[Federal Register Volume 61, Number 23 (Friday, February 2, 1996)]
[Notices]
[Pages 4188-4196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1721]
[[Page 4187]]
_______________________________________________________________________
Part VIII
Environmental Protection Agency
_______________________________________________________________________
Thirty-Seventh 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. 61, No. 23 / Friday, February 2, 1996 /
Notices
[[Page 4188]]
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41044; FRL-4991-6]
Thirty-Seventh 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 37th Report to the Administrator of the EPA on November
22, 1995. In its 37th Report, which is included with this notice, the
ITC revised the Priority Testing List by adding a group of 28
alkylphenols and alkylphenol ethoxylates to the List for consideration
by the EPA Administrator for promulgation of test rules under section
4(a) of the Act. The ITC also removed 43 previously-recommended
silicone chemicals and 5 isocyanates. The ITC's reasons for removing
these chemicals from the List are described in the 37th Report. As
noted in this Report, the ITC is soliciting use and exposure data for 9
of the 12 High Production Volume Chemicals that were recommended in its
36th Report (60 FR 42982, August 17, 1995) and consumer use and data
for the 10 isocyanates remaining on the List. There are no designated
or recommended with intent-to-designate chemicals or chemical groups in
the 37th Report. EPA invites interested persons to submit written
comments on the Report.
DATES: Written comments on the 37th ITC Report should be submitted by
March 4, 1996.
ADDRESSES: Comments on the 37th Report should be submitted to both the
ITC and the TSCA Public Docket. Send one copy of written submissions
to: John Walker, ITC Director, U.S. EPA (7401), 401 M St. SW.,
Washington, DC 20016. Send six copies of written submissions to: TSCA
Public Docket Office (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. B-607 NEM, 401 M St. SW.,
Washington, DC 20460. Submissions should bear the document control
number (OPPTS-41044; FRL-4991-6).
The public record supporting this action, including comments, is
available for public inspection in Rm. B-607 NEM at the address noted
above from 12:00 noon to 4 pm Monday through Friday, except legal
holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St. SW.,
Rm. ET-543B,Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency
Testing Committee's 37th 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 the 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
(ITC) to recommend chemicals and chemical groups to the Administrator
of the 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 37th Report. The Report was received by the Administrator on
November 22, 1995, and is included in this Notice. The Report
recommends a group of 28 alkylphenols and alkylphenol ethoxylates,
removes 43 silicone chemicals and 5 isocyanates previously recommended
for testing and solicits use and exposure data for 9 High Production
Volume Chemicals (HPVCs) and 10 isocyanates from the TSCA section 4(e)
Priority Testing List.
II. Status of List
The ITC's 37th Report requests use and exposure data for 9 HPVCs
and 10 isocyanates, adds 28 chemicals to and removes 48 chemicals from
the Priority Testing List. The current TSCA section 4(e) Priority
Testing List contains 5 chemicals and 9 chemical groups; of these 3
chemical groups and 3 chemicals were designated for testing.
A notice will be published at a later date in the Federal Register
adding certain of the substances recommended in the ITC's 37th Report
to the TSCA section 8(d) Health and Safety Data Reporting Rule (40 CFR
Part 716), which requires the reporting of unpublished health and
safety studies on the listed chemicals. That notice will also add some
of the chemicals to the TSCA section 8(a) Preliminary Assessment
Information Rule (40 CFR part 712). The section 8(a) rule requires the
reporting of production volume, use, exposure, and release information
on the listed chemicals.
III. Electronic and Oral Comments
The 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-41044]. A public version of this record including
printed paper versions of electronic comments, which does not contain
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 Non-
confidential Information Center, Rm. NE-B607, 401 M St., SW.,
Washington, DC 20460. Electronic comments can be sent directly to the
ITC at
W[email protected] and to the EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of ecryption.
The official record for the 37th 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
EPA address in ADDRESSES at the beginning of this document.
Authority: 15 U.S.C. 2603.
Dated: January 22, 1996.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Thirty-Seventh Report of the TSCA Interagency Testing Committee to the
Administrator, U.S. Environmental Protection Agency
Summary
This is the 37th 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 recommending 28 alkylphenols and alkylphenol
ethoxylates and removing 43 previously-recommended silicone chemicals
and 5 isocyanates. As noted in this Report, the ITC is
[[Page 4189]]
soliciting use and exposure data for 9 of the 12 High Production Volume
Chemicals that were recommended in its 36th Report (60 FR 42982, August
17, 1995) and consumer use and exposure data for the 10 isocyanates
remaining on the List. Comments on this Report should be submitted both
to the ITC and the TSCA Public Docket. The revised TSCA section 4(e)
Priority Testing List follows as Table 1.
Table 1.--The TSCA Section 4(e) Priority Testing List (November 1995)
------------------------------------------------------------------------
Report Date Chemical/Group Action
------------------------------------------------------------------------
26......... May 1990.............. 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- Recommended.
, chloro-,
hydroxymethyl
diaryl ethers.
30......... May 1992.............. 13 Siloxanes..... Recommended.
31......... January 1993.......... 24 Chemicals with Designated.
no 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 Recommended.
ether.
34......... May 1994.............. Tert-amyl methyl Recommended.
ether.
35......... November 1994......... 24 Chemicals with Designated.
insufficient
dermal
absorption data.
36......... May 1995.............. 12 High Recommended.
Production
Volume Chemicals.
37......... November 1995......... 28 Alkylphenols Recommended.
and alkylphenol
ethoxylates.
------------------------------------------------------------------------
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'' (Pub. L. 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et
seq.). Since its creation in 1976, the ITC has submitted 36 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 also 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 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
general recommendation to a specific 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 Table 2.
Table 2.--Revisions to the TSCA Section 4(e) Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name Action Date
------------------------------------------------------------------------
Alkylphenols and Recommended......... 11/95
Butylphenols ....................
88-18-6 2-tert-Butylphenola
98-54-4 4-tert-Butylphenola..
99-71-8 4-sec-Butylphenola...
1638-22-8 4-n-Butylphenolb.....
3180-09-4 2-Butylphenolb.......
27178-34-3 tert-Butylphenol
(mixed isomers)b
31195-95-6 Isobutylphenol (mixed
isomers)b
Pentylphenols
80-46-6 4-tert-Pentylphenola
94-06-4 4-(1-
Methylbutyl)phenolb
14938-35-3 4-Pentylphenolb
[[Page 4190]]
Octylphenols
949-13-3 2-Octylphenolb
1806-26-4 4-Octylphenolb
3884-95-5 2-(1,1,3,3-
Tetramethylbutyl)phe
nolb
27193-28-8 (1,1,3,3-
Tetramethylbutyl)phe
nol (mixed
isomers)a,c
1322-69-6
29932-96-5
30105-54-5
62744-41-6
27985-70-2 (1-
Methylheptyl)phenol
(mixed isomers)b
54932-78-4 4-(2,2,3,3-
Tetramethylbutyl)phe
nolb
Nonylphenols
104-40-5 4-Nonylphenolb
11066-49-2 Isononylphenol (mixed
isomers)b
17404-66-9 4-(1-
Methyloctyl)phenolb
25154-52-3 Nonylphenol (mixed
isomers)a,c
1300-16-9
84852-15-3 Branched 4-
nonylphenol (mixed
isomers)a
Dodecylphenols
104-43-8 4-Dodecylphenolb
27193-86-8 Dodecylphenol (mixed
isomers)a,c
1331-57-3
Octylphenol
ethoxylates
2315-66-4 Decaethylene glycol 4-
isooctylphenyl
etherb
2497-58-7 Hexaethylene glycol 4-
isooctylphenyl
etherb
9002-93-1 Polyethylene glycol 4-
(tert-octyl)phenyl
etherb
9036-19-5 Polyethylene glycol
mono(octyl)phenyl
etherb
68987-90-6 Poly(oxy-1,2-
ethanediyl),-(octylphenyl)-
-hydroxy-,
brancheda
Silicone Chemicals Remove previously 11/95
recommended
chemicals
107-50-6 Tetradecamethylcylohe
ptasiloxane
107-52-8 Tetradecamethylhexasi
loxane
107-53-9 Tetracosamethylundeca
siloxane
541-01-5 Hexadecamethylheptasi
loxane
541-05-9 Hexamethylcyclotrisil
oxane
546-56-5 Octaphenylcyclotetras
iloxane
556-68-3 Hexadecamethylcyclooc
tasiloxane
556-69-4 Octadecamethyloctasil
oxane
556-70-7 Docosamethyldecasilox
ane
556-71-8 Octadecamethylcyclono
nasiloxane
999-97-3 Hexamethyldisilazane
2370-88-9 Tetramethylcyclotetra
siloxane
2374-14-3 Trifluoropropylmethyl
cyclotrisiloxane
2471-08-1 Hexacosamethyldodecas
iloxane
2471-09-2 Octacosamethyltrideca
siloxane
2471-10-5 Triacontamethyltetrad
ecasiloxane
2471-11-6 Dotriacontmethylpenta
decasiloxane
2554-06-5 Methylvinylcyclosilox
ane
2627-95-4 Tetramethyldivinyldis
iloxane
2652-13-3 Eicosamethylnonasilox
ane
[[Page 4191]]
9004-73-3 Methylpolysiloxane
9006-65-9 Dimethicone
9016-00-6 Polydimethylsiloxane
18766-38-6 Docosamethylcyclounde
casiloxane
18772-36-6 Eicosamethylcyclodeca
siloxane
18844-04-7 Hexatriacontamethylhe
ptadecasiloxane
18919-94-3 Tetracosamethylcyclod
odecasiloxane
23523-12-8 Hexatriacontamethylcy
clooctadecasiloxane
23523-14-0 Triacontamethylcyclop
entadecasiloxane
23732-94-7 Hexacosamethylcyclotr
idecasiloxane
36938-50-8 Tetratriacontamethylh
exadecasiloxane
36938-52-0 Octatriacontamethyloc
tadecasiloxane
67762-94-1 Dimethylmethylvinylsi
loxane
68037-59-2 Dimethylhydropolysilo
xane
68607-75-0 Polymethyloctadecylsi
loxane
115631-68-7 Siloxanes and
silicones,
dimethylmethyl 3,3,3-
trifluoropropyld
149050-40-8 Octacosamethylcyclote
tradecasiloxane
150026-95-2 Dotriacontamethylcycl
ohexadecasiloxane
150026-96-3 Tetratriacontamethylc
ycloheptadecasiloxan
e
150026-97-4 Octatriacontamethylcy
clononadecasiloxane
150026-98-5 Tetracontamethylcyclo
eicosasiloxane
150026-99-6 Tetracontamethylnonad
ecasiloxane
150027-00-2 Dotetracontamethyleic
osasiloxane
Isocyanates Remove previously 11/95
recommended
chemicals
102-36-3 3,4-Dichlorophenyl
isocyanate
104-71-9 Phenyl isocyanate
104-12-1 p-Chlorophenyl
isocyanate
111-36-4 n-Butyl isocyanate
3173-53-3 Cyclohexyl isocyanate
------------------------------------------------------------------------
a Chemicals with production or importation volumes > 1 million pounds
that are being considered for designation.
b Chemicals with production or importation volumes < 1 million pounds
that are being recommended because they are structurally related to
alkylphenols or alkylphenol ethoxylates being considered for
designation.
c Alternate CAS numbers are listed for these chemicals.
d Listed as dimethylmethyltrifluoropropylsiloxane with no CAS number in
ITC's 30th Report (57 FR 30608, July 9, 1992).
III. Rationale for the Revisions
A. ITC's Activities During this Reporting Period
During the 6 months covered by this Report, the ITC evaluated
several chemical groups. For alkylphenols and alkylphenol ethoxylates,
1989 and 1993 TSCA production and importation volume data were reviewed
and online toxicology databases were searched. For silicone chemicals,
unpublished chemistry, toxicology, use and exposure data were reviewed;
these data were submitted in response to the ITC's 30th Report (57 FR
30608, July 9, 1992). For the isocyanates recommended in the ITC's 26th
Report (55 FR 23050, June 5, 1990), published and unpublished
toxicology, use and exposure data were reviewed.
B. Specific Rationales
1. Recommended chemicals-- Alkylphenols and alkylphenol
ethoxylates--Recommendation. Alkylphenols and alkylphenol ethoxylates
are being added to the Priority Testing List to obtain unpublished TSCA
section 8(d) studies and to determine if these studies meet U.S.
Government data needs.
Rationale for recommendation. Alkylphenols and alkylphenol
ethoxylates are being recommended to determine if there are unpublished
studies that contain data to meet the needs of the Department of the
Interior (DoI), the EPA and other U.S. Government organizations
represented on the ITC. The ITC wants to review these unpublished data
before determining if these chemicals should be designated for testing
to meet U.S. Government data needs. Alkylphenols and alkylphenol
ethoxylates are being recommended at this time because: (1) 1989 and
1993 TSCA production and importation volumes are in the multimillion
pound range, (2) releases to the environment can occur through
wastewater treatment systems and from agricultural runoff, (3)
alkylphenol ethoxylates can degrade to alkylphenols, (4) alkylphenols
can persist in the environment and be highly toxic to aquatic organisms
and (5) exposure to
[[Page 4192]]
alkylphenols and alkylphenol ethoxylates may result in estrogenic,
reproductive or other adverse effects.
Supporting information. The Substructure-based Computerized
Chemical Selection Expert System (SuCCSES) is used to identify
chemicals with shared substructures and associated health or ecological
effects and similar TSCA production or importation volumes (Walker,
Refs. 4 and 6). SuCCSES was used to identify the alkylphenols and
alkylphenol ethoxylates listed in Table 2. As indicated in Table 2,
nine of the alkylphenols and alkylphenol ethoxylates have 1989 and 1993
TSCA production and importation volumes greater than 1 million pounds
and are being considered for designation. The ITC is listing alternate
CAS numbers for some of these alkylphenols and alkylphenol ethoxylates
to increase the possibility of retrieving a study because it is filed
under a different CAS number. Table 2 also indicates that 19
alkylphenols and alkylphenol ethoxylates are being recommended because
they are structurally related to those being considered for
designation. Relevant data from these additional 19 chemicals will be
used to predict or gain insight into the activity of the 9 alkylphenols
and alkylphenol ethoxylates being considered for designation when no
data are available for those 9 chemicals. The ITC is recommending
structurally-related chemicals and alternate CAS-numbered chemicals to
increase the possibility of obtaining unpublished studies on
alkylphenols and alkylphenol ethoxylates that are related to those
being considered for designation.
Existing U.S. Government data needs. The ITC has identified several
data needs for alkylphenols and alkylphenol ethoxylates: (1) chemical
composition (major components and impurities), (2) environmental fate
of components and impurities and (3) health and ecological effects,
including toxicokinetics and endocrine-modulating effects.
Completed activities of the ITC, EPA and alkylphenol manufacturers.
The ITC is aware that for a few alkylphenols and alkylphenol
ethoxylates there are numerous studies including those already
developed under TSCA section 4 (Talmage, Ref. 3). The ITC is also aware
that for some of these chemicals, few health effects, environmental
fate and ecological effects data are available. The ITC reviews of
butylphenols, pentylphenols, octylphenols, and nonylphenols suggested
that these chemicals had potential to cause biological effects. Studies
by Soto et al. (Ref. 2), White et al. (Ref. 10) and Purdom et al. (Ref.
1) suggest that alkylphenols and alkylphenol ethoxylates may cause
endocrine-modulating effects. Soto et al. (Ref. 2) reported that
nonylphenol and 4-tert-butylphenol caused proliferation of human
estrogen-sensitive MCF7 breast tumor cells. White et al. (Ref. 10)
reported that 4-octylphenol, 4-nonylphenol and 4-nonylphenol
diethoxylate were capable of stimulating vitellogenin gene expression
in trout hepatocytes. Vitellogenin is a protein synthesized by the
liver of oviparous fish in response to stimulation by estradiol or
estrogenic compounds. Purdom et al. (Ref. 1) suggested that
alkylphenols or alkylphenol ethoxylates may have been responsible for
elevated vitellogenin concentrations in fish exposed to effluents from
15 sewage-treatment works.
The ITC previously designated three alkylphenols for testing. 2-
sec-Butylphenol was designated in the 32nd Report (58 FR 38490, July
16, 1993). In response to this designation, the EPA solicited parties
that would be interested in developing consent agreements for dermal
absorption testing. The ITC designated 4-(1,1,3,3-
tetramethylbutyl)phenol in its 11th Report (47 FR 54625, December 3,
1982) and 2,6-di-tert-butylphenol in its 18th Report (51 FR 18368, May
19, 1986). In response to these designations, the EPA implemented
testing and the alkylphenol manufacturers developed the TSCA section 4
chemical fate and aquatic toxicity data. These data have been published
(Walker, Refs. 5, 7, and 8).
The EPA has pursued testing for two other alkylphenols. The EPA
published a TSCA section 4 notice proposing reproductive effects and
developmental toxicity testing for dodecylphenol (56 FR 9092, March 4,
1991). The EPA worked with the alkylphenol manufacturers to develop
chemical fate and aquatic toxicity data for branched 4-nonylphenol
under a TSCA section 4 Enforceable Consent Agreement/Order (55 FR 5991,
February 21, 1990). These data for branched 4-nonylphenol have been
published (Walker, Ref. 8).
The TSCA section 8(d) rule that EPA promulgated for 2-sec-
butylphenol did not require submission of ecological effects data (59
FR 5956, February 9, 1994). The ITC is recommending that the EPA amend
this rule to require submission of ecological effects data in response
to the data needs of the DoI and EPA. In response to the ITC's
designations of 4-(1,1,3,3-tetramethylbutyl)phenol and 2,6-di-tert-
butylphenol, the EPA promulgated TSCA section 8(d) rules. The ITC will
include studies that were submitted in response to these rules in its
review of other unpublished studies that are submitted in response to
the TSCA section 8(d) rules that the EPA will promulgate for the other
alkylphenols or alkylphenol ethoxylates listed in Table 2. The ITC is
not recommending these three alkylphenols because TSCA section 8(d)
studies were previously submitted in response to these designations.
Related activities. The Organisation for Economic Cooperation and
Development (OECD) has three of the recommended and two of the
previously-designated alkylphenols in its Screening Information Data
Sets (SIDS) program. The recommended alkylphenols with their sponsoring
countries listed in parentheses are 4-tert-butylphenol (Japan),
nonylphenol (mixed isomers) (United Kingdom and United States) and
branched 4-nonylphenols (mixed isomers) (United Kingdom). The
previously-designated alkylphenols are 4-(1,1,3,3-
tetramethylbutyl)phenol and 2,6-di-tert-butylphenol (both the United
States). The National Toxicology Program has scheduled branched 4-
nonylphenols (mixed isomers) for a multigeneration reproductive effects
and developmental toxicity test. The National Academy of Sciences is
planning to review published data on hormone-related chemicals in the
environment and alkylphenols is one chemical group for which they will
be reviewing data. Industry convened the Endocrine Issues Coalition in
1995 to address scientific issues related to subtances in the
environment that potentially may modulate the endocrine system. The
CMA's Alkylphenols and Ethoxylates Panel is a member of this Coalition.
2. Removal of chemicals from the Priority Testing List--a. Silicone
chemicals. Fifty-six silicone chemicals were recommended for health
effects testing in the ITC's 30th Report to meet the data needs of the
Food and Drug Administration (57 FR 30608, July 9, 1992). In response
to this recommendation, the Silicones Environmental Health and Safety
Council (SEHSC) met with the ITC and the EPA to discuss unpublished
toxicity, use and exposure data. Most of the unpublished toxicity and
exposure data were submitted in response to the TSCA section 8(d)
reporting rule that was promulgated in response to the ITC's 30th
Report recommendations (58 FR 28511, May 15, 1993) and the technical
amendments to that rule (58 FR 47647, September 10, 1993). All of the
use data and some of the exposure data were submitted voluntarily to
the
[[Page 4193]]
ITC by the SEHSC. Interactions with the SEHSC facilitated information
exchange and data development for a previously-designated siloxane,
octamethylcyclotetrasiloxane (Walker and Smock, Ref. 9). The SEHSC
worked with the ITC and the EPA to develop a computerized system of
physical properties, effects and use data for the 56 recommended
silicone chemicals. The ITC has used the information in this system,
the TSCA section 8(a) production and exposure data, and the information
submitted voluntarily by the SEHSC to determine that, at this time, 43
of the previously-recommended silicone chemicals should be removed from
the Priority Testing List (Table 2). The specific rationales for
removing these chemicals are listed in the following Table 3.
Table 3.--Previously Recommended Silicone Chemicals Being Removed From
the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name Removal rationale
------------------------------------------------------------------------
999-97-3 Hexamethyldisilazane
9006-65-9 Dimethicone Highly reactive with
moisture and therefore
difficult to test for
health effects
9016-00-6 Polydimethylsiloxane Highly reactive with
moisture and therefore
difficult to test for
health effects
9004-73-3 Methylpolysiloxane
115631-68-7 Siloxanes and silicones, Synonyms for dimethyl
dimethylmethyl 3,3,3- silicones and siloxanes
trifluoropropyla that remains on the
Priority Testing List
67762-94-1 Dimethylmethylvinylsiloxan Site-limited intermediates
e used in the production of
siloxane polymers
68037-59-2 Dimethylhydropolysiloxane Site-limited intermediates
used in the production of
siloxane polymers
68607-75-0 Polymethyloctadecylsiloxan Siloxane polymers that are
e consumed in their end use
546-56-5 Octaphenylcyclotetrasiloxa Siloxane that has no
ne commercial sales or
applications at this time
2370-88-9 Tetramethylcyclotetrasilox Siloxane that has no
ane commercial sales or
applications at this time
2374-14-3 Trifluoropropylmethylcyclo Siloxane that has no
trisiloxane commercial sales or
applications at this time
2554-06-5 Methylvinylcyclosiloxane Siloxane that has no
commercial sales or
applications at this time
2627-95-4 Tetramethyldivinyldisiloxa Siloxane that has no
ne commercial sales or
applications at this time
Linear Siloxanes
107-52-8 Tetradecamethylhexasiloxan Siloxanes that are limited
e (L6)b to industrial applications
and transformed to
polymers during processing
541-01-5 Hexadecamethylheptasiloxan Siloxanes that are limited
e (L7) to industrial applications
and transformed to
polymers during processing
556-69-4 Octadecamethyloctasiloxane Siloxanes that are limited
(L8) to industrial applications
and transformed to
polymers during processing
2652-13-3 Eicosamethylnonasiloxane Siloxanes that are limited
(L9) to industrial applications
and transformed to
polymers during processing
556-70-7 Docosamethyldecasiloxane Siloxanes that are limited
(L10) to industrial applications
and transformed to
polymers during processing
107-53-9 Tetracosamethylundecasilox Siloxanes that are limited
ane (L11) to industrial applications
and transformed to
polymers during processing
2471-08-1 Hexacosamethyldodecasiloxa Siloxanes that are limited
ne (L12) to industrial applications
and transformed to
polymers during processing
2471-09-2 Octacosamethyltridecasilox Siloxanes that are limited
ane (L13) to industrial applications
and transformed to
polymers during processing
2471-10-5 Triacontamethyltetradecasi Siloxanes that are limited
loxane (L14) to industrial applications
and transformed to
polymers during processing
2471-11-6 Dotriacontmethylpentadecas Siloxanes that are limited
iloxane (L15) to industrial applications
and transformed to
polymers during processing
36938-50-8 Tetratriacontamethylhexade Siloxanes that are limited
casiloxane (L16) to industrial applications
and transformed to
polymers during processing
18844-04-7 Hexatriacontamethylheptade Siloxanes that are limited
casiloxane (L17) to industrial applications
and transformed to
polymers during processing
36938-52-0 Octatriacontamethyloctadec Siloxanes that are limited
asiloxane (L18) to industrial applications
and transformed to
polymers during processing
150026-99-6 Tetracontamethylnonadecasi Siloxanes that are limited
loxane (L19) to industrial applications
and transformed to
polymers during processing
150027-00-2 Dotetracontamethyleicosasi
loxane (L20)
Cyclic Siloxanes
541-05-9 Hexamethylcyclotrisiloxane Siloxanes that are limited
(D3)c to industrial applications
and transformed to
polymers during processing
107-50-6 Tetradecamethylcyloheptasi Siloxanes that are limited
loxane (D7) to industrial applications
and transformed to
polymers during processing
[[Page 4194]]
556-68-3 Hexadecamethylcyclooctasil Siloxanes that are limited
oxane (D8) to industrial applications
and transformed to
polymers during processing
556-71-8 Octadecamethylcyclononasil Siloxanes that are limited
oxane (D9) to industrial applications
and transformed to
polymers during processing
18772-36-6 Eicosamethylcyclodecasilox Siloxanes that are limited
ane (D10) to industrial applications
and transformed to
polymers during processing
18766-38-6 Docosamethylcycloundecasil Siloxanes that are limited
oxane (D11) to industrial applications
and transformed to
polymers during processing
18919-94-3 Tetracosamethylcyclododeca Siloxanes that are limited
siloxane (D12) to industrial applications
and transformed to
polymers during processing
23732-94-7 Hexacosamethylcyclotrideca Siloxanes that are limited
siloxane (D13) to industrial applications
and transformed to
polymers during processing
149050-40-8 Octacosamethylcyclotetrade Siloxanes that are limited
casiloxane (D14) to industrial applications
and transformed to
polymers during processing
23523-14-0 Triacontamethylcyclopentad Siloxanes that are limited
ecasiloxane (D15) to industrial applications
and transformed to
polymers during processing
150026-95-2 Dotriacontamethylcyclohexa Siloxanes that are limited
decasiloxane (D16) to industrial applications
and transformed to
polymers during processing
150026-96-3 Tetratriacontamethylcycloh Siloxanes that are limited
eptadecasiloxane (D17) to industrial applications
and transformed to
polymers during processing
23523-12-8 Hexatriacontamethylcyclooc Siloxanes that are limited
tadecasiloxane (D18) to industrial applications
and transformed to
polymers during processing
150026-97-4 Octatriacontamethylcyclono Siloxanes that are limited
nadecasiloxane (D19) to industrial applications
and transformed to
polymers during processing
150026-98-5 Tetracontamethylcycloeicos Siloxanes that are non-
asiloxane (D20) isolated components of
dimethyl siloxanes
------------------------------------------------------------------------
a Listed as dimethylmethyltrifluoropropylsiloxane with no CAS number in
ITC's 30th Report (57 FR 30608, July 9, 1992).
b L followed by a number refers to the number of repeating dimethyl
siloxanes in a linear chain.
c D followed by a number refers to the number of repeating dimethyl
siloxanes in a cyclic chain.
There are 13 siloxanes remaining on the Priority Testing List as
shown in the following Table 4:
Table 4.--Siloxanes remaining on the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
Cyclic Siloxanes
556-67-2 Octamethylcyclotetrasiloxane (D4)
541-02-6 Decamethylcyclopentasiloxane (D5)
540-97-6 Dodecamethylcyclohexasiloxane (D6)
69430-24-6 Cyclopolydimethylsiloxane (Dx)
Linear Siloxanes
107-46-0 Hexamethyldisiloxane (L2)
107-51-7 Octamethyltrisiloxane (L3)
141-62-8 Decamethyltetrasiloxane (L4)
141-63-9 Dodecamethylpentasiloxane (L5)
Phenyl Siloxanes
68083-14-7 Dimethyldiphenylsiloxanea
Polymers
63148-62-9 Dimethyl silicones and siloxanesa
9006-65-9
9016-00-6
67762-90-7 Dimethyl silicones and siloxanes, reaction products
with silica
68037-74-1 Dimethylmonomethylpolysiloxanes
[[Page 4195]]
70131-67-8 Dimethyl silicones and siloxanes hydroxy terminated
------------------------------------------------------------------------
aAlternate CAS numbers are listed for this chemical.
b. Isocyanates.
In its 26th Report, the ITC recommended a group of 43 isocyanates
for physical and chemical property testing in response to a nomination
from the EPA to support its TSCA New Chemicals Program (55 FR 23050,
June 5, 1990). The ITC removed 28 of these isocyanates from the
Priority Testing List in its 35th Report 59 FR 67596, December 29,
1994). The ITC is removing 5 more isocyanates from the List in this
Report (Table 2). 3,4-Dichlorophenyl isocyanate and p-chlorophenyl
isocyanate are being removed because 1993 production volumes were less
than 10,000 pounds. Phenyl isocyanate is being removed because 1993
production volumes were less than 1,000,000 pounds and there are no
currently identified U.S. Government data needs. n-Butyl isocyanate and
cyclohexyl isocyanate are being removed because there are no currently
identified U.S. Government data needs.
IV. Activities Related to Previously-Recommended Chemicals
A. High Production Volume Chemicals
The ITC solicited use and exposure data for 12 High Production
Volume Chemicals (HPVCs) in its 36th report (60 FR 42982, August 17,
1995) and suggested a 60-day submission deadline from the FR
publication date (October 17, 1995). In response to that solicitation,
the ITC received a September 15, 1995, submission from Eastman Chemical
Company for diethylene glycol monoethyl ether acetate (CAS No. 112-15-
2), a September 19, 1995, offer from the Zeneca Corporation to provide
use and exposure data for trichloromethane sulfenyl chloride (CAS No.
594-42-3) and an October 12, 1995, submission from Ferro Corporation
for diethylene glycol dimethyl ether (CAS No. 111-96-6). The ITC will
review the use and exposure data for these three HPVCs. The ITC
appreciates these timely responses and encourages the manufacturers,
processors, and users of the other nine HPVCs to contact the ITC with
offers to provide use and exposure data.
B. Isocyanates
The ITC is soliciting consumer use data for the nine diisocyanates
remaining on the Priority Testing List (Table 5). The data are being
solicited to address the information needs of the Consumer Product
Safety Commission (CPSC). For several of these isocyanates, the ITC is
continuing its review of exposure, health effects and chemical fate
information, including information based on structure-activity
relationships (SARs), in response to concerns of the Department of
Defense (DoD) and the EPA.
In its 26th Report, the ITC recommended a group of 43 isocyanates
for physical and chemical property testing in response to a nomination
from the EPA to support its TSCA New Chemicals Program (55 FR 23050,
June 5, 1990). As noted above in section III(B)(2)(b) of this ITC
Report, 33 of these isocyanates have been removed from the Priority
Testing List. The 10 remaining isocyanates are listed in the following
Table 5.
Table 5.--Isocyanates Remaining on the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical Name
------------------------------------------------------------------------
Monoisocyanate
329-01-1 (,,-Trifluoro-m-
tolyl)isocyanate
Diisocyanates
91-08-7 2,6-Toluene diisocyanate (2,6-TDI)
101-68-8 4,4'-Diphenylmethane diisocyanate (MDI)
584-84-9 2,4-Toluene diisocyanate (2,4-TDI)
4035-89-6 Tris(isocyanatohexyl)biuret
4098-71-9 Isophorone diisocyanate
5124-30-1 1,1'-Methylenebis(4-isocyanatocyclohexane)
5873-54-1 1-Isocyanato-2-((4-isocyanatophenyl)methyl)benzene
26447-40-5 1,1'-Methylenebis(isocyanatobenzene)
26471-62-5 Toluene diisocyanate (80% 2,4-TDI; 20% 2,6-TDI)
------------------------------------------------------------------------
For these 10 isocyanates, the ITC is reviewing data on 1993 TSCA
production and importation volumes, as well as published and
unpublished (TSCA section 8(d), 8(e), FYI, etc.) data on physical and
chemical properties, environmental fate and releases, health effects,
occupational exposures and uses. For each of these isocyanates, the ITC
is monitoring ongoing testing, including any testing that might be
considered by the International Isocyanates Institute, the CMA or the
OECD.
At this time, the ITC has determined that there are insufficient
consumer use and exposure data to permit an accurate assessment of
exposure or the need for additional testing of the diisocyanates listed
in Table 5. The ITC is soliciting consumer use data on these as well as
[[Page 4196]]
any other commercially relevant diisocyanates (e.g., hexamethylene
diisocyanate, CAS No. 822-06-0). Information on the presence of
diisocyanates in commercially available products is needed as well as
information on exposures that result from their use. The following
specific information is solicited:
\ Category of products in which diisocyanates (all forms) are
present, such as rigid and flexible foams, coatings, and adhesives
\ Specific diisocyanate present, by product category
\ Chemical form of the diisocyanate (monomer, prepolymer, oligomer,
polymer, etc.)
\ Weight fraction of diisocyanate in the product and the relative
amount of the different diisocyanate forms, particularly free monomer,
oligomer, and prepolymer (a rough range of weight fraction is
sufficient)
\ Percent of total manufactured/imported volume (rough estimate is
sufficient)
\ Form of the product (liquid, aerosol, foam, etc.)
\ General application of the product (sealant, paint, adhesive,
insulation, etc.)
\ Air monitoring or exposure simulation data for diisocyanates
resulting from use of any of the indicated product categories
References
(1) Purdom, C.E., Hardiman, P.A., Bye, V.J., Eno, N.C., Tyler,
C.R., and Sumpter, J.P. Estrogenic effects of effluents from sewage
treatments works. Chemical Ecology. 8:275-285 (1994).
(2) Soto, A.M., Justicia, H., Wray, J.W., and Sonnenschein, C.
p-Nonylphenol: an estrogenic xenobiotic released from ``modified''
polystyrene. Environmental Health Perspectives. 92:167-173 (1991).
(3) Talmage, S.S. Environmental and human safety of major
surfactants: Alcohol ethoxylates and alkylphenol ethoxylates. A
report to the Soap and Detergent Association. Lewis Publishers, Boca
Raton, FL (1994), 374pp.
(4) 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. Sci. Total Environ. 109/110:691-700
(1991).
(5) Walker, J.D. Review of ecological effects and
bioconcentration testing recommended by the TSCA Interagency Testing
Committee and implemented by EPA under the Toxic Substances Control
Act: Chemicals, tests and methods. pp. 92-115. In W.G. Landis, J.S.
Hughes and M.A. Lewis (eds.), Environmental Toxicology and Risk
Assessment, ASTM STP 1179. ASTM, Philadelphia, PA (1993).
(6) 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.
Toxicol. Model. 1:123-141 (1995a).
(7) Walker, J.D. Testing Decisions of the TSCA Interagency
Testing Committee for Chemicals on Canada's Domestic Substances List
and Priority Substances List: Di-tert-butylphenol, ethyl benzene,
brominated flame retardants, phthalate esters, chloroparaffins,
chlorinated benzenes and anilines. In T.W. LaPoint, F.T. Price, and
E.E. Little (eds), Environmental Toxicology and Risk Assessment:
Fourth Volume, ASTM STP 1262, ASTM, Philadelphia. In Press (1995b).
(8) Walker, J.D. Recommendations of the TSCA Interagency Testing
Committee: Aquatic toxicity, bioconcentration and chemical fate data
developed under section 4 of the Toxic Substances Control Act. pp.
669-701. In G.M. Rand (ed), Fundamentals of Aquatic Toxicology II,
Taylor Francis Publishers, Washington, DC (1995c).
(9) Walker, J.D. and W.H. Smock. Chemicals recommended for
testing by the TSCA Interagency Testing Committee: A case study of
octamethylcyclotetrasiloxane. Environmental Toxicology and Chemistry
14:1631-1634 (1995).
(10) White, R., Jobling, S., Hoare, S.A., Sumpter, J.P., and
Parker, M.G. Environmentally persistent alkylphenol compounds are
estrogenic. Endocrinology 135:175-182 (1994).
TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Brad Campbell, Member
Department of Commerce
Edward White, Member
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, Chair
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
Lyn Penniman, Member
Christine Whittaker, Alternate
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
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, FDA and NIOSH Members
Counsel
Mary Ellen Levine, Office of General Counsel, EPA
Technical Support Contractor
Syracuse Research Corporation
ITC 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, Phone: (202) 260-1825, Fax:
(202) 260-7895 Internet:
[email protected]
[FR Doc. 96-1721 Filed 2-1-96; 8:45 am]
BILLING CODE 6560-50-F