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

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS-41037; FRL-4071-41

Thirtieth Report of the Interagency

Testing Committee to the

Administrator, Receipt of Report and

Request for Comments Regarding

Priority Testing List of Chemicals

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: The Interagency Testing

Committee (ITC), established under

section 4(e) of the Toxic Substances

Control Act (TSCA), transmitted its 30th

Report to the Administrator of EPA 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.

The ITC removed two chemicals from

the Priority Testing List in the 30th

Report as a result of EPA actions.

Sodium cyanide and acrylic acid,

designated in the 27th ITC Report, were

removed because EPA issued a consent

order for sodium cyanide on December

17, 1991 (56 FR 65442), and for Acrylic

acid on March 4, 1992 (57 FR 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 of written

submissions to: TSCA Public Docket

Office (TS-793), Office of Pollution

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 8 a.m. to noon and 1 p.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 of EPA to promulgate

regulations under section 4(a) requiring

testing of chemicals 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 of EPA for

priority testing consideration. Section

4(e) directs the ITC to 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. Written and 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 of unpublished 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) rule requires

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 of one chemical group and 4

chloroalkyl phosphates to the Priority

Testing List, and the removal of sodium

cyanide and acrylic acid from the List.

The current Priority Testing List

contains 24 chemicals and 23 chemical

groups, 11 of these chemicals are

designated.

Authority: 15 U.S.C. 2603.

Dated: June 30, 1992.

Charles M. Auer,

Director, Existing Chemical Assessment

Division, Office of Pollution Prevention and

Toxics.

Thirtieth Report 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)

for testing under Section 4(a) of TSCA

and to facilitate coordination of

chemical testing sponsored or required

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

of siloxanes for a number of medical

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

of 56 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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Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

The Committee reviewed 350 studies

on the 5 chloroalkyl phosphates

recommended in the Committee's 23rd

Report and deferred them to provide an

opportunity for manufacturers 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

and the Chemical Manufacturers

Association to discuss completed,

ongoing and planned testing of chemical

groups and attended the March 18, 1992

U.S. House of Representatives 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 for Testing and

Materials on the role of the 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 of glycol 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).

Additions to the Priority Testing List

Additions to the Priority Testing List

are presented, together with the types of

testing recommended, in Table 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

Statutory member Agencies and Their

Representatives

Council on Environmental Quality

Charles Herrick. member (see Note 1)

Department of Commerce

Willie E. May, member.

Edward White, alternate (see Note 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 L Moyers, alternate

Occupational Safety and Health

Administration

Christine Whittaker, member and vice

chairperson

Surender Ahir, alternate

Liaison Agencies and Their

Representatives

Agency for Toxic Substances and

Disease Registry

Sharunda Buchanan, member

Consumer Product Safety Commission

Val Schaeffer, member (see Note 5)

Lakshmi C. Mishra

Department of Agriculture

Donald Deft, member

Ralph T. Ross, alternate (see Note 6)

Department of Defense

Randall S. Wentsel, member

Department of the Interior

Clifford P. Rice, member

Barnett A. Rattner, alternate

Department of Transportation

George Cushmac, member

James O'Steen, alternate

Food and Drug Administration

Edwin J. Mathews, member (see Note 7)

Raju Kanumula, alternate

National Library of Medicine

Vera Hudson, member

National Toxicology Program

Victor A. Fung, member (see Note 8)

U.S. International Trade Commission

James Raftery, member

Edward Matusik, alternate

Committee Staff

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

staff of Syracuse Research Corp.

(technical support contractor) and

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

personnel of the EPA Office of Pollution

Prevention and Toxies.

Chapter 1--Introduction

1.1 Background. Background on the

TSCA Interagency Testing Committee

(ITC) was provided most recently in

chapter 1.1 of the 29th Report that was

submitted to the EPA Administrator on

November 27, 1991 (56 FR 67424,

December 30, 1991).

1.2 Committee's previous reports.

Twenty-nine previous Reports to the

EPA Administrator have been 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 of the 29th

Report.

1.3 Committee's activities during this

reporting period. The Committee's

activities during this reporting period

(November 28, 1991 to May 27, 1992) are

described below.

1.3.a Chemical and chemical group

selections. During this reporting period,

the Committee initiated efforts to

develop a Priority Testing Candidate

List of chemicals and chemical groups

under consideration, reviewed data on

siloxanes and chloroalkyl phosphates,

conducted a partial review of glycol

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 the Committee'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 of the ITC's 27th and 29th

Reports.

Some chemical groups on the Priority

Testing Candidates List that the

Committee will be considering in the

future were listed in Chapter 1.3.b of the

29th Report.

1.3.b Comprehensive information

processing. The Committee's approach

to comprehensive information

processing is described in Chapter 1.3.b

of the 29th Report.

1.3.c Information dissemination. To

promote public understanding of the

Committee's functions, some of the

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 and Natural

Resources, chaired by Congressman

Mike Synar (D-OK). On March 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 of the Chemical

Manufacturers Association, the

Committee's Chairperson and Executive

Director met with the chloroalkyl

phosphate manufacturers on April 1,

1992 to discuss completed. ongoing and

planned testing and the status of the

ITC's review of chloroalkyl phosphates.

The manufacturers were asked to supply

samples of chloroalkyl phosphates for

EPA sponsored fish neurotoxicity tests.

They were encouraged to provide

information on the uses of chloroalkyl

phosphates, the levels of chloroalkyl

phosphates that might result from

processing anduse and information that

might explain the low (parts per 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 of the American

Society for Testing 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 for chemical fate

and ecological effects testing. The

Executive Director discussed ITC's role

in facilitating development of chemical

fate and ecological effects test methods.

1.3.d Information coordination.

Congress directed the Committee to

facilitate coordination of chemical

testing sponsored or required by U.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 the request of the 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 of this chemical. The

TSCA Section 8(d) reports were

submitted to the EPA as a result of the

Committee's recommendation for

physical and chemical property testing

of sulfones 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.

At the request of the Agency for Toxic

Substances and Disease Registry

(ATSDR), comments were provided on

ATSDR's Priority Data Needs for a

number of the 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 of the Priority Data 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 staff determined that the

Committee had considered about 75% of

ATSDR's 275 hazardous substances, had

recommended about 70 of them for

testing, had taken action on 33 of the 38

hazardous substances for which ATSDR

determined Priority Data Needs, and

had designated 3 of the 38 substances

for testing. For the 33 substances on

which the ITC had taken action, there

may be existing studies that could

satisfy ATSDR's Priority Data Needs.

For the 3 ITC designated 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 Data Needs.

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 studies received by

ATSDR from the Committee will be

screened and reviewed before the

Priority Data Needs are finalized.

1.3.e Referrals. During this reporting

period, the Committee did not refer any

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Fedeal bwg1S, / VoL -; No. 13/ Thnr, jlk nlsday 9, 1 Ntieds.*

chemicals to member agencies or other

organizations for testing consideration.

1.3.f Deferrals. During this reporting

period, the Committee deferred the five

chloroalkyl phosphates recommended in

the 23rd Report because of an interest

on the part of industry to voluntarily

take action on these chemicals. The

Chemical Manufacturers Association

(CMA) and several chloroalkyl

phosphate producers have approached

the ITC and EPA to discuss voluntary

testing for certain of the chloroalkyl

phosphates. It is the interest of the ITC

and ITC member agencies to ensare that

the hazard of these chemicals is well

characterized; additionaly, the

Committee believes that exposanm to

these chemicals shoulid be better

characterzed. The Committee

encorage CMA and the c€ kUoa1lC

phosphates' producers to offer a kmrAl

proposal to EPA. which ma result in a

testing consent order or other binding

agreement through a public process, to

develop hazard and exposure data. The

Committee also believes that.

considering the potential cancer risk of

these chemicals, voluntary exposure

controls on the part of industry may be

appropriate. The E41mmittee is deferfing

these five chloroalkyl phosphates

pending the results of future discussions

with industry.

1.3.g Removals. Two chemicals

designated in the Committees 27th

Report were removed from the Priority

Testing List, because EPA Implemented

the Committee's testing

recommendtios. On December 17,

1991 and March 4,1992. EPA published

Consent Orders for sodium cyanide (56

FR 65442) and acrylic acid (57 FR 7656),.

respectively. The most recent table of

removals from the Priority Testing List

was published in the Coituftea 29th

Report. As a result of the removals

made during this reporting period. 100

chemicals and 18 chemical groups have

been removed from the ITCs Priority

Testing List

1.4 The TSCA section 4(e) Priority

Testing List. Under Section 4(e)(1)(BJ.of

TSCA, Congress directed the Committee

to revise the Priority Testing 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

(Table 1).

The Priority Testing List includes 24

chemicals and 23 chemical groups that

have been recommended or designated

for testing (Table 2). Individual

chemicals in Priority Testing List

chemical groups are listed in Table I of

the 24th Report and in the paragraphs

following Table I of the 26th., 27th, 28th

and 29th Reports. For this 3th Report

the individual chemicals in Priority

Testing List chemical groups are listed

in tables that are included i chapters

2.4.a and 2.4.b. Lists of individi

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 that have been

removed from the ITCs Priority Testing

List with the 24 chemicals and 23

chemical groups currently on the Priority

Testing List, reveals that the Committe

has recommended or designated 124

chemicals and 41 chemical groups for

testing since their first meeting in

February 1977.

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

Re. ri Dt 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 wftk bdim*W~eugue

Reonawwnd wift m W&*Wdsig

Recommended . ir~wtmS@-sn

Recomndrled i* i tdelas Recommended

Recammerided Recum es with lnW4oH~esgrate@

Recom~mnded

Designs

Designated

De~al

Recommended wait biten esignaft

Recommended

Recom"med;

Reconw nded

Recommndeed

Recommended

Designated

Designated

Designated

Designated

Demgnned

Designate

Recommended

Recommended

Recommended

Recommenrded

Recommended

Recommended

Recommended

Recommended

90011
Federal Register /,Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

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

Report Date Chemical/Group Action

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 of the 2.3 Recommended with intent-to- recommended siloxanes for testing

Committee designate chemicals. None. because of FDA's request, because

2.1 Chemicals recommendedfor2.4 Recommended chemicals-24.a production volumes are substantial.

priority consideration by the EPA Siloxanes., because of uncertainties related to

Administrator. As provided by section .L Rationale for Recommendation human exposure, and because. of the • paucity of publicly-available health

4(e)(1)(B) of TSCA, the Committee is Recent questions related to the safety effects data for these substances. By

adding to the section 4(e) Priority of siloxanes for a number of medical

Testing List two chemical groups (see uses, including breast implants, recommending these chemicals, the

Table 1). The recommendation of these 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 to voluntarily submit

the data needs of Member Agencies. of 56 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 silicones and siloxanes, reaction products wir slica

Dtmethytmethylvinylsiloxane

30612
Federal Register I Vo. 57, NO 132 / Thiirsda, Jul 9 9, 01 ' Notfces

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 'Oliloxane op 

I NA = not assigned.

II. Summary of Recommended TestsSiloxanes are recommended for

autoimmune effects, cancer,

reproductive effects and developmental

toxicity testing and for epidemiological

studies (Table 11.

IlL Supportin nformation

A. Background On November 6, 1984,

the Committee designated

octamethylcyclaotetrasitoxane (OMCTSI

for chemical fate and ecological effects

testing in the Committee's 15th report

(49 FR 46931, November 29, 1984]. On

-May 31, 1991, at the request of EPA, 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 was not

recommended previously, recent

questiam related to the safety of

siloxanes for a'rmmber of medical 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 of the recoimnended chemicals

were chemicals identified by FDA. At

the request of FDA, 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 for othr

siloxanes identified by FDA. but FDA

and the Committee did not request that

they be recommended for testing at this

time.

B. Physical and chemical properties.

The Committee foiw limited

infoamation ocn measared physical and

chemical properties for the siloxanev

listed in Table 3:20 log octanol/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. Exposure infornorio -production/

use/disposal/exposure/release. The

siloxanes in Table 3 are 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 in medical devices. cosmetics

and toiletries, food and related 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 used in plastic

and rubber 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

radar equipment, and television circuit

components (Refs. 29 and 30). Siloxanes

are used in food applications; for

example, dimethyt antifoaming agent in

juices and beer (Ref. 38).

Dimethylpolysiloxanes are useful as a

low temperature damping medium, heat

transfer medium, dielectric coolant, and

a base fluid for low temperature silicone

fluids (Refe. 29 and 30).

Octamethylcyclotetrasiloxane is in

several silicone fluids, whichr are used in

a vaiely of applications including

antiperspirants, facal make-up, hair

sprays and skin care products,

fermentation processes, instant coffee

productio, food washing solutions, diet

soft dribks, paper coatings and sizing,

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 in window

cleaners and panel polishes (Refs. 56

and 66). In 1982, ,

octaMethylcyclotetrasiloxane,

decamethylcyclopentasiloxane, and

dodecamethylcyclobexasiloxane were

being evaluated for use in a variety 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 care product

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.

Human exposare-medical. Exposure

to sifoxanes may occur because of uses

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 of soft tissues such as

breast and testicular tissues. Siloxanes

are also used to fabricate tubal

occlusion devices for female

sterilization, encasement of pacemakers

and electrical leads, heart valves,

arteriovenus shunts, catheters, urethral

stents, penile prothesis, prosthetic finger

joints, artifical tendons, and intraocular

lenses as well as to construct elastomers

that are used as Implanted drug delivery

systems.

30613
Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

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 of dimethyl silicones

and siloxanes with silica (Refs. 50).

Monitoring. Atomic absorption

analyses of organic extracts identified

dimethylpolysiloxanes in various fruit

juices (orange, apple, pineapple, apricot,

tomato, lemon, grapefruit, mango, and

apricot juice) (Ref. 38).

Dimethylpolysiloxanes were

quantitatively detected in 51 of 98

samples above the detection limit of 0.2

ppm; 14 of the 51 samples were above 10

ppm and 1 sample 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 (0.3-12.4 jig/

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 in I 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 3 air samples from one

office building, and

tetradecamethylcycloheptasiloxane was

measured in 3 air samples (7.4-10.8 ,g/

m) from one office building (Ref. 74).

Octamethylcyclotetrasiloxane has also

been detected In 2 of 5 indoor air

samples collected in Northern Italy,

1983-4, at concentrations of 10 pg/m 3

and 13 1g/ i 3 (Ref. 9). Emissions of

hexamethylcyclotrisiloxane and

octamethylcyclotetrasiloxane to indoor

air have 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 have been

frequently detected in outdoor airborne

particles. Polydinethylsiloxane

concentrations were approximately 1

ng/m 3 in outdoor airborne particles at

telephone office sites in Wichita, KS,

Lubbock, TX, and Neenah, WI and 2 ng/

m3 in Newark, NJ. (Ref. 76).

Decamethylcyclopentasiloxane has been

detected at concentrations ranging from

0.21 to 0.9 pg/m 3 in 3 outdoor air

samples, octamethylcyclotetrasiloxane

has been detected at concentrations

ranging from 6.6 to 22.6 ttg/m 3 in 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 139 outdoor air

samples from 8 locations (Ref. 74).

Hexamethylcyclotrisiloxane was

detected in 4 of 6 water samples

collected from Lake Pontchartrain, LA,

in 1980; concentrations ranged from 0.02

to 0.3 pg/L. and

octamethylcyclotetrasiloxane was

detected in 1 of 3 samples 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 not recommending

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. Health effects information. Health

effects data were located for 9 of the 52

recommended siloxanes:

hexamethyidisiloxane,

octamethyltrisiloxane,

dodecamethylpentasiloxane.

decamethylcyclopentasiloxane.

hexamethylcyclotrisfoxane,

octamethylcyclo tetrasiloxane,

trifluoropropylmethylcyclotrisiloxane,

dimethicone, and polydimethylsiloxane.

Human studies. Available data

suggest that 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

of adverse 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 for at least

5 years and followed for 19 years

reported a higher than expected

incidence of cancers of the skin, large

intestine and lung, but a decrease in

mortality due to cancers of all 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 and rats resulted in

gastrointestinal absorption (Refs. 20 and

21). When injected,

polydimethylsiloxane distributes

throughout the body, but this process is

slow if the injection is to an area not

accessible to phagocytizing cells (Ref.

33).

30614
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

LD5o for 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 4.6 g/ 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, and 71). For

hexamethyldisiloxane and

polydimethylsiloxane, only irritation at

the injection site was observed

following subcutaneous administration

(Refs. 8 and 57). No effects were

observed following intraperitoneal

injection of 10 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 either produced

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 of hexamethyldisiloxane

produced no effects following dermal (20

exposures, dose not reported) or

inhalation (20 exposures to 4,400 ppm)

exposure. Dermal exposure for 21 days

to 40 mg/kg/day of

trifluoropropylmethylcyclotrisiloxane

produced no effects, but similar

exposure to 200 mg/kg/day reduced

weight gain, food consumption, serum

alkaline phosphatase activity and

increased activity of serum 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 (20 gavage doses of

20.0 g/kg) (Ref. 57).

Octamethylcyclotetrasiloxane reduced

body weight and increased liver weight

following both oral (2 g/kg/day by

gavage for 28 days) and inhalation (700

ppm for 6 hours/day for 90 days)

exposures (Refs. 22 and 24). In a chronic

study of polydimethylsiloxane in mice,

increased mortality was observed in

females but not in males exposed for 76

weeks to dietary doses of 1,250 mg/kg/

day, while subcutaneous implant of

polydimethylsiloxane for 2 years 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 of 200 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 of S9 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 of chromosomal 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 of natural

killer cells after 180 days; a time course study is currently underway (Ref. 52).

F. Ecological effects information. The

Committee is not recommending

ecological effects testing at this time

because it wants to review data

developed under TSCA Section 4 for

octamethylcyclotetrasiloxane and any

ecological effects data that may be

submitted under TSCA Section 8(d).

References

(1) Bateman, F.J.A. "Silicone barrier cream

in prevention of bedsores." British Medical

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) skin protection in

surgical patients." Archives of Surgery. 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." The New England 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 and latent pneunonitis

after subcutaneous injections of silicone in

transsexual men." American Review of

Respiratory Disease. 135(1):236-240 (1987).

(7) Chemcyclopedia 87. The Manual of

Commercially Available Chemicals. 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

and Cosmetic Toxicology. 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

of range finding toxicological tests on

octamethylcyclotetrasiloxane." TSCA 8d

submission 87-8214940, microfiche number

OTS-0206723, Washington, DC: OPPT,

USEPA (1985c).

(12) Dow Coming 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) Dow Coming Corporation. "Evaluation

of the dermal irritation potential of 13

personal care fluids." TSCA 8d submission

87-8215092,. microfiche number OTS-0206762,

Washington, DC: OPPT, USEPA (1985e).

30615

30615
Federal Register / Vol. 57, No. 132 / Thursday, July 9, 1992 / Notices

(14) Dow Coming Corporation.

"Comparative eye irritation of specially

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 of the primary skin irritation

potential and the effects of repeated

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 of the mesio 3/2 content of feces

and urine obtained 24 hours after the oral

administration of D4 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 of Dow 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

the American Medical Association. 234:308-

309 (1975).

(26) Endo, L.P., Edwards, N.L., Longley, S.,

Corman, LC., and Panush, R.S. "Silicone and

rheumatic diseases." Seminars in Arthritis

and Rheumatism. 17(2):112-118 (1987).

(27) Flaningam. O.L. "Vapor pressures of

poly(dimethylsiloxanes) oligomers." Journal

of Chemical and Engineering Data. 31:266-

272 (198).

(28) General Electric Company. "An

epidemiologic study of employees 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: KirkOthmer Encyclopedia of Chemical

Technology. 3rd Edition. Volume 20: pp. 922-

982 (1982).

(32) Hawthorne, G.A., Ballantyne, D.L.,

Rees, T.D., and Seidman, L "Hematological

effects of dimethylpolysiloxane fluid in rats."

Research Journal of the Reticuloendothelial

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."

Toxicology and Applied Pharmacology.

15(3):56-573 (1969).

(34) Hobbs, E.J., Fancher, O.E., and

Calandra, J.C. "Effect of selected

organopolysiloxanes on male rat and rabbit

reproductive organs." Toxicology and

Applied Pharmacology. 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 and Chemical Toxicology.

26(3):255-261 (1988a).

(37) Isquth. A., Slesinski, R., and

Matheson, D. "Genotoxicity studies on

selected organosilicon compounds: In vivo

assays." Food and Chemical Toxicology.

26(3):263-266. (1988b).

(38) Kacprzak, J.L "Atomic absorption

spectroscopic determination of

dimethylpolysiloxane in juices and beer."

Journal of the Association of Official

Analytical Chemists. 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

Toxicology and Environmental Health. 1:909-

920 (1976).

(40) Kim, Y.K. "Fluorine compounds,

organic: poly(fluorosilicones)" In: KirkOthmer Encyclopedia of Chemical

Technology. 3rd Edition. Volume 11: pp. 74-81

(1982).

(41) Koe, LC.C., and Ng,. W.J.

"Identification of odorous gases originating

from refuse waste." Water, Air, and Soil

Pollutibn. 33:199-204 (1987).

(42) Koe, L.C.C., and Tan, N.C. "GC-MS

identification of gaseous volatiles in

wastewater." Environmental Monitoring and

Assessment. 15:13-24 (1990).

(43] Lindley, D.D., and Hershey, H.C. "The

orthobaric region of octamethyltrisiloxane."

Fluid Phase Equilibria. 55:109-124 (1990).

(44) Lucas, S.V. GC/MS analysis of

organics in drinking water concentrates and

advanced waste treatment concentrates. Vol.

1. Analysis results for 17 drinking water and

16 advanced waste treatment and 3 process

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 Research and Clinical Oncology.

108(3):364-35 (1984).

(46) Marshall. T.C., Clark. C.R., Brewster,

D.W., and Henderson, T.R. "Toxicological

assessment of heat transfer fluids for use in

solar energy applications." Toxicology and

Applied Pharmacology. 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 In the water column

of Lake Pontchartrain." Chemosphere. 9:1253-

1265 (1985).

(49) NCI/DCE (National Cancer Institute/

Division of Cancer 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 (National Toxicology Program).

"NTP Report on the Immunotoxicity of

Polydimethylsiloxane in Female B8C3F1 Mice

(Contact Hypersensitivity Studies)." (no

date).

(52) NTP (National Toxicology Program).

"Status report on the potential effects of

silicone preparations on the immune system

in mice." Personal communication to Allan

Anderson. of the Food and Drug

Administration. from Albert E. Munson,

February 9 (1992).

(53) Onstot, J.D., Aylins, R.E., and Stanley, 1.S. "Characterization of HRGC/MS

unidentified peaks from the analysis of

human adipose tissue." U.S.EPA-50/5-87-

002A. Exposure Evaluation Division, Office of

Pollution Prevention and Toxics, Washington.

DC.. pp. 20. 22, 26 and 28 (1987).

(54) Pleil, J.D., and Whiton. R.S.

"Determination of organic emissions from new carpeting." Applied Occupational and

Environmental Hygiene. 5:693-699 (1990).

(55) Rae, V., Pardo. R.I., Blackwelder, P.L.,

and Falanga, V. "Leg ulcers following

subcutaneous injection of a liquid silicone

preparation' Archives of 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.

Test Rules Development Branch. Existing

Chemicals Assessment Division, Office of

30616
Federal Register / Vol. 57, No. 132 / Thursday, 'July 9, 1992 / Notices

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 and Toxicology. 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 and Reconstructive Surgery.

78(l):104-114 (1988).

(60) Siddiqui, W.H., and Hobbs, E.J.

"Subchronic dermal toxicity of

trifluoropropylmethylcyclotrisiloxane in

rabbits." Drug and Chemical Toxicology.

5(4):415-426 (1982).

(61) Silicones Health Council. "Aquatic

Half-life of OMCTS." and "Henry's Law

Constant of OMCTS." TSCA 4 submission

40-8994112, microfiche number OTS-0525564.

Washington, DC: OTS, USEPA (1989).

(62) Suskind, R.R. "The present status of

silicone protective creams." Industrial

Medicine and Surgery. 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." British Medical Journal.

3:19-22 (1968).

(65) Travis, W.D., Balogh, K., and Abraham,

J.L "Silicone granulomas: Report of three

cases and review of the literature." Human

Pathology. 16:19-27 (1985).

(66) Union Carbide Corporation. Silicone

Fluids. Union Carbide Corporation, U.S.A. pp.

1-67 (1982).

(67) Union Carbide Corporation. "Toxicity

and irritation assay results of some food,

drug or cosmetic product chemicals,' TSCA

8d submission 87-8214984, microfiche number

OTS-0206746, Washington, DC: OPPT,

USEPA (1985a).

(68) Union Carbide Corporation "Toxicity

and irritation assay results of some food,

drug or cosmetic 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 potential hazards 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 Science of the Total

Environment. 73:53-63 (1988).

(77) Winer, L.H.. Sternberg, T.H., Lehman,

R., and Ashley, F.L. "Tissue reactions to

Injected silicone liquids. A report of three

cases." Archives of Dermatology. 90:588-592 (196).

2.4.b. Chloroalkyl phosphates.

L Rationale for Recommendation

Four chloroalkyl phosphates are

recommended for physical and chemical

property, chemical fate, health effects

and ecological effects screening tests

(Table 4). 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 or predict 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 .......................... . ........... I DCPCEP

II. Summary of 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 for TCIEP).

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 of SuCSES 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 and chemical 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

foams Are used in furniture and bedding

that are sold for household, 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 of the data

obtained under TSCA Section 8(a) and

8(d) along with any other information

submitted as a result of the generic

request for voluntary use, exposure,

release, and physical and chemical

property data made in Chapter 1 of the

28th report (56 FR 41212, August 19,

1991).

D. Chemical fate information. No

chemical fate information was found.

E. Health effects information. Except

* for data described below for TCIEP and

TCEBP, no health effects information

was found.

Five acute toxicity studies on TCIEP

were reviewed. The oral LD50 for male

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 of 200 mg/liter

for 1-hour resulted in death of 3 of 10

rats (Ref. 5). TCIEP was not a skin

irritant; however, when 0.1 ml was

instilled Into the conjunctiva of rabbits

eyes, it was irritating (Refs. 6 and 7). In

comparison to the studies reviewed on

the five chloroalkyl phosphates

recommended in the ITC's 23rd Report:

by the oral route, TCIEP was less toxic

than TCIP and TDCP, and about the

same as TCEP and TCEEP; by the

inhalation route, TCIEP was more toxic

than TCEP, TCPP, TCIP, and TCEEP.

In a 90-day rat dermal toxicity study,

TCIEP increased liver weight at 500 mg/

kg/day and hypertrophy of the liver and

thyroid at 2500 mg/kg/day (Ref. 8). In a

pilot developmental toxicity test 800

mg/kg/day TCEBP 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's 23rd Report,

TCEBP was less toxic than TCEP, TDCP

or TCEEP.

The Committee is aware that Ames,

micronucleus, skin sensitization and 90-

day developmental toxicity tests were

completed for TCIEP and has requested

copies of these test reports from the test

sponsor.

F. Ecological effects information.

Except for TCIEP data, no ecological

effects information was found.

For TCIEP, the 2-day LC50 for

daphnids ranged from 4.1-5.3 mg/L and

the 4-day LC6 o for fathead minnows

ranged from 3.0-3.3 mg/L (Refs. 1 and 2).

In comparison to the studies reviewed

on the chloroalkyl phosphates

recommended in the ITC's 23rd Report,

LCo values for TCIEP were close to the

fish LC50 of TDCP (1.4 mg/L), but less

than the fish LC5 of TCPP (51 mg/L) or

the fish LC5 of TCEP (250 mg/L).

References

(1) Eastman Kodak Company. Acute

aquatic effects of Thermolin RJT on the

daphnid. Daphnia magna. Rochester, NY

(1987).

(2) Eastman Kodak Company. Acute

aquatic effects of Thermolin 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 RJT 90-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 of Pesticides 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."

The Science of the Total Environment. 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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