### Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 /, Notices

ENVIRONMENTAL PROTECTION
AGENCY [OPPTS-41037; FRL-4071-41

Thirtieth Report ofthe Interagency Testing Committee tothe Administrator, Receipt of Report and Request forComments Regarding PriorityTesting Listof Chemicals

AGENCY: Environmental Protection 

### Agency (EPA). ACTION: Notice.

SUMMARY: The Interagency Testing 

### Committee (ITC), established under section 4(e) ofthe Toxic Substances Control Act (TSCA), transmitted its 30th Report to the Administrator ofEPA on May 29, 1992. As noted in this Report, which is included with this notice, the Committee revised the Priority Testing List by adding one chemical group, the siloxanes, and four chloroalkyl phosphates: 1,2-ethanediyl tetrakis(2- chloro-1-methylethylene) phosphate (TCIEP); 2,2-bis(chloromethyl)-1,3- propanediyl tetrakis(2-chloroethyl) phosphate (TCEBP); oxydi-2.1- ethanediyl tetrakis(2-chloroethyl) phosphate (TCEDP);and 2-chloro-1- methylethyl bis(2-chloropropyl) phosphate (DCPCEP).These chemicals

are recommended. There are no designated or recommended with intentto-designate chemicals.

TheITC removed two chemicals from the Priority Testing List in the 30th Report as a result ofEPA actions. Sodium cyanide and acrylic acid, designated in the 27th ITCReport, were removed because EPA issued a consent order for sodium cyanide on December 17, 1991 (56FR 65442), and for Acrylic 

### acid on March 4, 1992 (57FR 7656).

EPA invites interested persons to submit written comments on the Report. DATES: Written comments should be 

### submitted by August 10, 1992. ADDRESSES: Send four copies ofwritten 

### submissions to: TSCA Public Docket Office (TS-793), Office ofPollution Prevention and Toxics, Environmental Protection Agency, Rm. NE G004, 401 M St., SW., Washington, DC 20460. Submissions should bear the document control number (OPPTS-.41037; FRL4071-4). The public record supporting this action, including comments, is available for public inspection in Rm. NE G004 at the address noted above from 8a.m. to noon and 1p.m. to 4 p.m., Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT. 

### Susan B.Hazen, Director,Environmental Assistance Division (TS-799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Rm. E-543B, Washington. DC 20460, (202) 554-1404, TDD (202) 554- 0551.
SUPPLEMENTARY INFORMATION. EPA has received the TSCA Interagency Testing Committee's 30th report to the Administrator.

I.Background

TSCA (Pub. L 94-469, 90 Stat.2003 et seq; 15 U.S.C. 2601 et seq.) authorizes the Administrator ofEPA to promulgate regulations under section 4(a) requiring testing ofchemicals and chemical
groups in order to develop data relevant
to determining the risks that such chemicals and chemical groups may present to health or the environment. Section 4(e) of TSCA established the Interagency Testing Committee to recommend chemicals and chemical
groups to the Administrator ofEPA for priority testing consideration. Section 4(e) directs the ITCto revise the TSCA section 4(e) Priority Testing List at least
every 6 months. The ITC's most recent revisions to this List are included in the Committee's 30th Report. The Report

was received by the Administrator on May 29, 1992, and is included in this Notice. The Report adds one chemical
group and 4 chloroalkyl phosphates to the TSCA section 4(e) Priority Testing List.

II. Writtenand Oral Comments

. EPA invites interested persons to submit detailed comments on the ITC's

new recommendations. The Agency is interested in receiving Information concerning additional or ongoing health and safety studies on the subject chemicals as well as information relating to the human and environmental
exposure to these chemicals.

A notice will be published at a later date in the Federal Register adding the substances recommended in the ITC's 30th Report to the TSCA section 8(d) Health and Safety Data Reporting Rule (40 CFR part 716), which requires the reporting ofunpublished health and safety studies on the listed chemicals. That notice will also add the chemicals
to the TSCA section 8(a) Preliminary Assessment Information Rule (40 CFR part 712). The section 8(a) rulerequires the reporting of production volume,
exposure, and release information on the listed chemicals.

III. Status of List

The ITC's 30th Report notes the addition ofone chemical group and 4 chloroalkyl phosphates to the Priority Testing List, and the removal ofsodium cyanide and acrylic acid from the List. The current Priority Testing List contains 24 chemicals and 23 chemical
groups, 11 ofthese chemicals are designated.

Authority: 15 U.S.C. 2603.
Dated: June 30, 1992.

CharlesM. Auer, Director, ExistingChemical Assessment Division,Office of Pollution Preventionand Toxics.

ThirtiethReport of the TSCA Interagency Testing Committee to the Administrator,Environmental Protection Agency
Summary

The U.S. Congress created the Interagency Testing Committee (ITC) under Section 4(e) of the Toxic Substances Control Act (TSCA) to recommend chemicals and chemical
groups to the Administrator of the U.S. Environmental Protection Agency (EPA) fortesting under Section 4(a) ofTSCA and to facilitate coordination of chemical testing sponsored orrequired by U.S. Government organizations represented on the Committee. Congress directed the Committee to:' (1) organize their recommendations as the Priority Testing List, (2) revise the Priority Testing List at least every 6 months and (3) transmit these revisions to the EPA Administrator for publication in the Federal Register. During this reporting period (11/28/91 to 5/27/92), the Committee revised the TSCA section 4(e) Priority Testing List by adding two chemical groups and removing two chemicals.

Recent questions related to the safety ofsiloxanes fora number ofmedical
uses, Including breast implants, prompted the Food and Drug Administration (FDA) to request that the Committee review the health effects of siloxanes. The Committee added a group of56 siloxanes to the Priority Testing List and recommended them for autoimmune effects, cancer, reproductive effects and developmental toxicity testing and for epidemiological studies.

The Committee also added a group of four chloroalkyl phosphates to the Priority Testing List and recommended them for screening tests, because there

are few publicly-available data and because these chemicals are structurally similar to five chloroalkyl phosphates that were recommended in the Committee's 23rd Report.

The Committee removed sodium cyanide and acrylic acid from the Priority Testing List because EPA implemented the Committee's testing recommendations. 

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The Committee reviewed 350 studies

on the 5 chloroalkyl phosphates recommended in the Committee's 23rd Report and deferred them to provide an opportunity formanufacturers to submit exposure data and to discuss voluntary testing.

During this reporting period, a few Committee members participated in EPA's, National Cancer Institute (NCI's) and National Toxicology Program (NTP's) chemical selection meetings, met with the Synthetic Organic. Chemical Manufacturers Association andthe Chemical Manufacturers Association to discuss completed, ongoing and planned testing ofchemical groups and attended the March 18, 

### 1992 U.S. House ofRepresentatives and March 25, 1992 U.S. Senate hearings on 

### TSCA reauthorization. The Committee's Executive Director coordinated testing with the National Toxicology Program, coordinated responses to the Agency for Toxic Substances and Disease Registry's (ATSDR)request for
comments on Priority Data Needs and presented an invited paper to the American Society forTesting and Materials on the role ofthe Committee's testing recommendations in facilitating
test method development.

Also during this reporting period, the Committee initiated efforts to develop a 

### Priority Testing Candidate List of chemicals and chemical groups under consideration, conducted a partial review ofglycol ethers' reproductive effects data, and formed two subcommittees to review non-public data on ethoxylated and imidazolium quaternary ammonium compounds and to review chemicals nominated by the Occupational Safety and Health Administration (OSHA).
Additionsto thePriority TestingList
Additions to the Priority Testing List

are presented, together with the types of testing recommended, inTable 1.

TABLE 1.-ADDITIONS TO THE SECTION 4(E) PRIORITY TESTING LIST

Group CAS No. Chemical Action Date Recommended Tests

Sioxanes

........................................................................................................ Recommended

..................... 5/92 Physical and chemical properties: None, at this time.
Chemical fate: None, at this time.
Health effects: Autolmmune effects, reproductive

effects, developmental toxicity, cancer and epi. demlology studies Ecological effects: None, at this time.

Ctdoroak" Phosphates

............ ........... Recommended

..................... 5/92 Physical and chemical properties: melting point octanol-water partition-coefficient, vapor pressure and water solubility.
Chemical fate: Aerobic biodegradation and hydrolysis rate screening. Health effects: Acute toxicity screening. Ecological effects: Algal toxicity, fish, aquatic and

benthic invertebrate acute toxicity screening.

TSCA Interagency Testing Committee
StatutorymemberAgencies andTheir Representatives
Council on Environmental Quality

Charles Herrick.member (seeNote 1) Department ofCommerce

WillieE.May, member. Edward White, alternate (seeNote 2)
Environmental Protection Agency

James B.Willis, member John S. Leizke,alternate
National Cancer Institute

Thomas P. Cameron, member Richard Adamson, alternate
National Institute for Environmental Health Sciences

Errol Zeiger,member James K.Selkirk, alternate
National Institute for Occupational Safety and Health

Robert W.Mason, member Henryka Nagy, alternate (see Note 3)
National Science Foundation

Carter Kimsey, member and Chairperson Jarvis LMoyers, alternate Occupational Safety and Health Administration Christine Whittaker, member and vice chairperson

Surender Ahir, alternate

Liaison Agencies andTheir Representatives Agency for Toxic Substances and Disease Registry

Sharunda Buchanan, member
Consumer Product Safety Commission

Val Schaeffer, member (seeNote 5) Lakshmi C.Mishra Department of Agriculture

Donald Deft, member Ralph T. Ross, alternate (see Note 6) Department ofDefense

Randall S. Wentsel, member Department ofthe Interior

Clifford P. Rice, member Barnett A. Rattner, alternate Department ofTransportation

George Cushmac, member James O'Steen, alternate
Food and Drug Administration

Edwin J.Mathews, member (seeNote 7) Raju Kanumula, alternate
National Library ofMedicine

Vera Hudson,member National Toxicology Program Victor A. Fung, member (seeNote 8)

U.S. International Trade Commission

James Raftery, member Edward Matusik, alternate

CommitteeStaff

John D. Walker, Ph.D., Executive Director Norma S.L Williams, Executive Assistant


### Support Staff
Mary Ellen Levine, Office of the General Counsel, EPA (see Note 9)

Notes: 1. Appointed on February 4, 1992. 2. Appointed on February 6. 1992. 3.Appointed on November 15, 1991. 4. Appointed on November 22, 1991. 5.Appointed on April 2,1992. 6.Appointed on December 19, 1991. 7. Appointed on December 26, 1991. 8. Appointed member on March 20, 1992. 9. Appointed on January 7,1992.

The Committee acknowledges the assistance and support given by the staffofSyracuse Research Corp. (technical support contractor) and 

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### Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

personnel of theEPA Office ofPollution Prevention and Toxies. Chapter 1--Introduction

1.1 Background. Background on the TSCA Interagency Testing Committee (ITC)was provided mostrecently in chapter 1.1 ofthe 29th Report that was submitted to the EPA Administrator on November 27, 1991 (56 FR 67424, December 30, 1991).

1.2 Committee's previousreports. Twenty-nine previous Reports to the EPA Administrator havebeen Issued by the Committee and published in the Federal Register. In these 29 Reports, the Committee recommended testing for 124 chemicals and 39 chemical groups. Chemical groups were defined most recently in chapter 1.2 ofthe 29th Report.

1.3 Committee'sactivitiesduringthis reporting period. The Committee's activities during this reporting period (November 28, 1991 to May 27, 1992) are described below.

1.3.a Chemical andchemical group selections.During thisreporting period, the Committee initiated efforts to develop a Priority Testing Candidate List ofchemicals and chemical groups under consideration, reviewed data on siloxanes and chloroalkyl phosphates, conducted a partial review ofglycol ethers' reproductive effects data, and formed two subcommittees to review non-public data on ethoxylated and imidazolium quaternary ammonium compounds and to review chemicals nominated by the Occupational Safety and Health Administration.

Siloxanes and chloroalkyl phosphates

are recommended, not designated, because the Committee wants to review the TSCA section 8(a) and 8(d) information and any use exposure and release information as well as any physical chemical property information that is voluntarily submitted,before deciding whether to designate or withdraw these chemicals for testing. These recommendations are consistent with theCommittee's practice of distinguishing between data needs and .data gaps and recommending testing for chemicals with data needs and of comprehensively evaluating chemicals and chemical groups as discussed in Chapter 1.3.a ofthe ITC's27th and 29th Reports.

Some chemical groups on the Priority Testing Candidates List that the Committee willbe considering in the future were listed in Chapter 1.3.b of the 29th Report.

1.3.b Comprehensiveinformation processing. The Committee's approach to comprehensive information processing is described in Chapter 1.3.b ofthe 29th Report.

1.3.cInformationdissemination. To promote public understanding ofthe Committee's functions, some ofthe activities that occurred during this reporting period are briefly described below.

Some Committee Members and staff attended recent hearings on TSCA reauthorization. On March 18,1992 hearings were held before the House of Representatives Subcommittee on Environment. Energy andNatural Resources, chaired by Congressman Mike Synar (D-OK). OnMarch 25,1992 hearings were held before the Senate Environment and Public Works Subcommittee, chaired by Senator Harry Reid (D-NV). EPA discussed Its revitalized chemical testing program.

At the invitation ofthe Chemical Manufacturers Association, the Committee's Chairperson andExecutive Director met with the chloroalkyl phosphate manufacturers on April 1, 1992 to discuss completed. ongoing and planned testing and the status ofthe ITC'sreview of chloroalkyl phosphates. The manufacturers were asked to supply samples ofchloroalkyl phosphates for EPA sponsored fish neurotoxicity tests. They were encouraged to provide information on theuses ofchloroalkyl phosphates, the levels ofchloroalkyl phosphates that might result from processing anduse and information that might explain the low (partsper billion) environmental concentrations of chloroalkyl phosphates. This exposure information is needed to provide some perspective for the chloroalkyl phosphate toxicity data. Additional meetings with the chloroalkyl phosphate manufacturers are planned.

At the invitation ofthe American Society forTesting and Materials (ASTM), the ITC's Executive Director presented a paper at ASTM's Second Symposium on Environmental Toxicology and Risk Assessment. The Symposium was convened on April 26- 29, 1992 in conjunction with ASTM's semi-annual meeting to develop and revise ASTM methods forchemical fate and ecological effects testing. The Executive Director discussed ITC's role in facilitating development ofchemical fate and ecological effects test methods.

1.3.dInformationcoordination. Congress directed the Committee to facilitate coordination ofchemical testing sponsored or required byU.S. Government organizations represented

on the Committee.This directive promotes conservation of U.S. government chemical testing resources. by eliminating unnecessary and duplicative testing. At therequest ofthe National Toxicology Program (NTP), TSCA Section 8(d) reports on health effects of bis-(4-chlorophenyl) sulfone (CAS No. 80-07-9) were provided to facilitate NTP's evaluation ofthis chemical. The TSCA Section 8(d) reports were submitted to the EPA as a result ofthe Committee's recommendation for physical and chemical property testing ofsulfones in their 27th Report. After the 27th Report was published, the NTP's Executive Committee deferred testing bis-(4-chlorophenyl) sulfone for subchronic and mutagenic effects until the TSCA Section 8 information could be reviewed. NTP Is currently reviewing this TSCA Section 8 information.

Atthe request oftheAgency for Toxic Substances and DiseaseRegistry (ATSDR), comments were provided on ATSDR's Priority Data Needs for a number ofthe 38 hazardous substances (41 CAS numbered chemicals) that were published in the October 17, 1991 Federal Register (56 FR 52178). The EPA and NTP provided comments during development ofthe PriorityData Needs. The ITC's comments are included in ATSDR's Docket number 42. These comments are summarized below. The National Cancer Institute described completed and ongoing studies on arsenic, cadmium, chromium, nickel and polychlorinated biphenyls. The Department-of Interior described ongoing wildlife studies on cyanide, polychlorinated biphenyls and selenium. The ITC staffdetermined that the Committee had considered about 75%of ATSDR's 275hazardous substances, had recommended about 70 of them for testing, had taken action on 33 ofthe 38 hazardous substances for whichATSDR determined Priority Data Needs, and haddesignated 3ofthe 38 substances for testing. For the 33 substances on which the ITChad taken action,there may be existing studies that could satisfy ATSDR's PriorityData Needs. For the 3 ITCdesignated substances, 33 studies were identified that may satisfy ATSDR's Priority Data Needs and 3 studies were identified that may provide useful information related to ATSDRs Priority DataNeeds.

In an effort to avoid duplication of effort, ATSDR is considering the Committee's comments and will formally respond to them along with other comments received on the 38 substances.The studiesreceived by ATSDR from the Committee willbe screened and reviewed before the Priority Data Needs are finalized.

1.3.e Referrals.During this reporting period, the Committee did notrefer any 30610

### Fedeal bwg1S, / VoL-; No. 13/ Thnr, nlsday jlk9, 1 Ntieds.*

chemicals to member agencies orother organizations fortesting consideration.

1.3.fDeferrals. During this reporting period, the Committee deferred thefive chloroalkyl phosphates recommended in the 23rdReport because ofan interest

on the part ofindustry to voluntarily take action on these chemicals. The Chemical Manufacturers Association (CMA) and several chloroalkyl phosphate producers have approached the ITCand EPA to discuss voluntary testing for certain ofthe chloroalkyl phosphates. It is the interest ofthe ITC and ITCmember agencies to ensare that the hazard ofthese chemicals is well characterized; additionaly,the Committee believes that exposanm to these chemicals shoulid bebetter characterzed. The Committee encorage CMA and thec€ kUoa1lC phosphates' producers to offerakmrAl proposal toEPA. which ma result ina testing consent order or other binding agreement through apublic process, to develop hazard andexposure data.The Committee also believes that. considering thepotential cancer riskof these chemicals, voluntary exposure controls on the partof industry maybe appropriate. TheE41mmittee is deferfing thesefive chloroalkyl phosphates pending the results offuture discussions with industry.

1.3.g Removals.Two chemicals designated in the Committees 27th 

### Report wereremoved from thePriority Testing List,because EPA Implemented the Committee's testing recommendtios. On December 17, 1991 andMarch 4,1992. EPA published Consent Orders for sodium cyanide (56 FR 65442) and acrylic acid (57 FR 7656),. respectively. The most recenttable of removals from thePriority Testing List

was published in the Coituftea 29th Report. As a result ofthe removals made during this reporting period. 100 chemicals and 18 chemical groups have been removed from the ITCsPriority Testing List

1.4 The TSCA section4(e)Priority TestingList.Under Section 4(e)(1)(BJ.of TSCA, Congress directed the Committee
to revise the PriorityTesting List at least
every 6 months and transmit the revised List to the EPA Administrator. Under this authority, the Committee Is revising the Priority Testing ist by 

### recommending two chemical groups (Table1).

ThePriority Testing List includes 24 chemicals and 23chemical groups that have been recommended ordesignated for testing (Table 2). Individual chemicals in PriorityTesting List chemical groups are listed inTable I of the 24th Report andin theparagraphs following Table I of the26th.,27th, 28th and 29th Reports.For this3th Report the individual chemicals in Priority Testing List chemical groups are listed in tables that areincluded i chapters 2.4.a and 2.4.b. Lists ofindividi chemicals are provided to minimize any ambiguities associated with TSCA Section 8(a) and 8(d) reporting requirements.

Combining the 100 chemicas and 18 chemical groups thathave been removedfromthe ITCsPriority Testing Listwith the24 chemicals and 23 chemical groups currently on the Priority Testing List,reveals thatthe Committe has recommended ordesignated 124 chemicals and41 chemical groups for testing since their firstmeeting in February 1977.

TABLE 2.-THE TSCA SECTION 4(M)PRIORITY TESTING LIST

Re. Dt ri Date Chemical/Group Actio

May I 988.

................................. May 1988

.............. . ................ November 1988

.......................... November 1988

................ NoventWe 1988

...................................... November 1988....................... November 1988

............. ... ... November 198

............. ......... November 1988

...................... May 1990

............... ............... May 1990

...................... ........... May 1990

...................... ..................... November 1990

........................... November 1990

....................... November 1990

. ........... ... November 1990

........................................ November 1990

.......................................... November 1990

..... ................... November 1990

....... . . ... .... November 1990

...... November 1990
November1990

.................... . November 1990...........................

ay 191

.... . ....... May 1991

..... ..................................... May 199

....................................... May 1991

..................................................... May lO9

... ................... May 1991

.......................... ......................... May 1991

........... .... . ..................... May 1991

. ... . . . ............. May 1991

............. . ............. May 1991

.................................................. May 1991

................. ......... ................ may 1991

. ................................ May 1991

........... .............................. May 1991

............................................. May 1991

....... .. ........................ May 1991

.................. ..................... Ethoxytated quaternary ammonium compounds

.............. Inldazolium quaternary ammonium compounds

....................... Tetrads(2-chloroetIyethylene diphosphate

............................ Tris(1,3-dichloro-2-propyl) phosphate

.................... Trs(1-chloro-2-propyl) phosphate

............................................. Tris(2-choro-l-propy phosphate

............................................... T hs(2-choroethyl)-phosphate

........................................................ Butyruldehyde

.................................................... ..... ................ Bromlnated flame retardants.. d

...................................... Isocyanates.. Brominated flame retardants.

...... . ... ...................... Alkyl phosphates

........... . . ... .................................... Acetophenone

........... . . ..................... Pheno l

..... .... ............................... Ethytacetate

................. . . ....... I

........... ....... 2,60-methylphenol

... ................................................ Aldehydes

......................... ............................ 2,4- nirtrophenol

......................................................................... 3.4-Dimethylphenol

.................................................................... S-pryl--nae.

. am...
............................................. ........ Sulfore

.............................. ........ . ............ ....... ............ ..... ........ Substantially produced chemicals in need of subchronic

tests. Acetone

................. ... ................. IsObutanol

........................................ DI-(2-ethylhexyl)adlpate

..... . .................... Dimethyl terephthalate

. .... ........................... Thiophenol.....

............ . ........ ... m-Dinitrobenzene

................................................. Allyl alcohol

. ........................ 2,4-Dichlorophenol

.......... . . .... ........... Alkynas

........................................................................................ Nitroalcohols

................................................................................. Phosphonlums

........ . . . ........................ Hydrazines

. . ......... .................... Oxsranes

................... . .......................... Alkoxysilanes

........................................... .................. Aldehyde hydrates

.................................. ..................... Reconmended Recommended Rtecommended st1b llSeale.dmgnt Recommended wftkbdim*W~eugue Reonawwnd m wift W&*Wdsig Recommended

. ir~wtmS@-sn Recomndrled i* i tdelas Recommended

Recammerided with lnW4oH~esgrate@ Recum es Recom~mnded

Designs

Designated De~al

Recommended waitbiten esignaft Recommended Recom"med; Reconw nded Recommndeed Recommended
Designated Designated Designated Designated Demgnned Designate Recommended

Recommended Recommended Recommenrded Recommended Recommended Recommended Recommended 

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### Federal Register /,Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

TABLE 2.-THE TSCA SECTION 4(E) PRIORITY TESTING UST--Contnued

ReDate Chemical/Group Action port

28 May 1991

............................................... Propylene glycol ethers and esters

.............................................. Recommended 28 May 1991

.. .......... . .......... Methyl ethylene glycol ethers

.................................. .......Recommended 28 May 1991 ..........................................-.......... Isothlocyanates

.................. .......... Recommended 28 May 1991

........................................ ...... Cyanoacrylates

.... . . ............................. . Recommended 29 November 1991

.......................................... White phosphorus

................................................................... Recommended 29 November 1991

....................................... Alkyl-,bromo-, chloro-, hydroxymethyl diaryl ethers

................... Recommended

30 May 1992

................................ ....... Siloxanes

................. ........ . ....... . Recommended

30 May 1992

....................................................... Chloroalkyl phosphates

............................................................. Recommended

Chapter 2-Recommendations ofthe 2.3 Recommendedwith intent-to- recommended siloxanes fortesting Committee designatechemicals.None. because of FDA's request, because

2.1 Chemicalsrecommendedfor2.4 Recommendedchemicals-24.a production volumes are substantial.
priorityconsideration by theEPA Siloxanes., because of uncertainties related to

Administrator. As provided by section

.L Rationale forRecommendation human exposure, and because.of the • paucity ofpublicly-available health 4(e)(1)(B) ofTSCA, the Committee is Recent questions related to the safety effects data for these substances.By adding to the section 4(e) Priority ofsiloxanes for a number ofmedical Testing List two chemical groups (see uses, including breast implants, recommending these chemicals, the

Table 1). The recommendation ofthese prompted the Food and Drug Committee is providing-manufacturers,
chemicals is made after considering the Administration (FDA) to request that the processors, and distributors the
factors identified in section 4(e)(1)(A) Committee review the health effects of opportunity to submit data under TSCA
and other relevant information, such as siloxanes. The Committee added a group Section 8 and tovoluntarily submit
the data needs of Member Agencies. of56 siloxanes to the Priority Testing physical and chemical property data

2.2 Designated chemicals.None. List (Table 3). The Committee and use exposure information.

TABLE 3.-RECOMMENDED SILOXANES

CAS No. Chemical Name

107-46-0 107-50-6 107-51-7 107-52-8 107-53:-9
141-62-8 141-63-9 540-97-6 541-01-6 541-02-6 541-05-9 546-56-5 556-67-2 556-68-3 556-69-4 556-70-7 556-71-8 999-97-3 2370-88-9 2374-14-3 2471-08-1 2471-09-2 2471-10-5 2471-11-6 2554-06-5 2627-95-4 2652-13-3 7013-67- 9004-73-3 9006-65-9 9016-00-6 18766-38-6 18772-36-6 18844-04-7 1919-94-3 23523-12-8 23523-14-0 23732-94-7 36938-50-8 36938-52-0 63148-62-9 67762-90-7 67762-94-1 Hexamethyldisiloxane Tetradecamethylcyloheptasiloxane Octamethyttisiloxane Tetradecamethylhexasiloxane Tetracosamethylundecasiloxane Decameyltetrastloxane Dodecamethyopentasiloxane Dodecamethylcyclohexasloxane Hexadecamethylheptasiloxane Decamethylcyclopentaslloxane Hexamethylcyclotrsiloxane Octphenylcyclotetrasloxane Octamethylcyclotetraslloxane Hexadecamethylcyclooctasiloxane Octadecamethyloctasioxane Docosamethyldecas#oxane Octadecamethylcyclononasiloxane Hexamethyldisliazane Tetramethylcyclotetrasiloxane Tdfluoropropylmethylcyclotrisiloxane Hexacosamethyldodecasdoxane Octacosamethyttridecesiloxane Triacontamethyltetradecasiloxane Dotriacontmethylpentadecasiloxane Methyvinylcyclosiloxane Tetramethyldivlnyldisiloxane Eicosamethylnonasioxane Non-end blocked siloxanes Methylpolysiloxane Dimethicone Polydmethylsiloxane Docosamethylcycloundecastloxane Eicosamethylcyclodecasdloxane Hexatrlacontamehylheptadecasiloxane Tetracosamethylcyclododecasiloxane Hexatriacontamethylcyclooctadecaslloxane Triacontamethylcyclopentadecasloxane Hexacosamethylcyclotiidecasiloxane Tetratrlacontamethylhexadecasiloxane Octatriacontamethyloctadecasiloxane Dimethyl silicones and siloxane Dimethyl siliconesand siloxanes, reaction products wir slica Dtmethytmethylvinylsiloxane 

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TABLE 3.-RECOMMENDED SILOXAES-Continued

CAS, No. aeiicat NNWn

68037-59-2 Dimethythydiopolysitoxa 68037-74-1 Dimethyfpofysiloxanes 68083-14-7 Dimethytdipeny oxane 69430-24-6 CyclopomettrWexane NA' Tetwcentamthrnonedecasiloxane NAI Octacosamethycyclotetradecasiloxane N;AI Dotetracontamethyleicosasiloxane NAI Tetcontemettqtoecosasiloxane NA' Octalicontamethykycyonadeasiloxane
NAI Tetsatreconamethykyloheptadcasiloxare NAI DotriacentamethylcyclohexadecaWoxane NAt Polymethylbctdecyrsiloxane N& Di~memerttUzfiuoa op 'Oliloxane

INA = not assigned.

II. Summaryof Recommended TestsSiloxanes are recommended for autoimmune effects, cancer, reproductive effects and developmental toxicity testing and for epidemiological studies (Table 11.

IlL Supportin nformation

A. BackgroundOn November 6, 1984, the Committee designated octamethylcyclaotetrasitoxane (OMCTSI for chemical fate andecological effects testing in the Committee's 15th report 

### (49 FR 46931, November 29, 1984]. On -May31, 1991, at the request ofEPA, the Committee recommended alkoxysi-loxanes for ecological effects testing in the Committee's 28th report (56 FR 4121, August 19, 1991).While health effects testing wasnot recommended previously, recent questiam related to the safety of siloxanes for a'rmmber ofmedical uses, inching breast implants, prompted FDA to request that the Committee review the health effects of siloxanes. The Committee is also concerned with widespread human exposure and environmntal release of gloxanes. Most ofthe recoimnended chemicals

were chemicals identified by FDA. At the request ofFDA, a few structuratly related methyl siloxanes,were identified using the Committee's substructurebased chemical selection expert system (SuCSES). SuCSES was also used to identify structural homologs forothr siloxanes identified byFDA. butFDA and the Committee did not request that they be recommended fortesting atthis time.

B. Physicaland chemical properties. The Committee foiw limited infoamation ocnmeasared physical and chemical properties for the siloxanev listed in Table 3:20 logoctanol/water partition coefficients Igenerated using High Pressure iUquid Chromatopaphy)t 1 measured loS octasokjwater partitimx coefficient, 15 melting points, 16 boilingpoints, 1 water solubility, 13 vapor 

### pressures, and I Henry's Law constant (Refs. 19, 27, 31.43, and 61).

C. Exposureinfornorio -production/ use/disposal/exposure/release. The siloxanes in Table 3are commercially available or have been identified in various medical uses.

Siloxanes have numerous medical, industrial, consumer, and military uses. They are used in.the drug and pharmaceutical, construction textile. transportation, electrical electronic. paper and processing Industries, tire. plastic, and rubber foundries, in chemical, petroleum, and gas processing

as well as inmedical devices. cosmetics and toiletries, food andrelated products, coatings, paint additives, inks,rubber and plastics, polishes, fibers, threads, and household.,automotive, and institutional products (Refs. 29, 30, and 66). Siloxanes also are usedin plastic andrubber lubricants. damping fluids, heat transfer fluids, oil defoamers. antifoams, viscous fluid drive clutches, speed control devices, liquid springs, dash pots, timing devices, thread and fiber lubricants, and textile softeners (Refs. 29 and 301.They are processed to meet electrical specifications for use in capacitors, pulse transformers, specialty transformers, air-borne and landbased radarequipment, and television circuit components (Refs. 29and 30). Siloxanes

areused in food applications; for example, dimethyt antifoaming agent in juices and beer (Ref.38). Dimethylpolysiloxanes are useful as a low temperature dampingmedium, heat transfer medium, dielectric coolant, and

a base fluidfor low temperature silicone fluids (Refe. 29 and 30). Octamethylcyclotetrasiloxane is in several silicone fluids, whichr areused in

a vaiely ofapplications including antiperspirants, facal make-up, hair sprays and skin care products, fermentation processes, instant coffee productio, food washing solutions, diet soft dribks, paper coatings andsizing, waste yeast tanks, adhesives, textile sizes, vacuum distillations, deasphalting, brine units, boier treatments, detergent manufacture, effluent treatments, industrial cleaning solutions, waste water treatment facilities, srfactairts, and inwindow cleaners and panel polishes (Refs. 56 and 66). In 1982, , octaMethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and dodecamethylcyclobexasiloxane were being evaluated for use in avariety of

consumer and industrial products, including household and car care products, specialty wax preparations, other chemical specialty formulations, and coatings (Refs. 66. " Decamethylcyclopentasiloxane is used in cosmetics and toiletries, as a vehicle and end blocking agent in antiperspirants and in aerosol products containing insoluble powders (Refs. 29 and 06). Hexamethyldisiloxane is used in cosmetic and personal careproduct formulations, in the production of octamethylcycloetrasifoxane, as an adhesion promotor-priming agent forphotolithography appicatioms, and as

an end blocking agent in the production of fluorosiliconetoils (Refs.7,31, and 401.

Humanexposare-medical. Exposure
to sifoxanes may occurbecause ofuses

as medical fluids, resins, gels and elastomers. Fluid siloxanes are used as lubricants in disposable syringes. Resins, gels and elastorners are used as implants for the augmentation and reconstruction ofsoft tissues such as breast and testiculartissues. Siloxanes

are also used to fabricate tubal occlusion devices forfemale sterilization, encasement ofpacemakers and electrical leads, heart valves, arteriovenus shunts, catheters, urethral stents,penile prothesis, prosthetic finger joints, artifical tendons, andintraocular lenses aswell as to construct elastomers that areused asImplanted drug delivery systems. 

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Occupational. The National Occupational Exposure Survey (NOES) conducted during 1981-1983 by NIOSH reported that 14,234 workers were potentially exposed to hexamethyldisiloxane, 367,371 workers

were potentially exposed to dimethyl silicones and siloxanes, 935 workers

were potentially exposed to octamethylcyclotetrasiloxane, 4,386 workers were potentially exposed to dimethyldiphenylsiloxane, and 6,903 workers were potentially exposed to reaction products ofdimethyl silicones and siloxanes with silica (Refs. 50).

Monitoring.Atomic absorption analyses oforganic extracts identified dimethylpolysiloxanes in various fruit juices (orange, apple, pineapple, apricot, tomato, lemon,grapefruit, mango, and apricotjuice) (Ref.38). Dimethylpolysiloxanes were quantitatively detected in 51 of98 samples above the detection limit of0.2 ppm; 14 ofthe 51 samples were above 10 ppm and 1sample had a dimethylpolysiloxanes content of 152 ppm.

Dodecamethylcyclohexasiloxane was identified in drinking water concentrates from New Orleans, LA and Seattle, WA and decamethylcyclopentasiloxane was identified in drinking water concentrates from New Orleans, LA and Cincinnati, OH (Ref.44).

Based on a method where airborne particles are collected on Teflon filters, extracted with an organic solvent, and then analyzed by pyrolysis gas chromatography/mass spectrometry (GC/MS), polydimethylsiloxanes were frequently detected in indoor airborne particles, especially in office buildings where many silicone-containing products were present, such as electrical
contact cleaners, photocopiers, and electronic equipment (Ref.76). Decamethylcyclopentasiloxane was measured in 29 air samples (0.3-12.4jig/ ms) from office buildings located in 7 cities,dodecamethylcyclohexasiloxane

was measured in 5 air samples (0.4-16.5 1g/m3 

### from office buildings located in 2 cities, hexadecamethylcyclooctasiloxane was measured inI air sample (38 /g/m) from office buildings located in 8 cities, octamethylcyclotetrasiloxane was measured in 11 air samples (0.4-37 ,g/ m) from office buildings located in 4 

### cities, hexamethylcyclotrisiloxane was measured in 3air samples from one office building, and tetradecamethylcycloheptasiloxane was measured in 3air samples (7.4-10.8 ,g/ m) from one office building (Ref.74). 

### Octamethylcyclotetrasiloxane has also been detected In 2 of5indoor air samples collected in Northern Italy, 1983-4, at concentrations of 10 pg/m3


### and 13 

### 1g/ i 3 

### (Ref.9). Emissions of hexamethylcyclotrisiloxane and octamethylcyclotetrasiloxane to indoor airhave been detected from new carpets (Refs. 35 and 54).

In a study designed to monitor personal exposure to volatile organic compounds, hexamethylcyclotrisiloxane and octamethylcyclotetrasiloxane were detected in air,breath, and tap water samples (Ref.75). The national survey of human adipose tissue conducted in 1982 analyzed 46 composite samples and found decamethylcyclopentasiloxane in 28 samples and octamethylcyclotetrasiloxane in 21 samples (Ref.53).

Environmental exposure.Based on a method where airborne particles are collected on Teflon filters, extracted with solvent, and then analyzed by pyrolysis/GC/MS, polydimethylsiloxanes havebeen frequently detected in outdoor airborne particles. Polydinethylsiloxane concentrations were approximately 1 ng/m 3in outdoor airborne particles at 

### telephone office sites in Wichita, KS, Lubbock, TX, and Neenah, WI and 2 ng/

m3 inNewark, NJ. 

### (Ref.76). 

### Decamethylcyclopentasiloxane has been detected at concentrations ranging from 0.21 to 0.9 pg/m 3

### in 3outdoor air samples, octamethylcyclotetrasiloxane has been detected at concentrations ranging from 6.6 to 22.6 ttg/m 3in 3 

### outdoor air samples taken from outside

an office building in Newark, NJ, and hexamethylcyclotrisiloxane has been detected at concentrations ranging from 0.9 to 149 Ug/m3 in 139outdoor air samples from 8 locations (Ref.74).

Hexamethylcyclotrisiloxane was detected in 4 of6 water samples collected from Lake Pontchartrain, LA, in 1980; concentrations ranged from 0.02
to 0.3 pg/L. and octamethylcyclotetrasiloxane was detected in 1of3samples at 0.03 #Lg/L (Ref.48). Octamethylcyclotetrasiloxane and dodecamethylpentasiloxane were found in the influent to a sewage treatment facility in Singapore, while only octamethylcyclotetrasiloxane was found in the post-aerated wastewater and sludge (Ref.42). Octamethylcyclotetrasiloxane and hexamethylcyclotrisiloxane have been detected as volatile emissions from refuse landfills (Ref.41).

D. Chemical fate information. The Committee is notrecommending chemical fate testing at this time because it wants to review data developed under TSCA Section 4 for octamethylcyclotetrasiloxane and any chemical fate data that may be submitted under TSCA Section 8(d).

E.Healtheffects information.Health effects data were located for 9ofthe 52 recommended siloxanes: hexamethyidisiloxane, octamethyltrisiloxane, dodecamethylpentasiloxane. decamethylcyclopentasiloxane. hexamethylcyclotrisfoxane, octamethylcyclo tetrasiloxane, trifluoropropylmethylcyclotrisiloxane, dimethicone, and polydimethylsiloxane.

Humanstudies.Available data suggestthat polydimethylsiloxane and * octamethylcyclotetrasiloxane are not absorbed through intact human skin (Refs. 10,23, and 34), and that 

### polydimethylsiloxane was not absorbed by the gastrointestinal tract (Refs.1,4. and 62).

There have been human case reports ofadverse effects from release of polydimethylsiloxane fluid into body tissues. These effects include granuloma formation, ulcer development and acute and latent pneumonitis illness (Refs. 5, 6,47, and 55). In some cases, adverse effects did not develop for years.The granulomas appeared to be similar to typical foreign-body reaction masses (Refs. 64, 65, and 77), and cases have been reported where these granulomas developed at sites distant from the site of injection of the liquid silicone fluid (Ref.25). Case reports have also suggested that silicone from breast implants and other prosthetic devices

can produce symptoms of autoimmune disease (Refs. 3, 26, 59. and 73). These symptoms are diverse and are similar to scleroderma, systemic lupus erythematosus, and systemic rheumatic disease, and have been described in the literature as human adjuvant disease (Ref.59). An epidemiologic study of workers exposed to silicones forat least 5years and followed for 19 years reported a higher than expected incidence ofcancers of the skin, large intestine and lung, but a decrease in mortality due to cancers ofall types (Ref.28). Laboratory studies.Available data suggest that hexamethyldisiloxane and octamethylcyclotetrasiloxane are not absorbed through animal skin (Refs. 10, 15, and 16). Oral administration of octamethylcyclotetrasiloxane to monkeys andrats resulted in gastrointestinal absorption (Refs. 20 and 21). When injected, polydimethylsiloxane distributes throughout the body, but this process is slow ifthe injection is to an area not accessible to phagocytizing cells (Ref. 33). 

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### Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

Acute animal toxicity tests have been conducted for octamethylcyclotetrasiloxane, hexamethyldisiloxane, dodecamethylpentasiloxane, and four polymeric methyl siloxanes. The oral LD5

### ofor these compounds ranged from 40 g/kg to >60 g/kg (Refs. 11, 12, 15, 46, 

### 57, 58, 63, 67, 68, 69, 71, and 72). The dermal LDEo was > 16 mL/kg and 4.6g/ kg for hexamethyldisiloxane and octamethylcyclotetrasiloxane, respectively (Refs. 63, 67, 68, 69, and 71). Following inhalation exposure to near saturated atmospheres, death occurred in 1-15 minutes (=4,000 ppm) and 8 hours (=1,300 ppm), for hexamethyldisiloxane and octamethylcyclotetrasiloxane, respectively (Refs. 57, 63, 69, and71). For hexamethyldisiloxane and polydimethylsiloxane, onlyirritation at the injection site was observed following subcutaneous administration (Refs. 8 and 57). No effects were observed following intraperitoneal injection of10 mL/kg of dodecamethylpentasiloxane or polydimethylsiloxane, but some deaths occurred at > 0.3 mL/kg of hexamethyldisiloxane (Refs. 32 and 57). All of these compounds eitherproduced

no irritation or slight irritation to the skin and eyes (Refs. 57, 63, 67, 15, 17, and 18).

Repeat exposure studies in rats and rabbits ofhexamethyldisiloxane produced no effects following dermal (20 exposures, dose notreported) or inhalation (20 exposures to 4,400 ppm) exposure. Dermal exposure for21 days to 40mg/kg/day of trifluoropropylmethylcyclotrisiloxane produced no effects, but similar exposure to 200mg/kg/day reduced weight gain, food consumption, serum alkaline phosphatase activity and increased activity ofserum enzymes; 5/ 12 animals died from exposure to 400 mg/kg/day (Refs. 11, i2, 13, 14, 60, 67, 68, 

### 69, and 70). Polydimethylsiloxane produced no effects following oraladministration (20gavage doses of 20.0 g/kg) (Ref.57). Octamethylcyclotetrasiloxane reduced bodyweight and increased liver weight following both oral (2g/kg/day by gavage for 28 days) and inhalation (700 ppm for6 hours/day for90 days) exposures (Refs. 22 and 24). In a chronic study ofpolydimethylsiloxane in mice, increased mortality was observed in females but notin males exposed for76 weeks to dietary doses of1,250 mg/kg/ day,while subcutaneous implant of polydimethylsiloxane for 2years resulted in mesenchymal tumors, some of which were malignant (Refs.8 and 45).

In a developmental toxicity study, an increase in postimplantation loss was observed in rats following subcutaneous administration of200 mg/kg of polydimethylsiloxane on gestation days 6-16, but this effect was not observed in

a second trial (Refs. 2 and 39). Additionally, no soft tissue or skeletal malformations were observed following oral (1,000 mg/kg/day, gestation days 6- 15) or dermal (200 mg/kg, gestation days 6-15) administration to rats, or subcutaneous administration to rabbits (1,000 mg/kg, gestation days 6-18) (Ref. 39).

Gene mutation assays in bacteria and mitotic recombination tests in yeasts

were negative for decamethylcyclopentasiloxane, hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, hexamethyldisiloxane and octamethyltrisiloxane. A weakly positive result was reported for octamethyltrisiloxane in the mouse lymphoma L5178Y forward mutation assay; negative results were reported for the other siloxanes, both with and without S9 activation (Refs. 36 and 49). Sister chromatid exchange assays in

mouse lymphoma cells were negative for decamethylcyclopentasiloxane, hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, and hexamethyldisiloxane. Chromosomal aberration assays in mouse lymphoma cells yielded negative results in the presence and absence ofS9 activation for decamethylcyclopentasiloxane, but mixed positive results were reported for others, as follows: hexamethylcyclotrisiloxane and octamethylcyclotetrasiloxane-positive with S9, negative without S9; and hexamethyldisiloxane-negative with S9, positive without S9 (Ref.36).

In in viva tests, hexamethylcyclotrisiloxane and hexamethyldisiloxane produced no evidence ofchromosomal aberrations in the rat bone marrow cytotogenicity assay (Ref.36). Porydimethylsiloxane fluid did not produce evidence of chromosomal effects in the mouse dominant lethal assay (Ref.39).

Dermal sensitization was not observed in mice following a challenge with polydimethylsiloxane (Ref. 51). Preliminary findings with subcutaneously-placed, siloxanecontaining implants indicated a doserelated decrease in activity ofnatural killer cells after 180 days; a time course study is currently underway (Ref. 52).

F.Ecologicaleffects information.The Committee is not recommending 

### ecological effects testing at this time because it wants to review data developed underTSCA Section 4 for octamethylcyclotetrasiloxane and any ecological effects data that may be submitted underTSCA Section 8(d).
References

(1)Bateman, F.J.A. "Silicone barrier cream in prevention ofbedsores." BritishMedical Journal. 554-555 (1956) (2)Bates, H., Filler,R., and Kimmel, C. "Developmental toxicity study of polydimethylsiloxane injection in the rat." Teratology.31(3):50. Abstract (1985).

(3)Brozena, S.J., Fenske, N.A., Cruse, C.W., Espinoza C.G.. Vasey, F.B., Geramin. B.F.. and Espinoza, L.R. "Human adjuvant disease following augmentation mammoplasty." Archives of Dermatology.124(9): 1383-1386 (1988).-

(4] Carter,H.B.N.. and Sherman, R.T. "Dimethicone (silicone) skinprotection in surgical patients." ArchivesofSurgery.116- 

### 117 (1957).

(5)Chastre,J., Basset, F., Viau, F., Dournovo, P., Bouchama, A.. Akesbi, A.. and 

### Gibert, C. "Acute pneumonitis after subcutaneous injections of silicone in transsexual men." TheNewEngland Journal of

Medicine.(1983). (6)Chastre,

### J., Brun. P., Soler,P., Basset, F., Trouillet, 

### l.L., Fagon, J.Y., Gibert, C., and 

### Hance, A.J. "Acute andlatent pneunonitis after subcutaneous injections ofsilicone in transsexual men." AmericanReview of RespiratoryDisease.135(1):236-240 (1987).

(7)Chemcyclopedia 87. TheManualof CommerciallyAvailableChemicals.Volume 5.Kuney, J.H. Ed. Washington, DC: American Chemical Society. p.180 (1987].

(8)Cutler,M.G.. Collings, A.J.. Kiss, I.S., 

### and Sharratt. M."A lifespan study of polydimethylsiloxane in the mouse." Food andCosmeticToxicology.12:443-450 (1974).

(9)De Bortoli, M., Knoppel, H., Pecchio, E., Peil, A., Rogora, L., Schauenburg, H., Schlitt., H., and Vissers, H. "Concentrations of selected organic pollutants in indoor and outdoor air in Northern Italy." Environment International. 12:343-350 (1986). (10) Dow Coming Corporation. "In vitro percutaneous absorption of octamethylcyclotetrasiloxane (D4)." TSCA 8d submission 86-890001542, microfiche number OTS-0520671. Washington. DC: OPPT, USEPA (1985b).

(11) Dow Chemical Corporation. "Results 

### ofrange finding toxicological tests on octamethylcyclotetrasiloxane." TSCA 8d submission 87-8214940, microfiche number OTS-0206723, Washington, DC: OPPT, USEPA (1985c).



### (12) DowComing Corporation. "Results of range finding toxicological tests on dimethyl cyclic tetramer." TSCA 8d submission 87- 8215081, microfiche number OTS-0206762. Washington, DC: OPr, USEPA (1985d).

(13) DowComing Corporation. "Evaluation 

### of the dermal irritation potential of13 personal care fluids." TSCA 8d submission 87-8215092,. microfiche number OTS-0206762, Washington, DC: OPPT, USEPA (1985e). 

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### Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / 

### Notices

(14) Dow Coming Corporation. "Comparative eye irritation ofspecially prepared Dow Corning 200 fluids with cover ietter." TSCA ad submission 87-8215080, microfiche number OTS-0206762. Washington. DC: OPPT, USEPA (19851).

(15) Dow Coming Corporation. "roxicity studies on hexamethyldisiloxane (DC 200 fluid)." TSCA FYI submission FYI-OTS0286-0469, microfiche number OTS-0000469- 0. Washington, DC: OPPT, USEPA (1986a).

(16) Dow Coming Corporation. "Toxicity studies on TX-135A." TSCA FYI submission FYI-OTS-0286-0469. Washington, DC: OPPT, USEPA (1980b).

(17) Dow Coming Corporation. "Comparison ofthe primary skin irritation potential and the effects ofrepeated prolonged skin exposures to various volatile experimental cosmetics fluids with SD alcohol 40." TSCA FYI submission FYI-OTS0286-0489, microfiche number OTS-0000469- 0, Washington, DC: OPPT,USEPA (1986c).

(18) Dow Coming Corporation. "Range finding eye irritation test on hexamethyldisiloxane (DC 200 fluid)." TSCA FYI submission FYI-OTS-0286-0469. microfiche number OTS-0000469-0, Washington. DC: OPPT, USEPA (1986d).

(19) Dow Corning Corporation. "The noctanol/water partition coefficient of octamethylcyclotetrasiloxane." TSCA 6d submission 88-880000065, microfiche number OTS-0513955. Washington, DC: OPPT. USEPA (1987).

(20) Dow Corning Corporation. "Metabolism of octamethylcyclotetrasiloxane in the monkey." TSCA 8d submission 86- 880000257. microfiche number OTS-0514147, Washington. DC: OPPT,USEPA (1988a).

(21) Dow Coming Corporation. "An
assessment ofthe mesio 3/2 content offeces and urine obtained 24 hours after the oral administration ofD4 to rats." TSCA 8d submission 86-880000346, microfiche number OTS-0516496, Washington, DC: OPPT, USEPA (1988b).

(22) Dow Corning Corporation. "A 28-day oral gavage study of octamethylcyclotetrasiloxane in male and female rats with attachments and cover letter dated 040888." TSCA 8d submission 86- 880000215. microfiche number OTS-0514105, Washidgton. DC: OPPT, USEPA (1988c).

(23) Iow Coming Corporation. "Dermal absorption ofDow Coming F-218 fluid in the adult male rat, primate and human." TSCA 8d submission 87-8215083, microfiche number OTS--020762, Washington, DC: OPPT. USEPA (1989a).

(24) Dow Coming Corporation. "Inhalation studies and industrial hygiene survey for octamethylcyclotetrasiloxane (D4)." TSCA ad submission 86-890000151S, microfiche number OTS-0516677, Washington DC: OPPT,USEPA (1989b).

(25) Ellenbogen, R., Ellenbogen. R., and Rubin. L. "Injectable fluid silicone therapy. Human morbidity and mortality." Journal of theAmericanMedicalAssociation.234:308- 309 (1975).

(26) Endo, L.P., Edwards, N.L., Longley, S., Corman, LC., and Panush, R.S. "Silicone and rheumatic diseases." SeminarsinArthritis and Rheumatism. 17(2):112-118 (1987). (27) Flaningam. O.L. "Vapor pressures of poly(dimethylsiloxanes) oligomers." Journal ofChemicaland Engineering Data. 31:266- 272 (198).

(28) General Electric Company. "An epidemiologic study ofemployees in the silicones industry final report." TSCA FYI submission FYI-OTS-0187-0532, microfiche number OTS-000032-0, Washington. DC: OPPT, USEPA (1987).

(29) General Electric Company. GE Silicones. Fluids. General Electric Company, U.S.A. pp.1-16(1991).

(30) General Electric Company. Material Safety Data Sheets on DF104O,SF69, SF99, SF1147, SF1173.SF1188, SF1202. SF1204. SF1705, VISC-12M, VISC-30ML VISC-0M. General Electric Company, Waterford, NY (1992).

(31) Hardman, B.B., and Torkelson. A. "Silicon compounds (silicones)." In: KirkOthmerEncyclopediaofChemical Technology.3rd Edition. Volume 20: pp. 922- 982 (1982).

(32) Hawthorne, G.A., Ballantyne, D.L., Rees, T.D., and Seidman, L "Hematological effects ofdimethylpolysiloxane fluid in rats." Research Journal oftheReticuloendothelial Society.7(5):587-593 (1970).

(33) Hine, C.H., Elliott, E.W., Wright, R.R., Cavali R.D.. and Porter, C.D. "Evaluation of

a silicone lubricant injected spinally." Toxicologyand AppliedPharmacology. 15(3):56-573 (1969).

(34) Hobbs, E.J., Fancher, O.E., and Calandra, J.C. "Effect ofselected organopolysiloxanes onmale rat and rabbit reproductive organs." Toxicology and AppliedPharmacology.21(1):45-54 (1972).

(35) Hodgson. A.T., Wooley, J.D. and Daisey, J.M. "Volatile Chemical Emissions from Carpets." Report submitted by Lawrence Berkeley Laboratory to the U.S. Consumer Product Safety Commission under Interagency Agreement CPSC-IAG-90-1256 (1992).

(38) Isquith,A.,Matheson, D.,and Slesinski. R. "Genotoxicity studies on selected organosilicon compounds: In vitro assays." Food andChemicalToxicology. 26(3):255-261 (1988a).

(37) Isquth.A.,Slesinski, R.,and Matheson, D. "Genotoxicity studies on selected organosilicon compounds: In vivo assays." Food and ChemicalToxicology. 26(3):263-266. (1988b).

(38) Kacprzak, J.L "Atomic absorption spectroscopic determination of dimethylpolysiloxane injuices and beer." Journal oftheAssociationofOfficial AnalyticalChemists.65(1): pp. 148-150(1982).

(39) Kennedy, G.L.,Keplinger, M.L.,and Calandra. J.C. "Reproductive, teratologic and mutagenic studies with some polydimethylsiloxanes." Journal of Toxicologyand Environmental Health.1:909- 920 (1976).

(40) Kim, Y.K. "Fluorine compounds, organic: poly(fluorosilicones)" In: KirkOthmerEncyclopediaofChemical Technology.3rd Edition.Volume 11: pp. 74-81 (1982).

(41) Koe, LC.C., and Ng,. W.J. "Identification ofodorous gases originating from refuse waste." Water,Air,andSoil Pollutibn.33:199-204 (1987).

(42) Koe, L.C.C., and Tan, N.C. "GC-MS identification ofgaseous volatiles in wastewater." Environmental Monitoringand Assessment. 15:13-24 (1990).

(43] Lindley, D.D., and Hershey, H.C. "The orthobaric region ofoctamethyltrisiloxane." FluidPhase Equilibria. 55:109-124 (1990). (44) Lucas, S.V. GC/MS analysis of organics indrinking water concentrates and advanced waste treatment concentrates. Vol. 1.Analysis results for 17 drinking water and 16 advanced waste treatment and 3process blank concentrates.EPA-800/1-84-O20A. (NTIS PB85-128221). Columbus, OH: Columbus Labs.Health Effects Research Laboratory. pp. 45,46,147,150 (1984).

(45) Maekawa, A., Ogiu,T.,Onondera, H., Furuta. K., Matsuoka. C., Ohno,Y., Tanigawa, H., Salmo. GS.. Matsuyama, M., and Hayashi, Y."Malignant fibrous histiocytomas induced in rats by polymers." Journal of Cancer ResearchandClinical Oncology. 108(3):364-35 (1984).

(46)Marshall. T.C., Clark. C.R., Brewster, D.W., and Henderson, T.R. "Toxicological assessment ofheat transfer fluids for use in solar energy applications." Toxicologyand AppliedPharmacology. 58'31-38 (1981). (47)Mason. J. and Apisamthanarax, P. "Migratory silicone granuloma." Archives of Dermatology.117(6):388-37 (1981).

(46) McFall.J.A., Antoine. S.R., and DeLeon, I.R. "Organics Inthe water column ofLake Pontchartrain." Chemosphere.9:1253- 1265 (1985).

(49)NCI/DCE (National Cancer Institute/ Division ofCancer Etiology). Short-term testing program. (no date).

(50) NIOSI-L National Institute for Occupational Safety and Health. National Occupational Exposure Survey (NOES) (1983).

(51) NTP (NationalToxicology Program). "NTP Report on the Immunotoxicity of Polydimethylsiloxane in Female B8C3F1 Mice (Contact Hypersensitivity Studies)." (no date).

(52) NTP (NationalToxicology Program). "Status report on the potential effects of silicone preparations on the immune system in mice." Personal communication to Allan Anderson. of the Food andDrug Administration. from Albert E. Munson, February 9 (1992).

(53) Onstot, J.D., Aylins, R.E., and Stanley, 

### 1.S. "Characterization ofHRGC/MS unidentified peaks from the analysis of human adipose tissue." U.S.EPA-50/5-87- 002A. Exposure Evaluation Division, Office of Pollution Prevention andToxics, Washington. DC.. pp. 20.22,26 and 28 (1987).

(54) Pleil, J.D., and Whiton. R.S. "Determination oforganic emissions from

new carpeting."AppliedOccupational and Environmental Hygiene.5:693-699 (1990). (55) Rae, V., Pardo. R.I., Blackwelder, P.L., and Falanga, V. "Leg ulcers following subcutaneous injection ofa liquid silicone preparation' Archivesof Dermatology. 125(5):670-473 (1989).

(56)Robinson. 

### J. Gray, D.A., Jacobson. R., Howard, P., and Santodonato. 1." echnical support document for octamethylcyclotetrasiloxane." Prepared for. TestRules Development Branch. Existing Chemicals Assessment Division,Office of 

### 30616

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Toxic Substances. Washington. D.C., May 29 (1985).

(57) Rowe, V.K., Spencer, H.C., and Bass, S.L "Toxicological studies on certain commercial silicones and hydrolyzable silane intermediates." Journal of

Industrial Hygiene and Toxicology. 30(6):332-352 (1948).

(58) Sandmeyer, E.E., and Kirwin, C.J. Jr. "Organic silicone esters." In: Potty's Industrial Hygiene andToxicology. Clayton. G.D.. and Clayton, F.E., Eds. Volume IIA; 3rd revised edition. New York, NY: John Wiley and Sons. 2396-2412 (1981).

(59) Sergott. T.J., Limoli, J.P., Baldwin, C.M. Jr., and Laub, D.R. "Human adjuvant disease possible autoimmune disease after silicone implantation: A review of the literature case studies and speculation for the future." Plastic andReconstructiveSurgery. 78(l):104-114 (1988).

(60) Siddiqui, W.H., and Hobbs, E.J. "Subchronic dermal toxicity of trifluoropropylmethylcyclotrisiloxane in rabbits." DrugandChemicalToxicology. 5(4):415-426 (1982).

(61) Silicones Health Council. "Aquatic Half-life ofOMCTS." and "Henry's Law Constant ofOMCTS." TSCA4 submission 40-8994112, microfiche number OTS-0525564. Washington, DC: OTS, USEPA (1989).

(62) Suskind, R.R. "The present status of silicone protective creams." Industrial MedicineandSurgery.24:413-16 (1955).

(63) SWS Silicones Corporation. Material safety data sheet for siloxane SWS-03314. Technical Resources, Incorporated. May (1992).

(64) Symmers, W.S.C. "Silicone mastitis in topless waitresses." BritishMedical Journal. 3:19-22 (1968).

(65) Travis, W.D., Balogh, K.,and Abraham, J.L "Silicone granulomas: Report ofthree cases and review ofthe literature." Human Pathology. 16:19-27 (1985). (66) UnionCarbide Corporation. Silicone Fluids.Union Carbide Corporation, U.S.A. pp. 1-67 (1982).

(67) Union Carbide Corporation. "Toxicity andirritation assay results ofsome food, drug orcosmetic product chemicals,' TSCA 8d submission 87-8214984, microfiche number OTS-0206746, Washington, DC: OPPT, USEPA (1985a).

(68) Union Carbide Corporation "Toxicity andirritation assay results ofsome food, drug orcosmetic product chemicals." TSCA 8d submission 87-8214985, microfiche number OTS-0206746, Washington, DC: OPPT, USEPA (1985b).

(69) Union Carbide Corporation. "Range finding toxicity studies with cover letter." TSCA 8d submission 87-8214982 microfiche number OTS-0206746, Washington, DC: OPPT, USEPA (1985c).

(70) Union Carbide Corporation. "Evaluation of potentialhazards by dermal contact." TSCA 8d submission 878214987, microfiche number OTS-0206746, Washington, DC: OPPT, USEPA (1985d).

(71) Union Carbide Corporation. "Silicone fluid Y-4081: Acute toxicity and primary irritancy studies." TSCA FYI submission FYIOTS-0386-046, microfiche number OTS0000469-0, Washington, DC: OPPT, USEPA (1986).

(72) U.S. FDA (U.S. Food and Drug Administration). Food additive safety profile, addendum. Online (1992).

(73) Varga, J.. Schumacher, H.R., and Jimenez, S.A.."Systemic sclerosis after augmentation mammoplasty with silicone Implants."Annals of Internal Medicine. 111(5): 377-383 (1989). (74) VOC data base.National Ambient Volatile Organic Compounds Data Base Update. U.S. Environmental Protection Agency. August 15 (1990).

(75) Wallace, L.A., Pellizzari, E.,Hartwell, T.. Rosenzweig, M.,Erickson, M.,Sparacino, C.,and Zelon, H. "Personal exposure to volatile organic compounds. 1. Direct
measurements in breathing-zone air, drinking water, food, and exhaled breath." Environmental Research.35:293-319 (1984). (76) Weschler, C.J. "Polydimethylsiloxanes associated with indoor and outdoor airborne particles." The Scienceofthe Total Environment. 73:53-63 (1988).

(77) Winer, L.H.. Sternberg, T.H., Lehman, R., andAshley, F.L. "Tissue reactions to Injected silicone liquids.A report ofthree cases." Archives of Dermatology. 90:588-592 (196).

2.4.b. Chloroalkyl phosphates.

L Rationale forRecommendation

Four chloroalkyl phosphates are recommended for physical and chemical property, chemical fate, health effects and ecological effects screening tests (Table4). The Committee recommends testing these four chloroalkyl 

### phosphates because they are structurally similar to the five chloroalkyl phosphates recommended in the 23rd Report (53 FR 46262, November 16,1988) and because there are insufficient data to reasonably determine orpredict physical and chemical properties, persistence and health or ecolgical effects.

TABLE 4.-RECOMMENDED CHLOROALKYL PHOSPHATES

CAS No. Chemical Name Acronym

34621-99-3 1,2-Ethanedyly tetrakis(2-chloro-1.methytethylene) phosphate

.................................................... TCIEP 38051-10-4 2,2-Bis(chloromethyl-1,3-propanediy tetrakis(2- chloroethyl) phosphate..............- " TCEBP 53461-82-8 Oxydi-2.1-ethanediyl tetrakis(2-chloroethyl) phosphate

................................................................ TCEDP 76649-15-51 2-Chloro-l-methylethyt bis(2-chloropropyl) phosphate

.......................... . ........... IDCPCEP

II. Summaryof Recommended Tests
Four chloroalkyl phosphates (TCIEP, TCEBP, TCEDP and DCPCEP) are recommended for determination of melting point, water solubility, octanolwater partition coefficient, and vapor pressure data, hydrolysis and aerobic biodegradation rate. Also recommended

are screening tests to develop acute health effects data (except for TCIEP) and fish, algae and aquatic and benthic invertebrates acute toxicity data (fish and aquatic invertebrate acute toxicity data are available forTCIEP).

III. Supporting Information
A. Background.In 1986, two chloroalkyl phosphates, tris(2- chloroethyl) phosphate (TCEP) and tetrakis(2-chloroethyl) 

### ethylenediphosphate (TCEEP)were identified for priority testing consideration during the Committee's 

### Sixth Scoring Exercise (52 FR 10409, April 1. 1987). On May 12, 1988, the Committee decided to expand this group to include other commercially-available chloroalkyl phosphates: tris(2-chloro-1- propyl) phosphate (TCPP), tris(2- chloroisopropyl) phosphate (TCIP), and tris(1,3-dichloroisopropyl) phosphate (TDCP). In its 23rd Report (53 FR 46262, November 16, 1988), the Committee recommended testing for TCEP.TCPP, TCIP,TDCP and TCEEP.

The Committee's computerized substructure-based chemical selection expert system (SuCSES) was developed in 1986 (Ref. 10). In 1988, some components ofSuCSES had not been integrated into the system and did not permit the Committee to identify all commercially-available chloroalkyl phosphates. In 1992, with these integrated components, SuCSES was used to identify four additional chloroalkyl phosphates: TCIEP, TCEBP, TCEDP and DCPCEP.

B. Physical andchemical properties. No information was found on physical and chemical properties measured at ambient temperature.

C. Exposure/informationproduction/use/disposal/exposure/ release. The chloroalkyl phosphates listed in Table 4 are commercially available and may be produced in substantial quantities. Actual production volumes are confidential business information. Chloroalkyl

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### Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

phosphates are used as flame retardants in flexible and.rigid polyurethane foams. These chloroalkyl phosphate-treated foamsAre used in furniture and bedding that are sold forhousehold, business, and transportation uses.

There are no publicly-available
exposure estimates, OSHA occupational exposure standards, publicly-available effluent monitoring data and Toxics Release Inventory data.Uncertainties related to exposure and release of chloroalkyl phosphates may be clarified after the Committee's review ofthe data obtained under TSCA Section 8(a) and 8(d) along with any other information submitted as a result of thegeneric request for voluntary use, exposure, release, and physical and chemical property data made in Chapter 1of the 28th report (56 FR 41212, August 19, 1991).



### D.Chemical fateinformation.No chemical fate information was found.

E.Healtheffects information.Except * 

### for data described below forTCIEP and

TCEBP, no health effects information

was found.

Five acute toxicity studies on TCIEP

were reviewed. The oral LD50 formale rats was 1.58 g/kg (Ref. 3). No rabbits died when 2 g/kg TCIEP was applied to abraded and non-abraded skin for 24 hours (Ref. 4). Inhalation of200mg/liter for 1-hour resulted in death of 3of 10 rats (Ref.5). TCIEPwas not a skin irritant; however, when 0.1 ml was instilled Into the conjunctiva ofrabbits eyes, it was irritating (Refs. 6 and 7). In comparison to the studies reviewed on the five chloroalkyl phosphates recommended in the ITC's23rdReport: by the oral route, TCIEPwas lesstoxic than TCIP and TDCP,and about the

same as TCEP and TCEEP;by the inhalation route, TCIEPwas more toxic than TCEP,TCPP, TCIP, and TCEEP.

In a 90-day ratdermal toxicity study, TCIEPincreased liverweight at 500 mg/ kg/day and hypertrophy ofthe liver and thyroid at 2500 mg/kg/day (Ref.8). In a pilot developmental toxicity test 800 mg/kg/dayTCEBP increased postimplantation loss at maternally toxic doses (Ref.9). In comparison to the TSCA 8(d) developmental toxicity studies on chloroalkyl phosphates recommended in the ITC's23rdReport, TCEBP was less toxic than TCEP, TDCP

orTCEEP.

The Committee is aware that Ames, micronucleus, skin sensitization and 90- day developmental toxicity tests were completed forTCIEPand has requested copies ofthese test reports from the test sponsor.

F.Ecological effects information. Except for TCIEPdata, no ecological effects information was found.

For TCIEP, the 2-day LC50for daphnids ranged from 4.1-5.3 mg/L and the4-day LC 6

### oforfathead minnows ranged from 3.0-3.3 mg/L (Refs. 1and 2). In comparison to the studies reviewed

on the chloroalkyl phosphates recommended in the ITC's23rdReport, LCovalues forTCIEP were close to the fish LC50ofTDCP (1.4 mg/L), butless than the fish LC 5 

### ofTCPP (51 mg/L) or the fish LC5 

### ofTCEP(250 mg/L). References (1)Eastman Kodak Company. Acute aquatic effects ofThermolin RJTon the daphnid. Daphniamagna.Rochester, NY (1987).

(2)Eastman Kodak Company. Acute aquatic effects ofThermolin RJT on the fathead minnow, Pimapholes promelas. Rochester, NY (1987).

(3)MB Research Laboratories, Inc. Report

on Thermolin 102 oral LD50 in rats.Project No. MB 77-1540, Spinnerstown, PA (1977).

(4)MB Research Laboratories, Inc. Report

on Thermolin 102 acute dermal toxicity in rabbits. Project No.MB 77-1540, Spinnerstown. PA (1977).

(5)MB Research Laboratories, Inc. Report

on Thermolin 102 inhalation toxicity in rats. Project No. MB 77-1540, Spinnerstown, PA (1977).

(6) MB Research Laboratories, Inc. Report

on Thermolin 102 primary dermal irritation in rabbits.Project No.MB 77-1540, Spinnerstown. PA (1977).

(7)MB Research Laboratories, Inc. Report

on Thermolin 102 rabbit eye irritation.Project No. MB 77-1540, Spinnerstown. PA (1977).

(8)Toxicol Laboratories Limited. "Thermolin RJT90-day dermal toxicity study in the rat." Report No.OLA/11/88, Ledbury, U.K. (198).

(9) Monsanto Co. "Pilot teratology study in rats with cover sheets and letter dated 4/10/ 90." Document No.88-900000115, Fiche No. OTS-0524046, Office ofPesticides and Toxic Substances, Washington, DC. (1990).

(10)Walker, J.D. "Chemical selection by the Interagency Testing Committee: use of computerized substructure searching to identify chemical groups for health effects, chemical fate and ecological effects testing." TheScienceofthe TotalEnvironment.109/ 110: 691-700 (1991).
[FR Doc. 92-15972 Filed 7-8-92; 8:45 am]

BLLING CODE 6560-50-F 

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