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CHrurcn lPnooucrsConpoRATIoNCARTERSVI LLE . EORGI A 0 1 2 0

POSTOF F ICEBOX 2 4 7 0

July13,2006TELEPHON 770-382-21 4

FAX 770-386-6053

Associate irectoror CommunicationsOfficeof theDirectorNationalnstitutesf HealthBuilding ,Room 449000Rockville ikeBethesda, D20892

Subject:May31,2006Request orCorrection f NationaloxicologyrogramTechnical eport 94,NIHPublicationumber 5-3953 RequesthatTR494bewithdrawnecause f factual rrors Additionalnformation

DearMadam r Sir:

A Request orcorrection assubmittedychemical roducts

CorporationCPC), Georgia orporationocatednCartersville,eorgia n

May31,2006underheauspicesfNIH'snformationuality uidelines. PC

requestedt that ime hatNational oxicologyrogram echnical eport 94

(TR494), IHPublicationo.05-3953,ewithdrawnecauseheconclusionspresentedn his echnicaleportwereaccepted y NTP'sBoard f Scientific

Counselors'Technicaleports eview ubcommitteen December, za04

based ponundocumentedeneticoxicologyatapresentedor he irst imeon

December, 2004, ndsubsequentlyncorporatedntoTR4g4.

As a result f a Freedom f Informationct request nadditionalageof

informationasprovidedo CPCon July 11,2AOOnadditiono thatprovidedsan attachmento ourMay31,2006Requestor Correction;hissingle ageof

additionalnformationsattached ereto longwith he NIH etterwhich

accompaniedt. Thisadditionalnformationoesnotprovide ny ndicationhat

Sample 07496n Appendix , TabteE3of TR494 san aliquot f theTR494

testarticle, otNo.5893, s stated nTR494.Theorigin f Sample 07496

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c x e v t c e u P n o D U c r s c o R e o R ' A T ' o NJ u r y 3 , 2 0 0 6

cannotbe verifiedhroughNational oxicology rogram ocumentsnd records,

thusCPC eiteratests requesthatTR4g4bewithdrawn.

Thecopyof a single ageBulkChemical hipment eport ttachedo this

letter emonstrateshat4 samples f Anthraquinone,esignateds Chemical

LotNo.'sGsru 2517770,64005,Y011, nd5893,wereshippedromBattelle,

NTP's ontractor,o BioRelianceorporationnJune22,2004.TheTR494est

article, ot5893, s ncludednthisshipment;he reportedastanalyzed urity

(BCR,11119 11120198)f thissample sg9.4% elative urity onflicts ith he

reported 9.8% urity f the estarticlen TR494.

lf onepresumeshat hese oursamples re he oursamplesnTables3,4,5, and6 of rR494Appendix - Genetic oxicology,henoneof these our

samples as ound o be mutagenico Salmonellayphimuriumtrains A98and

TA100withandwithout 9 metabolicctivation.WhenCPCsubmittedn

aliquot f theTR494estarticle,abeled ot5893when eceived y CpC, o

BioRelianceorporationor preincubationeneticoxicologyesting 112 ears

prior o Battelle'submission,ot5893was ound o bemutagenico Salmonella

typhimuriumtrains A98andTA 100without 9 metabolicctivationnd

mutagenico strainTA98with59 metabolicctivation.

NTPhasbeenunableo produce ny ecordselatinghegenetic

toxicologyestingesultsor he oursamplesdentifiedn heattached hipment

Report s LotNo.'sGSTU2517770,64005,Y011and5893,o thesamples

reportedor the irst imeon December , 2004 n TR494AppendixE as4074g6,

465343, 54984,andA40147.

Thisadditionalnformationas aisedwoadditionaloncernsegarding

theveracity f TR494.First,he Lot5893 estarticlesshown n heattached

shipmenteport s being 99.4o/oelative urity" s opposedo the99.8% urity

of theTR494estarticle tatedn TR494.Secondly,heattached hipment

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c x e v t c e l P R o D U c r s c o n p o R A T t o NJ u r y 3 , 2 0 0 6

report tates,RecommendedStorage onditions:oomTemperature-2SoC)".

Therecommendedtorage onditionstatedby Battelle onflictwith nformation

providedo the December,2004peer eview anelo answerheir oncerns

about ecompositionf mpuritiesn heAe duringmany earsof storage.

TR494 t page20,second olumn, escribesiscussionf this ssue uringhe

thirdpeer eview n December, 2004 s ollows,Dr.Klaunig sked f the

samples ssayed ere heoriginalestmaterial nd f anydegradation ight

haveoccurred uringhe nterval.Dr.Smith epliedhat hiswas hesame

material sed ntheanimal tudies, nd twasstored rozen nder rgon, o

degradationasunlikely.

Mutagenicityssaydata, irst ntroducedy NTP n the hirdpeer eviewofTR494 n December, 2004, urportso demonstratehat heTR494estarticle

is notcontaminatedy mutagenicmpurities,ven houghNTPhadbeennotified

4 and3 years arlier f positivemutagenicityssay esults n2 independenly

obtained nd ested liquots f theTR494 estarticle, ot5893 TheTR4g4est

compound,nthraquinone,AS # 84-6s-1,s nota mutagen,o hepresencef

a direct ctingmutagenicmpurityn heTR494 estarticle onfoundshe

conclusionsresentednTR4g4.

on February 8, 2004, oncern ver he confoundingffectsof

contaminationf theTR494 estarticlewithat eastonedirect-actingutagen

prompted TP'sBoard fScientificounselors'echnical eports eview

Subcommitteeo restricthescope f theconclusionsnTR494by adding

languagetatinghat hese onclusionspplied nly o "Anthracene-derived

Anthraquinone".ontaminationf theTR494estarticlewithmutagens as

believedo be he result f tsmethod f manufactureoxidationf Anthracene.

An explanationf the womore ommon lternative anufacturingrocesses,

the Friedel-Craftsrocess nd he Diels-Alderrocesswasalsopresentedn

TR494.Anthracene-derivednthraquinones very arely,fever,encounteredn

commercen heUnited tates.

Page of4

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C x e v r c e r P n o D U c r s C o n p o R A T I o NJulv 13" 006

The inalTR494,ssuednSeptember,005,wassubstantiallyltered

from hedocumentccepted y he NTP'sBoard f Scientific ounselors'

Technical eports eview ubcommitteen February 8,2004.Acceptancef

thealteredTR494on December , 2004wasbaseduponnewgeneticoxicology

testdataoffered yNTP'sprincipalnvestigatoro demonstratehat heTR494

testarticlewasnotmutagenico Solmonellayphimuriumtrains Ag8,TA1OO,

and A1537,withandwithoutatsg. NIEHS'sesponseo a Freedom f

lnformationct request ubmittedyCPChas evealedhatmutagenicityssay

datapurportingo demonstrateheabsence f mutagenicityn he TR494est

article annotbe associated ithan aliquot f theTR494 estarticle ubmitted y

NTP'scontractor, attelle,o BioRelianceoxicology estArticleRepository.CPC equestshatTR494bewithdrawnntilNTPcanprovide ocumentation

that he TR494estarticles notmutagenico Salmonellayphimuriumtrains

TA98,TA100, ndTA1537without rwithSg metabolicctivation,s sasserted

in TR494.

lf I cananswer nyquestionsoncerninghecontents f this etter, r

provide ny urthernformation,leaseelephone eat 770-382-2144xtension

272or emailmeat cook@cpc-us.com.

Sincerely,

2"zekJerryA. CookTechnical irector

Cc:Ms.HolliBeckermanaffe

Attachments2 pages

Page4 of 4

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DEPARTMENT oF FIEALTH & HI 4AN SERVICES pubtic eatth ervice

il:liil:iHlilxFJ''*'"phone:re.541-3411 F:S:"Jn"lli.!:fli$ffi:t"'Fax: 919-541-4395 Research riangle ark,NC 27709-2239E-mail:minneman@niehs.nih.oov

July11,2006

Mr. JerryA. CookTechnicalDirector

ChemicalProductsCorporationP.O.Box 2470Cartersville, eorgia 30120- 692

RE: FOI CaseNo. 32439

DearMr. Cook:

I write n further eferenceo my letter o youdatedMay 19, 2006. Onepagewas nadvertentlyomitted rom the responsiveecords ent o you.

Please ccept ur apologiesor thisemor. f youhavequestionsbout his elease, leasecontactme.

Sincerely,

I t . . \ / y t ,

pn//Lz2u.//Mz<,Kim L. Minneman

Freedomof InformationCoordinator

Enclosure

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BATTELLE-SHIP

BalfelleThe B:usin * of Innovation

Chernistry upportServicesor theNTP

NIH Contract o.: N0l-ES-05456

Battelle rojectNo.: G004110-CCR

NTP ChemTask o.: CHEM08048

CASNo. : 84-65- l

BULK CHEMICAL SHIPMENT REPORT

ANTHRAQUINONE

9-064-SHIP-379

Iune22,2004

CASNo. : 84-65- l

Battelle askNo.: 9-064-SHIP-379

NT P ChemTask o.: CHEM08048

ProgramSupported:GTX

Amount Shipped: 2 g of each ot into one 15-mLamberglassbottleeach, hipped t ambient emperafure

Shipping ate: 611104

Chernical ot No's.: GSTU 2517770, 4005, Y0ll, &5893

LastAnalyzedPurify:

LotNo. GSTU2517770BCLA, 2125-5122103):99.9o/o

Lot No. 64005 BCLA, 2125-5122103):99.8%

Lot No. 2Y01 (BCLA, 2124-5122103):99.4%

Lo t No. 5893 BCR, l/19-l l l21l98): 99.49'oelativepurity

Recommended torageConditions:Room emperature(-25"C)

Shippedo: bLn- -h4,Co&rt *p1BioReliance

Coordinator, hemicalRepository9630MedicalCenterDrive

Rockvil le,MD 20850

This reportwasprepared y DarrenBrown and eviewed or accuracy y MelissaCloud.

Approvody: Approved yr

Donnr B, Browning,B.S'

Trsk Lcadcr

MelissaA. Cloud, B.S.

Discipline Leader, DataManagsmctrt

Submittedo:

Dr. CynthiaS. Smith

National nstihrte f Environmental ealthSciences

Mail Drop: EC-06

4401Comrnons uilding,Suite10 0

Research rianglePark,NC 27709