[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
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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\.
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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
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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.
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Abbreviations used: in this report:
------------------------------------------------------------------------
Use Primary use category
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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.
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Route Route of administration
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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.
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------------------------------------------------------------------------
Spec Species
------------------------------------------------------------------------
R..................................... = Rats.
M..................................... = Mice.
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[FR Doc. 96-14149 Filed 6-7-96; 8:45 am]
BILLING CODE 4140-01-M
