[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             
----------------------------------------------------------------------------------------------------------------
                                                                                                        Review  
      Chemical CAS No.         Report No.           Primary uses            Route/exposure levels       order   
----------------------------------------------------------------------------------------------------------------
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                                                                                         
     B6C3F<INF>1Mice.                                                                                                
[[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