[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42554-42559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21206]
[[Page 42553]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
Forty-Second Report of the TSCA Interagency Testing Committee; Notice
Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 /
Notices
[[Page 42554]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41050; FRL-5797-8]
Forty-Second Report of the TSCA Interagency Testing Committee to
the Administrator; Receipt of Report and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The TSCA Interagency Testing Committee (ITC), established
under section 4(e) of the Toxic Substances Control Act (TSCA),
transmitted its Forty-Second Report to the Administrator of the EPA on
May 29, 1998. In the Forty-Second Report, which is included with this
notice, the ITC revised the TSCA section 4(e) Priority Testing List by
recommending four chemicals: 3-Amino-5-mercapto-1,2,4-triazole, ethyl
silicate, glycoluril, and methylal. There are no ``designated'' or
``recommended with intent-to-designate'' chemicals or chemical groups
in the Forty-Second Report. EPA invites interested persons to submit
written comments on the Report.
DATES: Written comments on the Forty-Second ITC Report should be
received by September 8, 1998.
ADDRESSES: Comments on the Forty-Second Report should be submitted to
both the ITC and the TSCA Docket. Send one copy of written comments to:
John D. Walker, ITC Executive Director (7401), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Send six copies of
written comments to: Document Control Office, Rm. G-099, Office of
Pollution Prevention and Toxics (7407), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. All submissions should
bear the docket control number OPPTS-41050.
Comments may also be submitted electronically by sending electronic
mail (e-mail) to the ITC ([email protected]) or the TSCA Docket
([email protected]). Electronic comments are preferred by the ITC.
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption. Comments will be
accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file
format. All comments in electronic form must be identified by the
docket control number OPPTS-41050. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on the
Forty-Second Report may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in Unit IV of this preamble.
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.,
Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency
Testing Committee's Forty-Second 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 these chemicals and chemical groups may present to health or
the environment. Section 4(e) of TSCA established the ITC to recommend
chemicals and chemical groups to the Administrator of the EPA for
priority testing consideration. Section 4(e) of TSCA directs the ITC to
revise the TSCA section 4(e) Priority Testing List at least every 6
months.
II. The ITC Forty-Second Report
The most recent revisions to the Priority Testing List are included
in the ITC's Forty-Second Report. The Report was received by the
Administrator of the EPA on May 29, 1998, and is included in this
notice. Four chemicals: 3-Amino-5-mercapto-1,2,4-triazole, ethyl
silicate, glycoluril, and methylal are being recommended because:
1. 3-Amino-5-mercapto-1,2,4-triazole is being considered for health
effects testing based on concerns related to effects on thyroid hormone
activity.
2. Ethyl silicate is under review for mutagenicity and subchronic
or chronic toxicity testing based on potential human exposures and
suspicions of genotoxicity or carcinogenicity.
3. Glycoluril is under review for carcinogenicity testing based on
a potential for human exposure and a suspicion of carcinogenicity.
4. Methylal is under review for carcinogenicity testing based on
its potential for human exposure and a suspicion of carcinogenicity.
III. Status of the Priority Testing List
The current TSCA section 4(e) Priority Testing List contains 11
chemical groups; of these, 4 chemical groups were designated for
testing.
IV. Public Record, Electronic Comment Submission, and Oral Comments
The EPA invites interested persons to submit detailed comments on
the ITC's Forty-Second Report.
An official record has been established for this notice, as well as
a public version, under docket control number OPPTS-41050 (including
comments and data submitted electronically as described below). A
public version of this record, including printed paper versions of
electronic comments and data, which does not contain any information
claimed as 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,
Environmental Protection Agency, 401 M St., SW., Washington, DC.
Electronic comments can be sent directly to the ITC at
[email protected] and to the TSCA Docket at [email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments will be
accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file
format.
The official record for the ITC's Forty-Second 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 this unit.
List of Subjects
Environmental protection, Chemicals, Hazardous substances, Health
and safety.
Authority: 15 U.S.C. 2603.
Dated: July 27, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Forty-Second Report of the TSCA Interagency Testing Committee
Administrator, U.S. Environmental Protection Agency
Summary
This is the 42nd Report of the TSCA Interagency Testing Committee
(ITC) to the Administrator of the U.S.
[[Page 42555]]
Environmental Protection Agency (EPA). In this Report, the ITC is
revising its TSCA section 4(e) Priority Testing List by recommending 3-
amino-5-mercapto-1,2,4-triazole, ethyl silicate, glycoluril, and
methylal. The revised TSCA section 4(e) Priority Testing List follows
as Table 1.
Table 1.--The TSCA Section 4(e) Priority Testing List (May 1998)\1\
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Report Date Chemical/Group Action
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26................................... May 1990............... 8 Isocyanates.......... Recommended with intent-
to-designate
27................................... November 1990.......... 62 Aldehydes........... Recommended with intent-
to-designate
28................................... May 1991............... Chemicals with Low Designated
Confidence Reference
Dose (RfD).
Acetone
Thiophenol
30................................... May 1992............... 5 Siloxanes............ Recommended
31................................... January 1993........... 24 Chemicals with Designated
insufficient dermal
absorption rate data.
32................................... May 1993............... 32 Chemicals with Designated
insufficient dermal
absorption rate data.
35................................... November 1994.......... 24 Chemicals with Designated
insufficient dermal
absorption rate data.
36................................... May 1995............... 9 High production Recommended
volume chemicals
(HPVCs).
37................................... November 1995.......... 22 Alkylphenols and Recommended
alkylphenol
ethoxylates\2\.
39................................... November 1996.......... 23 Nonylphenol Recommended
ethoxylates\2\.
41................................... November 1997.......... 29 Alkylphenols, Recommended
alkylphenol
ethoxylates, and
polyalkyphenols\2\.
42................................... May 1998............... 3-Amino-5-mercapto- Recommended
1,2,4-triazole\2\.
42................................... May 1998............... Glycoluril\2\.......... Recommended
42................................... May 1998............... Methylal\2\............ Recommended
42................................... May 1998............... Ethyl silicate\2\...... Recommended
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\1\ The Priority Testing List is available from the ITC's web site (http://www.epa.gov/opptintr/itc).
\2\Data requested using the ITC's Voluntary Information Submissions Policy (VISP), see http://www.epa.gov/
opptintr/itc/visp.htm.
I. Background
The 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 six
months..., the Committee shall make such revisions to the Priority
Testing List as it determines to be necessary and 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 41 semi-annual (May
and November) Reports to the EPA Administrator transmitting the
Priority Testing List and its revisions. In 1989, the ITC began
recommending chemical substances for information reporting, screening,
and testing to meet the data needs of its member U.S. Government
organizations. ITC Reports are available from http://www.epa.gov/
opptintr/itc within a few days of submission to the Administrator and
from http://www.epa.gov/fedrgstr after publication in the Federal
Register. The ITC meets monthly and produces its revisions to the List
with administrative and technical support from the ITC staff and
contract support provided by EPA. ITC members and staff are listed at
the end of this Report.
II. TSCA Section 8 Reporting
A. TSCA Section 8 Rules
Following receipt of the ITC's Report by the EPA Administrator and
addition of chemicals to the Priority Testing List, the EPA's Office of
Pollution Prevention and Toxics (OPPT) promulgates TSCA section 8(a)
Preliminary Assessment Information Reporting (PAIR) and TSCA section
8(d) Health and Safety Data (HaSD) rules for chemicals added to the
List. These rules require producers and importers of chemicals
recommended by the ITC to submit production and exposure reports under
TSCA section 8(a) and producers, importers, and processors of chemicals
recommended by the ITC to submit unpublished health and safety studies
under TSCA section 8(d). These rules are automatically promulgated by
OPPT unless requested not to do so by the ITC.
B. ITC's Use of TSCA Section 8 and ``Other Information''
The ITC reviews the TSCA section 8(a) PAIR reports, TSCA section
8(d) HaSD studies, and ``other information'' that becomes available
after the ITC adds chemicals to the List. ``Other information''
includes TSCA section 4(a) and 4(d) studies, TSCA section 8(c)
submissions, TSCA section 8(e) ``substantial risk'' notices, ``For Your
Information'' (FYI) submissions, ITC-FYI voluntary submissions,
unpublished data submitted to U.S. Government organizations represented
on the ITC, published papers, as well as use, exposure, effects, and
persistence data that are voluntarily submitted to the ITC by
manufacturers, importers, processors, and users of chemicals
recommended by the ITC. The ITC reviews this information and determines
if data needs should be revised, if chemicals should be removed from
the List, or if recommendations should be changed to designations.
C. Policy Promoting More Efficient Use of TSCA Section 8 Resources
In its 40th Report (62 FR 30580, June 4, 1997) (FRL-5718-3), the
ITC proposed the Voluntary Information Submissions Policy (VISP) to
promote more efficient use of TSCA section 8 resources. After the 40th
and 41st (63 FR 17658, April 9, 1998) (FRL-5773-5) Reports were
delivered to the EPA Administrator, the VISP was revised and posted on
the ITC's web site (http://www.epa.gov/opptintr/itc/visp.htm).
Revisions to the VISP included eliminating the need to submit a list of
studies, changing the milestone for notifying the ITC Director from 30
to 60 days, and providing clearer guidance for submitting electronic
data. The VISP is part of the ITC's Voluntary Information Submissions
Innovative Online Network
[[Page 42556]]
(VISION) that is described in the ITC's web site (http://www.epa.gov/
opptintr/itc/vision.htm). The ITC's VISION currently includes the VISP,
the TSCA Electronic HaSD Reporting Form (http://cyber22.dcoirm.epa.gov/
oppt/tsca.nsf/HaSDForm?openform), and instructions for the Form (http:/
/www.epa.gov/opptintr/itc/tsca-hlp.htm). The VISP provides examples of
data needed by ITC member U.S. Government organizations, examples of
studies that should not be submitted, the 60-, 90- and 120-day
milestones for meeting the objectives of the VISP, guidelines for using
the TSCA Electronic HaSD Reporting Form, and instructions for
electronically submitting full studies. The ITC implemented the VISP in
its 41st Report for the alkylphenols, alkylphenol ethoxylates, and
polyalkylphenols recommended in its 37th (61 FR 4188, February 2, 1996)
(FRL-4991-6), 39th (62 FR 8578, February 25, 1997) (FRL-5580-9), and
41st Reports.
III. ITC's Dialogue Group Activities During this Reporting Period
(November 1997 to May 1998)
Alkylphenols and Ethoxylates (AP&E)
The Chemical Manufacturers Association (CMA)-ITC AP&E Dialogue
Group was formed by the CMA's AP&E Panel and the ITC's AP&E
Subcommittee in March 1996 following the submission of the ITC's 37th
Report to the EPA Administrator in November 1995. The Group was created
to facilitate the ITC's retrieval of information on uses, exposures and
health, and ecological effects of alkylphenols and alkylphenol
ethoxylates, and the Panel's understanding of data needed by the U.S.
Government organizations represented on the Subcommittee. Since the
creation of this Dialogue Group, numerous activities have occurred: see
the ITC's 38th (61 FR 39832, July 30, 1996) (FRL-5379-2), 39th, 40th,
and 41st Reports. As a result of the Dialogue Group activities, the
Panel voluntarily provided the ITC with a database of 255 studies for
the alkylphenols and alkylphenol ethoxylates recommended in the 37th
Report and the nonylphenol ethoxylates recommended in the 39th Report.
In addition, at least 25 non-Panel member companies provided 240
submissions on alkylphenols and alkylphenol ethoxylates (each
submission contains one or more studies) in response to the TSCA
section 8(d) rule for the alkylphenols and alkylphenol ethoxylates
recommended in the 37th Report.
The AP&E Dialogue Group met twice during this reporting period. On
February 11 and April 22, 1998, the Dialogue Group met to discuss:
1. Use and exposure data for certain alkylphenols and alkylphenol
ethoxylates.
2. Progress and results of ongoing environmental and toxicological
studies being conducted or sponsored by chemical manufacturers on the
Panel, (e.g., mammalian in vitro and in vivo toxicology, mammalian
pharmacokinetic, biodegradation, aquatic toxicity, and avian acute
toxicity studies).
3. The ITC's VISION.
4. Information being generated by the Society of the Plastics
Industry (e.g., dialogue with the Food and Drug Administration (FDA) to
estimate dietary exposure to tris-nonylphenyl phosphite, nonylphenyl
ethoxylates, and nonylphenols).
5. Historic AP&E monitoring and research conducted by the U.S.
Geological Survey.
6. Recent AP&E monitoring conducted by the Silent Spring Institute
(published in Environmental Science and Technology 32:861-869; 1998).
7. EPA's ambient water quality criteria document for nonylphenol.
8. OPPT's Risk Management-1 (RM-1) document on p-nonylphenol.
9. Organization for Economic Cooperation and Development (OECD)
Screening Information Data Set (SIDS) dossiers on nonylphenol and
nonylphenol ethoxylates.
10. European nonylphenol ethoxylates risk reduction activities.
IV. 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
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CAS No. Chemical name Action Date
----------------------------------------------------------------------------------------------------------------
16691-43-3.......................... 3-Amino-5-mercapto-1,2,4- Recommended............ May 1998
triazole.
496-46-8............................ Glycoluril.............. Recommended............ May 1998
109-87-5............................ Methylal................ Recommended............ May 1998
78-10-4............................. Ethyl silicate.......... Recommended............ May 1998
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A. Chemicals Added to the Priority Testing List
At this time, the ITC is requesting that the EPA not promulgate a
TSCA section 8(d) rule for any of the recommended chemicals. The ITC is
encouraging producers, importers, processors, and users of the
recommended chemicals to use its VISION (http://www.epa.gov/opptintr/
itc/vision.htm) to provide voluntary electronic information submissions
and establish a dialogue with the ITC to discuss needed data.
1. 3-Amino-5-mercapto-1,2,4-triazole
i. Recommendation. 3-Amino-5-mercapto-1,2,4-triazole is being
recommended to obtain annual production/importation volumes and trends,
use, exposure, and health effects data needed by U.S. Government
organizations represented on the ITC.
ii. Rationale for recommendation. 3-Amino-5-mercapto-1,2,4-triazole
is being considered for health effects testing based on concerns
related to effects on thyroid hormone activity. Before designating 3-
amino-5-mercapto-1,2,4-triazole for priority testing consideration by
the EPA Administrator, the ITC wants to review the PAIR data and the
needed data listed below:
iii. Data needed
a. Recent non-Confidential Business Information (CBI) estimates of
annual production or importation volume data and trends.1
---------------------------------------------------------------------------
1E-mail voluntary information submissions to
[email protected].
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b. Use information, including percentages of production or
importation that are associated with different uses.1
c. Estimates of the number of humans and concentrations of 3-amino-
5-mercapto-1,2,4-triazole to which humans may be exposed from use,
manufacturing, or processing.1
d. Health effects.2
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2Provide voluntary information submissions through http://
www.epa.gov/opptintr/itc/vision.htm.
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iv. Supporting information. There is a need to determine potential
toxicity of
[[Page 42557]]
3-amino-5-mercapto-1,2,4-triazole based on concerns related to effects
on thyroid hormone activity (Ref. 3, Takaoka et al., 1994). Non-CBI
data reported to the EPA indicated that about 250,000 pounds of 3-
amino-5-mercapto-1,2,4-triazole were imported into the United States in
1993. 3-Amino-5-mercapto-1,2,4-triazole is reportedly used in organic
synthesis, processing of silver halide photographic materials, as an
antioxidant for aluminum and as a viscosity index improver, dispersant,
and antioxidant for lubricating oils. No published data were found on:
a. Environmental releases.
b. Environmental fate.
c. Occupational exposures.
d. Concentrations of 3-amino-5-mercapto-1,2,4-triazole to which
humans may be exposed.
A few data related to potential effects were found. 3-Amino-5-
mercapto-1,2,4-triazole was not included in the National Institute for
Occupational Safety and Health (NIOSH) National Occupational Exposure
Survey (NOES), and guidelines for occupational exposures have not been
established by NIOSH or Occupational Safety and Health Administration
(OSHA). Schafer et al. (Ref. 2, 1982) reported that 3-amino-5-mercapto-
1,2,4-triazole has an LD50 > 316 mg/kg body weight of quails
(Coturnix coturnix). 3-Amino-5-mercapto-1,2,4-triazole was reported to
be one of five chemicals structurally related to 3-amino-1,2,4-triazole
(Amitrol), a herbicide that affected thyroid hormone activity
(Ref. 3, Takaoka et al., 1994). In studies with rats, 3-amino-5-
mercapto-1,2,4-triazole was also reported to be a metabolite of
Amitrol (Ref. 1, Grunow et al., 1975).
2. Glycoluril
i. Recommendation. Glycoluril is being recommended to obtain annual
production/importation volumes and trends, use, exposure and health
effects data needed by U.S. Government organizations represented on the
ITC.
ii. Rationale for recommendation. Glycoluril is under review for
carcinogenicity testing based on a potential for human exposure and a
suspicion of carcinogenicity. The suspicion of carcinogenicity is based
on a potential for the formation of a nitrosamide. A document prepared
for the U.S. Government organization nominating glycoluril to the ITC
is available on the ITC's web site (glycoluril document) and in the
TSCA Docket for the ITC's 42nd Report (Ref. 5, TRI, 1997b). Before
designating glycoluril for priority testing consideration by the EPA
Administrator, the ITC wants to retrieve and review the most current
data on exposures and health effects. Data already included in the
glycoluril document should not be submitted to the ITC. Data needed are
listed below.
iii. Data needed
a. Recent non-CBI estimates of annual production or importation
volume data and trends.1
b. Use information, including percentages of production or
importation that are associated with different uses.1
c. Estimates of the number of humans and concentrations of
glycoluril to which humans may be exposed from use, manufacturing or
processing.1
d. Health effects.2
iv. Supporting Information. Data reported to the EPA in 1986, 1990
and 1994 indicated that the non-CBI annual production/importation
volumes for glycoluril ranged from 10,000 to 1,000,000 pounds.
Available use information suggested that glycoluril may be used as a
slow-release nitrogen fertilizer, but its use may be limited because of
the chemical's cost. It has also been reported that glycoluril resins
have been used in paint and coating formulations. No published data
were found on:
a. Environmental releases.
b. Environmental fate.
c. Ecological effects.
d. Health effects.
e. Occupational exposures.
f. Concentrations of glycoluril to which humans may be exposed.
Glycoluril was not listed in the Registry of Toxic Effects of Chemical
Substances (RTECS) or in NIOSH's NOES and guidelines for occupational
exposures have not been established by NIOSH or OSHA.
3. Methylal
i. Recommendation. Methylal is being recommended to obtain
production/importation volume data and trends, use, exposure, health
effects, especially in vivo mammalian metabolism and chronic effects
data needed by U.S. Government organizations represented on the ITC.
ii. Rationale for recommendation. Methylal is under review for
carcinogenicity testing based on its potential for human exposure and a
suspicion of carcinogenicity. The suspicion of carcinogenicity is based
on mutagenicity data from a number of bacterial and mammalian systems
and the potential for methylal to be metabolized to formaldehyde, a
rodent carcinogen. A document prepared for the U.S. Government
organization nominating methylal to the ITC is available on the ITC's
web site (methylal document) and in the TSCA Docket for the ITC's 42nd
Report (Ref. 6, TRI, 1997c). Before designating methylal for priority
testing consideration by the EPA Administrator, ITC wants to retrieve
and review the most current data on exposures and health effects. Data
already included in the methylal document should not be submitted. Data
needed are listed below.
iii. Data needed
a. Recent non-CBI estimates of annual production or importation
volume data and trends.1
b. Use information, including percentages of production or
importation that are associated with different uses.1
c. Estimates of the number of humans and concentrations of methylal
to which humans may be exposed from use, manufacturing, or
processing.1
d. Health effects, especially, in vivo mammalian metabolism and
chronic effects.2
iv. Supporting information. Data reported to the EPA in 1990
indicated that the non-CBI annual production/importation volume for
methylal was in the range of 1.2 to 6.4 million pounds. Methylal is
reportedly used in perfumery, as a chemical intermediate in the
manufacture of artificial resins and in organic synthesis, a solvent,
and a special fuel. NOES human exposure data from 1981-1983 were found,
as well as threshold limit values for human exposures. According to the
NOES, 156,795 workers, including 21,092 female employees, were
potentially exposed to methylal. No published data were found on the
ecological effects of methylal, in vivo mammalian metabolism, chronic
effects or concentrations of methylal to which humans were exposed.
Published acute, subchronic, mutagenic effects, environmental releases,
and environmental fate data were located as well as some metabolism
data.
4. Ethyl silicate
i. Recommendation. Ethyl silicate is being recommended to obtain
production/importation volume data and trends, use, exposure and health
effects, especially in vivo mammalian mutagenicity and subchronic or
chronic effects data needed by U.S. Government organizations
represented on the ITC.
ii. Rationale for recommendation. Ethyl silicate is under review
for mutagenicity and subchronic or chronic toxicity testing based on
potential human exposures and suspicions of genotoxicity or
carcinogenicity. These suspicions are based on in vitro mammalian
mutagenicity data. A document prepared for the U.S. Government
organization nominating ethyl silicate to the ITC is available on the
ITC's web site (ethyl silicate
[[Page 42558]]
document) and in the TSCA Docket for the ITC's 42nd Report (Ref.4, TRI,
1997a). Before designating ethyl silicate for priority testing
consideration by the EPA Administrator, the ITC wants to retrieve and
review the most current data on exposures and health effects. Data
already included in the ethyl silicate document should not be submitted
to the ITC. The ITC has an ongoing dialogue with the Silicones
Environmental Health and Safety Council (SEHSC) related to previously-
recommended siloxanes and anticipates that SEHSC will establish a
dialogue with the ITC to discuss data needed for ethyl silicate. Data
needed are listed below.
iii. Data needed
a. Recent non-CBI estimates of annual production or importation
volume data and trends.1
b. Use information, including percentages of production or
importation that are associated with different uses.1
c. Estimates of the number of humans and concentrations of ethyl
silicate to which humans may be exposed from use, manufacturing or
processing.1
d. Health effects, especially in vivo mammalian mutagenicity and
subchronic or chronic effects.2
iv. Supporting information. In the ITC's 28th Report (56 FR 41212,
August 19, 1991), ethyl silicate and 36 other alkoxysilanes were
recommended for ecological effects testing. In its 32nd Report (58 FR
38490, July 16, 1993), at EPA's request, all 37 alkoxysilanes were
removed from the Priority Testing List, before TSCA section 8(a) PAIR
or section 8(d) HaSD rules were promulgated (58 FR 38490, July 16,
1993). At the time alkoxysilanes were removed from the List, the EPA
indicated that other chemicals had a higher priority than the
alkoxysilanes. The ITC acknowledged that there were no existing U.S.
Government data needs, but agreed to reconsider any of these chemicals
if data were needed in the future.
Data reported to the EPA indicated that the non-CBI annual
production/importation volume for ethyl silicate was in the range of 7
to 20 million pounds in 1989 and 1 to 100 million pounds in 1993.
Ethyl silicate is reportedly used in weatherproofing and hardening
stone; in the manufacture of weatherproof and acid-proof mortars,
cements, refractory bricks, other molded objects; in heat- and
chemical-resistant paints, protective coatings for industrial buildings
and castings; in lacquers, as abonding agent; and as a chemical
intermediate. NOES data from 1981-1983 were found as well as threshold
limit values for human exposures, and data on concentrations of ethyl
silicate to which humans may be exposed. According to the NOES, 10,422
workers, including 2,566 female employees, were potentially exposed to
ethyl silicate. No published available data were found on:
1. Environmental releases.
2. Ecological effects.
3. Chronic health effects.
4. Mutagenicity from in vivo mammalian test systems.
Published data included those related to:
1. Acute and subchronic effects.
2. Metabolism.
3. Mutagenicity from in vitro mammalian test systems.
V. References
All references are available in the TSCA Docket for the ITC's 42nd
Report. The TSCA Docket is located in the TSCA Nonconfidential
Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC.
1. Grunow, W., H.J Altman, and C. Boehme. Uber den Staffwechsel von
3-Amino-1,2,4-triazol in Ratten [On the Metabolism of 3-Amino-1,2,4-
triazole in Rats]. Archives of Toxicology. 34(4):315-324. 1975.
2. Schafer, Jr., E.W., R.B. Brunton, E.C. Schafer, and G. Chavez.
Effects of 77 Chemicals on Reproduction in Male and Female Coturnix
Quail. Ecotoxicology and Environmental Safety. 6:149-156. 1982.
3. Takaoka, M., M. Teranishi, and S. Manabe. Structure-Activity
Relationships in 5-Substituted 3-Amino-1,2,4-Triazoles-Induced Goiters
in Rats. Journal of Toxicology and Pathology. 7:429-434. 1994.
4. TRI. 1997a. Ethyl Silicate--summary of data for chemical
selection by the National Cancer Institute (NCI) Chemical Selection
Working Group. Prepared by Technical Resources International, Inc.
under NCI Contract No. NO2-CB-50511 (1/96; rev. 9/96, rev. 8/97).
5. TRI. 1997b. Glycoluril--summary of data for chemical selection
by the National Cancer Institute (NCI) Chemical Selection Working
Group. Prepared by Technical Resources International, Inc. under NCI
Contract No. NO2-CB-50511 (6/97; rev. 9/97).
6. TRI. 1997c. Methylal--summary of data for chemical selection by
the National Cancer Institute (NCI) Chemical Selection Working Group.
Prepared by Technical Resources International, Inc. under NCI Contract
No. NO2-CB-50511 (7/96; rev. 8/97).
VI. TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Brad Campbell, Member
Juliet Healey, Alternate
Department of Commerce
National Institute of Standards and Technology
Malcolm W. Chase, Member
Barbara C. Levin, Alternate
National Oceanographic and Atmospheric Administration
Nancy Foster, Member
Teri Rowles, Alternate
Richard S. Artz, Alternate
Environmental Protection Agency
Paul Campanella, Member
David R. Williams, Alternate
National Cancer Institute
Victor Fung, Member, Chair
Harry Seifried, Alternate
National Institute of Environmental Health Sciences
William Eastin, Member, Vice Chair
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Albert E. Munson, Member
Christine Sofge, Alternate
National Science Foundation
A. Frederick Thompson, Member
Joseph Reed, Alternate
Occupational Safety and Health Administration
Lyn Penniman, Member
Val H. Schaeffer, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Jacqueline Ferrante, Member
Department of Agriculture
Clifford P. Rice, Member
Department of Defense
Colonel Richard Drawbaugh, Member
Captain Kenneth Still, Alternate
Department of the Interior
Barnett A. Rattner, Member
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
Scott Sherlock, OPPT, EPA
Technical Support Contractor
[[Page 42559]]
Syracuse Research Corporation
ITC Staff
John D. Walker, Executive Director
Norma S.L. Williams, Executive Assistant
TSCA Interagency Testing Committee, Environmental Protection Agency,
Office of Pollution Prevention and Toxics (MC/7401), 401 M St., SW.,
Washington, DC 20460, telephone: 202-260-1825, fax: 202-260-7895, e-
mail: [email protected], url: http://www.epa.gov/opptintr/itc.
[FR Doc. 98-21206 Filed 8-6-98; 8:45 am]
BILLING CODE 6560-50-F