rr..t

_J 

!iii 

;r~ 

GS"

£i.E 

II 

~2. 

0:.'" 

~~ ftI

.. 
. 	 ' 

Public reporting uti. for thiJ 'COnectian of ~lion it estimated to average 110001.11'9 pm' respoA84!t Inciuding time ftIr review'i'I18~_ 

&eafcldngllJdsting c:l.ag'iiources, pthel:tng aDd.main~, the data i-dc. and. QXl\Pl~dng~nMewmg tbecclJ.ed:ian clil\lannaticp; Sencl 

c~.nrsiud1u, the burden ~ta or my other lISped ofthis c:oIl.edien of In.formaaaa. i.Pdudi:DgauP~ for: this bImlID. 

, to 0Uef. tnfcn;natlcI.\'PoIic:y Brartc:h, JIM.223, us. Emrirotunental ~~,401 M. St:. S.W~ W~D.C. 2OUJO) IIld. to the ~aI 

'h ric Rec:h.1ctio:n Act I2I1lO.Q)l WasbJn D.C. 2Q5(Xl. 

CERTIFICAllON I , 

, I certify that to ,~best of lZ1Y knowledge and,'beUett. • • ,I 

1. The company r:wned !1'l Paxt I, sedion A, subSe:tion 1a of,tItis notice £Om to 1NIII.\lfactw'eor'iD\portlor a " commerdal'pu.rpo~ other than in 1I'al8l1 qu.antities solely fOr research and. cievelopment, the IUbIt8:Dce idenlified. in 

Put I, Seaioa B.' 	 ' 

, ,2.. All informaqan,provided in this notice 15 comp~ and truthful ..of the _ of au~ + • 	 ~ ~ ,,. 

, ' 	 ' 

S. 	 I am 5ubinittirtg'With th1Il'IOt:ice all testciata in mypossesalan OfccmtrDl a:n4.,a descripdon of aD otbardata.1IIft 1:0 


or reasOnably ucertainable by aae IINq1.1iNd. by §12O.SO of the P:ema:R~ ~ficatJDI1 ... " " 


Additional CUtlficatiOD S~mmtl: 

Ifyouare 5ubDilit1nS a PMN"mtenMdiate l'MN; Coftsoliciate1 PMN, or SNON, ~'~Co1lqwing"" ~n ' 


statement app~ " . 


III The Company'NlJlled inPut I, A lud remltte:l the .... ~,~..4O en. 7OOA5 ('b). 01' ., 

D' The Company Damed SA Put J,. S'8aIit:ted the _ol'51000 for U\IldImIedi " PMN(.&-t•.tO 01:700.43) Ut 

acc:ordaJlce witll40 CPR 100 45(bJ Ol' " ' " • •• ~ • ~ ~. • 	 : • '. I.. 

o The Compa.ny lamed ia Putt.Sec:tkmA.a smail a:mcemuder 40 CPa 700.43 aDd_ nD.DitIIcl 


a .. oIlS1~ in~with 40 CD,700.4S (I)). " ' , ' , ' 


If)'OlllU'e s~a low'vobmae exalpt5oJr. (LV&) appUcatlonlD with 4D c;n (el (1),01' a r..o" 
 N~a:nd law expOIUU e:Gzap,don (LollEX) applicatiCll\ In ac:cordance with CfIt 12!.5O{c) (2), chicktlIefo11owin& 


CII'I:ifiaItion stateD'ladl: , ' , 


:[] The ,~S1.tbmIttiI\gtbls ~tntend.t iO ~orbnpmt'tba MW cb.micaJ ~for . co~purpoees, other tbau In smaJl quantitJes eolely for resea:cb IQId deveJapment,.,UDder thete.rmI 


. of40 CFR. 72S.5O. ,.,'" , • .', ' 	 • I ' 	 , 

·CJ T.he .,£.milJar with the termt ofthh IeCtloa &:nil wiD. com.PIYWith thoIeterma;ud. 

,0'TbeJiew~~ior1Vhkh the~.lubDdttecllNll!l1anappliclbJe,,,,,,~~ ". 

[J Ifthia app~..tar iU\ LVBiil'~ With 40 CFa 723.50 (c)m, the ~in~tommnul.a 
 , .manufa.ctula of the e:3CIIiIIDpIeQ subeta:cn tor purpaaee wtthiD 1, year oftbadate of the ecpit'IIdaa gf the 


30 day~period. ' ' 


. ' 

" 

,.... 

Part I - GENERAL INFORMA nON 

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 of authorized. official b. 	 Agent (If 

applicable) 

Oty, 

(!. Uyou 11ft sumiUtt:Ing tIWI nottce. pert of ajcUlt subm.l.akm. mark 00 ~ 

Jolat Name of aulh«Jzed olftdal 

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. 	 U youhave submitted • notiCe of Boaa fide Intent to manufacture or 

Import for the chemh::allUbetaDce covenct by thJa notICIe, entli: the 

notice number aaalgnect. by EPA. " .... 

i. TypeoiNotice-MarkOO '1. D =ufacture 2. D'~ 

Option D 


'Va1ence Inc. 

Telephoae I 

I 

bolL -.-;..--.------------:::~ 

PoRtioa 

\ 

Telephone 

PoRtion 

President 

If you have had a prenot:lce,c:ammuDicati.aa (PC) COl\cmUng tIWI 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 nlnth Conedive Index (9(l) of CA nomiInclatun ruleund conventioN. 

item you claim as 

Cctmplete either item 1 (ClaM 1 or 1ltlbllances) or 1 (Polymers) a. appropriate. Complete an other item.. 

If another person will submit chemical identity information for you (lor either item 1 or 2), mark 00 the box at the risJ:!t. 

address of that ' ..... 

1. eta.. 1 or 1 chemicaisubmncel (for definitions of class 1 and class 2 substano!s, see the In.truc:tloD. ManWll) 

a. Class of substance Mark 00 1 0 Oass 1 or 2 0 au. 2 . 

b. Otemical name (C~tly correct Otemical Abstrac: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 bued on CA 9C nomenclature rules and conventions.). ' 

c. Please identify which method you usea to deVelOp 01' obtain the spedfled. chemical indentity informaUoo reported. in thia notice: 

(check oneh . 

[!] Method 1 (CAS InventcryExpert Service - a copy of the Identifk:atlon OMethod2 (Other Source) 

report obtained &om the CAS Inventory Expert Service IlWIt be 

submitted as an attechment to thiI notice) 

d.. Mo1ecul4r formula and CAS Registry Number (if a number already exUbI for the II.lbetmce) 

e. Po.. a cluI1 sublltance, provide a COQ\plete and correct.cbemic:al strudure diagram. For a clue 2aubltance - (1) u.tthe immediate 

precurscr sub8tanc:ea with their respectlve CAS Registry Numbca. (2) DeIcribe the.ture of the r-=tt.aa or pr~ (3) Ind.kate the 

range of oompoilltlon and. the typical campoilltion (where app.ropriate). (4) Provide a cmrect rep:_tatlve or partlal chemical 

strud:ure diagram, as COIJ'I'pleie ..can be known. Jforie can be f'IIUCIIably ac:ertIIined. 

Mark (X) thls box if you attach a 

FORM EPA 771()"1S . <RaY. 5-95) Pap. 
I Part I - GENERAL INFORMA nON ­ Continued 

~ Section B - CHEMICAL IDENTITY INFORMATION - Continued 

2. Pol~mers (Fo: a definition of polymer, see the Instruction. Manual) Confidential 

a. Indicate the number-average weight of the lowest molecular Weight compoetion of the polymer you intend to manufacture. . Indicate maximum Weight percent of low molecular weight species (not induding residual monomers, reactanbl, or solvents) below 

SOO and below 1,000 absolute molecular weight of that composition. •

Describe the method. of meUUl'ement or the basil for youre.timatea: GPC 0 OtherD :(SpecIfy) 

I) lowest number average moI8(Ular weight: 

til maximum weight '!Io below 500 molecular weight 

tiD maximum weight'!lo below 1000 molecular weight 

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

b. You must make separate confidentiality daimsfor monomer or other reactant identity, composition information, and residual information. 

Mark (X) the "Confidential" box next to any item you daim as confidential. 

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

• manufacture of the polymer. . . (2) - Mark (X) this column ifentry in column (1) is confidential 

(3) - Indicate the typical weight perc:ent of each monomer or other reactant in the polymer. 

(4) - Mark (X) the identity column If you want. monomer or other reactaDt lured at two weight percent or leu to be IDted a. part of the 

polymer de.crlptioD on the TSCA Chemical Sublltance Inventory. 

(5) - Mark (X) this column if entries in colWlUll (3) and (4) area:mfidentlal. . (6) ­ Indicate the l1'IUimum weight perc:ent of each mOJ)omer or other reactant that may be present u • residual in the polymer as manufactured for commerdal pu.rpoaes. 

(1) - Mark (X) this column if entry in column (6) is' confidential 

Monomer or other reactant and CAS Registry Number Coa1I­ Typical Identity Coaft. Maximum 

dmtial Mark 00 dmtial residual =. (1) (2) '(3) (4) (5) (6) • (7) 

" " ." ." 

" " 

" " 

" " .. GI!. 

o " " Mark (X) this box if you attach a continuatiaiillheet. 

Co Please Identify which method you uaedto dMop or obtaID the apedfled chemic:ll identity Informatfi:mreported in thie notke. (check one). . o Method 1 (CAS Inventory=Service ~ a copy of the idenI:lflcatklD report 0 Method 2 (otbar SIOUlC8) . 

obtained from Inventory Expert Service mUllt be IUI:Imitted as . 

I-­ an attachmmt to thia notice) 

d. The currently c:otTect Otemical Abstracts (00 name for the polymer that Is conaiItent with TSCA Inventory lIstfngs for!dmilar polymera. 

e. Provide a correct representative or partial chem1cal structure diagram. u complete .. can be known. ifOM can be reasoI\Ilbly .....tainecL 

- . 

, 

o Mark00 this box 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. 


. Provide the CAS Kep.uy NlUIlber If &Yallable. .If tIIel'e _wei_tified Irnpmlfet. eater "uldC!lltl.fied.· 


(b) -EatlDl~ u..e maxim.1UIl weipt 'Jro of eada Implldty. Ifthere_ uid_tIfied iDlpmu., eItbule their total weialll'Jro, 

Impurity and CAS Registry Number Maximum CoDfI.. percent (a) dentlaJ. (b) 

" X

% 

% 

" 

% 

" I· .. ­

" o Mark (X) this box if you attach • amtinuallon sheet. 

4. Synonym. - Enter any chemI.cal synQl'l)'DII for the new dlemical subetance kle.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 names for the flew IUllet.mce klenti8ad ill lOll. 

o Mark 00 this box if you attadl • c:ontinuatiQl'l sheet. 

6. Generic dlemical name - U you claim dlem1calld.entity ..CCIIIfldeDIiai. you anut provide • pnerkchemical name for your substance . 	 that l1MI8Ia the spectfk: dlembl identity of the new chemical subItance In the maXimum extent poaaible. 


Refer In the TSCA Qemical SubstlmcelnwnlDr}', 1985 Edltkla, Appmdtx Bfor guidance QI'I ~elDplnlJ. 

generic names.. .
 . Lithium Metal Phosphate 

0 Mark 00 this box if you attach • amtinuallClli sheet. 


7. Byprodlldl-- an,. ;.'" reIUltIngfrc:m the mmu.fllcture, proc:esIing, UI!Iet (]I' of the new chemiall subItanc:a Provld.e CAS 
 n '. If available. 	 . .~-. 

Byproduct CAS RepayNum_ Conti· 

0> (2) clenijal

-. 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 INFORMA nON ­ Continued 

~ Section C - 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 of production. Also estimate the 

maximum production volume £arany consecutive 12-month period during the first three years of production. Estimates should be on 

100% new chemical substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower 

product?-on volume than 10,000 kg/yr, specify the volume and mark (x) in the binding box. If granted, you are bound to this volume. 

Maximum first 12-month production (kg/yr) Maximum 12-month production (kg/yr) Confi.. lbadfq 

dentlal Optioa (100% new chemical substance basis) (100% new chemical substance basis) MakW 

J>< 

2. Use. Information - You must make separate confidentiality claims for the deeaiption of the category of use, the percent of pfodUdion volume 

devoted to each category, the formulatlcm of the new substance, and other use lnfarmatlOil. Mark 00 the "Confidential" Box next to any item you 

claim as oonfidentl.al. a. (1) - Desatbe each intended category Of use of the new c:he.mkal substance by fund10n and application. 

(2) - Mark 00 this column if entry in coJumnO) Is confidential busin_ ~tiOll (CBI). 

(3) ­ Indicate your wlllin~ 10 have the information provided In colUDID mbtncUng. 

(4) - Estlmate the percent c:t total produdioa for the first three}'8UI devoted Io..ch of WIll. 

(5) ­ Mark 00 this cohmin if entry 'in colUDID (4) II confidential bustn_ information ( . 

(6) ­ Estimate the percent of the new subatance as formulated in mixturel, su.spenIiona, emullliana, IIOlutlona, or g~ 

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

m- Marlc: 00 this column if entry in column (6) Is confidential busin_information (CBl). . . (8) - IncUcate I)(, of product volume expected for the Uated. ~UM"IIdcn. Mark more than OM box ifappoprlJite. Mark . (X) to indicate your willlnsn_1o have the use type provided In (8) bIncfIns. 

(9) - Marlc: 00 this column if ent:ry6es) in column (8) Is (are) caa.6d.entlal buslneallnformatiOll (CBI). 

Category of use (1) em Blacliq Procb:IIC<­ CBI I)(, In CBI " of subltance expected per use ~I 

(by function and application ie. a dispeniw dye for 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. 

·If you have identified, a "consumer~ U8e, pleue pmvide on a continuation sheet a detaned description of the use(s) of this chemiCal 

substance in consumer products. In addition include eatimatet of the concentration of the new chemical substance as expected in 

consumer products and describe the chemical reactions by which this .ubstance loies it. identity in the consumer product. 

o Mark 00 this box if you attach a COIItinWll:iOll ebeet. 

b. Generic Ifyou claim.:lcategory of use dllatptlCa lD IUbIed:Iort 2a ..ClXlfldential" en_ a geMri.c cIeIcriptkIa of that 

use category. the IDltI'IlctloD. Mamaal for exampl_ of pncicUII . 

de!lcription . 

Electrode material 

.. 

o Mark OOtlUa box ifyouattadla cmdnuat1cnllheet. 

3. Huud Informatloll- Induct. In the l'lOIica a copy of nIIIClNbIe facIdmile ollllY huud WIl'DIng sbItaneIIt" label. matariallafety data eheet. 

or other Infcnnatkla which will be=10 Illy perDl who Is reuoaably Ilbly 10 be expceed 10 1:hia!lUbttanc:e regarding protective nequipment or practic=- for the ufe transport. WIe. or dJapoeal of the new subetanc& u.tIn pm m hazard.1nformati9n you indude. 

. I Mar!( 00 thia box 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 of manufacture, proceuing, or UM 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.U have reporting requirement. if there 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 same operation will occur at more than one site, enter the number of sites. Identify the 

. addlti.onal sites on a continuation sheet, and if any of the 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 the major unit operation stepe and chemical a:mYC'IIclIIL Include interim storage and transport containel'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" new chemic:al1Ubltance basis), and entry point of an starling 

materials and feedstoclaI (indud:lng reaclanlll.lOlvents,. and catalyats, etc), and 01 an produd:II, rtcyde III:reIIn18. and wutes. Indude cleaning 

chemicals (nolie frequency if not used daily or per batch.). 

(3) 	Identifyby number the points of release, including JINll or inte:nrdltant rei..., 10 the environment of the new chemical substance. 

o Mark 00 this box if you 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 SUBMI11 EK ­ Continued 

2. Occupational Expoeu.re ­ You must make separate oonfidentiality cla.ima for the description of worker activity, physical form of the new chemical 

substance, number of workers expoeed. and duration of activity. Mark 00 the ·Confidential" box next to any item you claim as confident1al. 

(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 00 thia column if entry in oolumn (1) is oonfidential businesainformation (CBD. 

(3) ­ Describe an)! protective equipment and engineering controls used to protect workers. 

(4) and (6) - Indlcate you wUlingnessto have the in.fprmation provided. in ooiumn (3) or (5) binding. 

(5) - Indlcate the physical 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 In mixture). . .' 

(!) ­ Mark (X) thia column if entry in column (5) is confidential business information (CBD. 

(8) -- Estimate the lllIIXimum number of workers involved. in eac:h activity for all sites combined.. 

(9) ­ Mark (X) thia column if entry in column (8) is oonfidential business information (CBD. 

(10) and (11) ­ Estimate the maximUlnduration o!. actiY.'!r for any worker In hours per day and days J)eJ' year. 

(12) ­ Mark (X) thia column if entries 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 

Mark W ~/day Days/yr substance Mark W Expoaed 

(1) (2) (3) (4) (5) (6) m (8) (9) (10) (11) (12) 

o Mark 00 thia box if you attach a oontinuatlon sheaL X 

3. En'VirODmental 'R.eleue and DUpoai- You mUlt make separate c:anfldentlality cIaiIM fcx the releue numba' and. the amowIt of the new c:llemlal 

substance released. and other releaM I1'Id. dtIpoeallnformatlon. Mark 00 the ·Con.fldentlal* box next to e.c:b item you cl.aim • confidential. 

(1) ~ Enter the number of each releaM pciDt identlfled.ln the clelc:r.l.ption., part II. sec:tioD A. subeectian Id(3) . 

. (2) - Estimate the IIIl\01DI.t of the substance releued (a) directly to the envtraamer\t 01' (b) into amtrol technology (In kg/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 (stack air, fugitlve air (optional-eee InItructIon Manual), Niaca water, OIHlteOl' off-efte!aDd or Inc:ineratlan. P01W, or . other (specify» to which the new substance w111·be releued froiD that rel....pc:Ud. . . 

(5) - a. Desa:ibe coittrol technology, if any,,and amtrol ef8dency that wm be used to limit the r .....of the new subltance to the envirOnment. 

For releues disposed. of on land, charac:teri.ze the dJspoIIal method and state wbetber itis approved. tOl' dispoeal 01 RCRA hazardous waite. 

On a continuation sheet , for each site desaibe any additional dispoIIal methods that wIJl be used and whether the waateis subject to 

secondary or tertiary OIHIlte tre8tmerlt. J:I. BttImate the amount released to the environment after oontrol technology (In kg/day). 

(6) - Mark 00 this column if entries IncolUDll'lS (4) and (S) areoonfidentialbullDel!llllnfonnatlan (CBI). 

(!) - ldenlify the destlnlltlon(s) 01 releueI to waWr'. PIeQe supply NPOPS (Naliollal Pollutant DIIcbarge EHm1natIon SystEm) numbers fcx d1rect . dischargers 01' NPDPS numbers 01 tbePOIW (PubUdy 0wDed Tre8lm.clt Worb). Mark (X) if the POIW Dame or NPDPS • is confidential 

businese information (CBn. . 

Release AmoUnt ofnew subetance 

Number _t. 

(l) ~ (2b) 

CBI I:~ Control techDology and. efflc:ilN:y (you may wiab to optianaIly attach effidenc:y data) 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 this box 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 B for 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 B for ea=of processing, or use operation invo1~the new chemical substance. Uthe same operation Is 

performed at more 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 II conB.dentIaL 

(l) .... Diagram the major unit operation step and chemical conversions, including interim storage and transport containers (spec:l.fy-5 gallon pails, 55 

gallon diums, rail cars, tank trucb, etc). On the diagram. identify by letter and. briefly describe each worker activity. (2) ­ Provide the identity, 

the approximate weight (by kglday or kg/batcll. l00'lli new chemical substance basis), and entry point of all feedstoc:ks (including reactants, 

solvents and catal}'llts, etc) and of all products, recycle streams, and wastes. Include deanlng chemicals (note frequency If not used. daily or per 

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

Enter t of sUet 

. 

. 

o Mark 00 tbja. box iiyou attach • ~tinuali<m sheet. 

1. WCll'kIr~_ta11l1l.... (1) ­ From the cilagrmnbov ..pIOVIde the letter for each worka' dvity. Complete 2-8 for each worker ac:tlvtty deec:ribed. 

(2) - Fatimate the number of workenI expoeed.for all _lies amblned. . 

(4) -Esl:bDatethe typical dUl'llllcn 01 expoaure perwtll'ka' In (a) houri per day ad (b) dayI per yee. 

(6) - Deaaibe ph,...callorm of exposure and. 'lIi DJ!W c:hemtcalllUbllance (If in mixture), and. any protective equipment and. engineering controls, Ifany 

used to. prolact worbnL . . (7)- Fatimate the percent 01 the new subetulce _formulated when pecbgecIor UIIed II.ftnal'prod:uct. 

(9) ­ From the diagram above, enter the number of eadl releue point. Complete 9-13 for -=b releIIe pcmt identified. 

(10) ­ Estimate the amount oJ. the new substance reJ.eued. (a) direc:dy to the mvironment ell.' (b) into control technology to the envlronment . (in kg/day or kg/batch). •.. . 

(12) - Deaaibe U'Mldia of rei...(staclC air, fusitlw m (optional-Bee Instrw::t:tcas Manu.J), surface W1lter, 0l'Hite ell.' olf-site land. 01' indneratl.on, P01W, or other (sped.fy» and. CQIltrol technolOgy, If any, that wm be used. to Umit the releIIe 01 the newII1.1bstance to'the envlronment. 

(14) ­ Identify byproducta which may result &am the operatiCll'l. . . (3), (5), (8), (11), (13) and (15). Mark 00 this CXIluDm if my 01 the proceeding IIftI:rleI are caafidential buIdneII informal1oa (CBl). 

. Letter 'of CBI Duratloa CBI Protd.ve Equip. 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 

0) 001) : (1Ob) (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 if you attach a continuation sheet. 

FORM EPA mo.2S (Rev. 5-95) Pap 10 

. 
OPTIONAL POLLUTION PREVENTION INFORMAnON 

To claim information in this section as confidential circle or braclcetthe specific information that you claim as confidential. 

In this section you may provide information not reported elsewhere in this fofll,. regarding your 

efforts to reduce 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 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 

substitutionJ and/or inventory control. Recycling refers to the reclamation. of useful chemical 

components from wastes that would otherwise be treated or released as air emissions or water 

discharges, or land disposal. DescriptionS of pollution prevention, source reduction and 

recycling should emphasize potential risk reduction subsequent to compliance with existing 

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

this information to assess overall net reductions in toxicity or environmental releases and 

exposures, not the shifting of risks to other environmental med.iaor non-environmental areas 

<e.g., occupational or consumer exposure). In addition, information on the relative cost or 

performance characteristics of the PMN substance to potential alternatives may be provided. 

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

of this substance. See Instructions Manual and Pollution Prevention Guidance manual for . 

guidance and examples. 

.Describe tbe expected net benefits, such Ii(1) an overall rec:luction in risk to human health or the environment; (2.) a rec:lUdion in 

the volume manufactured; (3) a rec:luction in the generation of waste materialsthrough recycling.. soun:e rec:luction or other 

meanSi (4) a reduction'in potential toxicity at human expoeure and/or envtrorunental reieue; (5) an inaeue in product 

performance, a decrease in the cost of production and/or improved operation efficiencyof the neW cbemical substance in 

comparison to existing chemical substancesused in simi1ar applkatiol\l; or (6) the extent to which tbe new cbemical substarice 

may be a substitute for an existing substance that poses a greater overall risk to human health or the environment. 

. 

. 

-

• 

·0 Mark (X) this boX if you attach a continuation sheeL 

'. 

Palin 
-

Part III - LIST OF A TIACHMENTS 

'. 

Attach continuation sheets for !ledions of the form and lest data and other data (including physical/ chemiC:aJ. properties and 

structure/ac:tivity information), and optional Information after this page. Oearly identify the attachment and the Hdion of the form 10 

which it relatel$, if appropriate. Number consecutively the pages of the attadunents. In the column below, enter the inclWII.ve page 

numbers of each attachment. . . 

Marlc (X) the "Confidenlial8 box next to any attachment name you dalm as confidential. Read the IMtracticxl. Mamlai fer 

guidance on how to daimany information In an attachment as amfldentiaL You must Include with the sanitized copy of the notice 

form a sanitized version of any attachment In which you claim information as confidential 

Attachment name 

" 

Attachment 

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 the attac:bment name ad. number. 

FORM EPA 111()'2S (Rev. 5-95) Page 12 
YH 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 . of the 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 "befor the neat (1~ 

pure)cltemical substance. Properties that are measund for mixtures or formulations should be so noted ('!(. PMN substance In _ ).You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplify review and ensure 

that amfidenlial information is properly protected. Yau should submit this worksheet as a supplement to your submission of test 

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 of neat substance _ (s)_(I)_uv 

Vaporpressure "C @ Temperature Torr •

Density/relative density g/an3 

Solubility "C. @ Temperature 

Solvent giL 

Solubility in water • Temperature "C '''C 

Melting ten'I~ture "C 

Boiling/sublimation tem-perature • torr prellUl'e 

Spectra 

Dissociation amstant , " 

Partide size distribution 

" 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 It-) - to Y 


CONFIDENTIAL I¥ 
Full Notification Report: ~ 1 

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 

200 

300 (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..... ,~ ___ _____ _ 
Full Notification Report: ~~ 2 

ENGL 

4452 ::TINGEN 

The test substance does not require any labelling 
Full Notification Report: ~ 3 

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: 

"'1'7 

Full Notification Report: 4 

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 

Full Notification 5 

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: 

i ENGL

,Effects in the organs (related to treatment) : 

iMethOd' ENGL 

!BOdY responsible for test: 

! 

Icomments, I ENGL 

11 

Full Notification Report: ~.~ 6 

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 

ILimi t test x ] 

I 

o : > 5,415 mg/l 

95% confidence limits:

: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 
Full Notification Report: 8 

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 o 

Full Notification 9 

4.1. 30 Acute Toxicity: Administered cutaneously 

Number: 1 


of toxicity related to dose level used, 

of onset and duration: 

local 

scales 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 

Full Notification Report:f~ 10 

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 classified 

irritant 

classified as corrosive 

X 

White (SPF) 
Full Notification Report: 11 

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

Full Notification Report: 12 

substance does not require any label 
Full Notification Report: 13 

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 

0 
Full Noti ion Report: 14 

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 labell 
15 Full Notification ,f ' 1,'l'.1!~· IfI A" ",'" ,/'

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 
Full Notification Report: ~ 16 

(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 

basis the below and in

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) 
Full Notification Report: ~ 2 

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 weight 
Full Notification Report: 3 

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. 
Full Notification Report: 1 

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 

!precipitation : 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: 
Full Notification Report: 2 

: .-, did not show any evidence of mutagenic activity in this 

! bacterial systems. 
Full Notification Report: 1 

4.3.21 Mutagenicity: Non-bacteriological studies in vitro 

Number: 1 

iIn vitro mammalian cytogenicity 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 

lVehicle: 

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 
Full Notification Report: 2 

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. 
Full Notification Report: 1 

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 
Full Notification 4 

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 exposure 
Full Notification Report: tI~ 5 

5.1. 03 Growth inhibition test on algae 

Number: 1 

'Limit 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. No 

Full Notification 6 

classification is then required based on C.3 test on ...., 
Full Notification Report: 7 

5.1. 06 Inhibition of microbial activity (if available) 

Number: 1 I 

i 

Type 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 
Full Notification Report: 8 

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) 

ENGL 
Full Notification Report: ••• 1 

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 
LIValence RECEiVED

r: Cl ;:).,. U ,"' j (' vi i I 11'--' '-' "Technology, Inc. 

March 4, 2003 

Ms. Edna Pleasants 


Program Manager 


U.S. EPA 


Office of Pollution 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 of the 

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 of all of the safety and 

health studies which were conducted by Valence Technology BV in Ireland. 

In order to complete your files, we are providing copies of the summaries of the 


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 of the studies, however, should the agency feel that they would like to have 

copies of all or any of the full text of the 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 if you 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 


,