[Federal Register Volume 60, Number 127 (Monday, July 3, 1995)]
[Notices]
[Pages 34546-34550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16235]
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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 June 1995 Through Summer 1998
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 Counselors' Technical Reports Review
Subcommittee during their next seven meetings from June 1995 through
the summer of 1998. We plan to continue updating the listing with
announcements in the Federal Register once or twice a year. The next
meeting dates are June 20-21 and December 5-6, 1995. Specific dates for
1996, 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 May 1995 to October 1998 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-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,
FAX 919/541-0719 will furnish final agendas and other program
information prior to a meeting, and summary minutes subsequent to a
meeting.
Dated: June 16, 1995.
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 June 20, 1995 through Summer 1998
----------------------------------------------------------------------------------------------------------------
NTP
Chemical name/cas No. Use Route Species Exposure levels Tr
No.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review June 20-21, 1995
----------------------------------------------------------------------------------------------------------------
BUTYL BENZYL PHTHALATE; 85-68-7..... PLAS FEED RR MR: 0, .3%, .6%, OR 1.2%; 60/GROUP 458
FR: 0, .6%, 1.2%, OR 2.4%; 60/
GROUP.
T-BUTYLHYDROQUINONE; 1948-33-0...... FOOD FEED RMR R&M: 0, 0.125, 0.25, OR 0.5% IN 459
FEED; 70 RATS, 60 MICE.
CODEINE; 76-57-3.................... PHAR FEED RM R: 0, 400, 800, OR 1600 M: 0, 750, 455
1500, OR 3000 PPM; 60/GROUP.
[[Page 34547]]
1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE RUBR SP RMM RATS: 0, 60, OR 100 MG/KG MICE: 0, 455
(MONOMER); 147-47-7. 6, OR 10 MG/KG (CORE).
1,2-DIHYDRO-2,2,4-TRIMETHYLQUINOLINE RUBR SP RM RATS: 0, 36, 60, OR 100 MG/KG MICE: 456
(MONOMER); 147-47-7. 0, 3.6, 6.0, OR 10.0 MG/KG.
FEED RESTRICTION STUDIES............ ........ .......... RM Effect of dietary restriction on 460
toxicology and carcinogenesis
studies in F344/N rats and B6C3F1
mice.
SALICYLAZOSULFAPYRIDINE; 599-79-1... PHAR GAV RM R: 84, 168, OR 337.5 MG/KG; 70/ 457
GROUP M: 675, 1350, OR 2700 MG/KG;
60/GROUP.
SCOPOLAMINE HYDROBROMIDE TRIHYDRATE; PHAR GAV RMM R&M: 0,1,5, OR 25 MG/KG; 70/GROUP 445
6533-68-2. DIET RESTRICTION MICE: 0 OR 25 MG/
KG;70/GROUP.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review December 5-6, 1995
----------------------------------------------------------------------------------------------------------------
D & C YELLOW NO. 11; 8003-22-3...... DYE FEED R RATS: 0, 0.05, 0.17, OR 0.5%; 60/ .....
GROUP.
MOLYBDENUM TRIOXIDE; 1313-27-5...... METL INHAL RM R&M: 10, 30, OR 100 MG/M3; 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.
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).
SODIUM XYLENESULFONATE; 1300-72-7... DTRG SP RM R: 0, 60, 120, OR 240 MG/KG M: 0, .....
182, 364, OR 727 MG/KG (50/SEX/
GROUP).
TETRAFLUOROETHYLENE; 116-14-3....... FOOD INHAL RM MICE & FR: 0, 312, 625, OR 1250 MR: .....
0, 156, 312, OR 625 PPM; 50/GROUP.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review Summer 1996
----------------------------------------------------------------------------------------------------------------
ETHYLBENZENE; 100-41-4.............. RUBR INHAL RM R&M: 0, 75, 250, OR 750 PPM (50/SEX/ .....
SPECIES/GROUP).
INTERFERON AD+3'-AZIDO-3'- PHAR SC&GV MM DUAL ROUTES WITH BOTH COMPOUNDS: .....
DEOXYTHYMIDINE (AIDS INITIATIVE) AZT: 0, 30, 60, OR 120 (GAV) MG/
INTAZTCOMB. 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.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review Fall 1996
----------------------------------------------------------------------------------------------------------------
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).
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 Summer 1997
----------------------------------------------------------------------------------------------------------------
1-CHLORO-2-PROPANOL, TECHNICAL; 127- INTR WATER RM R: 0, 150, 325, OR 650 PPM M: 0, .....
00-4. 250, 500, OR 1000 PPM (50/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
----------------------------------------------------------------------------------------------------------------
COCONUT OIL ACID DIETHANOLAMINE TEXL SP RM R: 0, 50, OR 100 MG/KG M: 0, 100, .....
CONDENSATE; 68603-42-9. OR 200 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 DTRG SP RM R: 0, 50, OR 100 MG/KG M: 0, 100, .....
CONDENSATE; 120-40-1. OR 200 MG/KG (50/SEX/SPECIES/
GROUP).
[[Page 34548]]
OLEIC ACID DIETHANOLAMINE COS SP RM R: 0, 50, OR 100 MG/KG; 50/SEX/ .....
CONDENSATE; 93-83-4. GROUP M: 0, 15, OR 30 MG/KG; 55/
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).
POLYVINYL ALCOHOL; 9002-89-5........ PHAR IVAG M 25% PVA, VEHICLE, UNTREATED; 100/ .....
GROUP.
PRIMACLONE; 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).
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review Summer 1998
----------------------------------------------------------------------------------------------------------------
ETHYLENE GLYCOL MONOBUTYL ETHER SOLV INHAL RM R: 0, 31, 62.5, OR 125 PPM M: 0, .....
(EGMBE); 111-76-2. 62.5, 125, OR 250 PPM; 50/SEX/
SPECIES.
GALLIUM ARSENIDE; 1303-00-0......... ELEC INHAL RM R: 0, 0.01, 0.1, OR 1.0 MG/M3; 50/ .....
SEX/GROUP M: 0, 0.1, 0.5, OR 1.0
MG/M3; 50/SEX/GROUP.
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 RM R: 0, 220, 700, OR 7000 PPM; 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.
----------------------------------------------------------------------------------------------------------------
Table 2.--Short-Term Toxicity Studies Scheduled for Peer Review by the NTP Board of Scientific Counselors'
Technical Reports Review Subcommittee from May 1995 through October 1998
----------------------------------------------------------------------------------------------------------------
NTP
Chemical name/cas No. Use Route Species Exposure levels Tox
No.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review May 1995
----------------------------------------------------------------------------------------------------------------
Halogenated Ethanes Class Study:
1,2-DICHLORO-1,1-DIFLUOROETHANE; IND GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
1649-08-7. DAY; 5/GRP.
1,2-DIFLUROR-1,1,2,2- SOLV GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
TETRACHLOROETHANE; 76-12-0. DAY; 5/GRP.
HEXACHLOROETHANE; 67-72-1......... SOLV GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP.
PENTABROMOETHANE; 75-95-6......... IND GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP.
PENTACHLOROETHANE; 76-01-7........ SOLV GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP; FEMALE RATS 0, 1,24
MMOL/KG/DAY;.
1,1,1,2-TETRABROMOETHANE; 630-16-0 IND GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP.
1,1,2,2-TETRABROMOETHANE; 79-27-6. FLAM GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP.
1,1,1,2-TETRACHLOROETHANE; 630-20- INTR GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
6. DAY; 5/GRP.
1,1,2,2-TETRACHLOROETHANE; 79-34-5 SOLV GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GRP.
1,1,1-TRICHLOROETHANE; 71-55-6.... SOLV GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
DAY; 5/GROUP.
1,1,1-TRICHLORO-2,2,2- IND GAV R MALE RATS 0, 0.62, 1.24 MMOL/KG/ 45
TRIFLUOROETHANE; 354-58-5. DAY; 5/GRP.
METHYL ETHYL KETOXIME; 96-29-7.... PNT WATER RM R&M: 0, 625, 1250, 2500, 5000, OR 51
10000 PPM; 10/GROUP.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review June 1995
----------------------------------------------------------------------------------------------------------------
1,4-BUTANEDIOL; 110-63-4............ INTR .......... ........ Review of metabolism and 54
disposition studies and prediction
of lack of carcinogenicity in long-
term studies..
METHAPYRILENE HYDROCHLORIDE; 135-23- PHAR FEED R MALE RATS: 0, 50, 100, 250, 1000 46
9. PPM; 40/GRP.
O-NITROTOLUENE; 88-72-2............. RUBR FEED R MALE R: 0, 0 ALTERED MICROFLORA 20/ 44
GRP; 5000 PPM 60/GRP; 5000 PPM
ALTERED MICROFLORA 40/GRP.
O-TOLUIDINE HYDROCHLORIDE; 636-21-5. DYE FEED R O AND 0 ALTERED MICROFLORA; 20/GRP; 44
5000 PPM; 60/GRP.
1,1,1-TRICHLOROETHANE; 71-55-6...... SOLV MICRO RM R&M: 0, 0.5, 1.0, 2.0, 4.0, AND 8.0 41
% (10/S/S).
URETHANE; 51-79-6................... PNT WATER RM R&M: (DEIONIZED WATER VEHICLE) 52
0.011, 0.033, 0.11, 0.33, OR 1.0 G/
100 ML.
[[Page 34549]]
URETHANE + ETHANOL (COMBINATION) PNT WATER RM R&M:(WITH 5% ETHANOLIN WATER) 52
URETHCOMB. 0.011, 0.033, 0.11, 0.33, OR 1.0 G/
100 ML.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review August 1995
----------------------------------------------------------------------------------------------------------------
CIS & TRANS 1,2-DICHLOROETHYLENE; SOLV MICRO RM 55
540-59-0.
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
Short-Term Toxicity Studies Scheduled for Peer Review November 1995
----------------------------------------------------------------------------------------------------------------
M-CHLOROANILINE; 108-42-9........... INTR GAV RM R&M 0, 10, 20, 40, 80, 160 MG/KG, 43
20/GRP (RATS); 10/GRP (MICE).
O-CHLOROANILINE; 95-51-2............ DYE GAV RM R&M 0, 10, 20, 40, 80, & 160 MG/KG; 43
20/GRP (RATS);10/GRP (MICE).
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review March 1996
----------------------------------------------------------------------------------------------------------------
3,3',4,4'-TETRACHLOROAZOXYBENZENE; COMT GAV RM R&M: 0, 0.1, 1.0, 3.0, 10, OR 30 MG/ .....
21232-47-3. KG BODY WEIGHT (M&F 10/GROUP).
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies 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 PHAR GAV MM FEMALE MICE ONLY: 500, 1000 MG/KG/ .....
INITIATIVE); 7481-89-2. DAY.
3,3',4,4'-TETRACHLOROAZOBENZENE; HERB GAV RM R&M: 0, 0.1, 1.0, 3.0, 10, OR 30 MG/ .....
14047-09-7. KG BODY WEIGHT (M&F; 10/GROUP).
1,1,2,2-TETRACHLOROETHANE; 79-34-5.. SOLV MICRO RM .....
1,1,2,2-TETRACHLOROETHANE; 79-34-5.. 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 Scheduled for Peer Review October 1998
----------------------------------------------------------------------------------------------------------------
INDIUM PHOSPHIDE; 22398-80-7........ ELEC INHAL RM R&: 0, 1, 3, 10, 30, OR 100 MG/M3; .....
10/SEX/GROUP.
MAGNETIC FIELDS (EMF); ELECTROMAG... ELEC WB RM 60 HZ MAGNETIC FIELDS--20 MG, 2 G, .....
10 G CONTINUOUS AND 10 G
INTERMITTENT; 10/GROUP.
RETROVIRAL VECTORS RETROVIRVECT..... PHAR IP/IJ RM VARIOUS REGIMENS AND CONTROLS .....
INCLUDED.
----------------------------------------------------------------------------------------------------------------
Abbreviations used in this report:
USE Primary Use Category:
COMT Contaminates and/or Impurities
COSM Cosmetics, Perfumes, Fragrances, Hair Preparations, Skin Lotions
DTRG Detergents and Cleansers
DYE As or in Dyes, Inks, and Pigments
ELEC In Electrical and/or Dielectric Systems
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
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:
[[Page 34550]]
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. 95-16235 Filed 6-30-95; 8:45 am]
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