[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Notices]
[Pages 29412-29415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14149]



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[[Page 29413]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


National Toxicology Program (NTP) Board of Scientific Counselors' 
Meetings; Announcement of NTP Draft Technical Reports Projected for 
Public Review From December 1996 Through Fall 1998; Request for Public 
Input

    To earlier inform the public and encourage interested parties to 
comment or obtain information on projected long-term toxicology and 
carcinogenesis studies prior to public peer review, the National 
Toxicology Program (NTP) again publishes in the Federal Register a 
current listing of draft Technical Reports projected for evaluation by 
the NTP Board of Scientific Counselors' Technical Reports Review 
Subcommittee during their next five meetings from December 1996 through 
Fall 1998. We plan to continue updating the listing with announcements 
in the Federal Register once or twice a year. The next meeting dates 
are December 11-12, 1996. Specific dates for 1997 and 1998 meetings 
will be established at a later time.
    The attached Table 1 lists draft Technical Reports for long-term 
studies on chemicals within known or approximate dates of reviews and 
includes Chemical Abstracts Service (CAS) registry numbers, primary 
use, route of administration, species, exposure levels, and NTP report 
numbers (if assigned).
    Technical Reports of short-term toxicity studies are currently 
reviewed by mail; however, they may be reviewed in open meetings when 
necessary. The attached Table 2 lists the draft Technical Reports of 
short-term toxicity studies tentatively projected for review by mail 
from April 1996 to December 1996 and also includes Chemical Abstracts 
Service (CAS) registry numbers, primary use, route of administration, 
species, exposure levels, and NTP report numbers (if assigned).
    Those interested in having more information about any of the 
studies listed in this announcement should contact Central Data 
Management as early as possible by telephone or by mail at: MD E1-02, 
NIEHS, P.O. Box 12233, Research Triangle Park (RTP), North Carolina 
27709 (919/541-3419). The program would welcome receiving toxicology 
and carcinogenesis data from completed, ongoing or planned studies by 
others as well as current production data, human exposure information, 
and use and use patterns.
    The Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233, 
Research Triangle Park, North Carolina 27709, telephone 919/541-3971, 
FAX 919/541-0295 will furnish final agendas and other program 
information prior to a meeting, and summary minutes subsequent to a 
meeting.

Attachments

    Dated: May 21, 1996.
Kenneth Olden,
Director, National Toxicology Program.

 Table 1.--Summary Data for Technical Reports Scheduled for Review at the Meeting of the NTP Board of Scientific
                Counselors' Technical Reports Review Subcommittee From December 1996 through 1998               
----------------------------------------------------------------------------------------------------------------
      Chemical name/cas No.              Use              Route            Species           Exposure levels    
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled                                                                                 
 for Peer Review December 11-12,                                                                                
 1996:                                                                                                          
3'-Azido-3' -Deoxythymidine                                                                                     
 (AIDS):                                                                                                        
    30516-87-1..................  PHAR............  GAV.............  RM..............  Mice only: 0, 30, 60, or
                                                                                         120 mg/kg; 50/sex.     
Chloroprene:                                                                                                    
    126-99-8....................  PLAS............  INHAL...........  RM..............  R&M: 0, 12.8, 32.0, or  
                                                                                         80.0 ppm; 50/sex/      
                                                                                         species/group.         
Cobalt Sulfate Heptaphydrate:                                                                                   
    10026-24-1..................  PNT.............  INHAL...........  RM..............  R&M: 0, 0.3, 1.0, or 3.0
                                                                                         mg/m\3\; 50/sex/species/
                                                                                         group.                 
Ethylbenzene:                                                                                                   
    100-41-4....................  RUBR............  INHAL...........  RM..............  R&M: 0, 75, 250, or 750 
                                                                                         ppm (50/sex/species/   
                                                                                         group).                
Interferon AD + 3'-Azido-3' -                                                                                   
 Deoxythymidine:                                                                                                
    (AIDS)......................  PHAR............  SC&GV...........  MM..............  Dual routes with both   
                                                                                         compounds: AZT: 0, 30, 
                                                                                         60, or 120 (gav) mg/kg;
                                                                                         IFN: 500 or 5000 units 
                                                                                         3X/week.               
Isobutyraldehyde:                                                                                               
    78-84-2.....................  INTR............  INHAL...........  RM..............  R&M: 0, 500, 1000, or   
                                                                                         2000 ppm (50/sex/      
                                                                                         species/group).        
Oxazepam:                                                                                                       
    604-75-1....................  PHAR............  FEED............  R...............  0, 625, 1250, 2500,     
                                                                                         5000, or 10,000 ppm; 50/
                                                                                         sex/group.             
Polyvinyl alcohol:                                                                                              
    9002-89-5...................  PHAR............  IVAG............  M...............  25% PVA, vehicle,       
                                                                                         untreated; 100/group.  
Primaclone (Primidone):                                                                                         
    125-33-7....................  PHAR............  FEED............  RM..............  M: 0, 0.03, 0.06, or    
                                                                                         0.13% R: 0, 0.06, 0.13,
                                                                                         or 0.25% (50/sex/      
                                                                                         species).              
Tetrahydrofuran:                                                                                                
    109-99-9....................  SOLV............  INHAL...........  RM..............  R&M: 0, 200, 600, or    
                                                                                         1800 ppm (50/sex/      
                                                                                         species/group).        
Theophylline:                                                                                                   
    58-55-9.....................  PHAR............  GAV.............  RM..............  R: 7.5, 25, or 75 mg/kg;
                                                                                         50/group fm: 7.5, 25,  
                                                                                         or 75 mg/kg; 50/group  
                                                                                         mm: 15, 50, or 150 mg/ 
                                                                                         kg; 50/group.          
Chemicals Tentatively Scheduled                                                                                 
 for Peer Review in Summer 1997:                                                                                
1-Chloro-2-Propanol, Technical:                                                                                 
    127-00-4....................  INTR............  WATER...........  RM..............  R: 0, 150, 325, or 650  
                                                                                         ppm M: 0, 250, 500, or 
                                                                                         1000 ppm (50/sex/      
                                                                                         group).                

[[Page 29414]]

                                                                                                                
Coconut Oil Acid Diethanolamine                                                                                 
 Condensate:                                                                                                    
    68603-42-9..................  TEXL............  SP..............  RM..............  R: 0, 50, or 100 mg/kg  
                                                                                         M: 0, 100, or 200 mg/kg
                                                                                         (50 sex/species/group).
Diethanolamine:                                                                                                 
    111-42-2....................  TEXL............  SP..............  RM..............  MR: 0, 16, 32, or 64 mg/
                                                                                         kg; FR: 0, 8, 16, or 32
                                                                                         mg/kg; Mice: 0, 40, 80,
                                                                                         or 160 mg/kg (50/sex/  
                                                                                         species/group).        
Furfuryl alcohol:                                                                                               
    98-00-0.....................  FOOD............  INHAL...........  RM..............  R&M: 0, 2, 8, or 32 ppm 
                                                                                         (50/sex/species/group).
Lauric Acid Diethanolamine                                                                                      
 Condensate:                                                                                                    
    120-40-1....................  DTRG............  SP..............  RM..............  R: 0, 50, or 100 mg/kg  
                                                                                         M: 0, 100, or 200 mg/kg
                                                                                         (50/sex/species/group).
Oleic Acid Diethanolamine                                                                                       
 Condensate:                                                                                                    
    93-83-4.....................  COSM............  SP..............  RM..............  R: 0, 50, or 100 mg/kg; 
                                                                                         50/sex/group M: 0, 15, 
                                                                                         or 30 mg/kg; 55/sex/   
                                                                                         group.                 
Pyridine:                                                                                                       
    110-86-1....................  SOLV............  WATER...........  RMR.............  R: 0, 100, 200, or 400  
                                                                                         ppm MM: 0, 250, 500, or
                                                                                         1000 ppm FM: 125, 250, 
                                                                                         or 500 ppm MWR: 0, 100,
                                                                                         200, or 400 ppm (50/sex/
                                                                                         group).                
Chemicals Tentatively Scheduled                                                                                 
 for Peer Review Fall 1997:                                                                                     
Ethylene Glycol Monobutyl Ether                                                                                 
 (EGMBE):                                                                                                       
    111-76-2....................  SOLV............  INHAL...........  RM..............  R: 0, 31, 62.5, or 125  
                                                                                         ppm M: 0, 62.5, 125, or
                                                                                         250 ppm; 50/sex/       
                                                                                         species.               
Isobutene:                                                                                                      
    115-11-7....................  RUBR............  INHAL...........  RM..............  R&M: 0, 500, 2000, or   
                                                                                         8000 ppm (50/sex/      
                                                                                         species/group).        
Isoprene:                                                                                                       
    78-79-5.....................  RUBR............  INHAL...........  R...............  R: 0, 220, 700, or 7000 
                                                                                         ppm; 50/sex/group.     
Pentachlorophenol, purified:                                                                                    
    87-86-5.....................  PEST............  FEED............  R...............  R: 0, 200, 400, or 600  
                                                                                         ppm; 50/sex/group--1000
                                                                                         ppm stop study (60/    
                                                                                         sex).                  
Chemicals Tenatively Scheduled                                                                                  
 for Peer Review Summer 1998:                                                                                   
Gallium Arsenide:                                                                                               
    1303-00-0...................  ELEC............  INHAL...........  RM..............  R: 0, 0.01, 0.1, or 1.0 
                                                                                         mg/m\3\; 50/sex/group  
                                                                                         M: 0, 0.1, 0.5, or 1.0 
                                                                                         mg/m\3\; 50/sex/group. 
Methyleugenol:                                                                                                  
    93-15-2.....................  FOOD............  GAV.............  RM..............  R&M: 0, 37, 75, or 150  
                                                                                         mg/kg (50/sex/species/ 
                                                                                         group).                
Oxymetholone:                                                                                                   
    434-07-1....................  PHAR............  GAV.............  RM..............  MR: 0, 3, 30, or 150 mg/
                                                                                         kg; FR: 0, 3, 30, or   
                                                                                         100 mg/kg.             
Chemicals Tentatively Scheduled                                                                                 
 for Peer Review Fall 1998:                                                                                     
Indium Phosphide:                                                                                               
    22398-80-7..................  ELEC............  INHAL...........  RM..............  R&M: 0, 0.03, 0.1, or   
                                                                                         0.3 mg/m\3\.           
----------------------------------------------------------------------------------------------------------------



 Table 2.--Short-Term Toxicity Studies Scheduled for Review by the NTP Board of Scientific Counselors' Technical
                            Reports Review Subcommittee From April 1996 Through 1998                            
----------------------------------------------------------------------------------------------------------------
      Chemical name/CAS No.              Use              Route            Species           Exposure levels    
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies                                                                                     
 Tentatively Scheduled for Peer                                                                                 
 Review April 1996:                                                                                             
Magnetic Fields (EMF):                                                                                          
    Electromag..................  ELEC............  WB..............  RM..............  60 hz magnetic fields-- 
                                                                                         20 mg, 58 2g, 10 g     
                                                                                         continuous and 10 g    
                                                                                         intermittent; 10/group.
Methacrylonitrile:                                                                                              
    126-98-7....................  PLAS............  GAV.............  RM..............  R: 0, 7.5, 15.0, 30.0,  
                                                                                         60.0, 120.0 47 mg/kg/  
                                                                                         day; M: 0, 0.75, 1.5,  
                                                                                         3.0, 6.0, 12.0 mg/kg/  
                                                                                         day; Rats: 20/grp;     
                                                                                         mice: 10/grp.          
Methapyrilene Hydrochloride:                                                                                    
    135-23-9....................  PHAR............  FEED............  R...............  Male Rats: 0, 50, 100,  
                                                                                         250, 46 1000 ppm; 40/  
                                                                                         grp.                   

[[Page 29415]]

                                                                                                                
Short-Term Toxicity Studies                                                                                     
 Tentatively Scheduled for Peer                                                                                 
 Review May 1996:                                                                                               
M-Chloroaniline:                                                                                                
    108-42-9....................  INTR............  GAV.............  RM..............  R&M 0, 10, 20, 40, 80,  
                                                                                         160 43 mg/kg, 20/grp   
                                                                                         (rats); 10/grp (mice). 
O-Chloroaniline:                                                                                                
    95-51-2.....................  DYE.............  GAV.............  RM..............  R&M 0, 10, 20, 40, 80, &
                                                                                         160 43 mg/kg, 20/grp   
                                                                                         (rats); 10/grp (mice). 
Short-Term Toxicity Studies                                                                                     
 Tentatively Scheduled for Peer                                                                                 
 Review June 1996:                                                                                              
AZT+Methadone HCL (AIDS):                                                                                       
    Aztmethcomb.................  PHAR............  GAV.............  MM..............  AZT: 200, 400, or 800 mg/
                                                                                         kg/day with Methadone  
                                                                                         HCL: 5, 15, or 30 mg/kg/
                                                                                         day.                   
2', 3'-Dideoxycytidine (AIDS                                                                                    
 initiative):                                                                                                   
    7481-89-2...................  PHAR............  GAV.............  MM..............  Female mice only: 500,  
                                                                                         1000 mg/kg/day.        
3, 3', 4, 4'-                                                                                                   
 Tetrachloroazobenzene:                                                                                         
    14047-09-7..................  HERB............  GAV.............  RM..............  R&M: 0, 0.1, 1.0, 3.0,  
                                                                                         10, or 30 mg/kg body   
                                                                                         weight (M&F; 10/group).
1, 1, 2, 2-Tetrachloroethane....  SOLV............  GAV.............  RM..............  ........................
1, 1, 2, 2-Tetrachloroethane:                                                                                   
    79-34-5.....................  SOLV............  MICRO...........  RM..............  R&M; R:untreated        
                                                                                         control, vehicle       
                                                                                         control, 18, 37, 75,   
                                                                                         150, or 300 mg/kg body 
                                                                                         wt/day; M: untreated   
                                                                                         control, vehicle       
                                                                                         control, 88, 175, 350, 
                                                                                         700, or 1400 mg/kg body
                                                                                         wt/day; 10/group/sex.  
Short-Term Toxicity Studies                                                                                     
 Tentatively Scheduled for Peer                                                                                 
 Review August 1996:                                                                                            
1, 1, 1-Trichloroethane:                                                                                        
    71-55-6.....................  SOLV............  MICRO...........  RM..............  R&M: 0, 0.5, 1.0, 2.0,  
                                                                                         4.0, 41 and, 8.0% (10/S/
                                                                                         S).                    
Short-Term Toxicity Studies                                                                                     
 Tentatively Scheduled for Peer                                                                                 
 Review December 1996:                                                                                          
CIS & TRANS 1,2-                                                                                                
 Dichloroethylene:                                                                                              
    540-59-0....................  SOLV............  MICRO...........  RM..............  55.                     
CIS-1, 2-Dichloroethylene:                                                                                      
    156-59-2....................  SOLV............  MICRO...........  RM..............  55.                     
TRANS-1, 2-Dichloroethylene:                                                                                    
    156-60-5....................  SOLV............  MICRO...........  RM..............  55.                     
TRANS-1, 2-Dichloroethylene:                                                                                    
    156-60-5....................  SOLV............  GAV.............  RM..............  55.                     
TRANS-1, 2-Dichloroethylene:                                                                                    
    156-60-5....................  SOLV............  MICRO...........  RM..............  R&M: untreated control, 
                                                                                         vehicle control, 3125, 
                                                                                         6250, 12,500, 25,000,  
                                                                                         or 50,000 ppm; 10/group/
                                                                                         sex.                   
----------------------------------------------------------------------------------------------------------------



    Abbreviations used: in this report:

------------------------------------------------------------------------
               Use                          Primary use category        
------------------------------------------------------------------------
COMT.............................  Contaminates and/or Impurities.      
COSM.............................  Cosmetics, Perfumes, Fragrances, Hair
                                    Preparations.                       
DTRG.............................  Detergents and Cleaners.             
DYE..............................  As or in Dyes, Inks, and Pigments.   
ELEC.............................  In Electrical and/or Dielectric      
                                    Systems.                            
FOOD.............................  Food, Beverages, or Additives.       
HERB.............................  Herbicide(s).                        
INTR.............................  Chemical Intermediate or Catalyst.   
PEST.............................  Pesticides, General or Unclassified. 
PHAR.............................  Pharmaceuticals or Intermediates.    
PLAS.............................  As or in Plastics.                   
PNT..............................  Paint Ingredient.                    
RUBR.............................  Rubber Chemical.                     
SOLV.............................  Vehicles and Solvents.               
TEXL.............................  In Manufacture of Textiles.          
------------------------------------------------------------------------


------------------------------------------------------------------------
              Route                       Route of administration       
------------------------------------------------------------------------
FEED.............................  Dosed-Feed.                          
GAV..............................  Gavage.                              
INHAL............................  Inhalation.                          
IP/IJ............................  Intraperitoneal Injection.           
IVAG.............................  Intravaginal.                        
MICRO............................  Microencapsulation in Feed.          
SC&GV............................  Subcutaneous Inj.+Gavage.            
SP...............................  Topical.                             
WATER............................  Dosed-Water.                         
WB...............................  Whole Body Exposure.                 
------------------------------------------------------------------------


------------------------------------------------------------------------
                 Spec                                   Species         
------------------------------------------------------------------------
R.....................................      =  Rats.                    
M.....................................      =  Mice.                    
------------------------------------------------------------------------

[FR Doc. 96-14149 Filed 6-7-96; 8:45 am]
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