[Federal Register Volume 60, Number 101 (Thursday, May 25, 1995)]
[Notices]
[Pages 27774-27775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program; National Toxicology Program (NTP)
Board of Scientific Counselors' Meeting; Review of Draft NTP Technical
Reports
Pursuant to Public Law 92-463, notice is hereby given of the next
meeting of the NTP Board of Scientific Counselors' Technical Reports
Review Subcommittee on June 20 and 21, 1995, in the Conference Center,
Building 101, South Campus, National Institute of Environmental Health
Sciences (NIEHS), 111 Alexander Drive, Research Triangle Park, North
Carolina. The meeting will begin at 8:30 a.m. on both days and is open
to the public. The primary agenda topic is the peer review of draft
Technical Reports of long-term toxicology and carcinogenesis studies
and one short-term toxicity study from the National Toxicology Program.
Additionally, on June 21, a series of presentations will be made
concerning the toxicologic findings from collaborative prechronic
inhalation studies on carbon disulfide. There will be a presentation
titled ``Update on the New Diet (NTP-2000) for Rats and Mice in NTP
Toxicology and Carcinogenesis Studies''.
Tentatively scheduled to be peer reviewed on June 20 and 21 are
draft Technical Reports of six two-year studies, listed alphabetically,
along with supporting information in the attached table. Similar
information is given for the short-term report on 1,4-butanediol. All
studies were done using Fischer 344 rats and B6C3F1 mice, while one
two-year study also employed Sencar mice. The order of review is given
in the far right column of the table. Copies of the draft Reports may
be obtained, as available, from: Central Data Management, MD A0-01,
P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-3419).
In addition to the traditional two-year study results, the studies
with butyl benzyl phthalate, t-butylhydroquinone,
salicylazosulfapyridine, and scopolamine hydrobromide trihydrate
included groups run under mild dietary restrictions. A separate report
(see table) will deal with the effects of dietary restrictions on the
results of these four studies, and will draw some conclusions about the
usefulness of this approach to performing toxicology and carcinogenesis
studies.
Persons wanting to make a formal presentation regarding a
particular Technical Report must notify the Executive Secretary by
telephone, by FAX, or by mail no later than June 14, 1995, and provide
a written copy in advance of the meeting so copies can be made and
distributed to all Subcommittee members and staff and made available at
the meeting for attendees. Written statements should supplement and may
expand on the oral presentation. Oral presentations should be limited
to no more than five minutes.
The program would welcome receiving toxicology and carcinogenesis
information from completed, ongoing, or planned studies by others, as
well as current production data, human exposure information, and use
patterns for any of the chemicals listed in this announcement. Please
contact Central Data Management at the address given above, and they
will relay the information to the appropriate staff scientist.
The Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233,
Research Triangle Park, North Carolina 27709 (telephone 919/541-3971;
FAX 919/541-0719) will furnish a final agenda and a roster of
Subcommittee members prior to the meeting. Summary minutes subsequent
to the meeting will be available upon request.
Attachment
Dated: May 15, 1995.
Kenneth Olden,
Director, National Toxicology Program.
Summary Data for Technical Reports and Short-Term Toxicity Reports Scheduled for Review at the Meeting of the
Board of Scientific Counselors' Technical Reports Review Subcommittee June 20-21, 1995
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Review
Chemical CAS No. Report No. Primary uses Route/exposure levels order
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Long-Term Studies:
Butyl Benzyl Phthalate TR-458 Plasticizer for PVC-based Dosed-Feed (NIH-07): Male 3
85-68-7. flooring products. Also Rats: 0, .3%, .6%, or
used in biodegradable 1.2%; 60/group, Female
tampon ejectors, organic Rats: 0, .6%, 1.2%, or
intermediate. 2.4%; 60/group.
T-Butylhydroquinone TR-459 Antioxidant in vegetable Dosed-Feed (NIH-07): Rats 2
1948-33-0. fats and oils. & Mice: 0, 0.125, 0.25,
Intermediate. or 0.5% in feed; 70 Rats,
60 Mice.
Codeine 76-57-3........ TR-455 Antitussive, analgesic, Dosed-Feed (NIH-07 6
chemical intermediate, (Powdered)): Rats: 0,
naturally occurring. 400, 800, or 1600, Mice:
0, 750, 1500, or 3000
ppm; 60/group.
1,2-Dihydro-2,2,4- TR-456 Monomer polymerized for use Topical (Acetone): Rats: 7
Trimethylquinoline as a rubber antioxidant. 0, 60, or 100 mg/kg,
(Monomer) 147-47-7. Mice: 0, 6, or 10 mg/kg
(core), Rats: 0, 36, 60,
or 100 mg/kg Mice: 0,
3.6, 6.0, or 10.0 mg/kg.
Effect of Dietary TR-460 Feed Restriction Studies... .......................... 5
Restriction on
Toxicology and
Carcinogenesis Studies
in F344/N Rats and
B6C3F1Mice.
[[Page 27775]]
Salicylazosulfapyridine TR-457 Treatment of granulomatous Gavage (Corn Oil): Rats: 1
599-79-1. Colitis (vet.); 84, 168, or 337.5 mg/kg;
antibacterial. 70/group Mice: 675, 1350,
or 2700 mg/kg; 60/group.
Scopolamine TR-445 Anticholinergic; treatment Gavage (Deionized water): 4
Hydrobromide of motion sickness. Rats & Mice: 0,1,5, or 25
Trihydrate 6533-68-2. mg/kg; 70/group. Diet
Restriction: Mice: 0 or
25 mg/kg; 70/group.
Short-Term Study:
1,4-Butanediol 110-63-4 TOX-54 Chemical intermediate for Review of metabolism and 8
tetrahydrofuran, monomer disposition studies and
for polybutylene prediction of lack of
terephthalate resins; carcinogenicity in long-
intermediate in polyester term studies.
resins, used in production
of 1,4-butanediol
dimethanesulfonate.
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[FR Doc. 95-12819 Filed 5-24-95; 8:45 am]
BILLING CODE 4140-01-P