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Federal Register I Vol. 50. No. 223 I Tuesd~y. ~ovember. 19. 1985 I Notices 47603

Coordination Act. General commentsconcerning the project and its resourcesare requested: however. specific termsand conditions to be included as acondition of exemption must be clearlyidentified in the agency letter. If anagency does not file terms andconditions within this time period, thatagency will be presumed to have none.Other Federal. State, and local agenciesare requested to provide comments theymay have in accordance with theirduties and responsibilities. No other.formal requests for comments will bemade. Comments should be confined tosubstantive issues relevant to thegranting of an exemption. If an agencydoes not file comments within 45 daysfrom the date of issuance of this notice.it will be presumed to have nocomments. One copy of an agency'scomments must also be sent to theApplicant's representatives.

Daled:November13.1985.Kenneth F. Plumb.Secretary.IFR Doc. 85-27456 Filed 11-18-85; 8:45 am]BIWNG CODE 6717-G1-M

ENVIRONMENTALPROTECTIONAGENCY

[OPTS-41020 FRL-2924-6)

Seventeenth Report of theInteragency Testing Committee to theAdministrator; Receipt of Report andRequest for Comments RegardingPriority Ust of Chemicals

AGENCY:Bnvironmental ProtectionAgency (EPA).ACTION:Notice.

SUMMARY:The Interagency TestingCommittee (lTC). established undersection 4(e) of the Toxic SubstancesControl Act (TSCA), transmi tted itsSeventeenth Report to the Administratorof EPA on November 1. 1985. Thisreport, which revises and updates the'Committee's priority list of chemicals.adds three chemicals to the list forpriority consideration by EPA in thepromulgation of test rules under section4(a) of the Act. The new chemicals arecyclohe~ane. 2.6-di-tert-butylphenol,and diisodecyl phenyl phosphite. Noneof these chemicals is designated forresponse within 12 months. TheSeventeenth Report is included in thisnotice. The Agency invites interestedpersons to submit written comments on.the Report. and to attend FocusMeetings to help narrow and focus theissues raised by the lTC'srecommendations. Members of thepublic are also invited to inform BPA if

they wish to be notified of subsequentpublic meetings on these chemicals. ITCalso notes the removal of 7 chemicalsfrom the priority list because EPA hasresponded to the'ITC's previousrecommendations for testing of thechemicals. '

DATES:Written comments should besubmitted by December 19. 1985. FocusMeetings will be held on December 16,1985.

ADDRESSES:Send written submissionsto: TSCA Public Information Office (TS-793), Office of Pesticides and ToxicSubstances. EllNironmental ProtectionAgency Rm. E-I08. 401 M St., SW..Washington, D.C. 20460.

Submissions should bear thedocument control number (OPTS-41020).

The public record supporting thisaction. including comments, is availablefor public inspection in Rm. E-I07 at theaddress noted above from 8 a.m. tb 4p.m. Monday through Friday, exceptlegal holidays. Focus Meetings will be ,

held at EPA J-{eadquarters. ~. 2 SouthConference Area. 401 M St., SW.Washington, D.C. Persons planning toattend anyone of the F0l4.uSMeetingsand/ or seeking to be informed ofsubsequent public meetings on thesechemicals, should notify the TSCAAssistance Office at the'address listedbelow. To insure seatingaccommodations at the Focus Meeting,persons interested in attending are

'aksed to notify EPA at least one weekahead of the scheduled dates.FOR FURTHER INFORMATION CONTACT:

Edward A. Klein. Director. TSCAAssistance Qffice (TS-799), Office ofToxic Substances. EnvironmentalProtection Agency. 401 M St., SW..Washington, D.C. 20460.Toll Free: (800-424-9065). In Washington. D.C.: (554-1404). Outside the USA: (Operato,r-202-554-1404). .SUPPLEMEN1:ARY INFORMATION: EPA has

'received the Report of the TSCAInteragency Testing Committee to theAdministrator.

I. Background

TSCA (Pub. L. 94-469. 90 Stat. 2003 etseqi 15 U.S.C. 2601 et seq.) authorizesthe Administrator of EPA to promulgateregulations under section 4(a) requiringtesting of chemical substances andmixtures in order to develop datarelevant to determining the.risks thatsuch chemical substances and mixturesmay present to health and theenvironment.

Section 4(e) ofTSCA established anInteragency Testing Committee to make'recommendations to the Administratorof EPA of chemical substances and

Heinonline -- 50 Fed. Rea. 47603 1985

mixtures to be given priority.consideration in proposing test rules

under section 4(a). Section 4(e) directsthe Committee to revise its list ofrecommendations at least every 6months as necessary. The ITC may"designate" up to 50 substances andmixtures Itt anyone time for priorityconsideration by the Agency. For suchdesignations. the Agency must within 12months either initiate rulemaking orissue in the Federal Register its reasonsfor not doing so. The lTC's SeventeenthReport was received by theAdministrator on November 1. 1985. andfollows this Notice. The Report addsthree substances to the TSCA section4(e)priority list. '

II. New Section of 4(e) Priority List

The Seventeenth Report establishes athird section of the priorty list. This newsection is Part B of the list and containsthose chemicals and categories ofchemicals "recommended with intent-to-designate." Part A continues to list thosechemicals. mixtures. and categoriesdesignated for priority considerationand response by EPA within 12 months.

.and Part C contains those 'chemicals.mixtures. and categories that have beenrecommended for priority considerationwithout being designated for responsewithin 12 months.

The information received followingrecommendation with intent-to-designate of a chemical, mixture. orcategory of chemicals may influence thecommittee either to designate or notdesignate that chemical mixture, orcategory for EPA response within 12months. That decision would beannounced in a subsequent report to theAdministrator.

III. Written and Oral Comments andPublic Meetings

EPA invites interested persons tosubmit detailed comments 9n the lTC'snew recommendations. The Agency isinterested in receiving informationconcerning additional or ongoing health.and safety studies on the subjectchemicals as well as informationrelating to the human and environmentalexposure to these chemicals. A notice ispublished elsewhere in today's FederalRegister adding the three substancesrecommended in the lTC's SeventeenthReport to the TSCA section B(d) Healthand Safety Data Reporting Rule (40 CFRPart 716). The section 8(d) rule requiresthe reporting of unpublished health and,safety studies on the listed chemicals.These three chemicals will also beadded to the TSCA section 8(a)Preliminary Assessment Information

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47604 . Federal Register I Vol. 50. No. 223 I Tuesday. November 19. 1985 I Notices, .i

Rule (40 CFR Part 712) published Dated:November8.1985.elsewhere in this issue. The section 8(a) JosephJ.Merertda.rule requires the reporting of production Director.ExistingChemicalAssessmentvolume.use,exposure.and release Division,' .

information o? the Ii.stedchemical~. Seventeenth Report of the TSCA.Focus ~eetmgs wl~1~e.held to discuss Interagency TestingCommitteeto the

relevant Issues pertammg to ~he Administrator.EnvironmentalProtectionchemicals and to narrow the range of Agency .issues/effects which will be the focus ofthe Agency's subsequent activities in ~ummaryresponding to the ITCrecommendations. '. Section 4 of the Toxic SubstancesThe FocusMeetingswill be held on ControlAct of1976 (TSCA.Pub.L.94-.December16.1985at EPAHeadquarters. 469)provides for the testing ofRm.2 South Conference Area, 401M St.. chemicals in commercethat may presentSW..Washington, D.C.These meetings an unreasonable risk of injury to healthare intended to supplement and expand or the environment.It also provides forupon written comments submitted in the establishment of a Committee (ITC).response to this notice. The schedule for composedof representatives fromeightthe FocusMeetings Is as follows:9:30 designated Federal agencies. to '

a.m., cyclohexane:1 p.m.. 2.6-di-tert- re~ommendche,micalsubst~nces andbutylphenol:2 p.m..diis"Odecylphenyl mixtures (chemicals)to which thephosphite. Admipistrator of the U.S.Environmental

Persons wishing to attend one or more' Pr?te,ctionA~ency.(EPA)should giveof these meetings or subsequent .priority co.nslderatlonfor the

t. th h . I h Idcall promulgation of testing rules.mee lOgSon ese c emlca s s ou . .the TSCAAssistance Office at the toll Sect!on4(e)(1)(A)ofTSCA directs thefree number listed above at least one .Com~J1I.tteeto recom~end to th~EPA

k . d ~dmlJ1lstrator chemicals to which thewee 10 ~ vance. . . Administrator should give priority

A~lwrl.tte,nsubmissions ohouldbear consideration for the promulgation ofthe IdentJfymgdocket number (OPTS- testing rules pursuant to section 4(a).~1020). The Committeeis required to designateIV. Status of List those chemicals, fromamong its

. . '. recommendations.to which,theIn addition ~oaddmg the,th~ce . Administrator should respond within 12

rec~mmendatlons to the priority hst. the months by either initiating a rulemakingITCs Seventeenth Rep~rt notes the. proceedingunder section 4(a) orr~movalof seven chemicals fromthe hst publishingthe Administrator's reasonsmce the last ITCrep~rt bec,aus~EPA for not initiating such a proceeding.Athas responde~ to the Co~mlttee s prior least every 6 months, the Com~itteerecommendations for t~stlngof the makes those revisions in the TSCAchemicals.Subsequent to the lTC's section 4(e)PriorityList that it .

preparation of its Sixteenth Report, EPA determines to be necessary andresponded to the lTC's transmits them to the EPArecommendations for seven additional Administrator.chemicals.The seven chemicals As a result of its deliberations. theremoved and the dates of publication in Committeeis revising the TSCAsectionthe Federal Registerof EPA's responses 4(e)PriorityListby the addition of threeto the ITCfor these chemicals are: chemicals, and is noting the removal of .bisphenol A,'May 17,1985(50FR20691): seven as a result of responses by EPA;.carbofuran intermediates. July22,1985 The Priority List trad~tionallyhas.(50FR29761):2-chloro~1.3-butadiene. been divided into two parts: Part AAugust 6.1985(50FR34546):1.2- containlng those recommendeddibromo-4-(1.2-dibromoethyl) chemicals and groups designated forcyclohexane, May 8.1985(50FR19460): priority consideration and response bydiisopropylbiphenyl, May 3. 1985(50FR the EPAAdministrator within 12.18920):2-ethylhexanoicaCid.May 17. months. and Part B containing chemicals1985(50FR.20678):isopropylbiphenyl. and groups that hav~ b~en . .May 3. 1~85 (50 FR 18920). recomme~ded for ~rlorlty .conslderatlon

Thecurrentlistcontainseleven . by EPAWI~o~tbemgdesignatedfordesignated substances or groups of response wlthm 12m~nths.Although

bstances two hemicals . TSCAdoes not establIsh.a deadline forsu ,~ . , EPAresponse to non-designatedrecommend~dwith mtent-to-deslgnate chemicals and groups, the Committeeand two recommendedsubstances or 'anticipates that the EPAAdministratorgroups of substances. will respond in a timely manner.

Authority:15U.S.C.2603 Beginningwith this report. the part that

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has been called Part B in previousreports will be called Part C,

With this report. the Committee isestablishing a third pari. to be calledPart B. to contain thosechemcials andgroups "recommended with intent-to-designate." The "recommended withintent-to-designate" category is beingestablished to take advantage of recentrules, published on August 28. 1985.promulgating automatic reportingrequirements for non-designated ITCrecommendations und~r the TSCAsection 8(a) Preliminary Assessmentrule (50 FR 34805) and the-TSCA section8(d) Health and Safety Data Report!ng .rule (50 FR 34809).The 8(a) and 8(d)rules require the submission to EPA ofinformation on production. use.exposure and unpublished health andsafety studies that may not be publiclyavailable. The information receivedfollowing "recommendation with intent-to-designate" of a chemical or group ofchemicals may'influence the Committeeto either designate or not designate thatchemical or group. for EPA responsewithin 12 months. in a subsequent reportto the Administrator.

The chemcials being added to thePriority List are presented. together withthe.types of testing recommended. in thefollowing Table 1:

TABLE 1.-ADDITIONS TO THE SECTION 4(e)

PRIORITY LIST, NOVEMBER 1985

Chemical/Group Recommended 8IUd1ea

A. DesignalGd lorresponse within 12monlh8.

. B. Recommended with

Inlent.lCHI8signal.:Cyctohe.- I (CAS

No. 110-82-7).

None.

Health Effects: Chronic to>dcityinctucIing 0I1COg8I1icity endneurotoxic:ily: ter.,ogenIdty.reprOductIve toxicity.

Health Effects: ToxicoIdneIIcs;chronic toxicity.

Chemical Fate: Persistence Inaerobic end anaerobic 8ecfI.menta.

ECOlogIcaIEffects: Acute toxicityto benthic organisms; bIoc:on-cenlration In benthic 0rga-nisms.

2,6-OI-te,,-butyI-phenol" (CAS No.128-39-2).

/

c. Recommended withoutbeing designated lorresponse within 12monthS:

DiiSOdec;yI phenylphosphite ·(CASNo. 25550:098-5).

Health Effects: ToxIcoIdneliC8;aubc:lvonlc toxicity Includingneurotoxicity.

CA Index Names (9 CI)I Cvctohexan..·Phenol, 2.~(I,'-dime1hy\ elllyl}-·Phosphorous acid. diisodecyI phenyl esl.r.

TSCA Inte.ragency Testing Committee

Statutory Member Agencies and TheirRepresentative

Council on Environmental Quality. Harvey Doerksen, Member

. . Department of CQmmerceBernard Greifer. Member and

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47605

ChairpersonEnvironmental Protection Agency

John D. Walker, Member 1

Laurence Rosenstein, Alternate 1

National Cancer InstituteElizabeth K. Weisburger, MemberRichard Adamson. Alternate

National Institute of EnvironmentalHealth Sciences

DouglasBristol.Member 2

National Institute for OccupationalSafety and Health

Rodger L. Tatken, MemberNational Science Foundation

Rodger W. Baier, Me~ber 3

Jarvis L. Moyers. Alternate.Occupational Safety and Health

AdministrationStephen Mallinger, Alternate

Liaison Agencies and TheirRespresentatives

Consumer Product Safety CommissionMarilyn Wind IILakshmiMishra .

Department of AgricultureHomer E.FairchildRichard M.Parry. Jr.

Department of DefenseEdmundCummingsPatrick A. Truman

Food and DrugAdministrationArnold Borsetti,Vice Chairperson

National ToxicologyProgramDorothy Canter

Committee Staff

Robert H. Brink,f;xecutive SecretaryNorma Williams. ITCCoordinator

Support StaffAlan Carpien-Office of the General

Couns~,EPA .Vera W. Hudson-National I.ibrary of

MedicineNotes

(1) Appointed on May 30. 1985.'(2) Appointedon July24,1985.(3) Appointed on August 28, 1985..(4)Appointed on September 16,1985.(5)Appointed on June 27.1985.

The Committee a<,:knowledges and isgrateful for the asslstlance and supportgiven the ITC by the staffs or CRCS,Il)c., and Dynamac Corporation(technical support prime andsubcontractors) and personnel of theEPA Office of Toxic Substances.

Chapter I-Introduction

1.1 Background. The TSCAInteragency Testing Committee(Committee) was established undersection 4(e) of the Toxic SubstancesControl Act of 1976 (TSCA. Public Law94-469). The specific mandate of theCommittee is to recommend to theAdmil\istrator of the U.S. Environmental

Protection Agency (EPA) chemicalsubstances and mixtures In commercethat' should be given priorityconsideration for the promulgation oftesting rules' to determine their potentialhazard to human health and/or theenvironment. TSCA specifies that the .Committee's recommendations shall bein the form of a Priority List. which Is tobe published in the Federal Register.The Committee Is directed by section4(e)(1)(A) ofTSCA to designate thosechemicals on the Priority List to whichthe EPA Administrator should respond

. within 12 months by either Initiating arulemaking proceeding under section4(a) or publishing the Administrator'sreason for not initiat.ing such aproceeding. There is no .statutory timelimit for EPA response regardi.ngchemicals that ITC has recommended

. but not designated for response within12 months

At least every 6 months. theCommittee makes those revisions in thesection 4(e) Priority List that itdetermines to be necessary andtransmits them to the EPAAdministrator.

The Committee is comprised ofrepresentatives from eight statutorymember agencies. four liaison agencies,and one national program. The specificrepresentatives and their affiliations arenamed in the front of this report. TheCommittee's chemical review

.procedures and priorityrecommendations are described inprevious reports (Ref. 1).

1.2 Committee's previous reports.Sixteen previous reports to the EPAAdministrator have been issued by theCommittee and published in the FederalRegister (Ref. 1). Ninety~one entries(chemicals and groups Qfchemicals)were recommended for priorityconsIderation by the EPA Administratorand designated for response within 12months. In addition. one chemical andone group of chemicals werereco.mmended without being sodesignated; .'

1.3 Committee's activities during,this reporting period. Between April 1.~985, and Septeml:!er 30. 1985. theCommittee continued to reviewchemicals from its fourth and fifthscoring exercises. and from nominationsby Member Agencies. Liaison Agenciesand StateAgencies. .

The Committee contacted chemical .manufacturers and trade associations torequest information that would be ofvalue in its deliberations. Most of thosecontacted provided unpublishedinformation on current production.exposure. uses. and effects of chemicalsunder study by the Committee.

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Duringthis reporting period. thE:Committee reviewed availableinformation on 85 chemicals.Threechemicals were selected for addition tothe section 4(e)Priority List. and 18 weredeferred indefinitely. The remainingchemicals are still under study.

On April 4, 1985,the ITCpublished anIntent-to-Designatenotice (50FR13419)that listed three chemical substancesand described additional informationneeded by the ITC to reach a mo"reinformed decision on whether or not todesignate the chemical substances in asubsequent report to the EPAAdministrator. The three chemicalsubstances were IH-benzotriazole(CASNo. 95-14-7).C.I.PigmentGreen (CASNo. 1328-53-6)and N-ethyl-N-benzylaniline (CASNo.92-59-1).Adeadline of September 1.1985wasprovided for receipt of relevantinformation.

Information was received on aquatictoxicity. persistence and measuredamounts in various environmental watersamples for IH-benzotriazole.Theinformation shows that IH-benzotriazoleis unlikely to be present in theenvironment at concentrations that willcause significant environmental effects.The ITChas decided to deferindefinitely further consideration of IH-benzotriazole.

Information received on PigmentGreen 7 shows that the water solubilityof this pigment is in the range 2 X 10-16to 7 XI0-18mg/L at 20 .C. The majorpurpose in obtaining information onwater solubility was to evaluate datafrom aquatic toxicity tests using thepigment entirely in solution. Theextremely low.water solubility ofPigmentGreen 7 obviates aquatictoxicity testing of that sorl. The ITChasdecideil to defer indefinitely furtherconsideration of PigmentGreen 7.

None of the requested informationwas received on N-ethyl-N-benzylaniline. Howevere. otherinformation receive<;lby the Committeeshows that N-ethyl-N-benzylanilineis:(1)Produced at only one location'in theU.S.,(2) used as an intermediate in the

. production of dyes and (3)released towastewater treatment facilities in low tomoderate amounts where it is expectedto sorb to sludge solids. Given thepotential for low releases to surfacewaters at just one geographical location.the Committeehas decided to deferindefinitely further consideration of N-ethyl-N-benzylaniline.

1.4 The TSCA section 4{e)PriorityList. Section 4(e)(1)(B)of TSCAdirectsthe Commiltee to: . .make suchrevisions in the [pr.iority]list as itdetermines to be necessary and. . ..

,.47606 Federal ~~gister /. :Vol. 50. No. ZZ6il T\resday. November 19; 1985 I Notices

transmit them to the Administratortogether with the Committee's reasonsfor the J'twisions." Under this authority,the Committee is revising the PriorityList by adding three che.micals:cyclohexane; 2.6-di-tert-butylphenol;and diisodecyl phenyl phosphite. Noneof these chemicals is designated forresponse within 12 mpnths. The testingrecommended for these chemicals and

the rationales for the recommendationsare presented in Chapter 2 of this report. .

Seven chemicals are being. removedfrom the Priority List because the EPAAdministrator has responded to theCommittee's prior recommendations fortesting them. They are listed in thefollowing Table 2 with' citations to EPAresponses:

Chronic effects including oncogenicityand neurotoxicity (with specialemphasis on neuropathology)

Teratogenicity and reproductive toxicity

Physico/ and Chemica/Information'CAS Number: 11~82-7Synonym!!: Hexamethylene;

HexahydrobenzeneStructural Formula:

TABLE 2.-REMOVAlS FROM THE TSCA S';CTlON 4(e) PRIORITY LIST. APRil 1. 1985 THROUGH

SEPTEMBER 30.1985

EPA ,esponses

Fede,al Registe, citationChemical/Group .

Publication date .

BisphenolA 50 FR 20691 May17. 1985.Catboluranintermediales : 50 FR 29761 July22. 1985.2oChloro-l.3-bu1adiene : 50 FR 34546 Aug.26. 1985.

. 1.2.[)ibromo-4-t1.2-dibromoethyl)cyclOhexane 50 FA 19460 May8. 1985.Oiisopropylbiphenyl 50 FA 18920 May3. 1985.2-Ethylhe.anoicackl : 50 FA20678 May17. 1985.Isopropylbiphenyl 50 FA 18920 May3, 1985.

Empirical Formula: C&H12Molecular Weight: 84

. Melting Point: 6.5.C

BoilingPoint:8O.7.C . .Vapor Pressure: 100mmHgat 25.5CSpecific Gravity:0.7781(20/4.C)Solubility in Water: 55mglL at 25.C

(Ref.16.Kirk-Othmer,1963)Solubility in Organic Solvents: Soluble. in ethanol. ether. acetone. benzene.

petroleum ether. and carbontetrachloride

Chapter 2-Recommendations of the LogOctanol/Water PartitionCommittee Coefficient:3.16(esstimated; Ref.20.

. Konemann.1961)~.1. Chem~calsIY!commendedfor Description of Chemical:Colorless.

prlor~ty,consideration kY the EPA . flammable. mobile liquid with blandAdmInistrator. As provIded br sec!lon. to slightly pungent odor depending on .4(e)~1)(B)of TSCA. the Commltt~eIS presence of Impuritiesaddmg the followingthree chemIcal .substances to the section 4(e)Priority Rationale for Rocommendations

List:cyclohexane; ~:6-di-tert- I.Exposure information~A.butylphenol; and dllsodecyl ~henyl Production/use. Cyclohexane isphosphite. The recommendation of these currently produced by nine domesticchemicals is being mad~ aCte.r manufacturers (Ref.5. CEH.1983;Ref.considering the factors ldentlfje~In . 10.Exxon.1984;Ref.43.USITC.1984)..Insection 4~e)(1)(A).and other avadable. 1963.the U.S.production volumeWasrelevan.tmfo~matlon.as well as .the reported to be 1.66billion pound~ (Ref.professIonal Judgmentof CommIttee 43.USITC,1984).Annual'domesticmemb~rs production capacity is approximately 2.6

Sections 2.3and 2.4of t~ls report . billion pounds (Ref.5.CEH.1963). .present the recommendations and In 1982,approximately 96percent ofsupporting rationales. Secti~n 2.3. the'cyclohexane produced was used inpresents two recommendations wIth the manufacture of adipic acid andintent-to-designl!t~:Sec!lon2.4presents caprolactam via cycloh~xanol andone recommendationwIthout cyclohexanone, respectively, The restdesignation for response within 12 waS principally consumed In solventmonths. . uses. In 1981.about 5 percent of the

2.2 Chemicals designated for cyclohexarteproduced was used as aresponse within 12months. None. solvent for cellulose ethers. essential

2.3 Chemicals recommended with oils. rubber, and paint strippers (Ref.5...intent-to-designatebut not designated CEH.1963;Ref.6. CPS;1962J.for response within 12 months. ..Adipic acid and caprolactam are raw

2.3.aCyclohexane (9CI) . materials used in the production ofSummary of recommended studies. It nylon-6.6and nylon-e. respectively.

Is recommended'that cyclohexane be. :.. Adipic ~cid. cyclohexan?l, and .testcd for the following: . . cyclohexanone are also used as solvents.

Health Effecls: . and as intermediates In the manufacture

Removal of 74 entries was noted Inprevious reports (Ref. 1). To date. 81chemicals and groups of chemicals havebeen removed from the Priority List.

With the three recommendations andseven removals noted in this report. 15entries now appear on the section 4(e)Priority List. The Priorty List is dividedin the following Table 3 into three partsinaJl1ely,Table A.'Chemicals and Groupsof Chemicals Designated for ResponseWithin 12 Months. Table B, Chemicalsand Groups of Chemicals Recommendedwit~ Iptent-to-Designate. and Table C.Ch~micals and Groups of ChemicalsRecommended Without ~eingDesignated for Response Within 12Months. Table 3 follows:

'T ABLE 3.- THE TSCA SECTION 4(e) PRIORITY

. LIST,NOVEMBER1985

. Entry

A. Cllemlcalaand Groupe 01 Cllem!colaA_mendedand OI81gnatlcUorRftPOCIHWltnln12 Monlh8

1 Anthraquinone. : Nov.1984.2. CUmene Nov.1984.3. Mercaplobenzothiazole Nov. 1984.4. MethylcvdOpenlane May1985.5. Octamothylcyclote.,asilo.ane Nov. 1984.6. Pentabromoethyi!lenzene Nov.1984.7. SodiumN-methyl-N-oleoyltaUrine Nov. 1984.8. TelrabromobisphenolA May1985.9. Trietl1yleneglycolmonomethyletller ""y 1985:10.Trielhyleneglycolmonoelhylelher May1985.II. Trietl1yleneglycolmonobulylelhBt May1985

8. Cllemlcaleand Oroupe.01Chemlc811R~mmendeCIWI1I\lnl8nl-To-Oellgne'l

1. Clciohe.ane , Nov.1985.2. 2.6-Di:tert.bu1ylphenoL ; : N~. 1985.

C. Che~la and Groupe of Cll8mlca18RecommendedWIthout BeIng Dealgnaled for Reapon.. Wllhln 12Monilia. . .

1.3.4.OIchIorobenzOlrifluortde ~..2. OiIsodeCyIphenylphosphIle: Nov.1985.. .

Reference

(1) Sixteenth Report of the TSCAInlcragency Testing Committee to theAdministrator. Environmental Protection

. Agency. TSCA Interagency TestingCommittee. May 21. 1985. 50 FR 20930-20939.Includes references to Reporjs 1 through 15end annotative 119tof removals.

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Federal Register I .Vol. 50, Nd.:223 I Tuesday, .Nov.emb~r..19,'1985 I Notices 47607

of plasticizers and polyurethane resins(Ref. 5. CEH. 1983).

B. Evidence for exposure. TheNational Occupational Hazard Survey,conducted by the National Institute ofOccupational Safety and Health (Ref. 25.NIOSH. 1976) from 1972 to 1974.estimated that 68.863 workers in 4.653plants were potentially exposed tocyclohexane in the workplace in 1970.Preliminary data from the more recentNational Occupational Exposure Survey.conducted by NIOSH from 1980 to 1983.indicated that 42.560 workers, including12.020 women. were potentially exposedto the compound in the workplace in

'1980 (Ref. 26. NIOSH. 1984).The 8-hour time-weighted average

(TW A) permissible exposure limit (PEL)for cyclohexane is 300 ppm (1050 mg/m')based on its potential to cause eye andmucous membrane irritation (Ref. 29,OSHA. 1983); the a-hour TW A thresholdlimit value is the same (Ref. 1. ACGIH.1985). In plant inspections' conducted bythe. Occupational Safety and HealthAdministration (Ref. 30, OSHA. 1985)from 1981 through 1985, cyclohexanelevels in 114 workplace'atmospheresamples ranged from not detected to 227ppm. Available industry monitoring dataindicate that cyclohexane .concentrations are below the PEL. Forexample. the arithmetic mean of.56personal 8-hour TWA samples withpotential cyclohexane exposure wasdetermined to be 1.77 ppm (Ref. 40.Texaco. 1984): and. based on 3.586 airsamples (personal and area) taken atfour facilities with potentialcyclohexane exposure (Ref. 35. Phillips,1984), the average concentrations ofcycloh~xane ranged from 0.20 tQ0.54ppm and the maximum concentrationsranged from 0.44 to 113 ppm.

Workers may also be exposed tocyclohexane via inhalation or throughskin absorption in a wide variety ofindustries that use the compound. Forexample, cyclohexane was identified asone of th~ solvents found in breathingzone samples taken from a number ofshoe factors (Ref. 32. PerbelIini et al..1981) in which a commercial hexanemixture was 'used as a solvent. Thepercentage concentrations ofcyclohexane and n-hexane ranged from5 to 42 percent and 20 to 60 percent,respectively. These were the highestpercentage concentrations noted in theworkplace air. The percentageconcentrations for other solvents (2-

. mehtylpentane. 3-methylpentane. andmethylcyclopentane) ranged from 1 to 18percent. In addition. cyclohexane ispresent in regular,. premium, and .unleaded 'gasoline to the extent of 1.58volume percent (Ref. 3 API. 1985; Ref..36.

Sanders and Maynard. 1968); therefore,workers may also be exposed throughcontact with these refined petroleumproducts. .

General population exposure to .cyclohexane may occur, since it hasbeen found in ambient air samples(urban and rural) (Ref. 4. Amts andMeeks. 1981;Ref. 15. Holzer et aI., 1977:Ref. 17, Ioffe et al., 1977). surface watersamples (Ref. 9. Ewing et al.. 1977). andmarine waters (Ref. 22. McAuliffe et al..1980). suggesting the possibility ofwidespread dispersal. Additionalevidence for population exposure maybe inferred from the fact thatcyclohexane was qualitatively identifiedin five of six breast-milk samples takenfrom women in two states.Pennsylvania, and New Jersey.Cyclohexane was not found in either oftwo samples from Louisiana -(Ref. 42.USEPA,1985).

Consumer exposure to cyclohexanemay occur through dermal contact with.andl or .inhalation of. tbe compoundpresent in paints. paint strippers. andgasoline. and from spills of other refinedpetroleum product~ and crude oil.

II. Chemical fate information.Cyclohexane is expected to partitionlargely to the atmosphere with a portiongoing into water. Existing data indicatethat cyclohexane will nofpersist in airor in surface waters and will degraderapidly in both media. Therefore,chemical fate testing is not beingrecommended at this time.

III. Biological effects of concern tohuman health-A. Short-term (acute)effects. In an inhalation toxicity test.

. mice. rabbits; and cats exposed tocyclohexane at 18,000 ppm becamerecumbent within 30 minutes (Ref. 11.Flury and Zemik, 1931).The oral LDsofor the rat.was betw~en 8.0 and 39.0 mLIkg (6.22 and 30.3g/kg) (Ref. 19. Kimuraet al...1971).

B. Metabolism. Cyclohexane has beenshown to be absorbed by several routesincluding inhalation in humans (Ref. 24.Mutti et al.. 1981) and by oral anddermal routes in laboratory animals(Ref. 8. Elliot et al.. 1959: Ref. 37.Sandmeyer. 1984). Cyclohexaneadministered orally to rabbits wasfound in expired air and' urine. It wasoxidized predominantly to cyclohexanoland cyclohexanediol. and to a lesserextent to CCh (Ref. 8. Elliot et al.. 1959).Cyclohexanol appears to be ametabolite of inhaled cyclohexane inhumans (Ref. 31. PerbelIini andBrugnone. 1980). Cyclohexane inhibits invitro noradrenaline-induced respirationof hamster broWJ1fat cells (Ref. 34,Pettersson. et al.. 1980).

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In another metabolism and disposition. study (Ref. 27. NTP, 1984). followingintravenous administration of 0.76 mg/kg [14C]-cyclohexime to adult maleFischer 344'rats. it was demonstratedthat 54 percent of the dose was excretedin the breath in the first hour, 80 percentin 24 hours, and 83 percent in 72 hours.After oral administration at doses of2.000. 1.000, 200. and 100 mg/kg. 78. 76.62, and 63 percent, respectively, of thedose was excreted in the breath over 72hours; with the maximum rate ofexcretion generally occurring within 2 to8 hours. In the same experiments. 12. 15.29, and 29 percent. respectively, of thedose was excreted in urine, compared to14 percent excreted in urine followingthe intravenous dose. Greater excretionof polar metabolites in urine followingthe smaller oral doses is attributed torelatively greater metabolism in liverfollowing absorption from thegastrointestinal tract. No significantexcretion of HC in feces was observed.Unchanged cyclohexane accounted for93 to 99 percent ~f the radiolabelexcreted in breath, but less than 0.1percent of the radiolabel in the urine. Amaximum of 0.04-0.4 percent of the dosewas excreted in breath as the more toxiccyclphexanone or 0.09 to 0.6 percent ascyclohexanal. Less than 0.1 percent ofthe dose was excreted in the urine aseither of these compounds. Cyclohexanewas concentrated primarily in adiposetissues, but these concentrations werevery transient and total excretion wasquite rapid.

C. Carcinogenicity. There have beenrio carcinogenicity studies conductedusing currently accepted standardtesting protocols. It shou~d be noted.however. that cyclohexane was used asa vehicle control in two studies

.identified in the published literature.One study was designed to evaluate thecarcinogenic potential of middledistillates of shale oil and petroleum(Ref. 7. Easley. et at. 1982). The otherstudy compared the tumor-pro'motingactivity Qfpristane and a series of n-alkanes (Ref. 16. Horton. et aI., 1981).Both studies were not of sufficientduration and were conducted in onlyone rodent species using a limitednumber of animals. More importantly.neither investigation was designed todirectly address the carcinogenicity ofcyclohexane. Hence. because of theintended purpose of each study. theseinvestigations must be consideredinadequate for evaluating cyclohexane'scarcinogenic potential.

D. Genotoxicity. Cyclohexane did notexhibit genotoxic effects in variou~genotoxicity test systems. It wasnegative in the Ames test with

. -41608~' 'Fecrer~ ,Register f 'Vol:I50, Nd.;"223I Tuesday" Nove~ber '19.:1985 I Notices

Salmonella typhimurium !ltrains TA98,TA100. TA1535, and TA1537 with and'without metabolic activation (Ref. 23.McCann et al., 1975; Ref. 28, NTP. 1985);in an unscheduled DNA synthesis test.with a human lymphocyte cell culture(Ref. 33, Perocco et al.. 1983): in a,DNAcell-binding assay with Escherichia coli(Ref. 21. Kubinski et al.. 1981); and in amouse lymphoma forward mutationassay and a rat bone marrow cytogenicassay (Ref. 2, API. 1981). In an in vilrostudy (Ref; 39. Seemayer andManojlovic. 1982), cell cultures ofkidneys from Syrian golden hamsterswere incubated for 18 hoUl's withcyclohexane at various concentrations(not stated) and subsequently infectedwith SV40-virus. Inoculation of in vitrotransformed cells into Syrian goldenhamsters induced malignant,tumors athigh frequency: .no other informationwas given.'It was also positive in theSV40 virus-induced cell transformationsystem (Ref. 39. Seemayer andManojlovic.1982). .

E. Reproductive effects. teratogenicityand embrjiotoxicity. No publishedinformation was found.

F. Chronic effects. No publishedinformation was found.

G. Subchrollic effects-Rats exposedto cyclohexane in an inhalation chamberat concentrations o( 300. 1.000 or 2,000ppm, 6 hours/day. 5 days/week for 2weeks, showed reduced enzymeactivity. especially brain azoreductase(Ref. 38, Savolainen and Pfami. 1980).Rabbits exposed to cyclohexane at 434or 786 ppm for 6 hours/day for 50 daysshowed no toxic changes in the tissuesat the low-dose level and minormicroscopicchanges in liver and '

kidneys at the' high-dose level (Ref. 41.Treon' et aI., 1943): however, some of therabbits died after exposure tocyclohexane at concentrations rangingfrom 7.400 to 18.500 ppm. 6 hours/dayfor 10'days.

H. Neurotoxicity. Cyclohcxane hasbeen shown to be a central nervoussystem (CNS) depressant. Observedeffects have included dizziness. nausea.and unconsciousness (Ref. 37,Sandmeyer, 1984). At high vapor .concentrations, convulsions in rabbitshave also been reported (Ref. 14.Gosselin et aI., 1984). In addition,cyclohexane has been reported to besuspect in producing classical solvent-induced polyneuropathies (Ref. 10.Exxon. 1984). In a description of aclinical case (Ref. 12. Franco et at. 1979).peripheral neuropathy was' identified i~an automobHe 'painter exposed to paintsolvents. Analysis of environmental airsamples indicated the presence ofcyc1ohexane. acetone. toluene, xylene,and isobutyl alcohol in concentrations

below the TLV. No tricresyl phosphateor lead was observed. The authorsattributed the presence of neurologicsy~ptoms tp'cyclohexane exposure.basmg their conclusion on the symptomsand the apparent absence of substanceswith known neurotoxic properties.,

In one animal study (Ref. 13. Frontaliet al.. 1981) six to nine rats wereintermittently exposed to cyclohexane (9to 10 hours/day. 5 to 6 days/week) viainhalation for up to 30 weeks atconcentrations of 1.500 and 2.500 ppm.Post-exposure histologic examination ofboth tissue and sectional preparationsfrom the peripheral nervous system didnot reveal any pathologic alteration: theCNSwas not examined. In the same '

study, rats treated with n-hexane at2,500 ppm for 30 weeks and 5,000 ppmfor 14 weeks developed solvent-inducedgiant axonal neuropathies.

The experimental' evidenceaccumulated to date. relative tocyclohexane's neurotoxic potential. isvery limited. The human experience andthe conclusion drawn may bequestionable (Ref. 12, Franco et a1..1979). and the animal study (Ref. 13,Frontali et al.. 1981) reflects dataobtained from histologic observations ofonly the peripheral nervous system (an'dnot the CNS)following30weeks of .

exposure. No definitive experimentaldata appear to exist in the publishedliterature on the potential ofcyclohexane to induce pathologicchanges. not necessarily in theperipheral nervous system but moreimportantly in the CNS, following long-term chronic exposure.

I. Rationale for health effectsrecommendations. The large produ,ctionvolume and many of the uses ofcyc10hexane indicate the potential forwidespread human exposure. Thenumber of wor-kers occupationallyexposed is high. and there is thepossibility for general populationexposure from cyclohexane's use as asolvent. Cyclohexane has also beendetected in body fluids and in ambientair and water. Data are lacking onchronic effects, including oncogenicity.In particular. there is an absence ofinformati,on on the neurotoxicity (withspecial emphasis on extensivepathologic examination of the CNS) ofcyclohexane following long-term chronicexposure. In addition. no data areavailable on potential teratogenic andreproductive effects resulting fromexposure to this chemical. Based on thepotential for human exposure and thelack of adequate information on thehealth effects of cyclohexane. 'a chronictoxicity study. includ!ng bothoncogenicity and neurotoxicity is

HeinOnline -- 50 Fed. Rea. 47608 1985

needed, as well as testing forteratogenic and rep~dl;1ctive effect".

IV..Ecological effects. Several staticacute toxicity tests with aquaticorganisms ha vi!'indica ted modera tetoxicity (LCsovalues greater th,an 10 andless. than 100 mg/L), but measuredenvironmental concentrations (low p.g/Lor less) and expected rapid degradationin air and water suggest thatcyclohexane will not cause adverseecological effects at concentratio{lslikely to be found in the environment.Therefore. ecological effects testing isnot being recommended at this time.References

(1) ACGIH. 1985. TLVs: Threshold LimitValues and Biological Exposure Indices for1985-86. Cincinnati. OH: AmericanConferencesof GovemmentallndustrialHygienists. pp. 14. 37.

(2) API. 1981. Mutagenicity evaluation ofcertified cyclohexane: mouse lymphomaforward mutation assay. rat bone marrowcytogenetic assay [draft report). Washington.DC: American Petroleum Institute. ..,

(3) API. 1985. Unpublished information onconcentrations of cyclohexane in unleadedgasoline provided by C. Taylor. AmericanPetroleum Institute. March 19. 1985.

(4) Amst RR. Meeks SA. 1981. Biogel1ichydrocarbon contribution to the ambient airof selected areas. Atmas. Environ. 15(9):1443-1651.

(5) CEH. 1983. Chemical EconomicsHandbook. Sections 638.5061A-5063B.'MenloPark. CA: SRI Intemational. .. (6) CPS. 1982. Cbemical Products Synopsis.Courtland, NY: MansvilIe Chemical Products.

(7) Easley JR. Holland JM. Gipson LC,Whitaker MJ. 1982. Renal toxicity ,of middledistillates of shale oil and petroleum in mice.

. Toxicol. AppI. Pbannacol. 85:84-91.(8) Elliot TH, Parke DV. Williams RT. 1959.

Studies in detoxication. 79. Tbe metabolismof cyclo[lfC]hexane and its derivatives.Biochem. J. 72:193-200. .

(9) Ewing BB. Chian ESK. 'Cook Je. EvansCA. Hopke PK. Perkins EG.1977. Monitoringto detect previously unrecognized pollutantsin surface waters. EPA PubI. No. EPA 560/6-77-ml. p. 72. .

(10) Exxon. 1984. Unpublisbed informationon the production and toxicity ofcyc10hexane submitted by H.L. Hunter.Exxon Chemical Americas. August 30. 1984.

(11) Flury F. Zemik F. 1931. Hannful gases.fumes. vapors. smoke and dust. Berlin:Springer (In German). pp.,274-275.

(12) Franco G, Moglia A. Ghittorl S. 1979.Occupational polyneuropatby attributable tocyclohexane (In Italian. with English

. abstract). Med. Lavoro 2:118-124., (13) Frontali N. Amanlini MC. Spagnolo A.

Guarcini AM. Saltari MC,.~rognone F;Perbellinl L. 1981. Experimental neurotoxicityand urinary metabolites of tbe CI-CJaliphatic bydrocarbon!! used as glue solventsin shoe manufacture. Clln..Toxlcol..18:1357-1367. . " ' .

(14) Gosselih RE. SmiiliiW. Hodge HC.1984. Clinical Toxicology of Commercial

.__u_______ -- - ....-

Fedel'al Register / Vol. 50. No. 223 / Tuesday. November 19. 1985 / Notices 47609

Pr()(lul:ts. 5th ed. Baltimore/I.ondon: Williamsand Wilkins. pp. 11-150-151. .

(15) Itolzcr G. Shanneld 1-1,Ziatkis A.Derlsch-W. JUlirezP.Mayneld H. Liebich liM.1977.Cllllcl:lion and analysili of traceorgnanic emissions from nalural sources.J.Chromutogr. 142:755-764.

(16) lIorton AW. Bolewicz LC.BarstadAW. Bulls CK.1981. Comparison of thepromoting IIctivity of pristane and n-alkancs',in skin carcinogenesiswith their physical .effects on micellar modelsor biologicalmembrnnes.Biochim. Biophys. Acta 648:107-112.

(1711offeBV.lsidorov VA. Zenkevich tG.1977.Gas chromatographic-massspectromctric determination of volatileorganic compoundsin an urban atmosphere.J.Chromatogr. 142:787-795.

(181Kirk-Othmer. 1983.Kirk-OthmerEncyclopedia of Chemical Technology. 3rded. Vo{. 21.New York: JohnWiley toSons.Inc. pp. 378-389.

(19) Kimura ET.Ebert DM. DodgePW. 1971.Acute toxicity and limits of solvent,residuefor sixteen organic solvents. Toxico\. App\.Pharmaco\.19:699-704.

(20) Konemann H. 1981.Quantitativestructure-activity relationships in nsh toxicity

, studies. Part 1:Relationship for 50 industrial '

pollutants. Toxicology 19:209-221.(21) Kubinski H. Gutzke GE.Ku}>inskiZOo

1981.DNAcell-binding (DCBI assay forsuspectedcarcinogensand mutagens.Mutul.Res.89:95-136.

(22)McAuliffe CD.JohnsonJC.Creene SH.Canevari GP.Searl ro. 1980.Dispersion andweathering of chemically treated crude oilson the ocean.Eriviron. Sci.Techno\.14(12):1500-1518. ;

(23)McCann J.Choi E.Yamasaki E.AmesBN. 1975.Detection of carcinogensasmutagensin the Sa/moflcl/a/microsome test:assay of 300chemicals.Proc.Nutl. Acad. Sci.U.S.A.72:5135-5139. .

(24)'MulliA. Falzo!M. LucertiniS.Cavatorta A.Franchini I. Pedroni C.1981.Absorption and alveolar excretion ofcyclohexane in workers in a shoefactory. J.Appl. Toxico\. 1:220-223.

(25) NIOSH. 1976.National OccupationalHazard Survey (197Z-1974)Iduta basel.Cincinnati. OH: Department of Health andHuman Services.National Instil ute forOccupational Safety and Health.

(26) NIOSH. 1984.National OccupationalExposure Survey (1980-1983)Idata basel.Cincinnati. OH: Department of Health andHuman Services.Nationallnslitute forOccupational Safety and Health.

(27) NTP.1984.Personal communicationfrom D. Canter. National Toxicology Program.lune 11.1984.

(28) NTP.1985.Personal communicationfrom D. Canter. National Toxicology Program.October 3. 1985.

(29)OSHA. 1983.OSHA Safety and HealthStandards for Cenerallndustry. 29 CFR1910.Subpart Z. U.S.Department of Labor.Occl\Pational Safety and HealthAdministration. Pub\.No. 2206.Washington.DC: U.S.Covt. Printing Office. pp.600-601.

(3D)OSHA. 1985.Personal communicationfrom S.Mallinger. Occupational Safety andHealth Administration. October 3.1985.

(;J1)Perbellinl L. Brugnone F.1980. Lung'uptake and metabolism of cy.clohexaneIn

shoe factory workers. Inl. Arch. Occup.Environ. l'leallh' 45:261-269.

(32) Perbellini L.BrugnoneF.CaffuriE.1981.Neurotoxicmetabolites of "commercialhexane" in the urine of shoefactory workers. .Clin. Toxii:ol. 18:1377-1385.

(33) PeroccoP. BolognesiS. Alberghini W.1983.Toxic activity of seventeenindustrialsolvents and halogenatedcompoundsonhuman lymphocytes cultured in vitro.Toxicol. Lell. 16:69-75.

(34) Pellersson B. Curv~1IM. Enzell CR.. 1980. Effectsof tobaccosmokecompoundsonthe noradrenaline induced oxidativemetabolism in isolated brown fat cells.Toxicology 18:1-15.

(35)Phillips.1984.Unpublishedinformationon exposure to cyclohexane submitted by J.I.Moon. Phillips Petroleum Co. October 2. 1984.

(36) Sanders WN. Maynard JB. 1968.Capilla'ry gas chromatographic method fordeterminingthe cre.. hydrocarbons in full-range motorgasolines. Ana\. chem.40(3):527-535. .

(37) Sandmeyer J;:E.1984. Alicyclichydrocarbons. In: Clayton CD. Clayton FE.eds. Patty's IndustrialHygieneand .Toxicology. 3rd ed. Vo\. 2B. New York: JohnWiley &Sons. pp. 3227-3228.

(38) Savolainen H. PCafmP. 1980. Burdenand'dose-related neurochemicaleffects ofintermittent cyclohexane vapour inhalation inrats. Toxico\. Lett. 7:17-22-

(39) Seemayer NH. Manojlovic N. 1982.Enhancementof malignantcelltransformation by city smog extract andvarious fractions of Syrian hamster kidneycells infected with simian virus 40. BioI. Cell45:42.

(40) Texaco. 1984. Unpublished information.on worker exposure to cyclohexane .submilled by R.T.Richards.Texaco. Ine.September 19. 1984.

(41)Treon JF.Crutchfield WE.KitzmillerKV. 1943.The physiological response ofanimals to cyclohexane.methylcyclohexane.and certain derivatives of these compounds.II. Inhalation: J. Ind. Hyg. Toxicol. 25:323-346., (42) USEPA. 1985. Personalcommunication.froOlB. Fountos. U.S. EnvironmentalProtection agency. October 4.1985.

(43) USITC. 1984. U.S. International TradeCommission. Synthetic Organic Chemicals.United States Production and Sales. 1983.Pub\. No. 1588. Washington. DC: U.S. Covt.Printing Office. pp. 27. 37.

2.3.b 2.6-Di-tert-butylphenolSummqry of recommended studies. It

is recommended that 2.6-di-tert.butyl phenol (DTBP) be tested for thefollowing:A. Chemical Fate:

Persistence in aerobic and anaerobicsediments .

B. Health Effects:ToxicokineticsChronic toxicity

C. Ecological Effects:Acute loxicity to benthic organismsBioconcentration in benthic organisms

Physical and Chemica.1lnformation

CAS Number: 128-39-2

HeinOnline-- 50 Fed. Rea. 47609 1985

Synonyms: Phenol. 2.6-bis(1.1-dimethylethyl)-(9 CI); DTBP

Struclural Formula:

Empirical Formula: CI4HnOMolecular Weight: 206 .Melting Point: 39.C (Ref. 2. Ethyl. 1984)Boiling Point: 253Vaport Pressure: <0.01 mmHg at 20.CSpecific Gravity: 0.914 '

Solubility in Water: 2.5 m'g/L (Ref. 4.Geyer et al., 1981)0.4 mg/L(estimated: Ref. 9. Lyman et al., 1982)

solubility Organic Solvents: Soluble inisopentane. methyl' ethyl ketone.benzene. ethyl alcohol

Log Octanol/Water PartitionCoefficient: 5.43 (estimated; Ref. 9.Lyman et at.. 1982)

Description of Chemical: Light straw-colored crystalline solid

RaUonalefor RecommendatioDs - '

I. Exposure information-A.Production/use. DTBP is produced by atleast two domestic manufacturers.-Thequantity of,DTBP produced domesticallyis m'ultimillion pounds per year, b~t theexact production figures are confidential(Ref. 2.Ethyl. 1984).

DTBp is used primarily (about 95percent of production) as anintermediate in the pr04uction of high-molecular-weight hindered phenolicantioxidants (Ref.2.Ethyl. 1984).Thesecompounds are used to preventoxidative degradation of sy'ntheticpolymers and plastics (e.g.,polypropylene) during processing andservice. DTBP is also used directly as anoxidation inhibitor and stabilizer for fueloils. gasoline, plastics. rubber. and otherproducts. and as an intermediate forsynthetic resins, pesticides. and otherproducts.

B.Occupationalexposure.TheNational Occupational Hazard Surveyconducted by the National Institute forOccupational Safety and Health during.1972-1974 estimated that 2.192 people insix industries were exposed to DTBp inthe workplace In 1970 (Ref.10. NIOSH,1976). It was reported that occupa~lonalexposure to DTBP is confined to reactoroperators. maintenance people. andworkers involved in bulk shipment.loading and off-loading operations.DTBP is manufaclured and used as anintermediate primarily in closed .

47610 Federal Register I Vol. 50, No. 223 I Tuesday. November 19. 1985 I Notices~

systems. resulting in minimal workplacee~posure. Protective clothing (e.g..gloves. goggles. respiratorsJ and localand mechanical exhaust arerec.ommended to control eXI)osure todust during handling (Ref. 2. Ethyl. 1984J.

C. Environmental release. Release towastewater treatment plants fromproduction of DTBP may occur duringwashup or cleaning with solvents. and itis anticipated that this would result in

. the release of 0.002 to 0.004 pounds of

DTBP per day. If entrainment occursduring separation of the aqueous angorganic phases. releases to wastewater

. treatment plants could be greater than 6pounds per day (Ref. 8. Lopez-Avila andHites. 1981). Disposal of containers orsolvents with a residue of 0.1 to 1percltnt DTBP may result inenvironmental releases of 550 to 5.500pounds per year from processing. DTBPwas tenta tively fdentified in threeindustrial and one domestic wastewater

treatment facilities. These areunpublished data but a description ofthe analytical procedures was publishedby Shackelford et al. (Ref. 12. 1983).Releases of DTBP from use may occurduring accidental spills of fuelscontaining DTBP. Available monitoringdata for DTBP are summarized in Table4. The measured concentrationsprobably result from processing or use-related releases and not from

production. Table 4 follows:

TABLE 4.-MEASUREO CONCENTRATIONS OF CTBP IN WASTEWATER. RIVER WATER, AND

SEDIMENT

II. Chemicalfate information-A.Tronsport and persistence. Based on theestimated low water solubility and highsoil sorption coefficient (I<oe> 1.0(0)ofDTBP. the chemical. if released tolandfills. is expected to remain withinthe landfills. Limited data. on activatedsludge biodegradation suggest that lessthan 10percent of DTBPwouldvolatilize or mineralize.but more than '

45 percent would be transformed tometabolites or'remain as unextractableresidues in sludge after 5 days at 25 C(Ref. 3. Freitag et al.. 1982).Extrapolation from these data tosediments suggests that DTBP. or itsoxidation products (quinones). might notbe readily biodegrad~ble in sediments.

Measurements of DTBPand oxidationproducts in sediments at concentrationsof 70 to 760 ppm an'd 7 to 38 ppm.respectively. seem to confirmthissuggestion (Ref. 8. Lopez-Avila andHites. 1981).

B. Rationale for chemical faterecommendations. Based on thereported multimillion pound productionof DTBP. its occurrence in wastewaters.surface waters. and sediments. and itspotential to partition to and persist insediments. data are needed on thepersistence of DTBP in aerobic andanaerobic sediments.

III.Biologicaleffects of concern tohuman health-A. Carcinogenicity.Noinformation was found.

B. MutagelJicity. No information wasfound.

C, Reproductive f!ffects.teratogenicity. embryotoxicity. andfetotoxicity. DTBPwas nontoxic to

. mothers in fetal resorption studies withrats at a total dose of 0.25g for 21days.The DTBP treatment caused large .decreases in tbe number of litters.implantations. and normal fetuses (Ref.14. Telford el at.. 1962).

D. Special studies. Animal testsindicate that DTBP is both a mild eyeand skin irritant (Ref. 2. Ethyl. 1984).Doses applied were 1.0 to 8.0 g/kg.

E. Toxicity-l. Short-term (acute)effects. The acute toxicity of DTBP issummarized in Table 5:

TABLE 5.-ACUTE TOXICITYOF CTBP IN LABORATORYANINALS I

I Sax and number 01 animals not specilie<l.

2.Subacute/subchronic. In subacutefeedingstudies of DTBP in rata. 10maleSprague-Dawleyrats were fed DTBP at.a dose level of 4.55 mmol/kg/ day for 3weeks. Six control rats received alaboratory ration. Two of ten rats fedDTBPdied of hemorrhagingduring the 3weeks. In the two dead animals.hemorrhages in the epididymis. muscle.

thymus. pleural cavity. cranial cavity.submaxillary lymphnode. andintragastric blood pooling wereobserved. The prothrombin index wassignificantly decreased,in animals givenDTBP (Ref. 13. Takahashi and Hiraga.1978).

. F. Chronic. No information was found.

G. Rationale for health effectsrecommendations. DTBP is used inapplications where there Is the potentialfor human exposure. The sbort-termtoxicity of DTBPdoes not appear to behigh; however. on continued feeding.pronounced effects on -the prothrombinindex were observed. In addition. DTBPhas an irritant action. Therefore. studi~s

HeinOnline-- 50 Fed. Rea. 47610 1985

Sampling.

Source 01 DTBP dale Concentration Roference

SpecIaIilies Chemical Plant Wastewater .................... 1976-77 0.6 10 0.6 mg/L ................................ ReI. 6. Jungctaus e1 el.(1976).

Downstream liver waler ............................................... 1976-77 1.6 ug/L............................................. Rei. 6. JungcIaus e1 eI.(1978).

Downstream sodimenl.................................................. 1976-77 0.1 10 ISO mg/kg............................. Rei. 6. Jungc1aus el aI.(1978).

SOdimenl ne3I planl (0 1027 em depth) ................... 1976-77 0.510 180 mg/kg............................. Rei. 6. Lopez.AviIa andHites (1981).

Sedimenl I km downstream........................................ 1976-77 2210 760 mg/kg............................. Ref. 8. Lopez.Avila andHltas (1981).

SpocIes Route Lo,. (mg/ RelerencesKg)

Mouse........_....................._.............................. OIal....................._.............................................. 2.995 Ref. I, Ceo 81 eI.(1982).

Mouse .................................................................. Inlravenous ................................................_... 120 ReI. 5, James endGlen (1980).

Ral..____................................................. 0raI..............__._......._.._.................. 9.200 Ref. 2. Elhyl (1984).Rabbit .........................................................._..... SkJn......................:.............................................. 10.000 ReI. 2, Ethyl (1984).

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. Federal Register "Vol. 50. No. 223,' :ruesday. November 19. 1985 , Notices 47611

on the toxicokinetlcs of DTBP areneeded. as well as studies to delineatethe extent of its chronic toxicity.

IV. Ecological effects of concern-A.Acute effects. No empirical data werefound. However. using the datapublished by Saarikoski and Viluksela(Ref. 11. 1982) and Lipnick et al. (Ref. 7,1985). and using an estimated log P of5.43, the L<40to fish is estimated to beabout 0.28 mg/L. With respect to thisestimate, the effect of steric hindranceon the degree of toxicity is unknown.

B. Chronic effects. No informationwas found.

C. Bioconcentrotion. Abioconcentration factor (BCF) of 800after,1 day was measured in an alga(Chiarella) (Ref. 4. Geyer et a1.,1981).The measured BCF in a fish (goldenorfe), ,was 660 after 3 days (Ref. 3.Freitag et aI., 1982). The estima~ed BCFof DTBP, based on a log P of 5.43 andusing the method of Veith et al, (Ref. 15.1979) is 8.200: the acutal BCF may belower if DTBP is metabolized.

D. Rationale for ecological effectsrecommendations. The available testdata suggest relatively rapid partitioningof DTBP to biological tissues. Based onthis information. the lack of empiricaldata on toxicity. and the measured<:oncentrations of DTBP in sediments.data are needed on the acute toxicity ofDTBP to benthic organisms and on thebioconcentration of DTBP in benthicorganisms.References

(1) Cao C. Zhang. S. Zhang X. 1982.Toxicological study of 4 hindered phenolantioxidants. Beijing Yixueyuan Xuebao.14:105-109. rroXUNE Abstracl)

(2) Ethyl. 1984. Ethyl Corp. Published andunpublished infonnalion on the production.use. occupational exposure. release. andtoxicity of DTBP submitted by R. L Smith.Ethyl COIV..February 1. 1984.

(3) Freitag O. Geyer H. Kraus A.Viswanathan R. Kotyias D. Attar A. Klein W.Korte F. 1982. Ecotoxicological profileanalysis. VII. Screening chemicals for theirenvironmental behavior by comparativeevaluation. Ecotox. Environ. Safety 6:60-81.

(4) Geyer H. Viswanathan R. I:reitllg D.Korte F. 1981. Relationship between watersolubility DCorganic chemicals and theirbioaccumulation by the alga Chiarello.Chemosphere 10(11/12):1307-1313.

(5) 'ames R. Glen JB. 1980. Synthesis.biological evaluation. and preliminarystructure-activity considerations of a series oCalkyl-phenols as intravenous anestheticagents. J. Med. Chem. 23:1350-57.

(6) 'ungclaus GA. Lopez-Avila V Hites RA.1978. Organic compounds in an industrial'wastewater: a case study of theirenvironmental impact. Environ. Scl. Technol.12:6&-96.

(7) Lipnick RL Bickings CK. Johnson DE.Eustmunt OA: 1985. Comparison DCOSi\Rpredictions with fish t~xicity data for 110

phenDls. In: Bahner RC. and Hansen OJ. eds.Aquatic Toxicology a~d Hazard Assessment:Eighth Symposium. ASTM. STP 891.~hiladeJphia. 'PA: American Society CorTesting and Materials. in press.

(8) Lopez-Avila V. Hites RA. 1981.Oxidation of phenolic antioxidants in a riversystem. Environ. Sci. Techno\.15:138~1388.

(9) Lyman WJ. Reehl WF. Rosenblatt OH., 1982. Handbook of Chemical Property

Estimation Methods. New York: McCraw-HiliBook Co.. Chapter 1.

(10) NIOSH. 1976. National OccupationalHazard Survey (1972-1974) [data base].Cincinnati. OH: Department of Health andHuman Services. National Institute forOccupational Safety and Health.

(11) SaatikDski J. Viluksela M. 1982.Relation between physicochemical propertiesof phenols and their toxicity and 0

accumulation in fish. Ecotox. Environ. Safety6:501-512. '

, (12) Shackelford WM. Cline OM. Faas L.Kurth G. 1983. Evaluation of automatedspectrum matching for survey identificationoCwastewater components by gaschromatography-mass spectrometry. Ana\.Chim. Acta. 146(1):15-27. (Note: dataunpublished.)

(13) Takahasi O. Hiraga K. 1978.Therelationship between hemorrhage induced bybutylated hydroxytoluene and its antioxidantproperties or structural characteristicsToxicol Appl. Pharmacol. 46:611-814.

(14) TelCord IR. Woodruff CSt Unford RH.1962. Fetal resorption in the rat as influencedby certain antioxidants. Am. ,. Anat. 110:29-36. 0

(15) Veith GO. Defoe DL. Bergstedt BV.1979. Measuring and estimating thebioconcentration factor in fish. J. Res. Bd.Can. 36:1040-1048. .

2.4 Chemicals recommended withoutdesignation for respollse within 12months

2.4.a Diisodecyl phenyl phosphiteSummary of recommended studies. It

. is recommended that diisodecyl phenylphosphite (PDDP) be tested for thefollowing:

Health Effects:ToxicoklneticsSubchronic toxicity including

neurotoxicity

Physical and Chemical InformationCAS Number: 2555()-98-5Synonyms: Phenyl diisodecyl phosphite:

Phosphorous acid. diisodecyl phenylester (9 CI)

Structural Formula: .

@-o-

O-R/

P"O-R

R= i sodec'y.l

R=isodecylEmpirical Fonnula: C26HuChPMolecular Weight: 438Melting Point: No information was

found.Boiling Point: 200.C at 5 mmHg (Ref. 16.

Witco, 1982)Vapor Pressure: <1 mmHg at 20.C(Ref.

16. Witco. 1982)Specific Gravity: 0.940 25/15.S.C (Ref. 5.

o Borg-Warner. 1983)Solubility in Water: Insoluble (Ref. 5.

Borg-Warner. 1983);0.01-20 ppb(estimated)

Solubility in Organic Solvents: Solublein most common aprotic organicsolvents (Ref. 5. Borg-Warner. 1983)

Log Octanol/Water PartitionCoefficient: 7.4 (estimated)

Description of Chemical: Water-whiteliquid with a sligbt phenolic odor (Ref.16. Witco. 1982)

Rationale for Recommendations

I. 'Exposure information-A.Production/use. One manufacturerreported production of 1 to 10 millionpounds of the compound in 1983.Another manufacturer of PDDP is listedin the public portion of the TSCAInventory, but volume is not reported.Domestic production and importationvolumes of PDDPhave not beenreported by the U.S. International TradeCommission for the period 1977 through1963.PDDP;an organophosphite. is usedprimarily as a heat/light stabilizer andsecondary antioxidant for a variety ofpolymeric materials. including vinylpolymers and polyrethanes (Ref. 11,Minagawa et a1.. 1963;Ref. 3.'Aza et at,1982). poly(e1her ester) rubbers Ref. 2.Anon. 1962). and epoxy resins (Ref. 15.Uram. 1982; Ref. 13. Nippon Steel. 1980).The estimated domestic consumption ofphosphite antioxidants in plasticsapplications in 1980 was 25,,5millionpounds. with a projected growth to 34.5millionpounds by 1985(Ref.6. CEH.1982).

B. Evidence for exp()sure. The .

National Occupational Hazard Surveyestimated that 900workers werepotentially exposed to PDDPin theworkplace in 1970 (Ref. 12. NIOSH.1976). Manufacturers of PDDPrecommend the use of personalprotective equipment [e.g.. neoprenegloves. aprons. goggles (Ref. 16. Witco,1962). and organic vapor respirators(Ref: 5. Borg-Warner. 1983)) to limitworker exposure. The compound maycause skin Irritation. and onecommercial formulation contains 5percent by weight triphenyl phosphite. aneurotoxic ant (Ref. 5. Borg-Warner.1983).

HeinOnline-- 50 Fed. Rea. 47611 1985

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47612 Federal Register / Vol. 50."No.223 / Tuesday, November 19. i985 / Notices

II. Chemical fate information. In theenviroment. PDDP is expected to sorb tosoil and sediment due to its low watersolubility and low vapor pressure. Noinformation was found on itspersistence. but this phosphite mayhydrolyze or biodegrade in surface andground waters. Environmlmtal releasesshouJd be quite low. with most of therelease to landfills via discarded bagsand polymer trimmings. Therefore.chemical fate testing is not beingrecommended at this time. .

Ill. Biological effects of concern tohuman health-A. Toxicokinetics(absorption. distribution. and excretion).No information was found. .

B. Genotoxicity. No information wasfou'nd. .

C. Short-term (acute) effects. Theacute oral LDMvalue for the rat is 9.40glkg (Ref. 5. Borg-Warner. 1983).

D. Long-term (subchroniclchronic)effects. No information was found.

E. Reproductive and developmentaleffects. No information was found.

F. Rationale for health effectsrecommendations. Current productiondata for PDDP are not precise andappear to represent lower limits; e.g..one manufactuer of PDDP is not listed inthe public portion of the TSCAInventory. Available informatiQn doesindicate.that recent annual productionof PDDP is at least 1 to 10 millionpounds and may be higher. In addition.the dispersive use patlern for the varietyof products' that may contain PDDPsuggests potentially widespreadexposures. In addition to such polymericmalerials as vinyl polymers andpolyurethanes. epoxy resins. a'nd rubber.PDDP is also used in fluorinatedrefrigeration agents (Ref. 1. Ando el at..1982). heat-pump working fluids (Ref. 4.Berenbaum et at.. 1978). and epoxidizedesters and oils (Ref. 9. Kauder. 1968).Other potential uses include anantioxidant for xylenol (Ref. 10. Kotas eta1.. 1982). a catalyst component for thereaction of olefins with maleicanhydride (Ref.8. Kao Soap Co.. 1979).PVC cross-linking agents (Ref. 14.Sugahara. 1978). and as a solvent for anantimicro~ial solution (Ref. 7. HilI. 1982).

No data on the health effects of PDDPwere found that would permit anassessment of its potential hazard tohumans. However. PDDP is struct~rallyrelaled to triphenyl phosphite. aneurotoxicant (Ref. 5. Borg-Warner.1983). Because of the lack of healtheffects data and the exposure potentialdiscussed above. toxicokinetic andsubchronic toxicity testing. includingneurotoxicity. are being recommendedfor PDDP.

IV. Ecological effects of concern. Noinformation was found on the ecological

effects of PDDP. Releases of PDDP tosurface waters are .expected to be .insignificant, and the PDDP CjIisposedofin landfills should sorb strongly toparticulates until hydrolyzed orbiodegraded. Therefore. ecological .effects testing is not being recommendedat this time.

References

(1) Ando EoGoto Y. Moriyama K. TakeshitaI. Hirao K. 1982. Composilion or absorplionrefrigeration. European Patent Applicalion EP62516 AI. October 13. 1982. IAbstract fromDIALOG). .

(2) Anon. 1982. Stabilizer system forreducing discoloration of copolyether esterelastomers. Res. Disci. 215:76-79. (Abstractfrom ORBIT IV.)

(3) Aza AD. Keeley C. Rogers JL. BrilliantSO. 1982. Homogeneous storable liquidbarium-cadmium-triphosphite stabilizersystems for poly(vinyl chloride) resins.European Patent Application EP 47694 A2.March 24, 1982.IAbstract from DIALOG.)

(4) Berenbaum MB. Evans FE. Eibeck RE.Robinson MA. 1978. Stabilized heat activatedheat exchange absorplion pair. U.S. PatentNo. 4072027. February 7. 1978.IAbstract fromCA Search.1

(5) Borg-Warner. 1983. Material SafetyData Sheet and Technical Data Sheet onPDDP submitted by C.R. Holt. Borg-WarnerChemicals. Inc. April 2. 1984.

(6) CEH. 1982. Chemical EconomicsHandbook. Stanford Research Institute.Menlo Park. CA: SRI International. Seclions583.6892M. 583.7220A-D. 583.8801I,J.

(7) Hill NJ. 1982. Anlimicrobial Solution.U.S. Patent No. 4363883. December 14.1982.[Abstract from DIALOG.)

(8) Kao Soap Co. 1979. Alkenylsuccinicanhydrides. Japanese Patent Kokai TokkyoKoho 8112382. [Abstra!;t from ORBIT IV.)

(9) Kauder as. 1968. Stabilization ofepoxidized esters and oils. French Patent FR1519200. March 29. 1968. IAbstract from CA .Search.) .

(10) Kolas J. Ambrose 0, Spousta E.Elefanlova D.1982. Stabilizalion of phenolicmonomers. Czech. Putent 196011.January 3.1982.IAbstract from ORBIT V.)

(11) Minagawa M. Kubota N. Shibata T.1983. Copolymer light stabilizers having atleast one 2.2.5.5-letraalkyl piperidyt groupand synthetic resin compositions containingthem. European Patent Application EP6987iA2. January 19. 1983. lAbs tract fromDlAI.OG.) . .

(12) NIOSH. 1976. National OccupalionalHazard Survey (1972-74) (data baselCincinnali. OH: Department of Health andHuman Services. Nalionallnslitute forOccupational Safety and Heallh.

(13) Nippon Steel Corp. 1980. Coalingcompositions for metals. Japanese PatentKokai Tokkyo Koho 81141385.[Abstract fromORBIT IV.l

(14) Sugahara M. 1976. Crosslinkedpoly(vinyl chloride) pasles. Japanese PatentKokai Tokkyo Koyo )P {'811950.February 2.

_1978.(Abstract from CA Search.)(15) Uram JR. Jr. 1982. Transparent

composite laminate molding and transparentcompositions for its produclion. German

Heinonline-- 50 Fed. Req. 47612 1985

Offen. Patent 3203975. (Abstract from.ORBITIV.)

(16) ~Nitco. 1982. Wilco Chemical Corp.Material Safety Data Sheet on PDDPsubmitted by 0.5. Kauder. Witco ChemicalCorp. March 1984.

IFR Doc. 85-27385 Filed 11,:,,18-85; 6:45 am)BilLINGCODE 6560-50-..

FEDERAL EMERGENCYMANAGEMENT AGENCY

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Office of Management and Budget the

folIowing information colIection

package for clearance in accordance

with the Paperwork Reduction Act (44 .

U.S.C. Chapter 35).

Ty.pe:Extensionof3067-ot66.Title: Crisis Counseling Assistance

and Training.Abstract: In order to obtain a Crisis

CounselingGraht. the State IFGAgencynamed by the Governor. usualIy the

State Mental Health Agency.must send .a Jetter of request and a plan of servicesto FEMA.

Type of Respondents: State or LocalGovernments.

Number of Respondents: 3.BurdenHours: 1.720. .Copies of the above information

colIection request and supportingdocumentation can be obtained bycalling or writing the FEMA ClearanceOfficer. Linda Shiley. (202) 646-2624. 500C StreetS.W.. Washington. D.C. 20472.

Comments should be directed to MikeWeinstein. Desk Officer for FEMA.Office of Information and RegulatoryAffairs. OMB.Rm.3235.New Executive0ffice Building.Washington. D.C.20503.

Dated: November 12. 1985.

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Director. Administrative Support.

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