o. ! The S9 fractions are produced by dilution of the liver

homogenate with a KCl solution. Observations:

The preliminary (first) test was a standard plate incorporation assay; the main (second) test involved a preI incubation stage. !Results: with metabolic activation: without metabolic activation: ENGL Method (type of test) :

EEC B.13 I OECD 471 I [BOdY responsible for test: I RCC, RESEARCH AND CONSULTING COMPANY AG 

### i I 4452 ITINGEN

# \r----------~---------i I ENGL iComments:2 

### Full Notification Report: : .-, did not show any evidence of mutagenic activi ty in this ! 

### bacterial systems.1 Full Notification Report:
4.3.21 Mutagenicity: Non-bacteriological studies in vitro Number: 1 iIn vitro mammalian cytogenici ty I I ENGL IType of cell used: I Chinese Hamster V79 cells

, I I • iConcentratlon range in the main test (micrograms/ml) i with metabolic activation: Lower Upper 

# i 12,5 400 without metabolic activation: 

### 6,3 50 Concentrations producing toxicity a) In a preliminary test with metabolic activation: 

### > 400 microgram/ml without metabolic activation: 25 microgram/ml b) In the main test I with metabolic activation: 

### > 400 microgram/ml 

### i without metabolic activation: 50 microgram/ml 

### l Vehicle:

ENGL

DSMO Exposure period with metabolic activation: without metabolic activation: 4 28 hours hours Expression time:

Cells were cultured for about 72 hours prior to ENGL treatment Iselection time: I The doubling time for V79 cell was 12 hours. ENGL Fixation time: I 72 hours ENGL Metabolic activation system:

S9 fraction prepared from adult male Wistar Hanlbm rats induced by i.p. application of Phenobarbitale and Beta Naphthoflavone p.o. The S9 fractions are produced by dilution of the liver homogenate with a KCl solution. IObservations:

In the main experiments, in the absence of S9mix precipitation of the test item in culture medium was observed after treatment with 12.5 mcg/ml and above. In the presence of S9mix precipitation 6f the test item in culturemedium was observed after 4 hours treatment with 50 mcg/ml and above at preparation interval 18 hours (Exp.I) and with 25 mcg/ml and above at preparation interval 28

### 2 Full Notification Report: ces nor reduced numbers could be observed up to highest test item concentrations. In all experiments parts the evaluation of the mitotic indices and therefore the evaluation for cytogenetic damage was limited by strong testitem precipitation on the slides.
- Concentration showing clear toxicity indicated by reducedcell numbers or reduced mitotic indices were not evaluable for cytogenetic due to the interference of test item precipitation Results: with metabolic activation: without metabolic activation: ENGL 

### (type of test) : 473
RCC, responsible for test: RESEARCH AND CONSULTING COMPANY AG 4452 ITINGEN

condition applied, ENGL 

### tlll'did not aberrations in V79 cells.1 

### Full Notification Report:
5.0.00 ECOTOXICOLOGICAL STUDIES 

### Number: 1 5.1.01 Acute toxicity for fish 

### Number: 1 I I 

### iLC50 Values in mg/l 24h 48h 72h 

### 96h 

### > 100 

### > 100 

### > 100 

### > 100 LC 100 at 96 hours (mg/l) > 

### 100 INO observed effect concentration after 96 h: 100 mg/l i ENGL 

### species: I 

### Rainbow Trout (Oncorhynchus mykiss) !Type of test: static semi-static flow-through [ X [ J % 

### loss in concentration of the test substance over test Iperiod: Identity and concentration of any auxiliary solvent or details o.f any other method used for dispersal: I 

### None Water hardness: 144 mg CaC03 / 1 ENGL 

### Method (type of test) :

EEC Directive 92/68 

## I EEC C1 (OECD 203 and OPPTS 850.1075 Guidelines) Body responsible for test:

ANALYTICAL BIO-CHEMISTRY (A.B.C.) LABORATORIES INC. COLUMBIA, MISSOURI 65205
ENGL 

### Icomments: I 

### It was not possible to apply any analytical method to check

the concentrations during the test due to the nature of the test compound. It was therefore decided and agreed with CA that nominal concentration will be adopted for LCSO and NOEC value evaluation. i 

### All exposure concentration were greater than the solubility

of..- in dilution water as indicated by the presence of undissolved test substance during the exposure period.

### 3



### s hardness: Full Notification Report:**~** 

### 5.1. 02 Acute toxicity for daphnia 

### Number: 1 

## a Conc. in mg/l

24h 48h 100 

### > 100 iEC 100: 

### > 100 mg/l at 48 h i 

### observed effect concentration after 48 h: 

### > 100 mg/l es: magna Daphnia pulex X ] [ ] 

### concentration of**t~e** 

### test substance over test ity and concentration of any auxil or of any**ot~er** 

### method used for di 150 mg CaC03 / 1

### 4 Full Notification
S.1. 02 Acute toxicity for daphnia Number: 1 (type of test) : Directive 92/69 C.2 (OECD 202 and OPPTS 850.1010 Guidelines)
(A.B.C.) LABORATORIES INC. MISSOURI 65205

It was not possible to apply any analytical method to check the concentrations during the test due to the nature of the test compound. It was therefore decided and agree with CA that nominal concentration will be adopted for LC50 and NOEC value evaluation. exposure concentration were greater than the solubility in dilution water as indicated by the presence of ssolved test substance during the exposure5 Full Notification Report:

### tI~
5.1. 03 Growth inhibition test on algae Number: 1 'Limi t test [ N 

### 1**~Effect** concentration:Biomass, EbC50 at 72h 38 mg/l iEffect concentration: Growth, ErC50 at 72h 95 mg/l [Duration of test 96 hours ! I ISpecies / strain: I Unicellular Green Alga, Selenastrum capricornutum i !No observed effect concentration (growth): 25 mg/l INO observed effect concentration (biomass) 25 mg/l I 1% loss in concentration over test period: I I ENGL IIdentity and concentration of any auxiliary solvent or ildetails of any other method used for dispersal:

, None ]water hardness: mg CaC03/l ENGL Method:

EEC Directive 92/69 EEC C.3 (OECD 201 and OPPTS 850-5400 Guidelines) Body responsible for test:

ANALYTICAL BIO-CHEMISTRY (A.B.C.) LABORATORIES INC. COLUMBIA, MISSOURI 65205 I 

# Icomments, ENGL I It was not possible to apply any analytical method to check I the" concentrations during the test due to the nature of ! the test compound.

It was therefore decided and agree with CA that nominal concentration will be adopted for LC50 and NOEC value evaluation. 

### i All exposure concentration were greater than the solubility I of in dilution water as indicated by the presence of I undissolved test substance during the exposure period. : A grey coloration related to the .... was observed at the 

### i test dosage >/= 25 mg/L and the coloration remained in the

100 mg/L dose for the duration of the exposure .

.... may have attenuated light penetration that resulted in the reduced algal biomass observed in the 50 and 100 mg(L treatments. For this reason the toxicity observed during the study is not considered a direct adverse effect but an effect mediated by the loss of light penetration to the algae. No6 

### Full Notification classification is then required based on C.3 

### test on ....,7 Full Notification Report:
5.1. 06 Inhibition of microbial activity (if available) Number: 1 I iType of test: aerobic anaerobic [ X 

### 1 I lDuration of test: 3 hours I IIC50 at 3 hours: > 1000 mg/l I I iNo observed effect after 3 hours at concentration> 1000 mg/l ENGL iMethod: ! OECD 209 IBOdY responsible for test: I RCC, RESEARCH AND CONSULTING COMPANY AG I 4452 ITINGEN 

## I lcomments: I Down to the lowest test item concentration 

### i of the test item was suspended in the test

II test concentrations were clearly above the

. limit of". ENGL of 10 mg/L a part media. Thus, all water solubility

### 8 

### Full Notification Report:
5.1. 07 Longterm toxicity to Daphnia magna 

### Number: 1 !EC50 : 

### (reproduction) at 21 days: mg/l No observed effect I 

### IType of test: I 

### concentration after 21 semi-static ( ] 

### days: mg/l flow through ( ] 

### loss in concentration over the test period: ENGL 

### and concentration of auxiliary solvent or details methods for dispersal: CAC03 mg per litre available EC50/NOEC

EC50 NOEC End point

responsible for test: ENGL 

### s: and NOEC values for any other effect observed survival. growth) and length of time of appearance of brood, should be included, if available) ENGL1 

### Full Notification Report: •••
4.5.10 Assessment of toxicokinetic behaviour 

### Number: 1 ENGL 

### A3S0RPTION/DISTRIBUTION 7he proportion of particles less than 10 micron is about 30%(see particle size results). Therefore, there is some potential of inhalation of the dust from ..... Nevertheless results from acute toxicity study by inhalation performed in order to deeper evaluate the inhalation toxicity potential, did not reveal any adverse effects. No mortality was observed as well as no clinical sign, no effects on body weight and no macroscopic finding with the exception of brown coloration of lungs due to the presence of ...,. The low water solubility value ..**~_** 

### could indicate that the substance is unlikely to be absorbed and the possibility to bioaccumulate is not supported by the log Pow value which is not obtainable. The 28-day study showed adverse effects at the dose of 450 mg/kg/day (described in section 4.2.10); therefore absorption of test item is confirmed. METABOLISM No 'in vivo" evidence of metabolic activity on is available.

, During the Chromosomal aberration test on V79 

### cell line, the

exposure with S9mix (microsomal enzymatic system) did induce a toxic effect of .... at higher doses (400 mcg/ml) if compared with exposure without S9mix (25 and 50 mcg/ml) . This could lead to the conclusion that the liver enzymatic system can transform .... in a less toxic substance. Similar effects were seen also in the Reverse Bacterial study (Ames); see point 4.3.10 EXCRECTION No evidence of clear excretion of",., from the body is available. Dark feces were seen in rats treated at 600 and 1000 mg/kg/day from day 2 and in 200 mg/kg/day rat from day 3 from treatment during the DRF study. This effect was not considered test item-related but a passive effect in the digestive system.

# CONFIDENTIAL

fbqes 

# 31 --**5~** 

# 47

## RECEiVED 

# LIValence r: Cl ;:).,. U ,"' 

### j (' vi i I 11'--' '-' 

# "Technology, Inc.
March 4, 2003

Ms. Edna Pleasants Program Manager U.S. EPA Office ofPollution Prevention and Toxic Substances Ariel Rios Building 1200 Pennsylvania Avenue Washington, D.C. 20460 Re: PMN P-02-167 Dear Ms. Pleasants: Subsequent to filing the subject PMN and the completion of its review, we received a copy ofthe dossier which was filed by Valence Technology BV, Ireland in order to officially notifY that substance in the EU. The dossier in addition to providing the EU Competent Authority with the required administrative processing, worker exposure and related data also contained summaries ofall ofthe safety and health studies which were conducted by Valence Technology BV in Ireland. In 

### order to complete your files, we are providing copies ofthe summaries ofthe physical/chemical property determinations, toxicology studies, ecotoxicology studies, toxicokinetic summary and risk assessment. As you will see from these summaries, the material was not found to be hazardous by EU criteria and did not require a toxic to human health or the environment classification in the EU. When providing us with this copy ofthe dossier, and summary documents, we were not provided with the full text ofthe studies, however, should the agency feel that they would like to have copies ofall or any ofthe full text ofthe study reports, we are certain that we can obtain them from Valence Technology BV and provide them to the agency upon request. Please contact the undersigned ifyou have any questions. Sincerely,

# valy:Op~

# ~ynn Wodetzki Manager, Environmental Health and Safety 

# -10 (J-OZ-/l,7 

# .,sOOl30D0:3/ICf Valence Technology, Inc. 301 ConestOga Way, Henderson, Nevada 89015 Tel: 702-558-1000, Fax: 702-558·1001 

# ,