42982 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

ENVIRONMENTAL PROTECTION

AGENCY

[OPPTS–41043; FRL–4965–6]

Thirty-Sixth Report of the TSCA

Interagency Testing Committee to the

Administrator; Receipt of Report,

Request for Comments, Solicitation of

Use and Exposure Data

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: The TSCA Interagency

Testing Committee (ITC), established

under section 4(e) of the Toxic

Substances Control Act (TSCA),

transmitted its Thirty-Sixth Report to

the Administrator of EPA on May 23,

1995. This Report, included with this

notice, adds no chemicals to the Priority

Testing List for consideration by the

EPA Administrator for promulgation of

test rules under section 4(a) of the Act.

In this Report the ITC recommended 12

High Production Volume Chemicals

(HPVCs) for an information solicitation.

The ITC removed cyclohexanone, a

previously-designated chemical, and 34

previously-recommended chemicals

from the List: butyraldehyde, 9

chloroalkyl phosphates, sulfonyl bis(4-

chlorobenzene), m-dinitrobenzene, 4

cyanoacrylates, 2 methyl ethylene glycol

ethers and esters, 11 propylene glycol

ethers and esters, and 5 HPVCs. The

ITC’s reasons for removing these

chemicals from the List are listed in the

Thirty-Sixth Report. EPA invites

interested persons to submit written

comments on the Report.

DATES: Written comments on the ThirtySixth ITC Report should be submitted

by September 18, 1995.

ADDRESS: Send six copies of written

submissions to: TSCA Public Docket

Office (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, Rm. G–99 ET, 401 M

St., SW., Washington, DC 20460.

Submissions should bear the document

control number OPPTS–41043.

The public record supporting this

action, including comments, is available

for public inspection in Rm. B–607

NEM at the address noted above from 12

noon to 4 p.m., Monday through Friday,

except legal holidays.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to:

ncic@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

OPPT–41043. No CBI should be

submitted through e-mail. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found in

Unit III of this document.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M Street, SW., Rm. E–

543B, Washington, DC 20460, (202)

554–1404, TDD (202) 554–0551,

Internet: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received the TSCA Interagency Testing

Committee’s Thirty-Sixth Report to the

Administrator.

I. Background

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

et seq; 15 U.S.C. 260l 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 most recent

revisions to this List are included in the

ITC’s Thirty-Sixth Report. The Report

was received by the Administrator on

May 23, 1995, and is included in this

Notice. The Report solicits use and

exposure data for 12 HPVCs, and

removes cyclohexanone, a previouslydesignated chemical, and 34 previouslyrecommended chemicals from the List.

II. Status of List

The ITC’s Thirty-Sixth Report

requests certain use and exposure data

for 12 HPVCs, and removes one

previously-designated chemical, and 34

previously-recommended chemicals

from the List. The current TSCA section

4(e) Priority Testing List contains 5

chemicals and 8 chemical groups, with

3 chemical groups and 3 chemicals

designated for testing.

III. Electronic and Written Comments

EPA invites interested persons to

submit detailed comments on the ITC’s

Report. A record has been established

for this notice under docket number

‘‘OPPTS–41043’’ (including comments

and data submitted electronically as

described below). A public version of

this record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as confidential business

information (CBI), is available for

inspection from 12 noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

the TSCA Nonconfidential Information

Center, Rm. NE-B607, 401 M St., SW.,

Washington, DC 20460.

Electronic comments can be sent

directly to EPA at:

ncic@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for the ThirtySixth Report, as well as the public

version as described above, will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official record which

will also include all comments

submitted directly in writing. The

official record is the paper record

maintained at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Authority: 15 U.S.C. 2603.

Dated: August 11, 1995.

Paul J. Campanella,

Acting Director, Chemical Control Division,

Office of Pollution Prevention and Toxics.

Thirty-Sixth Report of the TSCA

Interagency Testing Committee to the

Administrator

Summary

This is the 36th Report of the TSCA

Interagency Testing Committee (ITC) to

the Administrator of the U.S.

Environmental Protection Agency

(EPA). In this Report, the ITC is revising

its TSCA section 4(e) Priority Testing

List by soliciting use and exposure data

for 12 High Production Volume

Chemicals (HPVCs), removing a

previously-designated chemical,

cyclohexanone, and removing 34

previously-recommended chemicals:

butyraldehyde, 9 chloroalkyl

phosphates, sulfonyl bis(4-

chlorobenzene), m-dinitrobenzene, 4

cyanoacrylates, 2 methyl ethylene glycol

ethers and esters, 11 propylene glycol

ethers and esters, and 5 HPVCs.

The revised TSCA section 4(e)

Priority Testing List follows as Table 1.
Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices 42983

TABLE 1.—THE TSCA SECTION 4(e) PRIORITY TESTING LIST (MAY 1995)

Report Date Chemical/Group Action

26 May 1990 15 Isocyanates Recommended with intent-to-designate

27 November

1990

62 Aldehydes Recommended with intent-to-designate

28 May 1991 Acetone Designated

28 May 1991 Thiophenol Designated

29 November

1991

10 Alkyl-, bromo-, chloro-, hydroxymethyl diaryl ethers Recommended

30 May 1992 56 Siloxanes Recommended

31 January 1993 24 Chemicals with no dermal toxicity data Designated

32 May 1993 32 Chemicals with insufficient dermal absorption data Designated

34 May 1994 White phosphorus Designated

34 May 1994 Ethyl tert-butyl ether Recommended

34 May 1994 Tert-amyl methyl ether Recommended

35 November

1994

24 Chemicals with insufficient dermal absorption data Designated

36 May 1995 12 High Production Volume Chemicals: Solicitation for Use and Exposure DataRecommended

I. Background

The TSCA Interagency Testing

Committee (ITC) was established by

section 4(e) of the Toxic Substances

Control Act (TSCA) ‘‘to make

recommendations to the Administrator

respecting the chemical substances and

mixtures to which the Administrator

should give priority consideration for

the promulgation of a rule for testing

under section 4(a).... At least every 6

months..., the Committee shall make

such revisions in the List as it

determines to be necessary and to

transmit them to the Administrator

together with the Committee’s reasons

for the revisions’’ (Public Law 94–469,

90 Stat. 2003 et seq., 15 U.S.C. 2601 et

seq.). Since its creation in 1976, the ITC

has submitted 35 semi-annual Reports

to the EPA Administrator transmitting

the Priority Testing List and its

revisions. These Reports have been

published in the Federal Register and

are available from the ITC. The ITC

meets monthly and produces its

revisions of the List with the help of

staff and technical contract support

provided by EPA. ITC membership and

support personnel are listed at the end

of this Report.

Following receipt of the ITC’s Report

and the addition of chemicals to the

Priority Testing List, EPA’s Office of

Pollution Prevention and Toxics

generally adds new chemicals from the

List to TSCA section 8(a) and 8(d) rules

that require manufacturers and

importers of these chemicals to submit

TSCA section 8(a) production and

exposure data and manufacturers,

importers and processors of the listed

chemicals to submit TSCA section 8(d)

health and safety studies within 60 days

of the rule’s effective date. The

submissions are indexed and

maintained by EPA. The ITC reviews

the TSCA section 8(a) and 8(d)

information and other available data on

chemicals and chemical groups (e.g.,

TSCA section 8(e) ‘‘substantial risk’’

studies, ‘‘For Your Information’’ (FYI)

submissions to EPA, and published

papers) to determine if revisions to the

List are necessary. Revisions can

include changing a recommendation to

a designation for testing action by the

EPA Administrator within 12 months,

modifying the recommended testing, or

removing the chemical or chemical

group from the List.

II. Revisions to the TSCA Section 4(e)

Priority Testing List

Revisions to the TSCA section 4(e)

Priority Testing List are summarized in

the following Table 2:

TABLE 2.—REVISIONS TO THE TSCA SECTION 4(e) PRIORITY TESTING LIST (NOVEMBER 1994 TO APRIL 1995)

CAS No. Chemical/Group Action Date

High Production Volume Chemicals Solicit use and exposure data 5/95

80–51–3 p,p′-Oxybis(benzenesulfonyl hydrazide)

81–84–5 Naphthalene dicarboxylic anhydride

99–54–7 3,4-Dichloronitrobenzene

100–29–8 4-Ethoxynitrobenzene

111–96–6 Diethylene glycol dimethyl ether

112–15–2 Diethylene glycol monoethyl ether acetate

119–33–5 4-Methyl-2-nitrophenol

121–60–8 4-(Acetylamino)benzenesulfonyl chloride

594–42–3 Trichloromethane sulfenyl chloride
42984 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

TABLE 2.—REVISIONS TO THE TSCA SECTION 4(e) PRIORITY TESTING LIST (NOVEMBER 1994 TO APRIL 1995)—

Continued

CAS No. Chemical/Group Action Date

626–17–5 1,3-Dicyanobenzene

929–06–6 2-(2-Aminoethoxy)ethanol

3089–11–0 Hexa(methoxymethyl) melamine

High Production Volume Chemicals Remove previously recommended chemicals 5/95

90–15–3 1-Naphthol

94–28–0 Triethylene glycol bis(2-ethylhexanoate)

97–88–1 n-Butyl methacrylate

106–63–8 Isobutyl acrylate

142–16–5 Bis(2-ethylhexyl)-2-butenedioate

Chloroalkyl phosphates Remove previously recommended chemicals 5/95

115–96–8 Tris(2-chloroethyl) phosphate

6145 –73–9 Tris(2-chloro-1-propyl) phosphate

13674–84–5 Tris(2-chloroisopropyl) phosphate

13674–87–8 Tris(1,3-dichloro-2-propyl) phosphate

33125–86–9 Tetrakis(2-chloroethyl) ethylene diphosphate

34621–99–3 1,2-Ethanediyl tetrakis(2-chloro-1-methylethyl) phosphate

38051–10–4 2,2-Bis(chloromethyl) 1,3-propanediyl tetrakis(2-

chloroethyl) phosphate

53461–82–8 Oxydi-2,1-ethanediyl tetrakis(2-chloroethyl) phosphate

76649–15–5 2-Chloro-1-methylethyl bis-(2-chloropropyl) phosphate

Cyanoacrylates Remove previously recommended chemicals 5/95

137–05–3 2-Propenoic acid, 2-cyano-, methyl ester

6197–30–4 2-propenoic acid, 2-cyano-3,3-diphenyl-,2-ethylhexyl ester

7085–85–0 2-propenoic acid, 2-cyano-, ethyl ester

64992–16–1 Ethanaminium, 2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-

oxo-2-propenyl]oxy]-N,N,N-trimethyl-, chloride

Propylene glycol ethers and esters Remove previously recommended chemicals 5/95

108–65–6 Propylene glycol monomethyl ether acetate

110–98–5 Dipropylene glycol

770–35–4 1-Phenoxy-2-propanol

20324–32–7 Dipropylene glycol methyl ether

20324–33–8 Tripropylene glycol methyl ether

28677–93–2 Methoxy-1-propanol

29387–86–8 Propylene glycol monobutyl ether

29911–28–2 Dipropylene glycol butyl ether

42978–66–5 Tripropylene glycol diacrylate

57018–52–7 Propylene glycol mono-tert-butyl ether

88917–22–0 Dipropylene glycol monomethyl ether acetate

Methyl ethylene glycol ethers and esters Remove previously recommended chemicals 5/95

3121–67–7 Ethylene glycol methyl ether acrylate

23783–42–8 Tetraethylene glycol methyl ether

Other Chemicals

80–07–9 Sulfonyl bis(4-chlorobenzene) Remove previously recommended chemical 5/95

99–65–0 m-Dinitrobenzene Remove previously recommended chemical 5/95

108–94–1 Cyclohexanone Remove previously recommended chemical 5/95

123–72–8 Butyraldehyde Remove previously recommended chemical 5/95
Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices 42985

III. Rationale for the revisions

A. ITC’s Activities During this Reporting

Period

During the 6 months covered by this

Report, November 1994 through April

1995, the ITC reviewed TSCA section

8(a) and 8(d) data, use data that were

solicited from manufacturers, and

toxicology data obtained from published

papers, for 17 HPVCs that were

previously recommended as chemicals

in need of subchronic (90–day) toxicity

data in the ITC’s 27th Report (56 FR

9534, March 6, 1991). The ITC also

reviewed available data for

butyraldehyde and 5 chloroalkyl

phosphates that were recommended in

the 23rd Report (53 FR 46262,

November 16, 1988); for sulfonyl bis(4-

chlorobenzene) that was recommended,

as a member of the sulfone group, in the

27th Report; for m-dinitrobenzene and 4

cyanoacrylates that were recommended

in the 28th Report (56 FR 41212, August

19, 1991); for 4 chloroalkyl phosphates

that were recommended in the 30th

Report (57 FR 30608, July 9, 1992); for

2 methyl ethylene glycol ethers and

esters and 11 propylene glycol ethers

and esters that were recommended in

the 31st Report (58 FR 26898, May 5,

1993); and for cyclohexanone that was

designated in the 35th Report (59 FR

67596, December 29, 1994).

B. Specific Rationales

1. Recommended chemicals—a.

HPVCs. A group of 35 HPVCs that did

not have 90–day subchronic toxicity test

data were recommended by the ITC in

its 27th Report (56 FR 9534, March 6,

1991). For these HPVCs, i.e., chemicals

with domestic production or

importation volumes greater than 1

million pounds, the ITC reviewed an

extensive amount of production,

importation, use, exposure and health

and safety data, as noted in the 35th

Report. After reviewing these data and

considering the data needs of U.S.

Government organizations represented

on the ITC, the ITC removed 18 of these

chemicals from the Priority Testing List

in its 35th Report. To facilitate

development of the ITC’s testing

decisions regarding designations for the

12 HPVCs listed in Table 2 of this

Report, the ITC needs to know specific

uses of the chemical, including use as

an intermediate in industrial processes

(with descriptions of those processes)

and use as an end product (including

use as an industrial or consumer end

product). For each use, the ITC needs to

know the estimated number of workers

or consumers that may be exposed to

the chemical and the estimated worker,

consumer, and environmental exposure

levels. The ITC also needs an estimate

of the quantities of diethylene glycol

dimethyl ether (CAS No. 111–96–6)

used as a solvent in semiconductor

clean rooms.

The use and exposure data needed by

the ITC should be submitted to the ITC

Executive Director at the address

provided at the end of this Report. The

ITC will review all data that are

received within 60 days of the date this

36th ITC Report is published in the

Federal Register, and will use these

data to determine if any of these HPVC

should be designated for testing or

removed from the Priority Testing List.

2. Removal of chemicals from the

Priority Testing List— a. HPVCs. The

ITC is removing 5 HPVCs from the

Priority Testing List (Table 2).

1-Naphthol (CAS No. 90–15–3) is

being removed because there are

sufficient data to reasonably determine

or predict effects and no additional U.S.

Government data needs were identified.

Two acrylate derivatives, n-butyl

methacrylate (CAS No. 97–88–1) and

isobutyl acrylate (CAS No. 106–63–8)

are being removed because some

ecological effects, chemical fate and

health effects screening data have been

developed, other testing is ongoing or

scheduled and there are no current U.S.

government data needs.

Two ethylhexyl derivatives,

triethylene glycol bis(2-ethylhexanoate)

(CAS No. 94–28–0) and bis(2-

ethylhexyl)2-butenedioate (CAS No.

142–16–5) are being removed because

testing to elucidate the relationship

between peroxisomal proliferation

caused by chemicals containing

ethylhexyl substructures and cancer is

ongoing and because there are no

current U.S. Government data needs.

b. Butyraldehyde. Butyraldehyde

(CAS No. 123–72–8) was recommended

for testing in the 23rd Report (53 FR

46262, November 16, 1988). The ITC

recommended that environmental

monitoring be conducted in the vicinity

of major manufacturing and use sites,

and that in-depth health and ecological

effects studies be conducted, if

warranted by monitoring data.

The ITC was particularly concerned

about potential reproductive and

developmental effects, and, in its 23rd

Report, included a discussion of studies

conducted by Moutschen-Dahmen et al.

(1975, 1976). The 1975 study

demonstrated that a single

intraperitoneal injection of 1 mg

butyraldehyde per animal produced

chromosomal damage and meiotic

anomalies, including degenerative

nuclei, multispindle cells and polyploid

cells at all stages of spermatogenesis in

male mice 1 month following the

treatment. The 1976 study examined

one group of male mice that received a

single intraperitoneal dose of 30 mg

butyraldehyde per kg, and a second

group that received 0.2 mg/L in their

drinking water for 50 days.

Administration of butyraldehyde by

either route damaged the spermatogenic

cells of the seminiferous tubules. In

addition to gross degeneration,

polyploidy was observed at all stages of

spermatogenesis and abnormal pairing

of sex chromosomes occurred at

metaphase I; there was also an increased

incidence, in the vas deferens, of

spermatozoa without acrosomes.

Three events, related to

butyraldehyde, occurred after the 23rd

Report was published. First, the ITC

received comments from the

Butyraldehyde Task Group of the

Chemical Manufacturers Association

(CMA). Second, butyraldehyde was

selected for review as part of the

Organisation for Economic Cooperation

and Development (OECD) Screening

Information Data Set (SIDS) program

and an OECD SIDS dossier was

developed by the CMA’s Oxo Process

Panel. Third, the ITC learned that the

National Toxicology Program (NTP) had

sponsored a reproductive screening test

of butyraldehyde.

The ITC received comments from the

CMA’s Butyraldehyde Task Group in

1989, 1993 and 1995 (CMA, 1989, 1993,

1995a,b). In 1989, the CMA commented

that butyraldehyde environmental

releases were below the levels reported

by the ITC that were based on the 1987

Toxic Release Inventory (TRI) and that

numbers of exposed workers were less

than estimates based on the National

Occupational Exposure Survey (NOES)

data (CMA, 1989). The Task Group

stated that the NOES projection of 5,392

workers overestimated the number of

workers potentially exposed to

butyraldehyde. The Task Group

estimated that no more than 500 to 600

workers are potentially exposed to

butyraldehyde at manufacturing and

processing facilities. In addition, the

CMA reported that concentrations of

butyraldehyde to which workers and the

general population were exposed were

less than 1 part per million and 1 part

per billion, respectively (CMA, 1989). In

1993, the CMA reported that, based on

1988 and 1991 TRI reporting,

environmental releases of

butyraldehyde were decreasing (CMA,

1993). In 1995, the CMA reported that,

based on 1992 TRI reporting,

environmental releases of

butyraldehyde were about 25% of 1987

TRI releases, and that butyraldehyde’s

offensive odor and low odor threshold

should mitigate the potential for
42986 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

significant worker exposures (CMA,

1995a).

The February 1993 OECD SIDS

butyraldehyde dossier noted in the

section on reproductive and

developmental toxicity that no data

were submitted. However, in the section

on genetic toxicity, the dossier

referenced the 1975 and 1976

Moutschen-Dahmen et al. studies that

were discussed in the 23rd Report. The

dossier was discussed at a September

1993 OECD SIDS meeting and the

participants agreed that no additional

testing should be required for

butyraldehyde and that dossiers should

be prepared for propionaldehyde and

isobutyraldehyde. At that meeting, it

was noted that reproductive and

developmental toxicity data were not

available for butyraldehyde, but that

data from analogs could be used to

predict toxicity. Dossiers for

propionaldehyde and isobutyraldehyde

were discussed at the February 1995

OECD SIDS Initial Assessment Meeting

(SIAM). At this SIAM, propionaldehyde

was assigned a low priority for further

testing and isobutyraldehyde was

selected for developmental toxicity

testing. The butyraldehyde dossier will

be discussed at an OECD SIAM in late

1995 or early 1996. In the interim, the

CMA’s Oxo Process Panel is sponsoring

two studies on butyl acetate that may

provide some indirect data on

butyraldehyde, because it is a butyl

acetate metabolic intermediate. The

Panel will begin a butyl acetate in vivo

(rats) hydrolysis study in mid-1995 and

complete a 90–day subchronic

neurotoxicity study (including an

evaluation of the effects of butyl acetate

on testicular toxicity and numbers of

elongated spermatids) in late 1995

(CMA, 1995b).

The NTP sponsored a 90–day

butyraldehyde subchronic toxicity study

in mice and rats (EHRT, 1986). This

study included sperm morphology and

motility and vaginal cytology

evaluations. Butyraldehyde

administered by gavage to mice at a

dose range of 150 – 600 mg/kg, and to

rats at a dose range of 75–300 mg/kg,

had no significant effects on sperm

morphology or motility, caudal,

epididymal or testicular weights, or on

the estrous cycle.

The ITC discussed studies related to

reproductive and developmental

toxicity of butyraldehyde, the CMA’s

exposure data, the OECD SIDS dossier,

the results of the OECD SIAM and the

CMA’s plans to conduct future studies.

The ITC is removing butyraldehyde

from the Priority Testing List because of

the ongoing international activities

(Table 2).

c. Chloroalkyl phosphates. Five

chloroalkyl phosphates were

recommended in the 23rd Report (53 FR

46262, November 15, 1988). Another 4

were recommended in the 30th Report

(57 FR 30608, July 9, 1992). The

published and unpublished data

received for these nine chloroalkyl

phosphates listed in Table 2 were

reviewed by the ITC. About 95% of the

data received were for the five

chloroalkyl phosphates recommended

in the 23rd Report; most of these data

were for tris(2-chloroethyl) phosphate

and tris(1,3-dichloro-2-propyl)

phosphate. Both of these chloroalkyl

phosphates caused cancer in rodents.

Chemical fate and monitoring data for

these two chloroalkyl phosphates

suggest that they would persist in the

environment. Aquatic toxicity data

suggest that both these chloroalkyl

phosphates would cause acute effects at

milligram per liter concentrations.

The ITC is removing the chloroalkyl

phosphates from the List because the

data or structure activity relationships

considered by the ITC do not indicate a

need to designate the chloroalkyl

phosphates for further testing at this

time. The structure activity

relationships considered by the ITC for

the chloroalkyl phosphates were based

on an analysis of beta-chloroalkyl

phosphate substructures identified by

the Substructure-based Computerized

Chemical Selection Expert System

(SuCCSES) developed by Walker (1991,

1995). The rationales for removing the

individual chloroalkyl phosphates

follow:

Tris(2-chloroethyl) phosphate (CAS

No. 115–96–8) and Tris(1,3-dichloro-2-

propyl) phosphate (CAS No. 13674–87–

8). The ITC is removing these chemicals

from the List because they are welltested and cause cancer in rodents.

Tris(2-chloroisopropyl) phosphate

(CAS No. 13674–84–5). The ITC is

removing tris(2-chloroisopropyl)

phosphate from the List, because

sufficient screening test data are likely

to be developed under the OECD SIDS

program and because it contains betachloroalkyl phosphate substructures

similar to those contained in tris(2-

chloroethyl) phosphate and tris(1,3-

dichloro-2-propyl) phosphate and this

substructural relationship to these

known rodent carcinogens may be

sufficient to predict its ability to cause

cancer in rodents.

Tris(2-chloro-1-propyl) phosphate

(CAS No. 6145–73–9), tetrakis(2-

chloroethyl) ethylene diphosphate (CAS

No. 33125–86–9) and 2,2-

bis(chloromethyl) 1,3-propanediyl

tetrakis(2-chloroethyl) phosphate (CAS

No. 38051–10–4). The ITC is removing

these chemicals from the List because

there are no current U.S. Government

data needs and because they all contain

beta-chloroalkyl phosphate

substructures similar to those contained

in tris(2-chloroethyl) phosphate and

tris(1,3-dichloro-2-propyl) phosphate

and this substructural relationship to

these known rodent carcinogens may be

sufficient to predict their ability to

cause cancer in rodents.

1,2-Ethanediyl tetrakis(2-chloro-1-

methylethyl) phosphate (CAS No.

34621–99–3), oxydi-2,1-ethanediyl

tetrakis(2-chloroethyl) phosphate (CAS

No. 53461–82–8) and 2-chloro-1-

methylethyl bis-(2-chloropropyl)

phosphate (CAS No. 76649–15–5). The

ITC is removing these chemicals from

the List, because their 1989 production

volumes were each less than 1 million

pounds and because they all contain

beta-chloroalkyl phosphate

substructures similar to those contained

in tris(2-chloroethyl) phosphate and

tris(1,3-dichloro-2-propyl) phosphate

and this substructural relationship to

these known rodent carcinogens may be

sufficient to predict their ability to

cause cancer in rodents.

d. Sulfonyl bis(4-chlorobenzene). In

its 35th Report, the ITC removed 25

sulfones from the Priority Testing List

(59 FR 67596, December 29, 1994). For

the remaining sulfone, sulfonyl bis(4-

chlorobenzene) (CAS No. 80–07–9), the

ITC determined that most of the

screening test data that would be

required under the OECD SIDS Program

had been developed.

Sulfonyl bis(4-chlorobenzene) shares

structural and functional relationships

with other sulfonylbenzenes. The NTP

has performed a number of short-term

toxicity and metabolism studies and has

developed a physiologically-based

pharmacokinetic model for sulfonyl

bis(4-chlorobenzene). The NTP is

planning to perform a two-species

rodent carcinogenicity assay to further

evaluate structure-activity relationships

and to determine the effectiveness of

shorter-term tests, including a 13–week

subchronic toxicity test in rats and

mice, to predict and model the

carcinogenic response. The ITC is

removing sulfonyl bis(4-chlorobenzene)

from the Priority Testing List because

most of the screening test data have

been developed and because the NTP

will be conducting health effects testing

(Table 2).

e. m-Dinitrobenzene. mDinitrobenzene (CAS No. 99–65–0) was

recommended for testing in the 28th

Report (56 FR 41212, August 19, 1991).

It is being removed as a discrete entry

from the Priority Testing List because it

is scheduled for future review within
Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices 42987

the framework of the OECD SIDS

program (Table 2). However, mdinitrobenzene will remain on the List

as a member of a category of chemical

substances designated by the ITC in its

32nd Report for dermal absorption

testing to develop data needed by the

Occupational Safety and Health

Administration (58 FR 38490, July 16,

1993).

f. Cyanoacrylates. In its 35th Report, the

ITC removed seven cyanoacrylates from the

Priority Testing List (59 FR 67596, December

29, 1994). The ITC is removing three

cyanoacrylates from the List because 1989

production volumes were less than 1 million

pounds per year and there are currently no

U.S. Government data needs. These three

cyanoacrylates, listed in Table 2, are 2-

propenoic acid, 2-cyano-, methyl ester (CAS

No. 137–05–3), 2-propenoic acid, 2-cyano3,3-diphenyl-, 2-ethylhexyl ester (CAS No.

6197–30–4) and ethanaminium, 2-[[2-cyano3-[4-(diethylamino)phenyl] -1-oxo-2-

propenyl]oxy]-N,N,N-trimethyl-, chloride

(CAS No. 64992–16–1).

For the remaining cyanoacrylate,

listed in Table 2, 2-propenoic acid, 2-

cyano-, ethyl ester (CAS No. 7085–85–

0), the ITC considered the available

screening data, the information from a

TSCA section 8(e) submission and the

ongoing attempts by the NTP to test this

chemical. The ITC determined that few

of the screening data that would be

required under the OECD SIDS program

had been developed. The common name

for this chemical is ethyl cyanoacrylate.

The TSCA section 8(e) submission

that the ITC considered was for an

adhesive product that contained 95%

ethyl cyanoacrylate (EPA, 1989). The

submitter stated that ‘‘a customer which

uses [a] cyanoacrylate adhesive among

other chemicals reported that three

pregnant women [had] experienced

premature childbirths,’’ and ‘‘two [of

the] premature babies died and one

continues on life support.’’ The

submission noted the similarity between

the affected women’s exposure/working

relationships.

The NTP has attempted to test ethyl

cyanoacrylate in laboratory animals.

Injection of ethyl cyanoacrylate into

animals yields a polymer. In the NTPconducted tests, where polymerization

was not considered, ethyl cyanoacrylate

was not mutagenic in the Ames test or

in rodent bone marrow micronucleus

tests. The NTP subchronic and chronic

studies have not been initiated because

of the high reactivity of the chemical

and the resulting difficulties in

implementing the delivery of an

effective concentration of the

unpolymerized chemical to the test

animals. Ethyl cyanoacrylate is being

removed from the Priority Testing List

because the TSCA section 8(e)

submission suggests that there may be a

need to examine exposure controls and

because the practical problems which

may prevent effective health effects

testing are being evaluated by the NTP.

g. Propylene glycol ethers and esters.

Propylene glycol ethers and esters were

recommended for developmental

toxicity and reproductive effects testing

in the 28th Report (56 FR 41212, August

19, 1991). Based on the

recommendations of the Consumer

Product Safety Commission (CPSC), the

Food and Drug Administration, and the

National Institute for Occupational

Safety and Health, the ITC revised the

TSCA section 4(e) Priority Testing List

by removing 29 of the 38 propylene

glycol ethers and esters originally

recommended and adding two new

propylene glycol ethers in its 31st

Report (58 FR 26898, May 5, 1993). The

ITC recommended these 11 propylene

glycol ethers and esters for an

information solicitation to obtain

consumer use data. After publication of

the 31st Report, the EPA promulgated

TSCA section 8(a) and 8(d) rules for the

chemicals in that Report (58 FR 68311,

December 27, 1993). After receiving

comments from the CMA’s Propylene

Glycol Ethers Panel, the EPA stayed

these TSCA section 8(a) and 8(d) rules

for propylene glycol ethers and esters.

After the stay was published (59 FR

14115, March 25, 1994), the ITC

initiated a dialogue with the CMA’s

Propylene Glycol Ethers Panel and

obtained recent production volume and

consumer use data for nine of the

recommended propylene glycol ethers,

and esters and three others that were not

recommended in the 31st Report.

As a result, eight of the propylene

glycol ethers and esters listed in Table

2 are being removed from the Priority

Testing List because the U.S.

Government consumer use data needs

stated in the 31st Report were satisfied.

Tripropylene glycol diacrylate (CAS

No. 42978–66–5) is being removed from

the propylene glycol ethers and esters

listed in Table 2 because another CMA

panel supplied commercial use

information that suggests consumer

exposure to this compound is likely to

be limited.

Dipropylene glycol (CAS No. 110–98–

5) is being removed from the propylene

glycol ethers and esters listed in Table

2 because a dipropylene glycol mixture

(CAS No. 25265–71–8) is being tested by

the NTP.

Dipropylene glycol methyl ether (CAS

No. 20324–32–7) is being removed from

the propylene glycol ethers and esters

listed in Table 2 because the CMA

provided consumer use data. However,

this chemical will remain on the

Priority Testing List as a member of a

category of chemical substances

designated by the ITC in its 35th Report

for dermal absorption testing to develop

data needed by the Occupational Safety

and Health Administration (59 FR

67596, December 29, 1994).

The CPSC will review data submitted

by the CMA in response to the ITC’s

recommendation, as part of a project on

glycol ethers in consumer products. The

ITC is including a summary of use data

received from the CMA for the

propylene glycol ethers and esters in the

public docket for this 36th Report and

forwarding a copy to the Chemical

Control Division in EPA’s Office of

Pollution Prevention and Toxics.

h. Methyl ethylene glycol ethers and

esters. In its 31st Report (58 FR 26898,

May 5, 1993), the ITC revised the TSCA

section 4(e) Priority Testing List by

removing 8 of 10 methyl ethylene glycol

ethers and esters recommended in the

28th Report (56 FR 41212, August 19,

1991). Ethylene glycol methyl ether

acrylate (CAS No. 3121–67–7) and

tetraethylene glycol methyl ether (CAS

No. 23783–42–8) were retained on the

List in order to obtain consumer use as

well as TSCA section 8(a) and 8(d) data.

In addition, ethylene glycol methyl

ether acrylate was retained on the List

because of its developmental effects

(30% mortality and 100% intrauterine

deaths at term in all 14 litters of mice

exposed to 650 mg/kg by gavage during

gestation days 7–14) as reported by

Hardin et al. (1987).

The reported 1989 production volume

for both compounds, obtained from the

1990 TSCA Inventory Update Rule, was

less than 1 million pounds each.

Information submitted by the CMA

suggests that consumer exposures to the

two chemicals are expected to be

limited. The ITC is removing ethylene

glycol methyl ether acrylate and

tetraethylene glycol methyl ether from

the methyl ethylene glycol ethers and

esters listed in Table 2 because

production volumes were less than 1

million pounds and consumer

exposures are expected to be limited.

i. Cyclohexanone. The Occupational

Safety and Health Administration

requested that the ITC designate

cyclohexanone in its 35th Report to

obtain adequate dermal absorption data

(59 FR 67596, December 29, 1994). The

ITC is removing cyclohexanone (CAS

No. 108–94–1) from the Priority Testing

List because adequate dermal absorption

data to estimate a dermal absorption rate

were identified in a study published in

1994 after the 35th Report was

transmitted to the EPA Administrator

(Mraz et al., 1994).
42988 Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 / Notices

References

(1) CMA. Letter from Geraldine V. Cox,

Vice President-Technical Director, Chemical

Manufacturers Association, Washington, DC,

to TSCA Document Processing Center

(October 24, 1989).

(2) CMA. Letter from Gordon D. Strickland,

Vice President-Technical Director, Chemical

Manufacturers Association, Washington, DC,

to John D. Walker, Executive Director, ITC

(August 24, 1993).

(3) CMA. Letter from Barbara O. Francis,

Associate Director, CHEMSTAR Panels,

Chemical Manufacturers Association,

Washington, DC, to John D. Walker,

Executive Director, ITC (February 22, 1995a).

(4) CMA. Letter from Barbara O. Francis,

Associate Director, CHEMSTAR Panels,

Chemical Manufacturers Association,

Washington, DC, to John D. Walker,

Executive Director, ITC (May 9, 1995b).

(5) EHRT. ‘‘Butyraldehyde: Sperm

morphology vaginal cytology evaluations in

rodents.’’ Contract No. NO1–ES–3–5026,

Study No. SMVCE–86–055. Submitted by

Environmental Health Research and Testing

for National Toxicology Program. Cincinnati,

OH (1986).

(6) EPA. Status report for a cyanoacrylate

adhesive product. EPA Document Control

No. 8EHQ–0989–0821 S. Microfiche No.

OTS0521301.

(7) Hardin, B.D., Schuler, R.L., Burg, J.R.,

Booth, G.M., Hazelden, K.P., MacKenzie,

K.M., Piccirillo, V.J. and Smith, K.N.

‘‘Evaluation of 60 Chemicals in a Preliminary

Developmental Toxicity Test.’’ Teratogenesis,

Carcinogenesis, and Mutagenesis. 7:29–48

(1987).

(8) Moutschen-Dahmen, J., MoutschenDahmen, M., Degrave, N., Houbrechts, N.,

and Colizzi, A. ‘‘Genetical hazards of

aldehydes from mouse experiments.’’

Mutation Research. 29:205 (1975).

(9) Moutschen-Dahmen, J., MoutschenDahmen, M., Houbrechts, N., Colizzi, A.

‘‘Cytotoxicity and mutagenicity of two

aldehydes: crotonaldehyde and

butyraldehyde in the mouse.’’ Bulletin de la

Societe Royale des Sciences de Liege. 45:58–

72 (1976).

(10) Mraz, J., Galova, E., Nohova, H. and

Vitkova, D. ‘‘Uptake, metabolism and

elimination of cyclohexanone in humans.’’

International Archives of Occupational

Environmental Health. 66: 203–208 (1994).

(11) Walker, J.D. ‘‘Chemical Selection by

the TSCA Interagency Testing Committee:

Use of Computerized Substructure Searching

to Identify Chemical Groups for Health

Effects, Chemical Fate and Ecological Effects

Testing,’’ Science of the Total Environment:

Vol. 109/110, pp. 691–700 (1991).

(12) Walker, J.D. ‘‘Estimation Methods

Used by the TSCA Interagency Testing

Committee to Prioritize Chemicals for

Testing: Exposure and Biological Effects

Scoring and Structure Activity

Relationships’’. Toxicology Modeling. Vol. 1,

pp.123-141 (1995).

TSCA Interagency Testing Committee

Statutory Organizations and Their

Representatives

Council on Environmental Quality

Brad Campbell, Member

Department of Commerce

Edward White, Member

Willie E. May, Alternate

Environmental Protection Agency

David R. Williams, Member

Lois Dicker, Alternate

National Cancer Institute

Victor Fung, Member

Harry Seifried, Alternate

National Institute of Environmental Health

Sciences

Errol Zeiger, Member

H.B. Matthews, Alternate

National Institute for Occupational Safety

and Health

Henryka Nagy, Member

David A. Dankovic, Alternate

National Science Foundation

Linda Duguay, Member

Occupational Safety and Health

Administration

Christine Whittaker, Member

Liaison Organizations and Their

Representatives

Agency for Toxic Substances and Disease

Registry

William Cibulas, Member

Consumer Product Safety Commission

Val Schaeffer, Member

Lakshmi C. Mishra, Alternate

Department of Agriculture

Clifford Rice, Member

Department of Defense

David A. Macys, Member

James N. McDougal, Alternate

Department of the Interior

Barnett A. Rattner, Member, Vice Chair

Food and Drug Administration

Edwin J. Matthews, Member

Raju Kammula, Alternate

National Library of Medicine

Vera Hudson, Member

National Toxicology Program

NIEHS, Members

Counsel

Mary Ellen Levine, Office of General

Counsel, EPA

Technical Support Contractor

Syracuse Research Corporation

Committee Staff

John D. Walker, Ph.D., M.P.H., Executive

Director

Norma S.L. Williams, Executive

Assistant, TSCA Interagency Testing

Committee, U.S. EPA/OPPT (MC/7401), 401

M St., SW., Washington, DC 20460, (202)

260–1825, Fax (202) 260–7895, Internet

walker.johnd@epamail.epa.gov.

[FR Doc. 95–20422 Filed 8–16–95; 8:45 am]

BILLING CODE 6560–50–F