[Federal Register Volume 59, Number 214 (Monday, November 7, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27467]


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[Federal Register: November 7, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

National Toxicology Program

    National Toxicology Program (NTP) Board of Scientific Counselors' 
Meetings; Announcement of NTP Draft Technical Reports Projected for 
Public Review From November 1994 Through Summer 1996.
    To earlier inform the public and allow interested parties to 
comment or obtain information on 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 Counselor's Technical Reports Review 
Subcommittee during their next four meetings from November 1994 through 
the summer of 1996. We plan to continue updating the listing with 
announcements in the Federal Register once or twice a year. The next 
meeting date is November 29, 1994. Specific dates for 1995 and 1996 
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, when necessary may be reviewed in opening 
meetings. The attached Table 2 lists the draft Technical Reports of 
short-term toxicity studies tentatively projected for review by mail 
during 1994 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 to: MD-A0-01, 
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, 
will furnish final agendas and other program information prior to a 
meeting, and summary minutes subsequent to a meeting.

    Attachments.

    Dated: October 31, 1994.
Richard Griesemer,
Deputy Director, National Toxcicology 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 November 29, 1994 Through Summer 1996          
----------------------------------------------------------------------------------------------------------------
 Chemical name/CAS number        Use           Route         Species          Exposure Levels         NTP TR No.
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                        Chemicals Tentatively Scheduled for Peer Review November 29, 1994                       
                                                                                                                
----------------------------------------------------------------------------------------------------------------
2,2-BIS (BROMOMETHYL)-1,3-  FLAM           FEED           RM             R: 0, 2500, 5000, OR 10000          452
 PROPANEDIOL 3296-90-0.                                                   PPM; 70/GROUP M: 0, 312,              
                                                                          625, OR 1250 PPM; 60/                 
                                                                          GROUP.                                
ISOBUTYL NITRITE 542-56-3.  INTR           INHAL          RM             R&M: 0, 37, 75, OR 150 PPM          448
NICKEL (II) OXIDE 1313-99-  INTR           INHAL          RM             R: 0, .62, 1.25, OR 2.5 M:          451
 1.                                                                       0, 1.25, 2.5, OR 5.0 MG/              
                                                                          M3; 50/GROUP.                         
NICKEL SULFATE HEXAHYDRATE  INTR           INHAL          RM             P: 0, 0.125, 0.25, OR 0.5           454
 10101-97-0.                                                              M: 0, .25, .5, OR 1.0 MG/             
                                                                          M3; 50/GROUP.                         
NICKEL SUBSULFIDE 12035-72- ENVH           INHAL          RM             R: 0, 0.075, OR 0.15 M: 0,          453
 2.                                                                       0.6, OR 1.2 MG/M3; 50/                
                                                                          GROUP.                                
TRIETHANOLAMINE 102-71-6..  DTRG           SP             RMM            MR: 0, 32, 63, OR 125; FR:          449
                                                                          0, 63, 125, OR 250; MM:               
                                                                          0, 200, 630, OR 2000; FM:             
                                                                          0, 100, 300, OR 1000 MG/              
                                                                          KG; 60/GROUP.                         
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                           Chemicals Tentatively Scheduled for Peer Review Summer 1995                          
                                                                                                                
----------------------------------------------------------------------------------------------------------------
BUTYL BENZYL PHTHALATE 85-  PLAS           FEED           RR             MR: 0, .3%, .6%, OR 1.2%;              
 68-7.                                                                    60/GROUP FR: 0, .6%,                  
                                                                          1.2%, OR 2.4%; 60/GROUP.              
T-BUTYLHYDROQUINONE 1948-   FOOD           FEED           RMR            R&M: 0, 0.125, 0.25, OR                
 33-0.                                                                    0.5% IN FEED; 70 RATS, 60             
                                                                          MICE.                                 
CODEINE 76-57-3...........  PHAR           FEED           RM             R: 0, 400, 800, OR 1600 M:             
                                                                          0, 750, 1500, OR 3000                 
                                                                          PPM; 60/GROUP.                        
1,2-DIHYDRO-2,2,4-          RUBR           SP             RMM            RATS: 0, 60, OR 100 MG/KG              
 TRITMETHYL-PQUINOLINE                                                    MICE: 0, 6, OR 10 MG/KG               
 (MONOMER) 147-47-7.                                                      (CORE).                               
1,2-DIHYDRO-2,2,4-          RUBR           SP             RM             RATS: 0, 36, 60, OR 100 MG/            
 TRIMETHYL-PQUINOLINE                                                     KG MICE: 0, 3.6, 6.0, OR              
 (MONOMER) 147-47-7.                                                      10.0 MG/KG.                           
SALICYLAZOSUL-PFAPYRIDINE   PHAR           GAV            RM             R: 84, 168, OR 337.5 MG/               
 599-79-1.                                                                KG; 70/GROUP M: 675,                  
                                                                          1350, OR 2700 MG/KG; 60/              
                                                                          GROUP.                                
SCOPOLAMINE HYDROBRO-PMIDE  PHAR           GAV            RMM            R&M: 0, 1, 5, OR 25 MG/KG;             
 TRIHYDRATE 6533-68-2.                                                    70/GROUP DIET RESTRICTION             
                                                                          MICE: 0 OR .25 MG/KG; 70/             
                                                                          GROUP.                                
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                            Chemicals Tentatively Scheduled for Peer Review Fall 1995                           
                                                                                                                
----------------------------------------------------------------------------------------------------------------
D & C YELLOW NO. 11 8003-   DYE            FEED           R              RATS: 0, 0.05, 0.17, OR                
 22-3.                                                                    0.5%; 60/GROUP.                       
ETHYLBENZENE 100-41-4.....  RUBR           INHAL          RM             R&M: 0, 75, 250, OR 750                
                                                                          PPM (50/SEX/SPECIES/                  
                                                                          GROUP).                               
MOLYBDENUM TRIOXIDE 1313-   METL           INHAL          RM             R&M: 10, 30, OR 100 MG/M3;             
 27-5.                                                                    50/SEX/SPECIES/GROUP.                 
NITROMETHANE 75-52-5......  FUEL           INHAL          RM             R: 0, 94, 188, OR 375 PPM;             
                                                                          50/GROUP M: 0, 188, 375,              
                                                                          OR 750 PPM; 50/GROUP.                 
TETRAFLUOROETHYLENE 116-14- FOOD           INHAL          RM             MICE & FR: 0, 312, 625, OR             
 3.                                                                       1250 MR: 0, 156, 312, OR              
                                                                          625 PPM; 50/GROUP.                    
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                           Chemicals Tentatively Scheduled for Peer Review Summer 1996                          
                                                                                                                
----------------------------------------------------------------------------------------------------------------
1-CHLORO-2-PROPANOL,        INTR           WATER          RM             R: 0, 150, 325, OR 650 PPM             
 TECHNICAL 127-00-4.                                                      M: 0, 250, 500, OR 1000               
                                                                          PPM (50/SEX/GROUP).                   
DIETHYANOLA-PMINE 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).                       
INTERFERON AD + AZT (AIDS   PHAR           SC&GV          MM             DUEL ROUTES WITH BOTH                  
 INITIATIVE) INTAZTCOMB.                                                  COMPOUNDS; AZT: 0, 30,                
                                                                          60, OR 120 (GAV) MG/KG;               
                                                                          IFN: 500 OR 5000 UNITS 3X/            
                                                                          WEEK.                                 
OXAZEPAM 604-75-1.........  PHAR           FEED           R              0, 625, 1250, 2500, 5000,              
                                                                          OR 10000 PPM; 50/SEX/                 
                                                                          GROUP.                                
PHENOLPHTHALEIN 77-09-8...  PHAR           FEED           RM             R: 0, 1.2, 2.5, OR 5%; M:              
                                                                          0, 0.3, 0.6, OR 1.2% IN               
                                                                          FEED (50/SEX/SPECIES/                 
                                                                          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).               
SODIUM XYLENESULFONATE      DTRG           SP             RM             R: 0, 60, 120, OR 240 MG/              
 1300-72-7.                                                               KG M: 0, 182, 364, OR 727             
                                                                          MG/KG (50/SEX/GROUP).                 
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 .                               
----------------------------------------------------------------------------------------------------------------

    Abbreviations used in this report:

USE   Primary Use Category:
COMT   Contaminates and/or Impurities
COSM   Cosmetics, Perfumes, Fragrances, Hair Preparations
DTRG   Detergents and Cleansers
DYE   As or in Dyes, Inks, and Pigments
ELEC   In Electrical and/or Dielectric Systems
ENVH   Environmental (Air/Water) Pollutants
FLAM   Flame Retardants
FOOD   Food, Beverages, or Additives
FUEL   As or in Fuel or Oil products
HERB   Herbicide(s)
IND   Industrial Uses
INTR   Chemical Intermediate or Catalyst
METL   Metals or in Metal Products
PAPR   as or in Paper or Paper Products
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

    TABLE 2.--Short-Term Toxicity Studies Scheduled for Peer Review by the NTP Board of Scientific Counselors   
                              Technical Reports Review Subcommittee During FY 1995                              
----------------------------------------------------------------------------------------------------------------
  CHEMICAL NAME/ CAS NO.         USE           ROUTE         SPECIES           EXPOSURE LEVEL        NTP TOX NO.
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                       Short-Term Toxicity Studies Scheduled for Peer Review October 1994                       
                                                                                                                
----------------------------------------------------------------------------------------------------------------
M-CHLOROANILINE 108-42-9/   INTR           GAV            RM             R&M 0, 10, 20, 40, 80, 160           43
 C61529B.                                                                 MG/KG, 20/GRP (RATS); 10/             
                                                                          GRP (MICE).                           
O-CHLOROANILINE 95-51-1/    DYE            GAV            RM             R&M 0, 10, 20, 40, 80, &             43
 C91001.                                                                  160 MG/KG; 20/GRP (RATS);             
                                                                          10/GRP (MICE).                        
O-NITROTOLUENE 88-72-2/     RUBR           FEED           R              MALE R: 0, 0 ALTERED                 44
 C62340C.                                                                 MICROFLORA 20/GRP; 5000               
                                                                          RPM 60/GRP; 5000 PPM                  
                                                                          ALTERED MICROFLORA 40/GRP.            
O-TOLUIDINE HYDROCHLORIDE   DYE            FEED           R              O AND O ALTERED                      44
 636-21-5/C02335B.                                                        MICROFLORA; 20/GRP; 5000              
                                                                          PPM; 60/GRP.                          
1,1,1-TRICHLOROETHANE       SOLV           MICRO          RM             R&M: 0, 0.5, 1.0, 2.0,                 
 (Superfund Chemical) 71-                                                 4.0, AND 8.0% (10/S/S).               
 55-6/C04626C.                                                                                                  
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                       Short-Term Toxicity Studies Scheduled for Peer Review November 1994                      
                                                                                                                
----------------------------------------------------------------------------------------------------------------
CYCLOHEXANONE OXIME 100-64- PLAS           WATER          M              0, 625, 1250, 2500, 5000,            50
 1/C88047.                                                                OR 10000 PPM; 10/GROUP.               
Halogenated Ethanes Class                                                                                       
 Study:                                                                                                         
    1,2-DICHLORO-1,1-       IND            GAV            R              MALE RATS 0, 0.62, 1.24              45
     DIFLUOROETHANE 1649-                                                 MMOL/KG/DAY; 5/GRP.                   
     08-7.                                                                                                      
    1,2-DIFLUROR-1,1,2,2-   SOLV           GAV            R              MALE RATS 0, 0.62, 1.24              45
     TETRA CHLOROETHANE 76-                                               MMOL/KG/DAY; 5/GRAP.                  
     12-0.                                                                                                      
    HEXACHLOROETHANE 67-72- SOLV           GAV            R              MALE RATS 0, 0.62, 1.24              45
     1.                                                                   MMOL/KG/DAY; 5/GRP.                   
    PENTABROMOETHANE 75-95- IND            GAV            R              MALE RATS 0, 0.62, 1.24              45
     6.                                                                   MMOL/KG/DAY; 5/GRP.                   
    PENTACHLOROETHANE 76-   SOLV           GAV            R              MALE RATS 0, 0.62, 1.24              45
     01-7.                                                                MMOL/KG/DAY; 5/GRP;                   
                                                                          FEMALE RATS 0, 1,24 MMOL/             
                                                                          KG/DAY;.                              
    1,1,1,2-TETRA           IND            GAV            R              MALE RATS 0, 0.62, 1.24              45
     BROMOETHANE 630-16-0.                                                MMOL/KG/DAY; 5/GRP.                   
    1,1,2,2-TETRA           FLAM           GAV            R              MALE RATS 0, 0.62, 1.24              45
     BROMOETHANE 79-27-6.                                                 MMOL/KG/DAY; 5/GRP.                   
    1,1,1,2-TETRA           INTR           GAV            R              MALE RATS 0, 0.62, 1.24              45
     CHLOROETHANE 630-20-6.                                               MMOL/KG/DAY; 5/GRP.                   
    1,1,2,2-                SOLV           GAV            R              MALE RATS 0, 0.62, 1.24              45
     TETRACHLOROETHANE 79-                                                MMOL/KG/DAY; 5/GRP.                   
     34-5.                                                                                                      
    1,1,1-TRICHLOROETHANE   SOLV           GAV            R              MALE RATS 0, 0.62, 1.24              45
     71-55-6.                                                             MMOL/KG/DAY; 5/GRP.                   
    1,1,1-TRICHLORO-2,2,2-  IND            GAV            R              MALE RATS 0, 0.62, 1.24              45
     TRIFLUOROETHANE 354-                                                 MMOL/KG/DAY; 5/GRP.                   
     58-5.                                                                                                      
    METHYL ETHYL KETOXIME   PNT            WATER          RM             R&M: 0, 625, 1250, 2500,             51
     96-29-7/C88009.                                                      5000, OR 10000 PPM; 10/               
                                                                          GROUP.                                
    3,3',4,4'-TETRACHLOROA  HERB           GAV            RM             R&M: 0, 0.1, 1.0, 3.0, 10,             
     ZOBENZENE 14047-09-7/                                                OR 30 MG/KG BODY WEIGHT               
     C88148.                                                              (M&F 10/GROUP).                      
    3,3',4,4'-TETRACHLO-    COMT           GAV            RM             R&M: 0, 0.1, 1.0, 3.0, 10,             
     ROAZOXYBENZENE 21232-                                                OR 30 MG/KG BODY WEIGHT               
     47-3/C88149.                                                         (M&F 10/GROUP).                       
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                       Short-Term Toxicity Studies Scheduled for Peer Review January 1995                       
                                                                                                                
----------------------------------------------------------------------------------------------------------------
CIS & TRANS 1,2-            SOLV           MICRO          RM             R&M: 0, 3175, 6250, 12500,             
 DICHLOROETHYLENE                                                         25000, OR 50000 (5/SEX/               
 (Superfund Chemical) 540-                                                SPECIES/GROUP).                       
 59-0/C56031.                                                                                                   
CIS-1,2-DICHLOROETHYLENE    SOLV           MICRO          RM             R&M: 0, 3175, 6250, 12500,             
 (Superfund Chemical) 156-                                                25000, OR 50000 (5/SEX/               
 59-2/C51581B.                                                            SPECIES/GROUP).                       
TRANS-1,2-DICHLOROETHYLENE  SOLV           MICRO          RM             R&M: 0, 3175, 6250, 12500,             
 (Superfund Chemical) 156-                                                25000, OR 50000 PPM (5/               
 60-5/C54591B.                                                            SEX/SPECIES/GROUP).                   
TRANS-1,2-DICHLOROETHYLENE  SOLV           GAV            RM             R: 0, 125, 250 OR 500 MG/              
 (Superfund Chemical) 156-                                                KG M: 0, 320, 640, OR                 
 60-5 /C54591C.                                                           1280 MG/KG (5/SEX/SPECIES/            
                                                                          GROUP).                               
DIPROPYLENE GLYCOL 25265-   INTR           WATER          RM             R&M: 0, 0.5, 1.0, 2.0, 4.0             
 71-8/C88031.                                                             OR 8.0% (10/S/S).                     
GLYOXAL DIHYDRATE 107-22-2/ PAPR           WATER          RM             R&M: 0, 1, 2, 4, 8, OR 16              
 C88038.                                                                  MG/ML (10S/S).                        
1,1,2,2-TETRACHLOROETHANE   SOLV           MICRO          RM             R&M: 0, 0.625, 1.25, 2.5,              
 (Superfund Chemical) 79-                                                 5.0, OR 10.0% (5/SEX/                 
 34-5/C03554B.                                                            SPECIES/GROUP).                       
1,1,2,2-TETRACHLOROETHANE   SOLV           GAV            RM             R: 0, 135, 270, OR 540 MG/             
 (Superfund Chemical) 79-                                                 KG M: 0, 337.5, 675, OR               
 34-5/C03554C.                                                            1350 MG/KG (50/S/S).                  
                                                                                                                
----------------------------------------------------------------------------------------------------------------
                        Short-Term Toxicity Studies Scheduled for Peer Review April 1995                        
                                                                                                                
----------------------------------------------------------------------------------------------------------------
METHAPYRILENE               PHAR           FEED           R              MALE RATS: 0, 50, 100,               46
 HYDROCHLORIDE 135-23-9/                                                  250, 1000 PPM; 40/GRP.                
 C55550E.                                                                                                       
----------------------------------------------------------------------------------------------------------------

    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
ENVH  Environmental (Air/Water) Pollutants
FLAM  Flame Retardants
FOOD  Food, Beverages, or Additives
FUEL  As or in Fuel or Oil Products
HERB  Herbicide(s)
IND  Industrial Uses
INTR  Chemical Intermediate or Catalyst
METL  Metals or in Metal Products
PAPR  As or in Paper or Paper Products
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 Expsoure

    SPEC Species:
R=Rats
M=Mice

[FR Doc. 94-27467 Filed 11-4-94; 8:45 am]
BILLING CODE 4140-01-M