Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPTS-41013 TSH-FRL #2484-7]

Thirteenth Report of the Interagency

Testing Committee to the

Administrator, Receipt of Report and

Request for Comments Regarding

Priority Ust of Chemicals

AGENCY: Environmental Protcction

Agency (EPA).

ACTION: Notice.

SUMMARY: The Interagency Testing

Committee (ITC), established under

secton 4(e) of the Toxic Substances

Control Act (TSCA), transmitted its

Thirteenth Report to the Administrator

of EPA on November 8, 1983. This

report, which revises and updates the

Committee's priority list of chemicals,

adds four designated chemicals to the

list for priority consideration by EPA in

the promulgation of test rules under

section 4(a) of the Act. The new

chemicals are 2-(2-butoxyethoxy)ethyl

acetate, ethylene bis(oxyethylene)

diacetate, 1,2,3,4,7,7-

hexachloronorbornadiene, and

oleylamine. The Thirteenth Report is

included in this notice. The Agency

invites interested persons to submit

written comments on the Report, and to

attend Focus Meetings to help narrow

and focus the issues raised by the ITC's

recommendations. Members of the

public are also invited to inform EPA if

they wish to be notified of subsequent

public meetings on these chemcials. EPA

also notes the removal of 19 chemicals

from the priority list because EPA has

responded to the ITC's prior

recommendations for testing of the

chemicals.

DATESWritten comments should be

submitted by January 13, 1984. Focus

Meetings will be held on January 16 and

17, 1984.

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, D.C. 20460. Submissions

should bear the document control

number (OPTS-41012).

The public record supporting this

action, including comments, is available

for public inspection in Rm. E-107 at the

address noted above from 8:00 a.m. to

4:00 p.m. Monday through Friday, except

legal holidays. Focus Meetings will be

held'at Waterside Mall, in Rm. 3908, 401

M St., SW., Washington, D.C. Persons

planning to attend any one of the Focus

Meetings and/or seeking to be informed

of subsequent public meetings on these

chemicals, should notify the TSCA

Assistance Office at the address listed

below. To insure seating

accommodiations at the Focus Meeting,

persons interested in attending are

asked to notify EPA at least 2 weeks

ahead of the scheduled dates.

FOR FURTHER INFORMATION CONTACT.

Jack P. McCarthy, Director, TSCA

Assistance Office (TS-799), Office of

Toxic Substances, Environmental

Protection Agency, 401 M St., SW.,

Washington, D.C. 20460, Toll Free: (800-

424-9065), In Washington, D.C.: (554-

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

554-1404).

SUPPLEMENTARY INFORMATION.

I. Background

Section 4(a) of 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 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 an

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 it determines to be 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 rulemaking or issue in the

Federal Register its reasons for not

requiring testing. The ITC's Thirteenth

Report was received by the

Administrator on November 8, 1983, and

follows this Notice. The report

designates four substances for priority

consideration and response by EPA

within 12 months.

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 four substances

designated in the ITC's Thirteenth

Report to the TSCA section 8(d) Health

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.

These four chemicals will also be added

to the TSCA section 8(a) Preliminary

Assessment Information 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.

Focus Meetings will be held to discuss

relevant issues pertaining to the

chemicals 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 Meetings will be held January

16 and 17, 1984, at Waterside Mall, 401

M St., SW., Washington, D.C., Rm. S355. These meetings are intended to

supplement and expand upon written

comments submitted in response to this

notice. The schedule for the Focus

Meetings is as follows: January 16, 9:30

a.m.-ethylene bis(oxyethylene)

diacetate, and 1:00 p.m.-2-(2-

butoxyethoxy)ethyl acetate: and January

17, 9:30 a.m.-1,2,3,4,7,7-

hexachloronorbornadiene, and 1:00

p.m.-oleylamine. Persons wishing to

attend one or more of these meetings

should call the TSCA Assistance Office

at the toll free number listed above at

least 2 weeks in advance.

After consideration of the data

pertaining to each chemical, and any

additional information provided in the

written comments and the Focus

Meetings, EPA will hold public meetings

on each chemical after preliminary

decisions have been made on the types

of testing that are needed. These

meetings will be several months in the

future, but separate notice of these

meetings will not be published at that

time. Therefore, anyone wishing to

attend these later meetings should

contact EPA now at the address given

for the TSCA Assistance Office in order

to be notified in advance of the public

meetings.

All written submissions should bear

the identifying docket number (OPTS41012).

III. Status of List

In addition to adding the 4

designations to the priority list, the

ITC's Thirteenth Report notes the

removal of 8 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 Thirteenth Report,

55674
Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

EPA responded to the ITC's

recommendations for 11 additional

chemicals. The 19 chemicals removed

and the dates of publication in the

Federal Register of EPA's responses to

the ITC for these chemicals are:

Biphenyl, May 23, 1933 (48 FR 23030);

cresols, July 11, 1983 (48 FR 31812);

ethyltoluene (mixed isomers), May 23,

1983 (48 23088); formamide, May 23, 1983

(48 FR 23098); mesityl oxide, July 5, 1983

(48 FR 30699); 4,4'-methylenedit niline,

July 11, 1983 (46 FR 3180b); and 1,2,4-

trimethylbenzene, May 23, 1983 (48 FR

2,3088); other trimethylbenzene isomers,

May 23, 1983 (48 FR 23088); seven

alkyltin compounds, November 8, 1983

(48 FR 51361); bis[2-ethylhexyl)

terephthalate, November 14, 1983 (48 FR

51845]; 1,3-dioxolane, November 14, 1983

(48 FR 51839]; 4-(1,1,3,3-

tetramethylbutyl)pbenol, November 15,

1983 (48 FR 51971); and tris{2-

ethylhexyl)trimellitate, November 14,

1983 (48 FR 51842). The current list

contains 20 designated substances or

groups of substances and one

recommended group of substances.

(Sec. 4, Pub. L 94-469, 90 Stat. 203; (15 U.S.C.

2601))

Dated: November 25, 1983.

Doin R. Clay,

ActingAssistant Administrator for Pesticides

and Toxic Substances.

Thirteenth 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,

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.

Every 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 4

chemicals and is noting the removal of 8,

as a result of responses by EPA.

The Priority List is divided into two

parts: part A contains those

recommended chemicals and groups

designated for priority consideration

and response by the EPA Administrator

within 12 months, and part B contains

chemicals and groups that have been

recommended for priority consideration

by EPA without being designated for

response within 12 months. Although

TSCA does not establish a deadline for

EPA response to nondesignated

chemicals and groups (part B of the

Priority List), the Committee anticipates

that the EPA Administrator will respond

in a timely manner.

The entries being added to the Priority

List are presented, together with the

types of testing recommended, in the

following Table 1:

Chemical/Group Recommended studies

A Designated for response within 12 months:

2-(2.Brtoxyethoxy)ethyf Health Effects: Subchonic

acetate (GAS No. toxicity; toxicokinetc stud124-17-4). les; reproductive effects.

Ethylene bis(oxyethylene) Health Effects: Subchronic

diacetate (CAS No. 111- toxicity; toxicollnetic stud21-7). Wes; reproductive effects.

1, 2. 3, 4. 7, 7-Hexach- Health Effects: Subchronlc

toronorbornadiene tests, including neurotoxs-

(CAS No. 3389-71-7). city; biochemical effects.

including enzyme-Inducing

capabilities.

Oleylamina (GAS No. Health Effects: Toicokntic

112-09-3). studies; Genotoxicity and

tsratogenicity studies it

percutaneous absorption Is

demonstrated.

B. Recommended but not

designated for response

within 12 months:

None ...................................

TSCA Interagency Testing Committee

Statutory Member Agencies and Their

Representatives

Council on Environmental Quality

Thomas H. Magness; III, Member(l)

Department of Commerce

Bernard Greifer, Member

Environmental Protection Agency

Carl R. Morris, Member

Arthur M. Stem, Alternate

National Cancer Institute

Elizabeth K. Weisburger, Member and

Chairperson

Richard Adamson, Alternate

Jerrold Ward, Alternate

National Institute of Environmental

Health Sciences

Dorothy Canter, Member

National Institute For Occupational

Safety and Health

Rodger L. Tatken, Member

Richard J. Lewis, Sr., Alternate

National Science Foundation

Winston C. Nottingham, Member and

Vice Chairperson

Occupational Safety and Health

Administration

Ralph Yodaiken, Member(2)

Liaison Agencies and Their

Representatives

Consumer Product Safety Commission

Arthur Gregory

Lakshmi Mishra

Department of Agriculture

Homer E. Fairchild

Richard M. Parry, Jr.(3}

Department of Defense

Arthur H. McCreesh

Department of the Interior

Vyto A. Adomaitis(4)

David R. Rosenberger(5)

Food and Drug Administration

Winston deMonsabert(6}

Arnold Borsetti(7)

Allen H. Heim

National Toxicology Program

Dorothy Canter

Committee Staff

Martin Greif, Executive Secretary

Norma Williams, ITC Coordinator

Support Staff

Alan Carpien-Office of the General

Counsel, EPA

Stephen Ells-Office of Toxic

Substances, EPA

Vera W. Hudson-National Library of

Medicine

Notes

(1) Mr. Magness was appointed on July 27,

1983.

(2) Dr. Yodaiken was appointed on July 11.

1983.

(3) Dr. Parry was appointed on September

9, 1983.

(4) Mr. Adomaitis was appointed on May

10, 1983.

(5) Mr. Rosenberger was appointed on May

10, 1983.

(6) Dr. deMonsabert retired from Federal

Service on August 18, 1983.

(7) Dr. Borsetti was appointed on August

16, 1983.

The Committee acknowledges and is

grateful for the assistance and support

given to it by the staffs of CRCS, Inc.,

and Dynamac Corporation (technical

support prime and subcontractors) and

personnel of the EPA Office of Toxic

Substances.

II I |I I I I

55675
Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

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

Administrator of the U.S. Environmental

Protection Agency (EPA) chemical

substances and mixtures in commerce

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 to designate those

chemicals on the Priority List to which

the EPA Administrator should respond

within 12 months by either initiating a

rulemaking proceeding under section

4(a) or publishing the Administrator's

reasons for not initiating such a

proceeding.

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, five liaison agencies,

and one national program. The specific

representatives and their affiliations are

named in the front of this report. The

Committee's chemical review

procedures and prior recommendations

are described in previouis reports (Refs.

I through 12).

1.2 Committee's previous reports.

Twelve previous reports to the EPA

Administrator have been issued by the

Committee and published in the Federal

Register (Refs. I through 12). Sixty-nine

entries (chemicals and groups of

chemicals) were recommended for

priority consideration by the EPA

Administrator and designated for

response within 12 months. In addition,

two groups were recommended without

being so designated. Removal of thirtyfive entries was noted in the previous

reports.

1.3 Committee's activities during this

reporting period. Between April 1, 1983

and September 30, 1983 the Committee

continued to review chemicals from its

third and fourth scoring exercises (see

Ref. 1 for methodology). During this

period, the Committee also completed

the fifth round of scoring chemicals, and

selected 82 additional chemicals for indepth review.

The Committee contacted 87 chemical

manufacturers and trade associations to

request information that would be of

value in its deliberations. Seventy-one

of those contacted privided unpublished

infoiYnation on current production,

expesure, uses, and effects of chemicals

under study by the Committee.

During this reporting period, the

Committee evaluated 36 chemicals for

priority consideration. Four chemicals

were added to the section 4(e) Priority

List, and 11 were deferred at this time.

The remaining 21 chemicals are still

under study.

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 four

chemicals: 2-(2-butoxyethoxy)ethyl

acetate; ethylene bis (oxyethylene)

diacetate; 1,2,3,4,7,7-

hexachloronorbornadiene; and

oleylamine. All four chemicals are

designated for response within twelve

months. The testing recommended for

these chemicals and the rationales for

the recommendations are presented in

Chapter 2 of this report.

Eight chemicals and groups of

chemicals are being removed from the

Priority List because the EPA

Administrator has responded to the

Committee's prior recommendations for

testing these chemicals.

They are: biphenyl; cresols;

ethyltoluene; formamide, mesityl oxide;

4,4"-methylenedianiline; 1,2,4-

trimethylbenzene; and

trimethylbenzenes.

With the 4 recommendations and 8

removals noted in this report, 32 entries

now appear on the section 4(e) Priority

List. The Priority List is divided in the

following Table 2 into two parts;

namely, Table 2A Chemicals and

Groups of Chemicals Designated for

Response Within 12 Months, and Table

2B, Other Recommended Chemicals and

Groups.

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

LIST NOVEMBER 1983

2A. Chemicals end Groups of Chemicals Designated for

Response Within 12 Months

Date of

Enty designation

1. Alkyl epox:des ........................................... Oct. 1T977.

2. Ani;lnr and bromo- chloro- and/or ni- Apr. 1979.

troanitines.

3. Aryl phosphates . ... ...... Apr. 1978.

4. Sis (2-ethylhexyl) terephthalate .............. Nov. 1982.

5. 2-(2-Butoxyethoxy) ethyl acetate .... Nov. 1983.

6. Calcium naphthenate .............................. May 1983.

7. Chlornated benzenes, mono- and dl- . Oct. 1977.

8. Chloinated benzenes, hi-, tetra-, and Oct. 1978.

penta-.

9. Cobalt naphth enate ............................... May 1983.

10. Cyclohxanone ..................... . Apr. 1979.

11. Dibutyltin bis(isOoctyl maleate) ........... Nov. 1982.

12. D;butyltin bls(isoocty mercaptpece- Do.

tate).

13. Dibutyltin bis(lauryl mercaptlde) ......... Do.

14. Dibutyttin dilaurate .................................. Do.

15. 1,2.Dichtorowopane ........................... Oct. 1978.

18. Dimethyltin bis(tsooctyl mercaptoace- Nov. 1982.

ste).

17. 1,3-Dioxohne ............. . ...... Nov. 1982.

18. Ethylene bls(oxyethylene) diacetate . Nov. 1983.

19. Glycidol and its derivatives ..................... Oct. 1978.

20. Halogenated alkyl epoxides ................... Apr. 1978.

21. 1,2,3,4,7,7-Hexachloronorbomadiene .... Nov. 1983.

22. Hydroquinone ......................................... Nov. 1979.

23. Lead naphthenate ............................... May 1983.

24. Methylolurea ....................................... Do.

25. Monobutyltin tris (laooctyl mercaptoa- Nov. 1982.

cetae).

26. Monomethytin hris (sooctyl mercap- Do.

toacetate).

27. Oleylamlne .......... ...................... Nov. 1983.

28. 2-Phenoxyethanol._......................... May 1983.

29. Oulnone ............................................... Nov. 1979.

30. 4-(1,13,3_Ttramethybuty phenol . Nov. 1982.

31. Tris(2-etlyhexy) tDnellitate............ Do.

2B. Other Recommended Chomlcals and Groups of

Chemicals

Entry Date of

recommendaio

1. Carboluran Internmdiates ................ Nov. 1982.

To date, 43 chemicals and groups and

groups of chemicals have been removed

from the Priority List. The cumulative

list is presented in the following Table 3.

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Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

References

(1) Initial Report to the Administrator,

Environmental Protection Agency, TSCA

Interagency Testing Committee, October 1.

1977. Published in the Federal Register of

Wednesday, October 12, 1977, 42 FR 55026-

55080. Corrections published in the Federal

Register of November 11, 1977,42 FR 58777-

58778. The report and supporting dossiers

were also published by the Environmental

Protection Agency, EPA 560-10-78/001,

January 1978.

(2) Second Report of the TSCA Interagency

Testing Committee to the Administrator.

Environmental Protection Agency. TSCA

Interagency Testing Committee, April 1978.

Published in the Federal Register of

Wednesday, April 19, 1978, 43 FR 16684-

16688. The report and supporting dossiers

were also published by the Environmental

Protection Agency, EPA 560-10-78/002, July

1978.

(3) Third Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, October

1978. Published in the Federal Register of

Monday, October 10, 1978, 43 FR 50630-50635.

The report and supporting dossiers were also

published by the Environmental Protection

Agency, EPA 560-10-79/001, January 1979.

(4) Fourth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, April 1979.

Published in the Federal Register of Friday,

June 1,1979, 44 FR 31866-31889.

(5] Fifth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, November

1979. Published in the Federal Register of

Friday, December 7, 1979, 44 FR 70664-70674.

(6) Sixth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, April 1980.

Published in the Federal Register of

Wednesday, May 28, 1980,45 FR 35897-35910.

(7) Seventh Report of the TSCA

Interagency Testing Committee to the

Administrator, Environmental Protection

Agency. TSCA Interagency Testing

Committee, October 1980. Published in the

Federal Register of Tuesday, November 25,

1980, 45 FR 78432-78446.

(8) Eighth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, April 1981.

Published in the Federal Register of Friday,

May 22, 1981, 46 FR 28138-28144.

(9) Ninth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, October

1981. Published in the Federal Register of

Friday, February 5,1982, 47 FR 5456-5403.

(10) Tenth Report of the TSCA Interagency

Testing Committee to the Administrator,

Environmental Protection Agency. TSCA

Interagency Testing Committee, April 1982.

Published in the Federal Register of Tuesday,

May 25, 1982, 47 FR 22585-22596.

(11) Eleventh Report of the TSCA

Interagency Testing Committee to the

Administrator, Environmental Protection

Agency. TSCA Interagency Testing

Committee, October 1982. Published in the

Federal Register of Friday, December 3, 1982,

47 FR 54625-54644.

(12) Twelfth Report of the TSCA

Interagency Testing Committee to the

Administrator, Environmental Protection

Agency. TSCA Interagency Testing

Committee, May 1983. Published in the

Federal Register of Wednesday, June 1, 1983,

48 FR 24443-24452.

Chapter 2-Recommendations of the

Committee

2.1 Chemicals recommended for

priority consideration by the EPA

Administrator. As provided by section

4{e)(1)(B) of TSCA, the Committee is

adding the following four chemical

substances to the section 4(e) Priority

List: 2-(2-butoxyethoxy)ethyl acetate;

ethylene bis(oxyethylene) diacetate;

1,2,3,4,7,7-hexachloronorbornadiene; and

oleylaniine. The recommendation of

these chemicals is being made after

considering the factors identified in

section 4(e)[1)(A) and other available

relevant information, as well as the

professional judgment of Committee

members.

The four recommendations designated

for re~ponse by the EPA Administrator

within 12 months and supporting

rationales are presented in section 2.2 of

this report.

2.2 Chemicals designated for

response within 12 months with

supporting rationales.

2.2.a Alkyloxyethylene Acetates

Summary of recommended studies. It

is recommended that ethylene

bis(oxyethylene) diacetate and 2-(2--

butoxyethoxy)ethyl acetate be tested for

the following:

Health Effects:

Subchronic toxicity

Toxicokinetic studies

Reproductive effects

Physical and Chemical Information

Ethylene bis(oxyethylene) diacetate

and 2-(2-butoxyethoxy)ethyl acetate

react vigorouly with oxidizing materials

(Refs. 3 and 4, Eastman Kodak Co., 1978,

1981). Available physical and chemical

information on the two compounds is

given in the following Table 4.

TABLE 4.-PHYSICAL AND CHEMICAL PROPERTIES OF THE ALKYLOXYETHYLENE ACETATES

Propery Ethylene bis(oxyethylene) dlacetate I 2-(2-Butoxyethoxy) ethyl aete b

CAS Number . .......................... ........................................ 111-21-7 ................................................................................................ 1 124-17-4,

Synonyms .. . ...... Tethyle glycol diacetate; TGD; .............. ............ ......... Dioethyleneglycol monobutyl ether acetate; DGfA

Ethanol. 2Z-[1.2-eanedylbt.oxy)Ibs-. diacetate (CA Index Ethanol. 2-(2-b4toxJethox)-. acetate (CA Index name).

name).

Structural Formula. ..........-.. . .....................

C> 0-CHIHIoh<CCcHJ.-E-CH'CHlO)1-C\CH

Empirical Formula ....................... C,%H,O ...................................................... ............. .. J,,O. Molecular Wigh ............................................................... 234 ............................... ............................ 204.

Melting Point .................................................... .......... Not found ............................................. ............. ........ ...... -32' C.

Boiling Point ...... ......................................................... 29...... . ............................... .. .......................... 235' C.

Vapor Pressure .................................................................. Not applicable (nonvolatile) ............................ ................................ 0,04 mniHg at 20' C.

Specific Gravity ....................... ........................................... 1.123 at 15.6/15.86 C ......................................................................... 0.980 at 20/20' C.

Solubility In Water .............................................................. Negligible .... .......................... ................................... . . . . 65 g/L at 20" C.

Log Octanol/W ater Partition Coeffiient .......................... -0.1 ................................................................................................... 2.01

Description of Chemical .................... . . Clear iquld; essenally odorless ....................................................... Colorless liquid; fant pleasant odor.

Eastman Kodak Co. 1981 (unless otherwise noted). 5

Eastman Kodak Co.. 1978. cEstimated (Ref. 10. Lyman at aL., 1982).

Rationale for Recommendations

I. Exposure information-A.

Production and use. The public portion

of the TSCA Inventory (Ref. 7, EPA,

1982) lists the 1977 U.S. production of

TGD as I million to 10 million pounds

and that DGBA as 0.1 million to I

million pounds. These figures were

reported as representing current

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Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

production (Ref. 5, Eastman Kodak Co.,

1982).

TGD is used primarily as a plasticizer

in bonding cellulose acetate in the

manufacture of cigarette filter tips.

DGBA is used primarily as a solvent in

printing inks and in high-bake enamel

coatings. It is also used as a coalescing

aid in latex paints and as a selective

solvent in industrial separations (Refs. 3

and 5, Eastman Kodak Co., 1978, 1982).

B. Evidence for exposure. According

to a 1972-74 NIOSH survey, the

estimated number of workers exposed to

TGD and DGBA are 152 and 21,461,

respectively (Ref. 12, NIOSH. 1982).

Approximately 50 workers were

potentially exposed to TGD and DGBA

during manufacturing for 50 and 80

hours annually per worker, respectively

(Ref. 5, Eastman Kodak Co., 1982).

Consumers may be exposed repeatedly

to TGD eluted from cigarette filter tips

during smoking (Ref. 6, Eastman Kodak

Co., 1983). The possibility of exposure to

DGBA when using latex paints also

exists.

II. Chemical fate information-No

data were found; however, based upon

their chemical structures both TGD and

DGBA are expected to biodegrade

readily in the environment. Neither

chemical is expected to persist.

Ill. Biological effects of concern to

human health-A. Aetabolism. No

information was found. However, by

analogy with other acetate esters the

compounds may undergo enzymatic

hydrolysis to the free alcohols (Ref. 13,

Sandmeyer and Kirwin, 1081). The

hydrolysis product of TGD would likely

be triethylene glycol, on which a

metabolism study has been performed

(Ref. 11, McKennis et al., 1962). The

hydrolysis product of DGBA is more

likely to be the monobutyl ether of

diethylene glycol, or butyl carbitol.

Oxidation of the hydrolysis products to

alkyloxy acetic acids may also occur

(Ref. 11, McKennis et al., 1962). These

types of metabolites may also have

testicular effects comparable to those of

the glycol ethers (Ref. 8, Foster et al.,

1983).

B. Effects on enzymes and other

biochemical systems. No information

was found.

C. Carcinogenicity and mutagenicity.

No information was found.

D. Short-term acute effects.

Application of 500 mg of TGD to the skin

of rabbits caused mild irritation; in

guinea pigs, TGD also caused slight skin

irritation but no sensitization.

Application of TGD to the eyes of

rabbits led to slight irritation (Ref. 5,

Eastman Kodak Co., 1982). When 500 mg

of DGBA was applied to the skin and

eyes of rabbits, irritation was reported.

Additional acute toxicity information

on the alkyloxyethylene acetates is

summarized in the following Table 5.

Table 5 Acute toxicity of the alkyloxyethylene acetates in

laboratory animals.

Animal Route Doe Reference

Triethylene qlycol diacetate (MrD)

Mouse Oral LD5 0 : > 3.2 q/kg Ref. 5

Rat Oral LDh0. 15.5 q/kq Ref. 5

Rat Ihl LT0)5 > 6.1 mq/L. Ref. 5

6 hours

Guinea piq Skin LDs: > 20 ml/kq Ref. 5

M22.46 /kq)

Diethylene qlyol monobutyl ether

acetate MDGBA)

Mouse Oral LD5 0: 6.6 mAl/kq Ref. 1

(6.5 qfkq)

Rat Oral LD50.7.1 al/kq Ref. 1

(7.0 q/kq)

Rat Oral LD50' 11.9 g/kqa Ref. 14

Rat Ihl Concentrated vapor of

unspecified concentration, Ref. 3

for 8 hoursb

Guinea piq Oral LD5 0 : 7.7 ml/kq Ref. 1

(2.6 qkq)

Guinea Piq Oral LDh0:2.3 q/kqa Ref. 14

Rabbit Oral L05 0 2.6 ml/kq Ref. 2

(2.5 q/kq)

Rabbit Oral L50:2.8 ml/kq Ref. 2

Rabbit Skin L 5 0 : 5.8 ml/kq Ref. 2

(5.7 q/kq)

Rabbit Skin LDSO: 5.5 ml/kq Ref. 1

Rabbit Skin t;D5 0 : 14.8 ml/kq

(14.5 q/kq) Ref. 3

aDissolved in 1% Tergitol ® . bone of six animals died.

E. Long-term (subchronic/chronic)

effects. Rats fed diets containing 0.1 and

I percent TGD for 90 days showed no

changes from controls in food intake,

weight gain, hematology, urine analysis,

gross pathology, or clinical signs (Ref. 5,

Eastman Kodak Co., 1982). Likewise, an

inhalation study of rats exposed to TGD

at 0.163 mg/L for 6 hours daily for 22

exposures over 29 days showed no

changes or lesions indicative of a toxic

response. No information was found on

the chronic effects of the compound.

For DGBA, the 90-day cutaneous [.Dzo

in rabbits was on the order of 2-3 ml/kg.

Skin application led to hematuria,

hernolysis in the kidneys, and renal

tublar degenerative changes (Refs. 2 and

1, Draize et al., 1944, 1948). No

information was found on the chronic

effects of the compound.

F. Teratogenicity/embryotoxicity/

fetotoxicity and reproductive effects. No

information was found. However, the

hydrolysis product of DGBA, namely the

monobutyl ether of diethylene glycol,

had no appreciable effect on maternal

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Federal Register / Vol. 48, No. 241 / Wednesday, December 14, 1983 / Notices

mortality or litter size in mice. An

analog, the monobutyl ether of ethylend

glycol, had a slight testicular effect in

mice (Ref. 9, Hardin, 1983).

G. Rationale for health effects

recommendations. Both TGD and DGBA

have a relatively low toxicity, but DGBA

may be absorbed through the skin, as

shown by the appearance of hematuria,

renal tubular changes, and ether effects.

The extent of enzymic hydrolysis of

DGBA is now known; moreover, the first

hydrolysis product would probably be a

glycol ether, a product of concern

because of the effects of certain of these

compounds on the male reproductive

system. Since both worker exposure and

poscible consumer exposure are

involved, the toxicokinetics and

biochemical disposition, as well as the

reproductive effects, should be

investigated. Additional subchronic

toxicity studies in other species are

needed to investigate the possible

adverse effects on the renal system.

IV. Exological effects-No ecological

effects testing is recommended because

neither TGD nor DGBA is expected to

be acutely toxic to aquatic organisms

and because neither is expected to

persist in the enviroment.

References

(1) Draize JH, Alvarez E, Whitesell MF,

Woodard G, Hagan EC, Nelson AA. 1948.

Toxicological investigations of compounds

proposed for use as insect repellents. I.

Pharmacol. Exp. Ther. 98:26-39.

(2) Draize JH, Woodard G, Calvery HO.

1944. Methods for the study of irritation and

toxicity of substances applied topically to the

skin and mucous membranes. 1. Pharmacol.

Exp. Ther. 82:377-390.

(3) Eastman Kodak Co. 1978. Material

Safety Data Sheet and Product Bulletin

(Publication No. M-149B) on diethylene

glycol monobutyl ether acetate.

(4) Eastman Kodak Co. 1981. Material

Safety Date Sheet on triethylene glycol

diacetate.

(5) Eastman Kodak Co. 1982. Unpublished

information on triethylene glycol monobutyl

ether acetate submitted to ITC by G.Y.

Brokaw, Eastman Kodak Co. July 13,1982.

(61 Eastman Kodak Co. 1983. Unpublished

information on potential consumer expousre

to TGD submitted to ITC by G. Ford, Eastman

Kodak Co. May 18,1983.

(7) EPA. 1982. Environmental Protection

Agency. TSCA Chemical Substances

Inventory (public portion). Washington, D.C.:

Environmental Protection Agency.

(8) Foster PMD, Creasy DM, Foster JR,

Thomas LV, Cook MW, Gangolli SD. 1983.

Testicular toxicity of ethylene glycol

monomethyl and monethyl ethers in the rat.

Toxicol. Appl. Pharmacol. 69:385-399.

(9) Hardin BD. 1983. Reproductive toxicity

of the glycol ethers. Toxicol. 27:91-102.

(10) Lyman WJ, Reehl WF, Rosenblatt DH.

1982. Handbook of Chemical Property

Estimation Methods. New York: McGraw-Hill

Book Co., Chapters 1 adn 7.

(11) McKennis H Jr., Turner RA, Turnbull

LB, Bowman ER, Muelder WW, Neidhardt

MP, Hake CL. Henderson R, Nadev FIG.

Spencer S. 1962. The excretion and

metabolism of triethylene glycol. Toxicol.

Appl. Pharmacol. 4:411-431.

(12) NIOSH. 1982. National Institute for

Occupational Safety and Health. National

Occupational Exposure Survey. Cincinnati:

National Institute for Occupational Safety

and Health.

(13) Sandmeyer EE, Kirwin CJ Jr. 1981.

Esters. In: Clayton GD, Clayton FE, eds.

Patty's Industrial Hyglen and Toxicology, 3rd

rev. ed. Vol. 2A:2259-2412.

(14) Smyth HF Jr., Seaton J, Fischer L. 1941.

The single dose toxicity of some glycols and

derivatives. J. Ind. Hyg. Toxicol. 23:259-268.

2.2.b 1,2,3,4,7,7-

Hexachloronorbornadiene

Summary of recommended studies. It

is recommended that 1,2,3,4,7,7-

hexachloronorbornadiene be tested for

the following:

Health Effects:

Subchronic tests, including

neurotoxicity

Biochemical effects, including

enzyme-inducing capabilities

Physical and Chemical Information

CAS Number: 3389-71-7.

Synonyms:

Hexachloronorbornadiene;

HEX-BCH;

Hexachlorobicycloheptadiene;

Bicyclo[2.2.1]hepta-2.

5-diene, 1,2,3,4,7,7-

hexachloro- (CA Index name)

Structural Formula:

C1 I

CI

Empirical Formula: C1H2CI

Molecular Weight: 299

Boiling Point: 118-120 ° C at 0.1 mmHg

Vapor Pressure: 10-s mmHg at 25 ° C

(estimated; Ref. 6, Lyman et al., 1982).

Solubility in Water: 15 mb/L at 250 C

(estimated; Ref. 6, Lyman et al., 1982).

Solubility in Organic Solvents: Soluble

in ether, ethanol, carbon tetrachloride,

chloroform, DMSO.

Log Octanol/Water Partition

Coefficient: 5.28 (estimated; Ref. 9, Veith

et al., 1979).

Description of Chemical: Oily liquid.

Rationale for Recommendations

I. Exposure information-A.

Production and use.

Hexachloronorbornadiene is an

intermediate in the manufacture of the

pesticide endrin (Ref. 10, Velsicol, 1982).

In recent years endrin has been

produced in the U.S. in one plant only,

which is in Memphis, Tennessee (Ref. 8,

SRI, 1982). Based on the 1981 production

volume of endrin of 2 million to 4 million

pounds (Ref. 5, Glaze, 1982), it can be

inferred that the production volume of

hexachloronorbornadiene in 1981 was

1.5 million to 3 million pounds.

However, the only manufacturer of the

compound has reported that production

was halted in 1982 (Ref. 11, Velsicol,

1983a).

B. Evidence for exposure.

Hexachloronorbornadiene has been

released to the environment through

waste discharges from the Memphis,

Tennessee manufacturing plant.

Aqueous wastes have been treated by

the Memphis municipal sewage

treatment plant, then dumped into the

Cypress Creek, which empties into the

Mississippi River. The compound has

been identified int he air within the

treatment facility (Ref. 3, Elia et al.,

1980], in the urine of the treatment plant

workers, in the effluent of the treatment

plant (Ref. 10, Velsicol, 1982), in the

waters and sediment of the Mississippi

River and tributaries (Ref. 1, Barthel et

al., 1966), and in edible portions of fish

caught in the Mississippi River (Ref. 14,

Yurawecz and Roach, 1978). Solid

wastes containing

hexachloronorbornadiene most recently

have been incinerated or burled in

secure landfills (Ref. 10, Velsicol, 1982).

but froip 1964 to 1972 they were

disposed of in surface landfills. The

compound has been found in well water

in the vicinity of these landfills (Ref. 2,

Clark et al., 1981).

Although the manufacturer reports no

current production, the compound is

persistent, and leaching into surface and

ground waters from waste residues of

the compound may be expected to

continue. Human exposure can occur as

a result of drinking water or eating fish

contaminated with the compound.

Residues of the compound and its

derivatives found in Mississippi River

fish are listed in the following Table 6.

BILLING CODE 6S6--50-l

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