U. S. ENVIRONMENTAL PROTEcrION AGENCY 

A EDA PREMANUFACTURE o rn NOTICE 

FOR NEW CHEMICAL SUBSTANCES 

lillili liil! ilill Ilill iii;: Ib II!'II;,: 1Ii!:I II II·; 11 .. 11 ". 1 U :\ 0 (j () () ~' ~ (J 

Enter the total number of pagel 


in the Premanufacture Notice 


·YOIIIII" pamde alllalo-..tJo. "'i".eII .... 1111. toIMIo the ecteal tWit .. b 


.ot ....Ye act•• d.at&. 


P.o. 36G399fwf. PittablUlh,fA 15lSt-U99, Aft!\. TSo. lIset Fcc. 

__ 10 or-.ably-w.uble1oy)'O.. Mae _lIble lIIlI"allelf yot! 

ollefoa yo. Gnaplde tIols (oaa.. )'0 ••ho.tld IUd lIIe "lulrvdiou Ma...llocrr-ualad..l't NotI.6cat1o.. " (the ....lnldl...... M.uI .. aI II n-allable ito. the Toxic 

S"bstacea Cocolool. Ad (TSeA) lafo_.lo.. Sen10e by caUl., 202.-5s.-t4OC. oc I""'., 202.5Sf..5603J. 

o U I. lIS«fee hu bee. 1It.lIlell for lhls .oliee (40 CHt 700.45), IadlGate ia the 1>0_ abon 1MT$-ucrfee IdmllfiGllllo .....ber yo. Jutye ,eaer.&led. 

Remember. YOllr _rfee ID •••ber ..... also .ppe.ICo.yo.rCGm!Spo..dl_, fee .....Itta....w'lI" .. __I to. EPA, HQ A.......U", O,......t.lou Be.... eft Il'M· 

So-c.alled "bladia,"l>u.. ...., '.d..4e4 Illeo..,lt.o..lth. fona foe)'Oll to iIldlColiU 

YOllr wiUla,._ u be boIa.dlo ced.t1a .......yo. lUke I. uu. aotlce,. ••dl 

....pmcltKtJo. YOI-c. prota:tlYc eq.,,.....t ..• nilOptlo." iIlt.ee4e4 to redllClC deLay. tUt lO.tlacl'f __pan)' the dftelopateal of OlUat orden CIt 

SI&alfk.uo.t UN ItoIl.... Ex. I_ 1M _ of ""_plIoa II'ptlGatlo... ",.dl .. 

TMEA, LVE,. LOIlEX) wbcre oatal.lal_.aIIoa proYI4e4 ill ••eIl.oClflaUoa" 

..lttdl .. , OIl ...........,ttcr wIoca ..... Ag...cy .."............_"loa IIppllcaUoa, 

dledd., .......I .. ' 1>0" I. tIols aotlGt dsla.JIaI. by ....,If p",!llbll the ......IK« 

n- ~ct' ..m.otl'" ito. die l.fo~1ota (ace" eIl_1c&I ide.1I1y) reported la 

llw:fonn. 

CONFlDENTlAUTY ClAIMS 

Yo" -..y d.al. _, Iafona.alioa 1......oUa! ... CI01l6dcatJ.aL To -.t.d •• _ ..... *"no. .....tc (X) ..... _ftde.tI,a1 boa - to tll.lafofta.1ota IUt )'0. daI.. 

.. e»..6d_UaL To MScrla d.al. I. _ oIItUdI..-t. dcde or bracl<cl the 

lalo~)'Oa cW", .. coafideall&!. U XO!I dal. lafonn.HgA ill the AgtiU.lll 

maOdc:ptj.al ma Jlalt.aJao ,myfd" I MAlt'"" Balg, pith, IOU" (Jpdudial 

..uacbmnt:;). Foe addl(.Ioa&ll"""""''''''' o. elMalla, lafonlt.otlo.... 

UlafideaU..... reod tlac taltrudlou Ma••aI. 

00 M.uk 00 If Ally 1.'oon.l_ 1ft till....Ieo " d.w.cd u e»..fid.,ntl&!. 

Fonn Approved. O.M.B. No. 2OiIUn12. ApptOYlll F.ltpins 1().31 

AGENCY USE ONLY 

03 S[P 22 


TYPE Of' NonCE (Oedc O.ly Oa.d 

o 

rn 

o 

o 

o 

o 

o LYE Modlflatloa o LOREX Modlfk.atIOlll 

lSlHlSACONSOUDATEDPMNl 0 Y.. 

I 01 melltlal.. 


Il'_li.,. C-.....lcatloa , ""I."lred, .,.ler' 0" P"'Ie Jl 


P&d J - CENUAL INFORMAnON TEST DATA AND OlHER DATA

Yo. .ut prori4e the c:umI;IlU:r coCl'td Ocadc&l Ab...-(CA) N....e 01 lIle Yoa .1ft ",.,M10 .....It aU teat cI.d.a ill :r-r,--10. or co.1ntI __dl_kal ........ce,. ...... II)'O'1 daI. doe Id...UIy _ co.fl4eaII&!. Yo....y ... to ptMWe .......pU_ at aU ........... kaOWll to or.............1' 

ntluuhe _oIUt pcno. 10 .....Il dle.lc&Il4eatlty ....10....... 1 ... for yo.., ".1 __ataI...1e loy ,..-.Ifthese"• .1ft """'ell to tic 1t.e.aJ Ito ...... 

}'OU........10" will ao( "e a).plde ud 1M ... mw wiU .01 bq'" ."tU EPA elyho_1al.ffeda 01 1M .uafactaa,.p_I""dlltdbaUo. 

NceI_IIt... Iato~ A Idtou Ia ...ppod of)'OOII: .....10.1_ ......'d .... e»••-.-..ord..,.....,. "fdie _ dInllc&llllbst.mcc. StandAJd 

releJUCe :r01ll'TS _ fee IdCIIlfflcadOlll a••bcr. Y04I ....1Ib.1t _ odglul Jltcrat.... dlaIIIou ...,be.......cd foe "'iIlllioe opea IId_Wk 

ad two mpla of this aotlce I.d.dlas all tell dw. U )'011 d.alllli!d .lAy Utcratlte. emal!kktat dati fwdHa II EnrUsh!. loll,mmad... of4A 

lalonutlo.... e»ul4catlal. ....ack AftItiud Ulpy mall &180 be ••bmltted. mqsl bu,bmHtcd Iflbq dp apt IVl'£iIII the pm IlIe"',",. Y04I.lt.oOl 

de.uI, JeI_lIf:r wlldhcr........o. tlae •• or oa ... .....roc- Aloo, 

P&d D - H'lIMAN EXPOSURE AND ENVIRONMENTAL RELEASE lIle dlealc&l co.podt_ 01. III.. l...aed ..riaI ........ d be dlacackriz:cd.. 


Followl., ate _pi.. 01. _ .........Iioer d.alL DaI.t aho ... d be 


U the....... several "'lAafadlla,. pl'ClICtS8ln" Of _ opctaUona to be "coaibe4 I. .......Itfe4 .a»niiag10 Ihe "'i.I_CIlta01. S'720.5O of llioe hema,factllft 


P.art II. Mdlou A ....... of th.. _da:, "'P",d.oe tile sectIou ....eeded. NoClfk&loo. Itll.. (40 CHt P&d 7201.. 


Test DlIU (Oedc Below any lad.dell Ia thlillOliee) P&d m - UST OF AITAOIMENTS 

Att.c:h addltloa&l ah.NU If the....... "",oap.p_to ......-«. q.catl_ fully. 
 Y.. Ye Label ucIl co.t1autlo••heel willa lIIe mnapolldlttg 1IOClio. Ur.41tt,. I. Pad. • brito_talI.e d.. 0 o Otherdata 0 Ul.llst theM IlUdomeala, By tatd.oc oIher d...d lIlA., opUoul Y.. IU&Ic. _ ..cala ,uonu"o. IadHed I. the ..oClcc. • Kulth effecII ... lKl • EaYl__talcff....ata Y.. OPTIONAL tNFOIMA11ON 0 Stnoda~act"'lty mlllo""'" 

T. d.at.a _t ..lhe,...-i " 

llioe ._...boIt.oacc. 0.. ,.,.. 11 of...1iI fOl1ft, .paot to_ ...... ,.....,k1e4 foe)'O. 10 

Yo. -..y Ittd"deany 1.10_.....111.)'0. W.aN EPA toe»uldcr I. "".aluiac • PhJ1lk.allOlcaIcal P.,.pertl ..·00 Y.,. 

Ole coatrol of tlac ...b..1It« 

deacril>c poUalioe. ,.....,.,..uo...... lOOCJdl.g l.fo__1oa )'0. -..y ........ IefIldln, 

llioe ._.1Ibtbacc. 

EPA FORM mO-25 (Rev. S-9S) Replaces previous editions of EPA Form m0-25 

Company Sanitized 

I 
PubUc repoding burden foe Chis eoUectioa oC Wormatioa Is estimabid to avera~ 110 hours per respotue, lndudins time foe reviewing instruc:tiOC1Li 

searching edsCing data IOun:es" gathering and znal.ntalnlng the ciata neccled. and completing and reviewing the collection ollnlonnatioa.. Send 

commenb rq;atding the burdat atimate« _yother aspect ollhls eoUectioa 01. Won:n.ttioa.lnclud.in& .uu,edoasfoe reducing Chis burden, 

to OdG, Wormatloa Policy BraDCtt. PM-223~ (,1.5. Envtroamental Profedioa Aptcy. 401 M. St., S. W... WIt'Ihingtoa. D.C 20&60; and to the Office c 

M.n.gema.'lt and Bu~ P Reduction Ad. (2070.0012), Washington. D.C. 2Q5Ql. 

CERTIFICATION 

I certify that to the best of my knOwledge and belief. 

1. 	 The company named in Part Lsection A, lubsec:tion la of this notice fonn intends to manufacture or import for A 

commercial pwpose. other than in small quantities solely for research and development, the substance identified in 

Part I, Section B. 

2. 	 All information provided in this notice is complete and truthful as of the date of submission. 

3. 	 I am lubmitting wlth this notice all test data in my possession or control and a description o(an other data known to 

or reasonably ascertainable by me as required by §720.50 of the Prcmanulaaure Notification Rule. 

Additional Certifica.tion Statements: 

If you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, check the following user fee certification 

statement that applies: 

o 	The Company named in Part I, Section A has remitted the fee of 52500 spedflCd in 40 CFR 700.45 (b), or 

rn 	The Company named in Part I, Section A has remitted the fee oE $1000 for an Intermediate PMN (defined @ 40 Cf'R 700.4: ) in 

accordance with 40 CFR 700.45(b), or 

o The Company named in Part I, Section A is a small business concern under 40 CFR 700.43 and has remitted 

a fee of$100 in accordance with 40 CFR 700.45 (b). 

If you are submitting a low volume exemption (LVE) application in accordance with 40 CPR 723.50 (c) (1) or a Low 

release and low exposure exemption (loREX) application in accordance with 40 CFR 723.50 (c) (2), check: the following 

certification statements: 

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

commercial purposes, other than in small quantities solely for research and development. under the terms 

of 40 CPR 723.50. 

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

o The new chemical substance (or which the notice is submitted meets all applicable exemption conditions. 

o Ifthis application is for an LVE in accordance with 40 CFR m.50 (c)(t), the manufacturer intends to commence 

manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 

30 day review period. 

The aa:uracyof the statements you mabin Ibis notice should reflect your best pn!dictioo of the anticipated facts repdillg the dMmical 

substance described 1Ie.mn. Ally bowing and willful misinlel"pl'eQtioa isSIiljed 10 crimirI.JI penalty pursuant 10 18 USC 1001. -C-o-n-fj-d-en-U-'t-11 

Si~~re and title of Authorized Official (Original Signature Required) Date 

x v 

Signature of agent - (if appUcable) Oat.:

FORM EPA 7710-25 (Rev. 5-95) Page 2 
II. Person 

Submitting 

Notia! 

On us.) 

b. Agent(if 

applicable) 

Part I - GENERAL INFORMATION 

Oly, SCate, ZIP Code 

Name olauthorized oltidal 

Malltng address (number and street) 

Oty. SCate. ZIP Cod~ 

Telephone 

c If you are submitting this notia! as part of a joint submission. mark 00 Ibis \lox. ---------------iIoJoint Name olauthorized official 

Submitter 

(if applicable) 

Mailing address (number and street) 

2. Technical 

Contact 

On US.) 

aly.State, ZIP Code 

Name 

Company 

Mailing 1dd.re9s (number and street) 

aly, State, ZIP Code 

PositiOll 

Telephone 

Position 

Telephone I 

If you have hada prenotice communication (PC) concerning this notice 

and EPA assigned a PC Number to the notice, enter the number. Mark (X) 

if none >- D 

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

substance covered by this notice. enter the exemption number assigned 

by EPA. U you previously BUbmitted. a PMN for this substana! enter the 

PMN number assigned by EPA (i.e. withdrawn or Incomplete). 

--)IJo..... 

If you have submitted a n.otl.oe 01 Booa fide Intent to manufacture or 

import for the chemicalsubstanoe covered by this noUce. enter the 

notice number assigned by EPA. >­

Mark (X) 

if none >- 0 

Mark 

if none 

00 --~~ D

D Manufacture 	 Import Type of Notice - Mark 00 1. 	 2. Only 	 Only 

3. Both D Binding OpUon D 8indingOption D 

Mark (x) 	 Mark(x) 

FORM EPA 7110-25 <Rev. S-9S) 	 Page 3 

X 
Part'l - GENERAL INFORMATION - Continued 

to any llcm you chim as canflclentW. 

Complete eiChec Item 1 CO ..1 01" 2 Alb.tancu, 0( 2 (Polymect) .. appropriate. Coatpldc aU other ttema. 

Uanotbet' penon wtJl Nbadt chemI.a.lldentity lnformation loe you (loe dCher Uan 1 oe 2). mark OQ the boll: at the rJP.t. 0 

the and Iddmls 0( that In. conlinuadoo sheeL > 

1. a.•• 1 01" 2 ch_lcal8Ubltaclcc. flor defi.nltioas 0(dass t and c::lus 2 subslanCll!S, _the "'.truett-. Marlaal) 

a. Class 01 substanoe - M.ui: 00 til Oa.ss 1 or 2 D Oass 2 

b. 	0u:mi.eaJ. name (Currendy c:orted Oumdcal Abstracts (CA) Name that Is c:onslstCllt with 1!:iCA Inventory Ii.stiags lor IIlmUac IlUbstanaes. 

Fora- 1 Nbstanca a CA index Name must be provided. For aus 2 substll.!:lO!S dCher a CA 1ndC'JC Name or CA Preferred Name 

be pRlYIded. whichever is appropriate bued on CA 9C1 nommdature rules and conventions.). 

c. Please Identify which method :you used to devdop oe obtain the sped.fied chem.icallndenlity lnfonnatioo reported In this notice: 


(check one).


[!J Method 1 (CAS Inventory Expert 5et'vic:e - a copy of the Identification DMethod 2 (Other Source) 

report obtained from the CAS Inventory Expert Service must be 

submitted as an attachment to thi$ notice) 

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

CAS' 

e. 	For a da•• l substance, provide a complete and o:xrect chetn.lcal structure diagram. For a cia ..2 substance - (1) Ust the immediate 

precursor substances 'WIth thdr respective CAS Registry Numbers. (2) Describe the nature of the reaction or procas. (3) Indicate the 

range of composition and the typical composition (where appropriate). (() Provide a axrect repcesentative oe partial chemical 

structure diagram. as complete IS can be known. if one can be reuonably ascert.a1ned. 

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

FORM EPA 771().25 (Rev, S09S) 	 Page ( 
Part I. - GENERAL INFORMA nON ­ Continued 

~ Section B - CHEMICAL IOEN1TfY INFORMA nON - Continued 

2. Polymen (For. definldon of polymer, IJCe th~ I".lnaction. Manual) 

a. Indicate the number-average weight of the lowest 1llOl.ecular weight c:xxnposllion ol the polymer you Intend to manufacture . ~:I .lndk:ate awd.m.um weight pera:nt oflow IllOlecu1ar weight .pedes (not Indudlng res1dualmonomers, reactanb, or solvenb) below 

SOO ;wi below 1,000 absolute IllOIecular weight ol that ClOInposltion. 

DeKrlbe the method. 01 DltulU'Cment oc the baN foe 7-r e.tim.atel:ere 0 OdwlrD :(Spedly> 

D lawat l\IUI\!Iu a--ae anoI«uI.ar W'dihc: 

U) IIWdI:nwn weight 11; below SQ.'l1l\OlcQd.ar waght 

NA un awdmwn W'<i&ht below 1000 1I'IOl«u1u -'&he: 

o Mark ()O this box II you_attach a continua don .neet. 

b. You must make separate coafidentlality daims foe monomer or other reactant identity. composition Wonnation, and residuallnforma!ion. 

Mark 00 the -Con/idendal- box next to any item you claIm as coafidential. . 

(l) - Provide the spedfic d:lem.lca1 name and CAS Regbtry Number (If a number exists) ol each monomer or other reactant used In the 

manufacture of the polym«. 

(2) - Mark (X) this column II entry In column mIs cnnfidential 

(3) - Indicate the typical weight percent of each monomer or other reactant In the polymer. 

(4) - Mark 00 the Identity column if)'Oll want a monomer oe other rcactanlll.1td at two weight percent or Ie•• to be luted at part of the 

polymer dellCription on the TSCA Chemical Subatance Inventory. 

(5) - Mark 00 this column It entries In columN (3) and (4) are confidentW. 

(6) - Indicate the maximum weight percent ol each IllOMmCf or other reactant thaI may be present as a resldu.alln the polymer as 

manufactured for commercial purposes. 

(7) - Mark (Xl this column It entry In column (6) is cnnlidential 

Monomer or other reactant and CAS Registry Number ConCi- Identity Conn- Maximum 

m denlial "", .." ....Itl"n Mark 00 denlial residual I~~I (2) (3) (4) (5) (6) (1 ) 

,. ,.. 

,. ,. 

-'" ,. 

,. ,. 

,. ,. 

~ 'L 

,. ,. 

o Mark (X) this box It you attach. continuation .neet. 

c. Please identity which method. you used 10 develop or obtain the specified chemlcalldentily information reported In this notice. (check one). o Method. 1 (CAS Inventory Expert Service - • copy ol the identiftcation report 0 Method. 2 (other source) 

obtained from CAS Inventory Experl ServIce must be submitted as 

an attachment to this notice) 

d. The currently correct OIem1ca1 Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for simUar polymers. 

e. Provide., 'l>r!"'CI representative or partial chemical struclUre diagram. as complete as can be mown. if one can be reasonably ascertained. 

o Mark(X) INS box if you attach a COf\linuation ,hC<i!!. 

FORM EPA 7710.25 (Rev. 5-95) PageS
Part I - GENERAL INFORMATION - Continued 

~ Section B - CHEI'dlCAL IDENTITY INFORMATION - Continued 

1 Imp.cU_ 

e..) -IohaIU)'....to •..,.dty Uo...., H _ • .ob., ...tldp«ed 10'" pnMIllla .... dr...tcal ....fad:veof (orCDao-.:tal ............. 

ho'li4ellle CAS &ecWrJ N...berlf.vaIW>le. V ....roe Are ..waUfted ......... nIoU -..w.ufw.­

(I)) -EstI1IUII& IM ......._ welpa'Jr. of eadlllllplldty. If1Il_Me .aIdcadfIecI ..,..,..... ..........Waf -'lioa 'Jr.. 

lInpurity and CASRegbtry Number Maximum 

(a) per~ :-.

'" 

'" . '" 

'" 

'" 

'" 

... 

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

4. SYllollym_ - Enter Ally chemical synonyms foe the new cheadcal:rubstance Ident1f1ed in IUbsedlon 1 or 2. ~I -

X 

o Mark (X) !his box Ii you attach a continuation sheet. 

S. TRde identification - List trade names for the new chemical Identified in aubeection 1 or 2. 

o Mark 00 this box Ii you attach a continuation sheet. 

6. Cellule chemical name - Ii you daJ.m chemical identity as confidential.. you 1I\1Iat provide a generic chemical name for your substance 

that reveals the specific chemical identity of the new c:bemic:allUbItana! to the maximum extent possible. 

Refer to the TSCA O\emic.al Substance Inventory, 1985 Edition, Appendix B for guidance on developing , , 

generic names. 

Substituted Benzamine thio-ether 

o Mark 00 this boxil you attach a continuation sheet. 

7. Byproducts - pesaibuny byproducts resulting from the manufacture. proc:esslng.. use, or disposal 01 the new chemical subslanc:e. Provide the C \S 

Registry Nuinber if available. 

Byproduct CAS Registry Number 

(1) (2) de;:~i

0 Mark (X) this box if you atta<:h a continuation sheet. 

FORM EPA n}()"25 (Rev ~·95) P;age6 
Part I - GENERAL INFORMA nON - Continued 

.. Section C - PRODUCIlON,IMPORT, AND USE INFORMATION: 

Mark 00 the ~Confidenlial' box next to any Item you dUm as coafidentIa.I. 

L Production volume - Estimate the 1DIximum production volume during the first 12 months of production. Also estimate the 

maximum production volume for any consecutive 12-month period during the first thm:years ofproduction. Estimates should b eon 

1()()<K, new chem.iea.l substance basis. fqr /l1..#w Volume E:umption qpliazlion. if)'0" choose to Irtmt: your lfDtia tz1l1icnDtr produc iorr 

'DOlume'MII 10,DOO kg/yt, t>p«ify ,he f1Oi" ___k (r) in the tnrlllillg ""x. IfgnrnUd, you«re """rill 14 fhU wlllme_ 

Maximum first 12-month production Ckg/yr) Maximum 12-month production ()(:g/yr) Confi­ liadu 

(100~ new chemical substance buis) (100~ new chemical substance basis) dentia1 ~, 

; X 

2­ Ule lnlormatiOl1 - You must maIce separate exmfidentiality dalms foe the description 01 the category 01 use, the percent of produdion volume 

devoted to each category, the formulation 01 the new substana, and other use Wonnalion. Mark 00 the "Con1I.dendal- Box next to any item yOll 

claim as ronfidentiaL a. (t) - Desaibe I*:h intended category of Wfe of the new chemical substance by function and appUcadon. a) - Mark 00 this column If entry in rolumn (I) Is confidential busin_ information (CBl). 

(3) - Indicate your willingness to have the information provided in cclumn 0) binding. . 

(4) ­ Estimate the percent of total production foe the ftrst three years devoted to each category of Wfe. 

(5) - Marie 00 this colwnn if entry in rolumn (4) Is confidential business information (CBl). 

(6) ­ Estimate the peromtof the new substance as formulated in uUxtures, ~ons,. emulsions, lIOI.utions, 01' gels 

as manwactured for commercial purposes at sites under your exmtrol associated with each eategory of Wfe. 

(7) - Marie 00 this column 1£ entry in ro\wnn (6) Is confidential bustn_ Wormation (CBl). 

(8) ­ Indicate 'J{, of producl volume expected for the listed "use-sectors. Mark lX\O('e than one box 1£ appropriate. Mark 

O() to indicate your wt1lingness to have the use type provided in (8) binding. 

(9) ­ Mark 00 this column if entry(ies) in rolumn (8) Is (are) confidential business Information (CBl). 

Category 01 use (1) CBI ."..IIa, Produc- CBI 'J{,1n !CHI 'J{, of substance expected per Wfe ~I 

(by function and application i.e. a dispersive dye for 0pti0tI lion 'J{, Form­ (8) M.arit.: !,.) ulation finishing polyester fibers) [Site- il..On- Indus- Com­ ~iIlclinl 

a> (3) (4) (5) (6) (7) limited swner Irlal mercia] Option (9) 

X ~ X X 

'JI, i'­

~. 

'JI, 'JI, 

'JI, '" ~ '" .,. 'JI, 

'JI, ~ 

~ 'JI, 

"If you have identified a "consumerM use, please provide on a continuation sheet a detailed description of the use(s) of this chemical 

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

consumer products and describe the chemical reactions by which this substance loses its identity in the consumer product. 

o Marie (X) this box U you attach a continuation sheet. 

b. Generic If you dal.m any category of Wfe desaiption in lIUbsection 2a lIS confidential, enter a generic desaiptlon of that 

use category. Read the Inlltruction. Manual for examples 01 peri<: use descriptions. 

deKription 

Raw Material 

..J Mark (X) this box if you atl.lch a continuation sheet. 

3. Hazard Information - Indude in the notice a copy of reasonable faaimi.\e of any hazard warning al.ltement, label, rnatt!rlal safety data sheet. ..... 

nor other information which wl1l be provided \0 any person who is reasonably likely to be expo6ed to this substanoe regilding protective I~ ~- equipment or practices foe the safe handling. transport. use. or disposal of the new substance. List in part III hazard Wonnation you Indude. 

Mark (X) this box if attach hazard information. 

FORM EPA 771()'25 (Rev. 5-9S) Page 7 
PMN Page 8 ; Page 10 of 18 

box next to any item you 

Complete section A for each type of manufacture. processing, or use operation involving the new chemical substance at industrial sites you 

control. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting requirements if or use these "........,ti....n. 

the will occur. 

Site address (number and slreet) 

-------------------------,~ 

.J 

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

additional sites on a continuation sheet, and if any of the sites have significantly different 1 production rates or operations. include all the information requested in this section for those 

I. Batch 

1. Continuous 

Maximum (100% _ chemical Hours/day .~.) 

d. Process description Marl< (X) to indicate your willingness to have your process description binding. 

Use 

Batches/year 

Days/year 

[TI 

[TI 

D 

(I) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon 

drum. rail car. tank truck. etc.). 

(1) Provid~ the identity. the approximate weight (by kg/day or kglbatch on a 100"10 new chemical substance basis). and entry point of all starting materials and 

feedstocks (including reactants. solvents. catalysts. etc.), and of all products. recycle streams, and wastes. Include cleaning chemicals (note frequency if not 

used daily or per batch.). 

(3) Identify by number the points of release. including small or interminent releases, to the environment of the new chemical substance. If releasing to two media 

.llhe same step. assi,gn a second release number for the second medium. 

Mark (X) this box if allach a continuation sheet. 

EPA FORM 7710·25 (Rev 5·95) Page 8 
Part II ­ HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued 

~ Section A ­ INDUSTRIAL SITES CONTROLLED BY TIlE SUBMITrEK - Continued 

2. Oc:capadooal - You. must make:a:=te coalidentiality da.Ims for the detaiptlon of worker ectMty, physiad form of the new chemical 

substance. number of warken expo..t.. and untian Of activity. Mark 00 the -CoNI.denW- box next to any itam you. daim at confidential.. 

. (l) - Desaibe the activities (e.g. bag dumping. tote fWing. unloading drums, umpling, deanlng.. etc.) In whlc:h wod:en may be exposed to the 

substance. 

(2) - Mark 00 this column itentry In column (1) is c:o.nfidential business Information (CBI). 

(3) - Describe any prolective equlpment and engl.neerlng Q)fttrois used to protect workers. 

(4) and (6) -Indlcate you willingness ID have the information provided in column (3) or (5) binding. 

(5) -Indicate the physk:al formes) of the newc:hernI.calsubstance (e.g. lOUd: aystal, granule. powder, or dust) and 'I. new chemical substance (if pal 01 a mixture) at the time 01 exposure. 

(7) - Mark 00 this column itentry In column (5) is amfidential business information (CBI). 

(8) - Estimate the muimum Dumber 01 'WOl'kers involved in eac:h activity lor .n lites COIllblned. 

(9) - Mark 00 this column itentry in column (8) is confidential business information (CBI). 

(10) and (t l) - Esthnate the D'Wdmum duration of the activity for any worker In hours per day and days h. year. 

(12) - Mark 00 this column itenlries in columns (10) and (11) are confidential business information (CB ). 

Wor1ca- acti~ CBI Protectlv" Eq.l.....-u .WIIlI 1'1l),IlQ110CUl(.1 Bladla, CB[ 'of CBI Maximum duration ;:Sl (e.g. bag dumping. drums) Ea,I--'1lI Coac.o" ~~w (e.g.aolid:powdet) =-c:, Worbn and Dew ExpaNd Mrs/day Days/yr 

m m r.n (() auba~c:c ll.} l'7\ (8) (9) (10) nn 12) .. .. ~ 

-!.-~- .... -­

X" Y - X . ~ 

0 Mark (X) this box it you attach a a:mtinualion sheet. 

3. Envirorunenlal R.eleue and DbpoIal- You must make separate CIOl\fiden tiality claims for the release Dumber and the amount of the new chemi ~ 

substanc:e releaxd and otha- release and disp<ll$&l inlormalioa. Mark 00 the -Confidential- box next to each itam you dalm as confidential.. 

(1) - Enter the number of -=II rel_ point identified in the process desaiption,. part II, section A, subsection Id(3). . 

(2) - Esthnate the amount of the new substance released (a) dI.n!ctly to the envlrorlment or (b) into comrol teclmology (in kg/day or leg/batch). 

(3) - Mark 00 this column it entries in colUlJUla (1) and (2) are CIOnfidenUal business information (CBI). 

(4) - Identify the media 01 release Le. stack air, fugitive air (optiooaJ..-lnsUuction Manual),lUriace water, on-site Of off·lite land or indneratiOl • 

POTW. or other (please !!p!d.fy) to which the new substance will be reJeued. from that release point. 

(5) - a. Describe control technology, if any, ,and oontrol efficiency that will be Uged to limit the release of the newsubstance to the environment. 

For releases disposed ofon land,. characterize the disposal method and state whether It is approved.for disposal 01 RCRA hazardous waste. 

On a c:ontinuatl.on .beet, foe each site desaibe any additional disposal methods that wiI.l be WIed and whether the waste Is sub)ed to 

HCOndary Of ta'Uaryon..te treatment b. Estimate the amount rel.eased to the environment after CIOntrol technology (in kg!day). 

(6) - Mark 00 this column itentries in columns (4) and (5) are ClOIIfidenUal buIiness information (CUl). 

('7) - Identif), the destination(,) of releases to water. Please supply NPDES (National ponutant Dbcharge Elimination System) numbers foe dire< 

dischargers or NPDES numbers of the POTW (PubUdy Owned Trcalment Works). Mark 00 it the POTW name or NPDES , Is confidential 

business infonnatioo (CUI). 

Release Amount ofnew substance CRI ,Melfiaor Control technology and eltk:lenc:y (you may Wish to optionallyattach efficiency data) ;:Sl Number rpl"" If'd release I ....... (U (2a) (2b) .... lIfdt.1I 

(3) (4) (Sa) : w.ut 6<l (Sb) 6) 

1 ',.;; I 

X li' II 

I K

t ..... f-­

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(7) Mark (}Q the o POlW provide name(s) below:: CBI o Navigable o Other SpeciEy providR NPOES • ~I 

destinalion(s) 01 - wata-way 

releases to water. 

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

FORM EPA 7711).25 (Rev. 5-95) Page 9 
Part 11- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE - Continued 

~. Section B - INDUSTRIAL SITES CONTROLLED BY onrERS 

Complete lledion B foe typical processlnJ: use operations Involving the newc:hmUc:a1lUbitance lit lites you. do not mntrol.Jmporters do not haw to c:omple«e this lledion foe operatioN ou the U5...however, you mutt npext_y proce!IIIIIng oe ute activities after import. See the lNtructions 

Manual OJmpIdc ......te1tdi7tt B!". ctldt typeofproassmg,at' IUe opaaticm in""'., rile IIt1I1 dIt:mit:al Ifthe same operaUOft Is penorn ed 

at more than one lite desaibe the typical operation <XlmII\Ol\ to these Illes. Identify addilioaalililes Oft • ClOaCinuattoa aheet. 

~. OperalioCl DCKripti_ - To daim Wormation in this IIedion ., mafide.ntial. d.rde oe bracbt the tped8cWOID'I&I1oa that you. claim as ClOnfidentiel 

(1) - Diagram the m.Ijoc urdt operation .ups and chemical. conversions, including Intaim and transport contalnoen (,pedfy­ 5 gllllon PI Ib, 

SSgalJon c:trums. rail c:an. taDk truc:b. etc). On the dlagra.m.ldentify by letter and bri4!Gy d-=ribe each worker IIdlvtty. (2) - Provide the Identity, 

the approximate welsht (by kg!day or kg/batch. on an lOO'J1, newchemical. IUbKance bub), and entry point of aU feecUtoc::b (lnducling n!Actants, 

IOlvents and ...=ts. etc) and of aU products. reqde streams, and wastes. Jndude dean.lng chemicals (note fNqUelC)' II DOt used daily oe p« 

batch). (3) -Id by1\Wl\ba' the points of ftIease. induding ImaIJ oe Inllennltllenl releases, to the envlro_tof the new chemicalllUbstance. 

(4) Please enter the • 01 lit_( rememba' to Identify the IocatiOl\S of these lita on a continuation theet) : 0 

, Ol.les . 

o Mark 00 this box II you. attach a continuation sheet. 

Z. Worker ExpoeurrlEnYiroamallall.dute 

(1) - From the diagram above. provide the letter for: each worker activity. Complete 2-8 foe each worker activity dec:ribed. 

Q) ­ Estimate \he number of workers exposed for: aU ates oombined. 

(4) ­ Estimate \he typlcal. duration of p« worker In (II) hoW'll p« day and (b) days per yeas:. 

(6) - Desaibe physlcal form 01 exposure and "" new chemical. substance Of In mixture), and any protective equipment and engineering conlrois w i!d 

to protect workers. 

(7) ­ Estimate \he percent of the new aubetance as formulated when packaged or used .,• final product. 

(9) ­ From the process dio'Igram above, enter the number of each release point. Complete 9-13 for each reJ,e.a,e point Identified.. 

(lO) ­ Estimate the amount 01 the I\eW substance released (Il) directly to the environment or (b) into control technology to the enviro_t 

(in kglday or kglbatch). 

(12) ­ Describe medla of releae i.e.. stdair, fuPtive air (optional__ Instructions Manual), surface water, on-lite or: olf-lite land or Incineration, 

P01W. orother (specify) and mntro( technology, U any. that wDl be 1.-:1 to limit the release of the new subsbnce to the environment. 

(14) - Identify byproduds which may rendt &om the operatlOl\. 

(3), (5), (8). (11), (13) and (15) - Mark 00 this column If any of the prooeed.lng entries are conlldential business informatiOft <CBD. 

Letter 'ol CBl Duratlon CBI Protective Equip. I 'fom CBI Release Amountol CBI Media of Release ;:Sl 

01 Workers of Engineering Controlsl fonn- Number New &cControl 

Ad- Exposed Exposure Physic:al Form and. "" ulalion SubstAlnce Technology 

ivity new substance ReIeeed 

I 

(lOa) : (lOb) (t) (2) (3) (4a) I (4b) (5) (6) (7) (8) (9) (t1 (12) 13) 

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(14) - Byproducts: 5) 

o Mack (X) this box if you attach a a>ntinWilion sheet. 

FORM EPA mO-25 (Rev. 5-95) Page 10 
OPTIONAL POLLUOON PREVENTION INFORMATION 

To claim inCormation in this section as confidential circle or bracket the specific information that you claim as mnfidential. 

.. ' 

In this section you may provide iIuonnation not reported elsewhere in this fonn regarding your 

efforts to reduce or minimize potential risks associated with activities surrounding 

manufacturing, processing, use and disposal of the PMN substance. Please include new 

infonnation 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 toxidty of chemical wastes by technological 

modification, process and procedure modification, product refonnulation, raw materials 

substitution, and!or inventory control. Recycling refers to the reclamation of useful chemical 

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

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

recycling should emphasize potential risk reduction subsequent to compliance with existing 

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

this infonnation to assess overall net reductions in toxicity or envirorunental releases and 

exposures, not the shifting of risks to other environmental media or non--environmental areas 

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

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

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

of this substance. See the revised Instructions Manual that includes a Pollution Prevention 

manual for guidance and examples. 

Describe the expected net benefits, such as (l) an overall reduction in risk to human health or the environment; (2) a reduction in 

the volume manufactured; (3) a reduction in the generation of waste materials through recycling. source reduction or other 

means; (4) a reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product 

perionnance, a. decrease in the cost of production and/or improved operation efficiency ofthe new chemical substance in 

comparison to existing chemical substances used in similar applications; or (6) the extent to which the new chemical substance 

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

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

fORM EPA 7710-2S (Rn'. S-9S1 P"g-e 11 
Part III -- LIST OF AITACHMENTS 

Attach continuation sheets for sections of the form and test data and other data (including physicaVchemical properties and 

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

which it relates, ifappropriate. Number consecutively the pages of any paper attaclunents. In the column below, enter the inclusive page 

numbers ofeach attachment. Electronic attachments can be identified by filename. 

Marie (X) the "Confidential" box next to any attachment name you claim as confidential. Read the Instructions Manual for guidance on 

how to claim any information in an attachment as confidential. You must include with the sanitized copy of the notice form a sanitized 

version ofany attachment in which you claim information as confidential. 

#I Attachment name Attachment Filename Attachment Contipage number(s) dential 

1 Physical and Chemical Properties Worksheet 1 D 

2 Material Safety Data Sheet 2-3 D 

3 Acute Oral Toxicity Study 4-5 D 

4 Ames Test 6-7 D 

5 Skin primary Irritation Study 8-9 D 

6 Skin Sensitization Study 10-14 D 

7 CAS Inventory Expert Service 15-16 D 

8 Infrared Spectra 17 D 

9 H-NMR spectra 18 D 

10 HPLC Spectra 19 D 

D 

D 

D 

D i D 

D 

D 

D 

D 

D 

D 

D 

D 

D 

[ 1 Ma.rk (Xl this box if you attach a continuation sheet. Enter the atlllchment name and number. 

EPA FORM 1710-25 (Rev 5·95) Page 12 
ATTACHMENT 1 

Physical and Chemical Properties Worksheet 

Cover Sheet - Not Included in Page Count 

13 

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET 

To assist EPA's review ofphysical and chemical properties data, please complete the following worksheet for data you provide and 

include it in the notice. Identify the property measured. the page of the notice on which the property appears. the value ofthe property. 

the units in which the property is measured (as necessary). and whether or not the property is claimed as confidential. If the attachments 

are electronic, give the attachment nwnber (found on page 12) at (b). The physical state ofthe neat substance should be provided. 

These measured properties should be for the neat (100"10 pu.re) chemical substance. Properties that are measured for mixtures or 

formulations should be so noted ('Yo PMN substance in -l. You are not required to submit this worksheet; however. EPA strongly 

.recommends that you do so. as it will simplify review and ensure that confidential information is properly protected. You should submit 

this worksheet as a suPlllement 10 your submission of lest data. This worksheet is not a substitute for submission of lesl data. 

Property Mad {X Page Value Mcasurcdo Conti· 

if nwnber Estimato: ....... (a) provided (1)) (c) MortlXI 

(MorEl (41 

Physical state ofneat substance 0 D . (s) ~(I) D(g) M 0 

Vapor pressure 

@ Temperature °C D Torr 0

Density/relative density 0 glcm3 M 0 

Solubility 

@ Temperature °C D 0 

Solvent gil 

Solubility in water@ Temperature °C 10 0% - gIL - E 0

Melting temperature D °C 0 

Boiling! sublimation temperature@, torr pressure 0 °C M 0 

Spectra 0 See Attachments 0 

Dissociation constant D 0 

Particle size distribution D 0 

Octanol! water partition coefficient D D 

Henry's Law constant D 0 

Volatilization from water D 0 

Volatilization from soil D 0 

pH @ concentration D 0 

Flammability D 0 

Explodability D 0 

Adsorption! coefficient D ]g] 

Other - Specify D 10 

Other - Specify D D 

D MIII1c (X) this box if you attach. """,.."",t"", sheet En\ef !he attachment"""'" and number. 

t • 
ATfACHMENT 2 

Materials Safety Data Sheet 

Cover Sheet - Not lncluded in Page Count 

15 
Material Safety Data Sheet 

Date Prepared: March 11, 2003 

Section I - Material Identification 

Trade Name: 

Chemical Family: Industrial Specialty Chemical 

Importer: .• IC. 

Product Information Telephone number: 

Emergency Telephone Number: CHEMTREC 1-800-424-9300 

Section" -Ingredients Information 

.- ,., '" t" ......~"

>97% 

OSHA PEL and EPCRA 3021372 N/A 

Section III - Physical Characteristics 

Specific Gravity : No information found 

Solubility in Water : Not soluble 

pH value : Not applicable 

Odor : None 

Appearance : Pale tan liquid 

Melting Point : No information found 

Boiling Point : Over 200 degree C 

Section IV - Fire and Explosion Hazard 

Fire and Explosion Hazard : No hazard 

Extinguish Media : Dry chemical, C02. water or foam. 

Fire Fighting Instructions : Keep personnel removed and upwind of fire. Wear self-contained breathing 

apparatus. 

Section V - Reactivity Data 


Stability : Stable 


Incompatibility: Avoid strong oxidizing agents. . 


Decomposition: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides 


Polymerization: Will not occur. 

\ page 2 

Section VI - Health Hazard Data 

Heath Hazards: low hazard in normal handling. 

Acute Oral Toxicity: lD50 >2.000 mg/kg (rats) [Chemical Safety) 

Ames Test Negative 

Skin Irritation: Mild irritant ~.I.1. U.5 (gUinea-pig) [Chemical Safety ) 

Skin Sensitization: Negative (guinea-pig) [ Fuji Internal lab ] 

Carcinogenicity: This chemical is not listed by NTP. IARC or OSHA as a carcinogen. 

Sign and Symptom of Exposure: No information found. 

First Aid Procedure: 

In case of eye or skin contact, immediately flush with plenty of water for 15 minutes. With eye 

contact, get immediate medical attention. If inhaled, move to fresh air. If not breathing give 

artificial respiration. If swallowed, do not induce vomiting and get immediate medical attention. 

Section VII - Precautions for Safe Handling and Use 

Steps to be taken in case material is spilled: 

Scoop up carefully and place in closed container. 

Consult with federal, State and local Regulatory Agencies for appropriate disposal methods. 

Waste Disposal: 

Consult with Federal, State, and local Regulatory Agencies for appropriate disposal methods. 

Precaution to be taken in handling and storing: 

Keep container closed and keep in cool area. 

Avoid inhalation and contact with skin and eyes. Wash thoroughly after handling. 

Section VlII- Control Measure 


Respiratory Protection : Not normally required 


Ventilation : Mechanical exhaust recommended. 


Protective Gloves : Latex type. 


Eye Protection : Protective eye glasses or goggles 


Protective Clothing : Suitable protective clothing is required. 


Others : Shower and eye-wash. 


Section IX - Shipping Information 


Hazard Class: Not regulated by DOT. 


UN Number : N/A 


Packaging : N/A 


NFPA Rating: H-1 F-O R-O 


/ 

ATTACHMENT 3 

Acute Toxicity Study 

Cover Sheet - Not lncluded in Page Count 

/8 

Acute Oral Toxicity Study in Rat with 

Test Period: 1112612002 - 1212212002 

Report prepared: 1212612002 

Test Facility: Chemical Safety Test Center. Saitama Laboratory 

25-1, Oh-azakuroiwa, Yoshimicho, Hikigun, Saitamaken. Japan 

Test Supervised by: Yoshihiko Kamba 

Summary 

Acute oral toxicity of provided by :o~, Ltd. was studied using 

male Sic: Wistar rats. The test substance was dispersed in corn oil (the dispersion 

concentrations were adjusted to keep the feed rate at 10 mllkg) and was administered 

through a metal stomach tube. 

Results: 

Dose (mg/kg) Mortality Unusual Behavior LOSO (mg/kg) Classification 

500 o None >2,000 Less than Mild 

2000 o Sluggishness 

Based on the above, the acute oral toxicity of BEHTA is classified less than mild, using 

the method presented by Hodges et al (American Industrial Hygiene Association 

Quarterly 1949). 

Purpose ofStudy 

Evaluate the acute oral toxicity in rat of - ---- orovided by 

Test Substance and Test Method 

Test Substance: Liquid. 

The dose levels of 500 mglkg and 2000 mglkg were selected. The test substance was 

dispersed in corn oil (the dispersion concentrations were adjusted to keep the feed rate at 

10 mllkg). 

Four weeks old Slc:Wistar male rats (breeder: Nihon SLC) were obtained from Sankyo 

Lab Service and were kept for six days for acclimation. The average body weight of the 

test animals was approximately 100 g when the study started. 

l<f 

The animals were kept in a study room at temperature 23 ±2 degree C, RH 50 ± 10%, 

ventilation - air replacement. 17 timeslhour, and with illumination 12 hours/day. The 

animals were kept in plastic cages and were fed solid feed (MF: Oriental Yeast Industries) 

and water freely until 16 hours prior to the administration ofthe test substance. Only 

water was given between 16 hours prior to and 3 hours after the administration. 

A group offive was selected for each dose level and control. 

The test substance dispersion was administered through metal stomach tube. 

Observations ofthe animals were made immediately after the administration through 6 

hours after the administration, then every day until the 14th day. All animals were put to 

death after the 14th day and autopsy was conducted. 

Results 

Table 1. Mortality 

Dose tlofanimals day day day day day day day day day 

(mglkg) tested 1 2 3 4 5 6 7 8 14 

500 5 0 0 0 0 0 0 0 0 0 

2000 5 0 0 0 0 0 0 0 0 0 

Table 2. Body Weight Change Unit: g 

Dose 10 number day day day day day day day 

(mglkg) 0 1 2 3 4 7 14 

500 1 93 101 108 115 118 134 175 

2 97 107 111 115 117 132 173 

3 98 106 111 117 122 138 179 

4 101 110 115 121 126 142 185 

5 98 107 112 118 123 140 180 

Average 97.4 106.2 111.4 117.2 121.2 137.2 178.4 

2000 6 95 100 110 116 123 140 180 

7 95 92 100 107 113 128 170 

8 101 107 115 118 125 138 185 

9 105 103 104 117 126 145 186 

10 103 98 98 109 117 133 180 

Average 99.8 100 105.4 113.4 120.8 136.8 180.2 

In both test groups, no mortality was observed. In 2,000 mglkg group, the sluggishness 

was observed 30 minutes after the administration but it disappeared in 6 hours. Also in 

2,000 mglkg group, the body weight gain slowed down in the early stage but it was 

normal after 14 days. 

No abnormality was observed in autopsy at the termination. 
ATTACHMENT 4 

Ames Test 

Cover Sheet - Not Included in Page Count 

z/ 

Ames Test , Material Safety Test Center 

1. Test Method: Plate method based on the methodology published by Ames et al (1975) 


and Maron et al (1983) and the guideline for mutagenicity test using bacteria from 


Ministry ofHealth, Labor, and Welfare Japan. 


2. Test Substance: 


3. Solvent: DMSO 


4. Bacteria Strain: Salmonella TAlOO, TA1S3S, TA98, TA1S37 were obtained from Dr. 


Ames of University of California and WP2uvrA was from National Institute of Health 


Science. Only bacteria of which genetic nature were verified were preserved. 


Culture of bacteria grown up to the stationary phase was stored iri small vials at -80 


degree C after 8.2% of OM SO was added. For use in study, it was thawed and seeded to 


nutrient broth at 1 :SOO ratio and was shaken for 10 hours at 37 degree C. 


S. S9 and S9mix: Rat liver S9 was obtained from Kikkoman. S9mix was prepared by 


mixing 10% S9, 4mM NADPH, 4mM NADH, SmM G-6-P, 8 mM MgCI2, 33mM KCI, 


and 100mM sodium phosphate buffer solution (pH7.4). 


6. Plate method: For each concentration level, 0.1 ml of test substance solution was 


mixed with O.S ml of 0.1 M sodium phosphate buffer solution or 0.5 ml ofS9mix and 0.1 


ml of bacteria culture (see 4.). 2 ml oftop agar that contains O.OS J.1 mollml of 


histidinelbiotine was mixed into this and the mixture was spread and set on a minimum 


glucose agar plate. Then the plate was kept upside-down at 37 degree C for 48 hours. At 


the end ofincubation, the number of revertant colonies was counted. Only one plate was 


used for each concentration level, while 2 plates each were used for the negative(solvent) 


control and the positive control. 


7. Observation of growth inhibition: The presence of growth inhibition toxicity was 


checked by comparing the number of fine amino-acid dependent bacteria colonies 


in the test plates with the negative(solvent) control. 


8. Judging the results: As a basic rule, the results were considered positive when the 


number ofrevertant colonies increased as the test substance concentration increased and 


the number of revertant colonies was twice as many as that of the negative(solvent) 


control. 


9. Conclusion: According to this test, the mutagenicity in bacteria of BEHTA is 


considered negative. 

Results of Ames Test Test No: M-02-S201 

Test Sample: 1 . Lot # Y#.I .. 

Test Date: 1112612002 - 1112812002 

Revartant Colony Count 

Bacteria Strain TA 100 TA 1535 WP2IM'A TAG8 TA1537 

S9Mix No Yes No Yes No Yes No Yes No I Yes 

Control (OMSO) 

Count 

Avg 

89 

112 

103 

96 

8 

15 

12 

13 

34 

31 

31 

29 

21 30 

22 34 

10 14 

12 16 

101 100 12 13 33 30 22 32 11 15 

'Mth Test Sample (dissolved In OOSO) 

(mlcrogrammelplate) 

0.3 88 99 8 4 25 21 17 20 5 10 

1.2 88 88 10 7 27 29 G 20 6 8 

4.9 80 115 8 6 18 18 15 20 8 11 

20 82 118 5 11 21 34 11 10 4 11 

78 95 90 4 7 20 29 11 14 5 7 

313 81 87 8 10 24 27 12 15 7 9 

1250 81 81 4 8 16 28 21 11 8 10 

5000 83 80" 6 7' 19 24' 10 23" 9 5' 

• Precipitation was noticed 

Conclusion Negative Negative Negative Negative Negative Negative Negative Negative Negative Negative 

Positive Control 

Substance AF-2 B(a)P NaN3 2-AA Af-2 2-AA AF-2 B(a)P 9-AA B(a)P 

(mictogrammelplate) 0.01 5 0.5 2 0.01 10 0.1 5 80 5 

Count 

Avg 

452 

413 

1098 

1087 

375 

395 

398 

367 

90 

104 

479 

466 

4« 

503 

333 

301 

505 

514 

300 

292 

433 1093 385 383 97 473 474 317 510 296 

AF-2 2-{2.furyl)-3-{5-nitro-2-futyl)aaytamide 

B(a)P Benzo{a)pyrene 

NaN3 SocfIUlll azide 

2-AA 2-Aminoanthracene 

9-AA 9-Aminoaaidide 
ATfACHMENT 5 


Primary Skin Irritation Study 


Cover Sheet - Not lncluded in Page Count 
Skin Primary Irritation Study in Guinea-pig with 

Study period: 1112512002 -<1112812002 

Report prepared: 1112912002 

Facility: Chemical Safety Test Center Saitama Laboratory 

25-1, Oh-azakuroiwa, Yoshimi-cho, Hiki-gun, Saitama-ken, Japan 

Supervisor: Noriko Ohyama 

I. Summary 

Skin primary irritation study in guinea-pig was conducted with· fhe test 

substance was applied for 24 hours to flanks of test animals using occlusive adhesive. 

The results ofskin examinations at 3 hours and 48 hours after the adhesive was removed 

were as follows: 

Test Substance Appearance Primary Irritation Index Classification 

BEHTA Liquid 	 0.5 Mild irritant 

II. 	 Purpose ofStudy 

Evaluation ofskin primary irritation in guinea-pig with < which was provided by 

..,td. 

III. 	Test Substance and Study Method 

I. 	 Test Substance: 

2. 	 Preparation ofTest Solution: Used without dilution. 

3. 	 Test Animal: Hartley white female guinea-pig were purchased from Sankyo Lab 

Service and were kept in metal cages. They were fed solid feed (RC4: Oriental Yeast 

Industries) and water freely for 5days prior to the test. Healthy animals, a group of 

six, with body weight of approximately 350 g were selected for study. Animals were 

kept in a study room at 23 ± 2°C, RH 50 ± 10%, ventilation - air replacement rate 17 

timeslhour, and with illumination for 12 hours (6:00 - 18:00) a day. 

5 

4. 	 Study Procedures: The flanks oftest animals were shaved with electric hair trimmer 

and electric shaver. The cloth (2 x 4 cm) of occlusive patch test adhesive was 

moistened with 0.2 ml ofthe test substance and was applied to the test spot of each 

animal for 24 hours. Examinations of the test spot were made at 3 hours, 24 hours, and 

48 hours after the adhesive was removed and the appearance of the skin was rated as 

follows: 

Erythema formation Edema formation 

None o o 

Light 1 1 

Clear 2 2 

Medium 3 3 

Heavy/Scab/Corrosion 4 4 

Classification: 

P.I.!. 	 Classification 

oto less than 0.5 	 Non irritant 

0.5 to less than 2.0 	 Mild irritant 

2.0 to less than 5.0 	 Moderate irritant 

5.0 to less than 6.0 	 Strong irritant 

6.0 to 8.0 	 Corrosive 

P.Ll. (Primary Irritation Index) is calculated as follows: 

P.LI. = the sum of erythema and edema formation ratings (avg. ofsix test 

animals) after 3 hours and 48 hours of application divided by two. 

IV. Results 

The following ratings were obtained. 

Test 

Animal 

1 

2 

3 

4 

5 

6 

Total 

Average 

3 hours 

Erythema Edema 

0 0 

0 0 

0 0 

0 0 

0 0 

0 0 

0 0 

0 0 

48 hours 

Erythema 

1 

1 

1 

1 

1 

1 

6 

1 

Edema 

0 

0 

0 

0 

0 

0 

0 

0 

Total of Average: 1.0 P.I.1. 0.5 

According to this study, P.LI. of is 0.5 ano is classified mild irritant. 

Note: Positive control test to validate the reliability of the test method is conducted 

periodically with dodecanoic acid, sodium saIl. 
ATTACHMENT 6 

Skin Sensitization Study 

Cover Sheet Not Included in Page Count 

),,7 

Skin Sensitization Study in Guinea-pig with 

Study period: 111612002 - 17J2712002 

Report prepared: 17J2712002 

Facility: I _ Ltd. Raw Material Test Center 

210 Nakanuma, Minamiashigara-shi, Kanagawa-ken, Japan 

Test Supervised by: Atsuko Yuasa 

I. Summary 

Skin sensitization study in guinea-pig was conducted with based on Cumulative 

Contact Enhancement Test method. The number of animals used for testing was: 

4 - preliminary test, 10 - sensitization test group, and 5 - control. 10% ethanol dispersion 

was used for sensitizing and 1 %,0.3%, and 0.01 % dispersions were used for challenging. 

The results were as follows: 

Conc;:entration(%) Solvent Test Group Control 

Positive (%) Avg. Rating Positive Avg. Rating 

1 Ethanol o 0.1 o o 

0.3 Ethanol o o o o 

0.01 Ethanol o o o o 

o Ethanol o o o o 

According to this study, 's not considered a skin sensitizer. 

n. Purpose of Study 

Evaluation ofskin sensitization in guinea-pig with 

Ill. Test Substance and Study Method 

I. 	 Test Substance: . clear colorless liquid) 

2. 	 Preparation ofTest Dispersion: Dispersed in ethanol. 

Preliminary test: 50%, 30%, 10%, 3%, 1 %,0.3% 

Sensitization: 1 0% 

Challenging: 1%, 0.3%, 0.01% 
3. 	 Test Animal: Hartley white female guinea-pigs (Breeder: Nihon Charles River) were 

purchased from Orientlil Yeast and were kept in metal cages. 6 weeks old animals 

(body weight: 350 - 400 g) were used for the preliminary test and 3 weeks old animals 

(body weight: 200 - 250 g) were used for the sensitization test. They were fed solid 

feed (RC4: Oriental Yeast Industries) and water freely and healthy animals were 

selected for study. Animals were kept in a study room at 23 ±2 degree C, RH 50 ± 

10%, ventilation - air replacement rate 15 timeslhour, and with illumination for 12 

hours 

(7:00 - 19:00) a day. 

5. 	 Number of Animals Used: 4 - preliminary test, 10 - sensitization test group, and 5 ­

control. 

6. 	 Study Procedures: 

Study was planned and carried out based on Cumulative Contact Enhancement Test 

method. 

Preliminary test (group of 4): 

Day -14: Epidennal injection of 0.1 ml each of Freund's Complete Adjuvant (FCA) 

was made to two spots of the lower back of the preliminary test group 

animals. 

Day -7: 0.1 ml of each preliminary test dispersion was applied for 24 hours using 

occlusive adhesive to the flank of FCA treated (see above) animals. 

Examinations ofthe skin was made up until 48 hours after the removal of 

adhesive to detennine the concentration range for the sensitization test. 

Sensitization (group of 10) 

Day 0: First sensitization. 2 x 4 cm of lint cloth was moistened with 0.2 ml of 50% 

test 

substance dispersion and was applied for 24 hours to the lower back of test 

animals by occlusive adhesive. 

Day 2: Second sensitization. The same application as the first. 

Day 7: Third sensitization. The same application as the first after 0.1 ml each of FCA 

was injected at two spots in the test area. 

Day 9: Fourth sensitization: The same application as the first. 

Challenging: 

Day 21: 0.1 ml of each test dispersion was applied for 24 hours to the flank of animals 

by occlusive adhesive. 

Examination: 


Day 22: 3 hours after the adhesive was removed. 


Day 23: 24 hours after the adhesive was removed. 

Day 24: 48 hours after the adhesive was removed. 

7. 	 Rating of Skin Reaction 

0; No reaction 

1: Light erythema 

2: Clear erythema 

3: Heavy erythemalEdema 

4. Blister/Scab 

8. Classification is based on positive reaction ratio and rating. 

Rating 

Positive Ratio 0-1.0 1.0 - 2.0 2.0 - 3.0 

0-200.4 A B 

20 - 500.4 B B C 

50 - 800.4 C o 

80%-	 C o 

A: Very mild 	 B: Mild C: Moderate 0: Strong E: Severe 

IV. Results 

Table 1 Examination Results: Preliminary test - Primary skin irritation (n=4) 

3 hours after removal. 24 hours after removal. 48 hours after removal. 

Cone. % 50 30 10 3 0.3 50 30 10 3 0.3 50 30 10 3 

Rating 

1 1 1 2 4 4 4 0 0 2 3 4 4 0 0 2 3 

2 3 3 2 0 0 0 2 1 2 1 0 0 2 1 2 1 

3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

4 0 0 0 0 0 0 2 3 0 0 0 0 2 3 0 0 

5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 

Table 2 Examination Results: Sensitization Test Group (n=lO) 

3hrs 24 hrs 48 hrs 

after after after 

remova remova remova 

I I I 

1°,.{, 	 0.30.4 0.010.4 10.4 0.30.4 0.010.4 10.4 0.3% 

Rating 	 0 9 10 10 10 10 10 10 10 

1 1 0 0 0 0 0 0 0 

2 0 0 0 0 0 0 0 0 

3 	 0 0 0 0 0 0 0 0 

4 0 0 0 0 0 0 0 0 

Positive Over 

ratio(0.4) rating 1 10 0 0 0 0 0 0 0 

Over 

rating 2 0 0 0 0 0 0 0 0 

Avg rating 0.1 0 0 0 0 0 0 0 

>3.0 

o 

E 

4 

0 

0 

0 

0 

0.3 

4 

0 

0 

0 

0 

0.01% 

10 

0 

0 

0 

0 

0 

0 

0 

30 

Table 3 Examination Results : Control Group (n=5) 

3hrs 24 hrs 48 hrs 

after after after 

remova remova remova 

I I I 

1% 0.3% 0.01% 1% 0.3% 0.01% 1% 0.3% 0.01% 

Rating 0 4 4 4 4 4 4 4 4 4 .. 1 0 0 0 0 0 0 0 0 0 

2 0 0 0 0 0 0 0 0 0 

3 0 0 0 0 0 0 0 0 0 

4 0 0 0 0 0 0 0 0 0 

Positive Over 

ratio(%) rating 1 0 0 0 0 0 0 0 0 0 

Over 

rating 2 0 0 0 0 0 0 0 0 0 

Avg rating 0 0 0 0 0 0 0 0 0 

~ 

According to this study - ~s not considered a skin sensitizer. No unusual behavior 

ortest animals was observed uring the test period . 

..3/ 

ATfACHMENT7 

CAS Expert Inventory Service 

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32 
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A1TACHMENT 8 


Infrared Spectra 

Cover Sheet Not Included in Page Count 

3S 
100 

95 

90 

85 .: 

80 ­.. 

i.i 

J 

~ ~ 

-' 

75 -

70 ­

IF! 

~ 65­

60 

55 

50 -'­

45 -­

40 

=/ 

4000 

, 

i 

3500 3000 2500 2000 

Wavenumbers (cm-1) 

1500 1000 500 

8 11: Thu Nov 21 10:46:22 2002 

;q-,,/: 64 2002, 11.2 I (~.) ~fur t<aJ:j} r~t, 

5J'~~~: 4.000 
ATfACHMENT 9 

H-NMR Spectra 

Cover Sheet Not Included in Page Count 

37 
co. 

37 

J'1dH BllJ~dS 

01LN3WHJVLLV 

3 F 6 ~ta (NEt3 ,AcOH~) 

PUMP : LC-IOATVP SYSTEM CONTROLER: SCL-IOA VP 

DETECTER : SPD-IOAVVP AUTO INJECTER : SIL-IOAD VP 

CHROMATOPAC: 6400 DX2 

sample size 

'0.01mg/10ml 

column : Tsk-gel ODS -80TS 03120 column size : 4.6 X 150mm 

flow rate : l~lImin pressure : kg{ 

detector : 254nm range : Aux 

eluent A H20 ; 0.05%AcOH/0.2%Et3N 

BTHF/cl"h<:N =7/3 ; 0.05%AcOH/0.2%Et3N 

" B /,4 :: ~O / <.0