Federal. Register j Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

iOPTS-41021; FRL-3017-21

Eighteenth Report. of the Interagency

Testing Committee to the . --. .-

Administrator; Receipt of Report and

Request for Comments Regarding

Priority 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

Eighteenth Report to the Administrator

of EPA on May 1, 1986. This report,

which revises and updates the

Committee's priority list of chemicals,

adds one chemical to the list for priority

consideration by EPA in the

promulgation of test rules under section

4(a) of the Act, The new chemical is

tributyl phosphate. This chemical is not

designated for response within 12

months. Two substances previously

recommended with intent to designate,

cyclohexane and 2,6-di-tert-butylphenol

(50 FR 47603), are now designated for

response within 12 months. The

Eighteenth Report is included in this

notice. The Agency invites interested

persons to submit written comments on

the Report, and to attend a Focus

Meeting to help narrow and focus the

issues raised by the ITC's

recommendations. Members of the

public are also invited to inform EPA ifthey wish to be notified of subsequent

public meetings on these chemicals. ITC

also notes the removal of 6 chemicals

from the priority list because.EPA has

responded to the ITC's previous -

recommendations for testing of the

chemicals.

DATES: Written comments should be

submitted by June 18, 1986. A Focus

Meeting Will be held on June 17. 1986.

ADDRESSES: Send written submissions

to: TSCA Public Information Office (TS793), Office of Pesticides and Toxic .

Substances, Environmental Protection

Agency, Rm. E-108, 401 M St., SW.,

Washington, DC 20460.

Submissions should bear the document

control number (OPTS-41021).

The public record supporting this

action, including comments, is available

for public inspection in Rm. E-107 at the

address noted above from 8 a.m. to 4

p.m. Monday through Friday, except

legal holidays. The Focus Meeting will

be held at EPA Headquarters, Rm. 103.

NE Mall, 401 M St., SW., Washington,

DC. Persons planning to attend the

-Focus Meeting and/or sdeking to be

informed.of subsequent public meetings

on this chemical, should notify the

TSCA Assistance Office at the address

listed below. To insure seating

accommodations at the Focus Meeting,

persons, interested in attending are

asked to notify EPA. atleast one w.eek

ahead of the scheduled date.

FOR FURTHER INFORMATION CONTACT:

Edward A. Klein, Director, TSCA

Assistance Office (T,--799), Office of

Toxic Substances, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Toll Free: (800-

424-9065). In Washington, DC: (554-

1404). Outside the USA: (Operator-202-

554-1404).

SUPPLEMENTARY INFORMATION: EPA has

received the Report of the TSCA

Interagency Testing Committee to the

Administrator.

1. Background

TSCA-(Pub. L. 94-469, 90 Stat. 2003 el

seq.; 15 U.S.C. 2601 et seq.) authorizes

the Administrator of EPA to promulgate

regulations under section 4(a) requiring

testing of chemical substances and

mixtures in order to develop data

relevant to determining the risks that

such chemical substances and mixtures

may present to health and the.

environment.

Section 4(e) of TSCA established and

Interagency Testing.Committee to make

recommendations to the Administrator

of EPA of chemical substances and

mixtures to be given priority

consideration in proposing test rules

under section 4(a). Section 4(e) directs

the Committee to revise its list of

recommendations at least every 6

months as necessary. The ITC may

"designate" up to 50 substances and

mixtures at any one time for priority.

consideration by the Agency. For-such

designations, the Agency must within 12

months either initiate rutlemaking or

issue in the Federal Register its reasons

for not doing so. The ITC's Eighteenth

Report was received by the

Administrator on May 1, 1986, and

follows this Notice. The'Report adds one

'substance to the TSCA section 4(e)

priority list.

II. Written and Oral Comments and

Public Meetings

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 is

published elsewhere in today's Federal

Register adding the substance

recommended in the ITC's Eighteenth

Report to the TSCA section 8(d) Heilth

and Safety Data Reporting Rule (40 CFR

Part 716). The section 8(d) rule requires

the reporting of unpublished health and

safety studies on the listed chemicals,

This chemical will also be added to the

TSCA section 8(a) Preliminary

Assessment Informatiofi Rule (40 CFR

Part 712] published elsewhere in this

issue. The section 8(a) rule requires the

reporting of production volume, use,

exposure, and release information on

the listed chemicals.

A Focus Meeting will be held to

discuss relevant issues pertaining to this

chemical and to narrow the range of

issues/effects which will be the focus of

the Agency's subsequent activities in

responding to the ITC recommendations.

The Focus Meeting will be held on June

17, 1986 t EPA Headquarters, Rm. 103

NE Malil, 401 M St., SW., Washington,

DC. This rae6ting is intended to

supplement and expand upon written

comments submitted in response to this

notice. The meeting will be held at 10

a.m.

Persons wishing to attend this meeting

or subsequent meetings on this chemical

should call the TSCA Assistance Office

at the toll free number listed above at

least one week in advance.

All written submissions should bear

the identifying docket number (OPTS41021).

III. Status of List

In addition to adding the one

recommendation to the priority list, the

ITC's Eighteenth Report notes the

.removal of six chemicals from the list

since the last ITC report because EPA

has responded to the Committee's prior

recommendations for testing of the

chemicals. Subsequent to the ITC's

preparation of its Seventeenth Report,

EPA responded to the ITC's

recommendations for six additional

chemicals. The six chemicals removed

and the dates of publication in the

Federal Register of EPA's responses to

the ITC for these chemicals are:

anthraquinone, November 6, 1985 (50 FR

46090); cumene, -November 6, 1985 (50 FR

46104; mercaptobenzothiazole,

November 6, 1985 (50 FR 46121);

octamethylcyclotetrasiloxane, October

30, 1985 (50 FR 45123);

pentabromoethylbenzene, November 13,

1985 (50 FR 46785); sodium N-methyl-Noleoyltaurine, November 6, 1985 (50 FR

46178). The report also notes that

cyclohexane and 2,6-di-tert-butylphenol,

which were originally recommended

with intent to. designate (50 FR 47603,

November 19, 1985), have now been

designated for response within 12

months by the ITC.

18368
Federal Register / Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

The current list contains seven

designated substances, one chemical

recommended with intent-to-designate,

and two recommended substances.

Authority: 15 U.S.C.'2603.

Dated: May 6, 1986.

J. Merenda,

Director, Existing Chemical Assessment

Division.

Eighteenth Report of the TSCA

Interagency Testing Committee to the

Administrator, Environmental Protection

Agency

Summary

Section 4 of the Toxic Substances

Control Act of 1976 (TSCA, Pub. L. 94-

469) provides for the testing of

chemicals in commerce that may present

an unreasonable risk of injury to health

or the environment. It also provides for

the establishment of a Committee (ITC),

composed of representatives from eight

designated Federal agencies, to

recommend chemical substances and

mixtures (chemicals) to which the

Administrator of the U.S. Environmental

Protection Agency (EPA) should give

priority consideration for the

promulgation of testing rules.

Section 4(e)(1)(A) of TSCA directs the

Committee to recommend to the EPA

Administrator chemicals to which the

Administrator should give priority

consideration for the promulgation of

testing rules pursuant to section 4(a).

The Committee is required to designate

those chemicals, from among its

recommendations, to which the

Administrator should respond within 12

months by either initiating a rulemaking

proceeding under section 4(a) or

publishing the Administrator's reason

for not initiating such a proceeding. At

least 6 months, the Committee makes

those revisions in the-TSCA section 4(e)

Priority List that,it determines to be

necessary and transmits them to the

EPA Administrator. 'As a result of its deliberations, the

Committee is revising the TSCA section

4(e) Priority List by the addition of one

chemical, and is noting the removal of

six as a result of responses by EPA. The

Committee also is designating two

chemicals that have been recommended

with intent-to-designate in the

seventeenth report.

The Priority List is divided into-three

parts. Part A contains those

recommended chemicals and groups

designated for priority consideration

and response by the EPA Administrator

within 12 months. Part B contains those

chemicals and groups recommended.

with intent-to-designate. This category

was established by the Committee in its

seventeenth report (50 FR 47603;

November 19, 1985) to take advantage of

rules promulgating automatic reporting

requirements for non-designated ITC

recommendations under the section 8(a)

Preliminary Assessment rule and the

TSCA section 8(d) Health and Safety

Data Reporting rule. Information

received following recommendation

with intent-to-designate may influence

the Committee to either designate or not

designate the chemical or group of

chemicals in a subsequent report to the

Administrator. Part C contains

chemicals and groups of chemicals. that

have been recommended for priority

consideration by EPA without being

designated for response within 12

months.

The changes to the Priority List are

presented, together with the types of

testing recommended, in the following

Table 1:.

TABLE I .- ADDITIONS TO THE SECTION 4(E)

PRIORITY LIST-MAY 1986

Chemical/group Recommended studies

A. Designated foi

response within

12 months:

Cyclohexane

(CAS No.,

110-82-7).

2,6-Di-fert.

butylphenol 2

(CAS No.

128-39-2).

Health Effects: Chronic toxicity including oncogenicity and neurotoxicity;

teratogenicity; reproductive toxicity.

Health Effects: Toxicokinetics: chronic

toxicity.

Chemical Fate: Persistence in aeroblc

and anaerobic sediments.

Ecological Effects: Acute toxicity to

benthic organisms; bioconcentraton

in benthic organisms.

NOTE: Cyclohexane and 2,6-Oi-terl-butylphenol were recommended with intent-to-designate by the Committee in the

seventeenth report (50 FR 47603).

B. Recommended

with intent-todesignate:

Tributyl Health Effects: Chronic toxicity includphosphate Ig oncogenic, neurotoxic, renal, re-

(CAS No. productive and developmental ef126-73-8). fects.

Chemical Fate: Persistence in anaerobic soils and sediments..

Ecological Effects: Chronic effects on

aquatic and terrestrial plants: chronic effects on daphnids and/or other

aquatic invertebrates; acute and

chronic effects on benthic organiams and soil invertebrates, if

found persisent under anaerobic

conditions.

C. Recommended

without being

designated for

response within

12 months:

None.

CA Index

Names (9

Cl):

1. Cyclohesxane

2. Phenol. 2,6,-

bis(1,l.

dimethyl

ethyl).

3. Phosphoric,

acid, tributyl

ester.

TSCA Interagency Testing Committee"

Statutory Member Agencies and Their

Representatives

Council on Evironmental Quality

Harvey Doerksen, Member

Department of Commerce

Patrick D. Cosslett, Member(l)

Environmental Protection Agency

John D. Walker, Member and Vice

Chairperson

Laurence S. Rosenstein, Alternate

National Cancer Institute

Richard Adamson, Member(2)

EliZabeth K. Weisburger, Alternate(3)

National Institute of Environmental Health

Sciences

James K. Selkirk, Member(4)

National Institute For Occupational Safety

and Health

Rodger L. Tatken, Member and

Chairperson

National Science Foundation

Rodger W. Baier, Member

Jarvis L. Moyers, Alternate

Occupational Safety and Health

Administration , .

Stephen Mallinger, Alternate

Liaison Agencies and Their Representatives

Consumer Product Safety Commission

Lakshmi C. Mishra (5)

Department of Agriculture

Richard M. Parry, Jr.

Elise A. B. Brown(6)

Department of Defense . Edmund Cummings

Food and Drug Administration

Arnold Borsetti

National Library of Medicine

Vera Hudson

National Toxicology Program

Dorothy Canter

Committee Staff

Robert H. Brink. Executive Secretary

Norma Williams, ITC Coordinator

Support "Staff

Alan Carpien-Office of the General

Counsel, EPA

Notes

(1) Appointed on December 2, 1985.

(2) Appointed on October 28. 1985.

(3) Appointed on October 28, 1985.

(4) Appointed on February 21, 1986.

(5) Appointed on December 13, 1985.

(6) Appointed on January 6,1986.

The Committee acknowledges and isgrateful for the assistance and support

given the ITC by staff of Dynamac

Corporation (technical support

contractor) and personnel of the EPA

Office of Toxic Substances.

Chapter 1-Introduction

1.1 Background. The TSCA

Interagency Testing Committee

(Committee) was established under

section 4(e) of the Toxic Substances

Control Act of 1976 (TSCA, Pub. L. 94-

469). The specific mandate of the

Committee is to recommend to the.

18369
Federal Register / Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

Administrator of the U.S. Environmental

Protection Agency (EPA) chemical

substances and mixtures in commetce

that should be given priority

consideration for the promulgation of

testing rules to determine their-potential

hazard to human health and/or the

environment. TSCA specifies that the

Committee's recommendations shall be

in the form of a Priority List, which is to

be published in the Federal Register.

The Committee is directed by section

4(e)(1)(A) of TSCA the designate those

chemicals on the Priority List to which I

the EPA Administrator should respond

within 12 mo nths by either initiating a

rulemaking proceeding under section

4(a) or publishing the Administrator's

reason for not initiating such a

proceeding. There is no statutory time

limit for EPA response regarding

chemicals that ITC has recommended

but not designated for response within

12 months.

At least every 6 months, the

Committee makes those revisions in the

section 4(e) Priority List that it

determines to be necessary and

transmits them to the EPA

Administrator. /

The Committee is comprised of

representatives from eight statutory

member agencies and six liaison

agencies. The specific representatives

and their affiliations are named in the.

front of this report. The Committee's

chemical review procedures and priority

recommendations are described in

previous reports (Ref. 1 and 2).

1.2 Committee's previous reports.

Seventeen previous reports to the EPA

Administrator have been issued by the

Committee and published in the Federal

Register (Ref. 1 and 2). Ninety-one

entries (chemicals and groups of

chemicals) were recommended for

priority consideration by the EPA

Administrator and designated for

response Within 12 months. In addition,

four chemicals and one group of

chemicals were recommended without

being so designated.

1.3 Committee's activities during

this reporting period Between October

1, 1985, and March 31.1986, the

Committee continued to review

chemicals fromits fourth and fifth

scoring exercises, and from nominations

by Member Agencies, Liaison Agencies

and State Agencies.

The Committee contacted chemical

manufacturers and trade associations to.

request information that would be of

value in its deliberations. Most of those

contacted provided unpublished

information on current production,

exposure, uses, and effects of chemicals

under study by the Committee.

During this reporting period, the

Committee reviewed available

information on 32 chemicals and 3 large

classes of chemicals. One chemical was

selected for addition to the section 4(e)

Priority List, and 12 were deferred

indefinitely. The remaining chemicals

are still under study.

On February 12, 1986, the ITC

published an Intent-to-Designate notice

(51 FR 5250) that listed isopropanol and

described additional information needed

by the ITC to reach a more informed

decision on whether or not to designate

isopropanol in a subsequent report to

the EPA Administrator. A deadline of

March 31, 1986 was provided for receipt

of relevant information.

The Committee requested information

on genotoxicity, carcinogenicity, and

reproductive and developmental effects

on isopropanol per se, uncontaminated

with isopropyl sulfate. Information has

been received indicating that some of

the requested information is being

developed in ongoing studies. The

Committee is awaiting details on these

studies and expects to make a decision

on isopropanol prior to the next report

to the EPA Administrator.

In its seventeenth report to the

Administrator of EPA (Ref. 2), the ITC

announced the establishmeit of a "recommended with intent-to-designate"

category, to take advantage of recent

rules promulgating automatic reporting

requirements for non-designated ITC

recommendations under the section 8(a)

Preliminary Assessment rule (50 FR

34805) and the TSCA section 8(d) Health

and Safety Data Reporting rule (50 FR

34809). The 8(a) and 8(d) rules require

the submission to EPA of information on

production, use, exposure and

unpublished health and safety studies

that may not be publicly available. The

ITC noted that information received

following "recommendation with intentto-designate" of a chemical or group of

chemicals may influence the Committee

to either designate or not designate that

chemical or group of chemicils in a

subsequent report to the Administrator.

When a chemical or group of

chemicals is placed in the "recommended with intent-to-designate"

category in a report to the

Administrator, the ITC will review

information submitted to the EPA and to

the ITC following recommendation and

will then take one of the following

actions:

(a) Designate the chemical or group in

the next ITC report, or

(b) Recommend the chemical or group

without designation, in the next ITC

report, providing a rationale for not

designating the chemical or group, or

(c) Remove the chemical or group

from the Priority List, in the next ITC

report, providing a rationale for that

removal, or

(d) Defer a decision, stating the

reasons for the deferral and noting that

a decision will be announced on or

before a given date.

It is anticipated that deferral of a

decision will occur infrequently. On

occasion, however, the volume and/or

complexity of information received may

make it necessary to delay a decision.

Whenever the deferral option is

required, it is anticipated that a final

decision (Designation, Recommendation

or Removal) will be announced within 6

to 9 months following the report in

which the chemical or group of

chemicals was placed in the

"recommended with intent-to-designate"

category.

1.4 The TSCA section 4(e) Priority

List. Section 4(e)(1)(B) of TSCA directs

the Committee to: ". . . make such

revisions in the [priority] list as it

determines to be necessary and...

transmit them to the Administrator

together with the Committee's reasons

for the revisions." Under this authority,

the Committee is revising the Priority

List by adding one chemical: tributyl

phosphate. Tributyl phosphate is being

recommended with intent-to-designate

in this report. In addition, the Committee

is designating for response within 12

months two chemicals that were

recommended with intent-to-designate

in the seventeenth report. The

designated chemicals are cyclohexane

and 2,6-di-tertbutylphenol. The testing

recommended for these chemicals and

the rationales for the recommendations

are presented in Chapter 2 of this report.

Six chemicals are being removed from

the Priority List because the EPA

Administrator has responded to the

Committee's prior recommendations for

testing them. They are listed in the

following Table 2 with citations to EPA

responses:

18370
Federal Register / Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

TABLE 2.-REMOVALS FROM THE TSCA SECTION 4(E) PRIORITY LIST OCTOBER 1, 1985

THROUGH MARCH 31, 1986

EPA resp

Chemical/group FEDERAL

REGISTER

Citation

Anthraquinone ............... 50 FR 46090

Cumene ......................... 50 FR 46104

Mercaptobenzothia- 50 FR 46121

zole.

Octam thylcyclotetra- 50 FR 46123

siloxare.

Pentabromoethytben- 50 FR 46785

zene.

Sodium N..tethyl-N- 50 FR 46178

ouoyltaurine.

Removal of 81 entries was

previous reports (Ref. 1 and 2

87 chemicals and groups of ch

have been removed from the

List.

With the one recommendat

removals noted in this report,

now appear on the section 4(

List. The Priority List is divid

following Table 3 into three p

namely, A, Chemicals and Gr

Chemicals Designated for Res

Within 12 Months, B. Chemic

Groups of Chemicals Recoms

with Intent-to-Designate, and

Chemicals and Groups of ChI

Recommended Without Beinj

Designated for Response Wit

Months. Table 3 follows:

TABLE 3.-THE TSCA SECTION 4

LIST-MAY 1986

Entry

A Chemical and groups of chemicals

recommended as designated for response within 12 months:

1. Cyclohexane

2. 2.6-Di-ert-butyfphenol

3. Methyl cyclopentane

4. Tetrabromobispherto A

5. Triethylene glycol monomethyl ether

6. Triethylene glycol monoethyl ether

7. Tnethylene glycol monobutyl ether

B. Chemicals and groups o

recommended with intent-toEntry

1. Tributyt phosphate ...............................

C. Chemicals and groups of chemicals

recommended without being designated

for response within 12 months:

1. 3.4-Oichlorobenzotrifluoride ................

2. Diisodecyl phenyl phosphite ..............

References

(1) Sixteenth Report of the TS'

Interagency Testing Committee

Administrator. Environmental P

Agency. TSCA Interagency Test

Committee. May 21. 1985, 50 FR

onses

Publication date

Nov. 6. 1985,

Nov. 6. 1985.

Nov. 6, 1985.

Includes references to Reports 1 through 15

and an annotative list of removals.

(2) Seventeenth Report of the TSCA

Interagency Testing Committee to the

Administrator. Environmental Protection

Agency. TSCA Interagency Testing

Committee, November 19, 1985, 50 FR 47603-

47612.

Chapter 2-Recommendations of the

Committee

ct. 3, 1985. 2.1 Chemicals recommended for

priority consideration by the EPA Nov. 13. 1985. Administrator. As provided by section

Nov. 6. 1985. 4(e)(1)(B) of TSCA, the Committee is

adding the following chemical substance

to the section 4(e) Priority List: Tributyl

noted in phosphate. The recommendation of

). To date. tributyl phosphate is being made after

hemicals considering the factors identified in

Priority section 4(e)(1)(A) and other relevant

information, as well as-the professional

ion and six judgment of Committee members. In

10 entries addition, the Committee is designating

e) Priority for response within 12 months two

ed in the chemical substances that were

'arts; recommended with intent-to-designate

oups of in the seventeenth report. The

sponse designated chemicals are cyclohexane

als and and 2,6-di-tert-butylphenol.

nended 2.2 Chemicals designated for

C, response within 12 months.

emicals 2.2.a Cyclohexane.

In the seventeenth report to the

hin 12 Administrator of EPA (50 FR 47603),

cyclohexane was recommended with

intent-to-designate. The rationale for

(e) PRIORITY that recommendation appears in the

seventeenth report. Information

Date of reviewed by the Committee in response

designation to the seventeenth report included any

public comments on the Committee's

recommendations; production volume,

use, exposure, and release information

May 1986. reported by manufacturers of

May 1986. cyclohexane under the TSCA section

May 1985.

may 1985. 8(a) Preliminary Assessment rule; health

May 1985. and safety studies submitted under the May 1985. TSCA section 8{d} Health and Safety May 1985.

Data Reporting rule; and any

unpublished and published data f chemicals available to the Committee. The

designate: information included acute toxicity

studies, skin and eye irritation studies

Date ot and additional genotoxicity studies

recommendation (Phillips Petroleum Co., 1986). Summary

data from acute toxicity, skin irritation

May 1986 and repeated dose (six months) studies

were also received from other

submitters (Eastman Kodak Co., 1986;

May 1985. Dow Chemical Co., 1986). Although November 1985. ecological effects testing was not

recommended for cyclohexane,

information dealing with environmental

CA persistence also was received (Shell Oil

to the Co., 1986).

rotection" After reviewing the information, the

ing Committee concluded that data are still

20930-20939. lacking on chronic (two-year) effects,

especially oncogenicity and

neurotoxicity. Teratogenic and

reproductive effects studies also are

absent. For these reasons and for the

reasons previously presented (50 FR

47603) the Committee is now designating

cyclohexane for response within twelve

months and recommending that it be

tested for the following:

Health Effects:

Chronic effects including oncogenicity

and neurotoxicity (with special

emphasis on neuropathology.

Teratogenicity and reproductive

toxicity.

References

(1) Dow Chemical Co., Midland. MI. Letter

from L. Hampton to Document Control

Officer, U.S. EPA. January 31.1986.

(2) Eastman Kodak Co., Rochester, N.Y.

Letter from R. L. Raleigh to U.S. EPA. January

15, 1986.

(3) Phillips Petroleum Co.. Bartlesville, OK.

Letter from J.R. Rust to Document Control

Officer/OPTS, U.S. EPA. January 15, 1986.

(4) Shell Oil Co., Washington, DC. Letter

from E.L. Hobson to U.S. EPA. February 5,

1986.

2.2.b 2,6-Di-tert-butylphenol.

In the seventeenth report to the

Administrator of EPA (50 FR 47603), 2,6-

di-tert-butylphenol was recommended

with intent-to-designate. The rationale

for that recommendation appears in the

seventeenth report. Information

reviewed by the Committee in response

to the seventeenth report included any

public comments on the Committee's

recommendations; production volume,

use, exposure and release information

reported by manufacturers of Z,6-di-tertbutylphenol under the TSCA section 8(a)

Preliminary Assessment rule; health and

safety studies submitted under the

TSCA section 8(d) Health and Safety

Data Reporting rule; and any

unpublished and published data

available to the Committee. The

information included data on acute oral

and percutaneous LD50 studies with

rats; skin and eye irritation with rabbits;

skin depigmentation, skin sensitization

and delayed contact hypersensitivity

with guinea pigs; rat hepatocyte primary

culture and DNA repair tests; an Ames

Salmonella microsomal assay;

intravenous toxicity to mice and a report

on the physiological response of

experimental animals to the absorption

of alkylated phenols and anilines (CibaGeigy, 1986; DuPont, 1986; Ethyl, 1986;

Shell, 1986). Also included was a

suminary on ecological effects (Dow,

1986).

After reviewing the information, the

Committee concluded that data are still

lacking on toxicokinetics, chronic

toxicity, persistence in sediments, acute

18371
Federal Register / Vol. 51, No. 96 / Monday, May 19, 1986*/ Notices

toxicity to benthic organisms and

bioconcentration in benthic organisms.

For these reasons and for the reasons

previously presented (50 FR 47603) the

Committee is now designating 2,6-ditert-butylphenol for response within

twelve months and recommending that

it be tested for the following:

Chemical Fate:

Persistence in aerobic and anaerobic

sediments

Health Effects:

Toxicokinetics and chronic toxicity

Ecological Effects:

Acute Toxicity to benthic organisms

Bioconcentration in benthic organisms

References

(1) Ciba-Geigy. Ciba-Geigy Corp., Ardsley,

N.Y. Letter from A. DiBattista to U.S. EPA.

February 12, 1986.

(2) Dow. Dow Chemical Co., Midland, MI.

Letter from L. Hampton to U.S. EPA. January

•31, 1986.

(3) DuPont. E.I. DuPont de Nemours and

Co., Wilmington, DE. Letter from K.D. Dastur

to U.S. EPA. January 14,1986.

(4) Ethyl. Ethyl Corporation, Baton Rouge,

LA. Letter from L L. Weir to Document

.Control Officer, Office of Pesticides and

Toxic Substances, U.S. EPA. February 4, 1986.

(5) Shell. Shell Oil Co., Washington, DC.

Letter from E. L. Hobson to U.S. EPA.

February 5,1986. 2.3. Chemicals recommended with

intent-to-designate but not designated

for response within 12 months.

2.3.a Tributyl Phosphate.

Summary of recommended studies. It

is recommended that tributylphosphate

(TBP) be tested for the following:

A. Chemical Fate: Persistence in

anaerobic soils and sediments. . B. Health Effects: Chronic toxicity

including oncogenic, neurotoxic, renal,

reproductive and developmental effects.

C. Ecological Effects: Chronic effects

on aquatic and terrestrial plants; "

Chronic effects on daphnids and/or

other aquatic invertebrates.

Acute and chronic effects on benthic

organisms and soil invertebrates,

depending on the results from

persistence studiesPhysical and Chemical Information

CAS Number: 126-73-8.

Synonyms: Phosphoric acid, tributyl

ester (9C); TributoXyphosphine oxide;

Tri-n-butyl phosphate.

Acronym: TBP.

Structure:

O-CH 2CCB2 CH2 3

0 = P 0CH2CH2CH2CH3

O-CH2CH2CH2 CH3

Empirical Formula: C 12H 27 0 4 P.

Molecular Weight: 266.32.

Melting Point: < -80°C (Ref. 47, TDB,

1986).

Boiling Point: 289*C at 760 mmHg (Ref.

11, CRC, 1983).

Vapor Pressure: 7.3 mmHg at 150*C

(Ref. 23, Laham et al., 1984); 0.07 mmHg

at 25°C (estimated; Ref. 48, U.S. EPA,

1985).

Air Vapor Density: 9.2 (Ref. 28,

Monsanto, 1985).

Solubility in Water: 420 mg/L at 25°C

(Ref. 17, General Electric, 1983); 280 mg/

L (Ref. 39, Saeger et al., 1979).

Solubility in Organic Solvents: Soluble

in ether, benzene carbon disulfide,

ethanol, mineral oil, and gasoline (Ref.

11, CRC, 1983).

Specific Gravity: 0.977-0.978 at 20/

20°C (Ref. 28, Monsanto, 1985).

Log Octanol/Water Partition

Coefficient (log P): 4.0 (Ref. 39, Saeger et

al., 1979); 2.36 (Ref. 20, Hansch and Leo,

1979).

Description of Chemical (ambient

conditions): Clear, colorless, odorless

liquid (Ref. 47, TDB, 1986).

Rationale for Recommendations

I. Exposure information-A.

Production/use.. There are at least three,

and maybe as many as five,

manufacturers of TBP in the United

States. CEH (1981, Ref. 8) reported that

:at least 5 million pounds of the

compound were produced in 1979.

Annual production since then has been

reported at 3 million pounds for'1982

and estimated at 3 million pounds for

1983 (Ref. 9, CEH, 1983). Current annual

production has been estimated at 3.to 5

million pounds (Ref. 48, U.S. EPA, 1985.)

A major use of TBP is as a

nonflammable component of hydraulic

fluids in the control systems of

- commercial aircraft, Industrial fluids

and lubricants account for another large

share. Liquid phosphate esters are the

basestocks for fire-resistant oils used in

die-casting, air compressors, gas

turbines, and many- other applications.

TBP may also be used as a solvent/

plasticizer for certain polymers, an

industrial solvent, an antifoam agent,

.rand a pigment grinding assistant. It has

been estimated (Ref. 28, Monsanto, 1985)

that about 24 percent goes into hydraulic

fluids, 50 percent into uses as a

plasticizer, and 26 percent for

miscellaneous uses. B. Occupational exposure. The

National Occupational Hazard Survey,

conducted in 1972, estimated that

323,477 workers were potentially

exposed to TBP in the workplace (Ref.

31, NIOSH, 1976). Preliminary data from

the National Occupational Exposure

Survey indicate that, in 1980, 12,111 - -

• workers (including 427 women) were

potentially exposed to the compound in

- the workplace (Ref. 32, NIOSH, 1984).

The following limits have been

established for workplace airborne

concentrations of TBP:

8-hour TWA-PEL 5 mg/m 3 (Ref. 34,

OSHA, 1985).

8-hour TLV-TWA 2.5mg/m 3 (0.2 ppm)

(Ref. 2, ACGIH, 1985).

C. Environmental release. It is likely

that most TBP is released to surface

waters from industrial effluents and

from the release of hydraulic fluids to

storm drains and drainage ditches and

to land and water via landfill disposal of

oil wastes and plastics.

There is considerable evidence for

widespread, low-level environmental

exposures to TBP. It has been detected

in fish and human lipid tissues, in

municipal and industrial effluents, river

water, estuarine water, ground water,

drinking water, snow, and sediments.

LeBel and Williams (1983, Ref. 25)

analyzed 16 human adipose tissue

samples from cadavers and found TBP

at 9.0 ng/g, on an extracted fat basis, in

the tissue from one cadaver. Dunlap et

al. (1979, Ref. 14) found TBP at 1.7 ug/L

in ground water below a landfill. Grob

and Grob (1974, Ref. 18) measured TBP

in water at or near Zurich, Switzerland,

and found concentrations of 10 to 82 ng/

L. Zoeteman et al. (1981, Ref. 51)

measured TBP in ground waters in the

Netherlands at 0.01 to 0.1 ug/L. Meijers

and van der Leer (1976, Ref. 26) found

TBP at up to 10 ug/L in the Waal River

in the Netherlands. Sheldon and Hites

(1978, Ref. 42) reported finding TBP in

Delaware River water at 60 to 2,000 ng/

L. Shackelford et al. (cited in U.S. EPA,

1985, Ref. 48) reported finding TBP in

plant effluents form a variety of

industries. Mean concentrations were

from 15 ug/L to 1,880 ug/L. Williams and

LeBel (1981, Ref. 50) examined drinking

water form 29 municipalities across

Canada and found-measurable TBP in

samples from each location, as well as

in water form the Atlantic and Pacific

Oceans, the Great Lakes, Lake

Winnipeg, the St. Lawrence River, and

the Columbia River. Concentrations

ranged from*0.2 to 62 ng/L. Piet et al.

(1981, Ref. 36) identified TBP at 100 ng/L

in drinking Water processed from

surface water using sand filtration. The

unfiltered water had no detectable T13P.

TBP appears to be found nearly

everywhere in the environment at low

concentrations. No information was

found on the natural occurrence of TBP.

II. Chemical fate information-A.

Transport. TBP has moderate solubility

in water and moderate vapor pressure at

- ambient temperatures. It also has a

18372
Federal Register ./ Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

moderate log P value (4.0, measured).

The physical and chemical . "

characteristics-of TBP indicate that it

wil partiti6n throughout the-environment

and appearatmost everywhere,

including biolipids '

B. Persistence. A study of the primary

biodegradation of TBP by a river water

die-away method (Ref. 39, Saeger et al.,

1979) found 50 percent loss of the parent

compound in about 3.5 days and

complete loss in 7 days. These.same

investigators, using a carbon dioxide

evolution method, also reported CO2

evolution at 30 percent of theory in 7

days and 81 percent of theory in 28 days.

Initial concentrations of TBP in the test

units were 1 and 20 mg/L, respectively.

These results indicate relatively rapid

and complete biodegradation of TBP is

aerated surface waters. There was no

evidence of nonbiological degradation of

TBP in sterile controls. Francis et al.

(1980, Ref. 15) observed no anaerobic

biodegradation of TBP incubated for 30

days at 28*C with anaerobic bacteria

isolated from a waste disposal site. No

other information on anaerobic

biodegradation was found., and the

potential for anaerobic biodegradation

must be considered unknown.

Hydrolysis is very slow at most

environmental pH's (Ref. 48, U.S. EPA.

1985). Atmospheric oxidation is not

expected to be significant.

C. Rationale for chemical fate

recommendations. Because of its

moderate water solubility, log P, and

vapor pressure, TBP should partition to

natural waters, soils and sediments,

biota, and air. TBP appears to be'

biodegraded rapidly and 1completely.in

aerobic surface waters. Its fate in soils

and sediments is not clear. It is likely to

persist in the atmosphere until returned

to earth by virtue of its high vapor

density or in precipitation. TBP that

partitions to biota may become a part of

the food chain. The ubiquitous

environmental appearance of TBIP at

low concentrations may mean that it is

not effectively degraded below some

threshold concentration or that the

continuous release of TBP into the

environment leads to some low-level

equilibrium concentration reflecting

both input and removal processes. The

monitoring evidence, showing

widespread low concentrations of TBP,

justifies the consideration of potential

environmental effects resulting from

continuous, low-level exposures. Tests

should be conduct 9 d to evaluate the

persistence of TBP in anaerobic

sediments and soils.

111. Biological effects of concern to

human health-A. Metabolism and

toxicokinetics. Suzuki et al. (1984. Ref.

46) sttidied the excretion and '.....

biotransformation of TBP in.rats. In

animals dosed with [ 4C]-TBP, 66

percent of an oral dose and 81 percentof

an intraperitoneal dose were excreted in

24 hours. The two major metabolities

present in urine were the hydrolysis

products dibutyl and monobutyl

phosphates. Other metabolites present were the result of oxidation of the butyl

chain.

The effect of TBP on enzyme activity

in rats has been studied by Oi*shi et al.

(1980, Ref. 33). In animals fed a diet

containing 0.5 or 1 percent TBP for 10

weeks, serum transaminase and alkaline

phosphatase activities were

significantly decreased. There was no

difference in cholinesterase activity in

serum, whereas brain cholinesterase

activity was significantly increased.

Blood coagulation time was significantly

prolonged.

B. Acute and subchronic (short-term)

effects. The acute effects of TBP have

been studied by Smyth Carpenter (1944,

Ref. 43), Chambers and Casida (1967,

Ref. 10), Vanedkar (1957, Ref. 49), Suzuki

et al. (1977, Ref. 45), Sabine and Hayes

(1952, Ref. 38), Johannsen et al. (1977,

Ref. 21), and Mlitomo et al. (1980, Ref.

27). Sites and biological effects-of acute

testing were paralysis due to weak

cholinesterase inhibition, anesthetic

effect, skin and mucous membrane

irritation, lung edema, and degeneration

of kidney tubules.

Laham et al. (1983. Ref. 22) studied the

effect of TBP in rats fed 0.28 and 0.42

mL/kg TBP by gavage for 14 days. In the

high-dose group, a significant (p<0.05)

reduction of caudal nerve conduction

velocity accompanied by morphological

changes in the sciatic nerve were

observed in males. In both sexes of the

high dose groups, electron microscopy

showed a retraction of Schwann cell

processes of the surrounding sciatic

unmyelinated fibers, indicating an early

response to a chemical insult.

In another study, Laham et al. (1984,

Ref. 23) administered TBP by gavage to

rates at concentrations of 0.14 and 0.42

mL/kg for 14 consective days. In the

high dose group, a significant decrease

in hemoglobin in females, a low

incidence of degenerative changes in the

testes in males, significant changes in

amylase and triglyceride activity in

females and an increased amylase

activity in males were observed. In

addition, a significant increase in

potassium level was observed in

females both low- and high-dose groups.

Mitomo et al. 1(1980, Ref. 27) studied

the effects of TBP on rats and mice that

were fed TBP daily ii their diets at

con.cen-trations of 0, 0.05, 0.2, and 1.0

percent for 3 months. Results of the

studies showed a dose-dependent

derpression in body weight gaifi; an

increase in liver, kidney, and testes

weights; a decrease in uterus weightand ari incieAse in blood urea nitrogen

valu s; in both'rhice and rats at high-'

dose levels.' Diar'rhea was alio 'observed:

Similar effects were seen in 9- and 10-

week studies when TBP was fed to rats

(Ref. 33, Oishi et al., 1980).

Cascieri et al. (1985, Ref. 7) fed rats

diets cohtaining TBP at levels of 0, 8, 40,

200, 1,000 or 5,000 ppm for 90 days.

Significant changes were seen in blood

parameters and liver weight at the

highest dose. Urinary bladder cell

hyperplasia was observed in both sexes

at the-highest dose. At 1,000 ppm it was

only noted in the males.

In a recent study, TBP was

administered by gavage over an 18-week

period to rats. Low-dose animals

received 0.20 g/kg/day throughout the

experiment and the high dose animals

received 0.30 g/kg/day for the first six

weeks. For the remaining twelve weeks,

the high-dose level was increased to 0.35

g/kg/day. All test rats examined

developed diffuse epithelial hyperplasia

of the urinary bladder (Ref. 24, Laham et

al., 1985).

C. Genotoxicity. Hanna and Dyer

(1975, Ref. 19) tested tributyl phosphate

in S. typhimurium, E. coli and

Drosophila. No mutagenic effects were

observed.

D. Oncogenicity. No information was

found. Trimethyl phosphate, a structural

analog, was tested for carcinogenicity in

rats and mice (Ref. 30, NC, 1978). It

induced adenocarcinomas of the

endometrium in female mice and benign

fibromas of the subcutaneous tissue in

male rats. .

E. Reproductive and developmental.

effects. When tested in chicken eggs,

TBP was found to be weakly teratogenic

(Ref. 37, Roger et al., 1969). No

mammalian reproductive and

developmental effects information was

found in the literature searched.

F. Chronic (long-term) effects. No

information was found.

G. Observations in humans. Workers

exposed to 15 mg/m3 of TBP complained

of nausea and headache (Ref. 1. ACCIH,

1980). The principal routes of exposure

are skin contact and inhalation. Signs of

exposure include nausea, headache,.

irritation of the eyes and dermatitis (Ref.

44, Stauffer, 1984).

14. Rationale for health effects

recommendations. Thousands of

workers and consumers are potentially

exposed to TBP. There is a potential for

human exposure to low levels of TBP

due to its uses as a flame retardani in

aircract hydraulic fluid, for uranium.

extraction, as an industrial solvent, and

18373
Federal Register / Vol. 51, No. 96 / Monday, May 19, 1986 / Notices

as a plasticizer. TBP has been detected

at low levels,in municipal and industrial

effluents, sediments, and in river,

estuarine, ground, and drinking waters.

It has also been detected in human and

fish lipid tissues.

Available information on health

effects are limited to acute and

subchronic effects. In view of the lack of

information on the chronic health effects

of T13P, the induction of urinary bladder

hyperplasia and the carcinogenic effect

of trimethyl phosphate, studies-on

chronic toxicity, including oncogenic,

neurotoxic, renal, and reproductive and

developmental effects, are

recommended.

IV. Ecological effects of concern.-A.

Acute and subchronic (short-term)

effects. TBP produces acute .

toxicity

with a variety of aquatic organisms, at

low mg/L concentrations, as shown in

Table 4. TBP inhibits the growth of some

TABLE 4.-ACUTE TOXICITY TESTS WITH A VARIETY OF AOUATIC ORGANISMS

24 -hr 48 hr 72=hr g6-hr Organism LC, o LC. LC. LC. Reference

(mg/LI (mg/L) (mg/L) (mg/L)

Rainbow trout ......................................................................................................... 5 to 9 Dave and Lidm an (1978, Ref. 12).

Rainbow trout ........................................... .............................................................. 11.0 M onsanto (1985, Ref. 28).

Zebrafish .................................................. . 11.4 11.4 ..................... 11.4 Dave et al. (1981, Ret. 13).

Goldfish .......................................................................... ................ ............ 8.8 Sasaki el at. (1981), Ref. 40)

Killfish.......... ......................................... 9.6 Sasaki et al. (1981), Re. 40).

Fathead minno ............................. ................ 6.4 Monsanto (1985, Ref. 28). Chlorelta ..... ........................ 5 to 10....... ........... AQUIRE (1986, Ret. 3).

Daphnia .................................................. 12.8 3.7 2.1 ........... Dave et al. (1981, Ret, 13).

B. Chronic (long-term) effects.

Penman and Osborne (1976, Ref. 35)

reported that TBP, at dosesof 0.1 to:0.2

percent, had no reproductive effects on

the two-spotted spider mite. A related

compound, trimethyl phosphate,

produced reproductive effects on

guppies, toads, quail, and mites, all at

relatively high doses (Ref. 48, U.S. EPA,

198.5].

C. Other ecological eff'ects (biological,

behavioral, or ecosystem processes).

Bringmann and Kuhn (1982, Ref. 6)

determined effects concentration (EC)

values for immobilization of Daphnia

magna. The EGo, EC5o, and ECteo were 5,

30 and 41 mg/L, respectively.

D. Bioconcentration and food-chain

transport. Given its octanol/water

partition coefficient, TBP is likely to

partition into lipids of biota. Saeger et

'al. (1979, Ref. 39) calculated a

bioconcentration factor of 190. Sasaki et

al. (1981, Ref. 40) studied the absorption

and elimination of phosphoric acid

esters bykillifish and goldfish. "'hey

found that the amount of TBP in the fish

varied with the. species and that.

bioconcentration in the killifish was

about three times greater than in

goldfish, using a static water system.

In a followup study, using continuousflow systems Sasaki et al. (Ref. 41, 1982)

found TBP taken up rapidly by killifish

and reaching a steady-state

concentration within I day. It remaitied

at that concentration during 38 days of

exposure. The bioconcentration ratio

during this time was almost constant,

varying from 21 to 35. When exposure to

TBP was stopped, elimination was very

rapid, with half gone within 1.25 hours

and no detectable TBP after 24 hours.

E. Rationale for ecological effects

recommendations. The available

information shows that TBP has acute

effects on a variety of aquatic organisms

at moderately low concentrations (low

parts per million). TBP also has been

found acutely toxic to terrestrial plants

at 5,000 ppm. Nevertheless, there is low

concern for the acute effects of TBP

since it does not appear that TBP will

persist in aerobic environments at

concentrations likely to cause acute

effects to biota. However, it does appear

that nearly all biota are continuously

exposed to low concentrations of TBP

and the long-term effects of that

algae at concentrations of 3 to 10 mg/L

(Ref. 48,. U.S. EPA, 1985). Bringmann and

Kuhn (Refs. 4 and 5, 1978, 1980) found

that TBP inhibited the growth of an

Entosiphon protozoa sp. at 14 mg/L, a

Scenedesmus algal sp. at 3.2 mg L, and

a Microcystis bacteria sp. at 4.1 mg/L.

Gast and Early (1956, Ref. 16)

investigated the phytotoxicity of several

solvents by dipping plant foliage quickly

into solutions of the solvents and

observing the effects. Of 86 solvents

investigated, TBP was the most toxic.

Exposure to a 0.5 percent solution of

TBP killed all of the six species tested,

including bean, corn, cotton, cucumber,

tobacco, and tomato.

TBP applied to vegetation reduced the

growth of the roots of rice, radish, and

soybean plants at concentrations of 10

to 100 ug/g of soil (Ref. 29, Muir, 1984).

, A single-dose oral LDo for the white

leghorn adult hen was reported as 1.8 g/

kg (Ref. 21, Johannsen et al., 1977).

exposure are largely unknown. The

acute toxicity data with terrestrial

plants and algae and the growth

inhibition observed with rice, radish,

and soybeans lead to the conclusion

.that long-term studies need to be

conducted with both aquatic and

terrestrial plants exposed to TBP at low

concentrations. The data from the acute

daphnid tests by Dave et al. (1981, Ref.

13) showed a high ratio between the 24-

and 48-hour LCso's (12.8/3.6=3.5),

suggesting potential chronic effects.

Long-term studies, using low TBP

concentrations, should be conducted

with daphnids and/or other aquatic

invertebrates. If anaerobic persistence

studies indicate long half-lives for TBP

'in soils and sediments, bioassays should

be conducted with representative

benthic organisms and soil

invertebrates.

References

(1) ACGIH. "Documentation of the

Threshold Limit Values." 4th Ed. Cincinnati,

OH: American Conference of Governmental

Industrial Hygienists (1980).

(2) ACGIII. "TLV's. Threshold Limit Values

and Biological Exposure Indices for 1985-86."

Cincinnati, OH: American Conference of

Governmental Industrial Hygienists. p. 31

(1985].

(3] AQUIRE. Aquatic Information Retrieval

Database [data base]. Baltimore, MD:

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substances for their toxicity threshold: Model

organisms Microcystis (Diplocystis

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Mitteihingen Internationa/e Vereinigung fuer

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2.4 Chemicals and groups of chemicals

recommended without being designated for

response within 12 months. Non&.

(FR Doc, 86-11070 Filed. 5-16-86; 8:45 aml

BILLING CODE 6560-50-M

[OPTS-51621; FRL-3012-S]

Certain Chemicals Premanufacture

Notices

Correction

In FR Doc, 86-10015, beginning on

page 16587, in the issue of Monday, May

5, 1986, makethe following corrections:

1. On page 16588, first column, under

"P86-931", fifth line,. "1,1000-2,000"

should read "1,000-2,000".

2. On page 16589, first column, under

"P86-946", sixth line; "5/kg" should read

"5 g/kg".

3. On the same page, second column,

under "P86-948", sixth line "g/kg"

should read "5-g/kg".

BILLING CODE 1505-01-M

Im i " , , .................... .. . . . .. .........

18375