[Federal Register Volume 60, Number 159 (Thursday, August 17, 1995)]
[Notices]
[Pages 42982-42988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20422]
[[Page 42981]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
Thirty-Sixth Report of the TSCA Interagency Testing Committee to the
Administrator; Receipt of Report, Request for Comments, Solicitation of
Use and Exposure Data; Notice
Federal Register / Vol. 60, No. 159 / Thursday, August 17, 1995 /
Notices
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[[Page 42982]]
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 Thirty-Sixth 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: [email protected]. 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: TSCA-H[email protected].
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
previously-designated chemical, and 34 previously-recommended 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:
[email protected]
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 Thirty-Sixth 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.
[[Page 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
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-, Recommended
chloro-,
hydroxymethyl diaryl
ethers
30......... May 1992 56 Siloxanes Recommended
31......... January 1993 24 Chemicals with no Designated
dermal toxicity data
32......... May 1993 32 Chemicals with Designated
insufficient dermal
absorption data
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 Designated
insufficient dermal
absorption data
36......... May 1995 12 High Production Recommended
Volume Chemicals:
Solicitation for Use
and Exposure Data
------------------------------------------------------------------------
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 Solicit use and 5/95
80-51-3............ p,p'-
Oxybis(benzenes
ulfonyl
hydrazide)
81-84-5............ Naphthalene
dicarboxylic
anhydride
99-54-7............ 3,4-
Dichloronitrobe
nzene
100-29-8........... 4-
Ethoxynitrobenz
ene
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)be
nzenesulfonyl
chloride
594-42-3........... Trichlorometha
ne sulfenyl
chloride
[[Page 42984]]
626-17-5........... 1,3-
Dicyanobenzene
929-06-6........... 2-(2-
Aminoethoxy)eth
anol
3089-11-0.......... Hexa(methoxyme
thyl) melamine
................. High Production Remove 5/95
Volume previously
Chemicals recommended
chemicals
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 Remove 5/95
phosphates previously
recommended
chemicals
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(chloromethy
l) 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 5/95
previously
recommended
chemicals
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)p
henyl]-1-oxo-2-
propenyl]oxy]-
N,N,N-trimethyl-
, chloride
................. Propylene glycol Remove 5/95
ethers and previously
esters recommended
chemicals
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 Remove 5/95
glycol ethers previously
and esters recommended
chemicals
3121-67-7........ Ethylene
glycol methyl
ether acrylate
23783-42-8......... Tetraethylene
glycol methyl
ether
Other Chemicals
80-07-9 Sulfonyl bis(4- Remove 5/95
chlorobenzene) previously
recommended
chemical
99-65-0 m- Remove 5/95
Dinitrobenzene previously
recommended
chemical
108-94-1 Cyclohexanone Remove 5/95
previously
recommended
chemical
123-72-8 Butyraldehyde Remove 5/95
previously
recommended
chemical
------------------------------------------------------------------------
[[Page 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
[[Page 42986]]
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 well-tested 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 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 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. m-Dinitrobenzene (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
[[Page 42987]]
the framework of the OECD SIDS program (Table 2). However, m-
dinitrobenzene 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-cyano-
3,3-diphenyl-, 2-ethylhexyl ester (CAS No. 6197-30-4) and
ethanaminium, 2-[[2-cyano-3-[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 NTP-conducted 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).
[[Page 42988]]
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., Moutschen-Dahmen, M., Degrave, N.,
Houbrechts, N., and Colizzi, A. ``Genetical hazards of aldehydes
from mouse experiments.'' Mutation Research. 29:205 (1975).
(9) Moutschen-Dahmen, J., Moutschen-Dahmen, 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
[email protected].
[FR Doc. 95-20422 Filed 8-16-95; 8:45 am]
BILLING CODE 6560-50-F