[Federal Register Volume 59, Number 47 (Thursday, March 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5493]
[[Page Unknown]]
[Federal Register: March 10, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Toxicology Program (NTP) Board of Scientific Counselors'
Meetings; Announcement of NTP Draft Technical Reports Projected for
Public Review From June 1994 Through Fall 1995
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 four meetings from June 1994 through the
fall of 1995. We plan to continue updating the listing with
announcements in the Federal Register once or twice a year. The next
meeting dates are June 21-22, 1994 and November 29-30, 1994. Specific
dates for 1995 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-time toxicity studies are currently
reviewed by mail; however, when necessary may be reviewed in open
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: March 3, 1994.
Richard Griesemer,
Deputy Director, National Toxicology Program.
Table 1.--Long-Term Studies Tentatively Scheduled for Public Peer Review by the NTP Board of Scientific
Counselors' Technical Reports Review Subcommittee From June 21, 1994, Through Fall 1995
----------------------------------------------------------------------------------------------------------------
NTP TR
Chemical name/Cas No. Use Route Species Exposure levels No.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review June 21-22, 1994
----------------------------------------------------------------------------------------------------------------
Acetonitrile, 75-05-8.............. Solv...... Inhal..... Rm..... R:0, 100, 200, or 400 PPM M: 0, 447
50, 100, or 200 PPM; 50/group.
1-Amino-2,4-dibromoanthraquinone, Dye....... Feed...... Rm..... R: 0, .2, .5, 1.0, 2.0, M: 0, 1.0, 383
81-49-2. 2.0 %/50/per group.
Benzethonium chloride, 121-54-0.... Germ...... Sp........ Rm..... R&M: 0, 0.15, 0.5, 1.5 MG/KG/50/ 438
group.
Tert-butyl alcohol, 75-65-0........ Phar...... Water..... Rm..... R: 0, 0.125, 0.25, 0.5% (M). 0, 436
0.25, 0.5, 1.0% (F). M: 0, 0.5,
1.0, 2.0% (M&F)/50 per group.
Init/prom comparative mouse study Phar...... SP........ Mm..... DMBA/Acetone (50, 25, 2.5UG), DMBA
(DMBA/TPA/BPO/MNNG) init/prom. 2.5, TPA 5UG, BPO 20MG, DMBA/TPA
(2.5, 25, 50UG/5UG), DMBA/BPO
(2.5, 25UG/20MG) and MNNG/Acetone
(1000, 500, 100UG), MNNG 100UG,
TPA, 5UG, BPO 20MG, MNNG/BPO
(100, 500, 1000UG/20MG), MNNG/TPA
(100, 1000UG/5UG).
Init/prom comparative mouse study Phar...... Sp........ Mm..... DMBA/Acetone (25, 2.5, 25UG), DMBA 441
(DMBA/TPA/BPO/MNNG) imit/prom. 2.5, TPA 5 UG, BPO 20MG, DMBA/TPA
(.25, 2.5, 25/5UG), DMBA/BPO
(2.5, 25UG/20MG) and MNNG/Acetone
(1000, 500, 100UG), MNNG 100UG,
TPA 5UG, BPO 20MG, MNNG/BPO (100,
500, 1000UG/20MG), MNNG/TPA
(1000, 1000UG/5UG).
Init/prom comparative mouse study Phar...... Sp........ Mm..... DMBA/Acetone (25, 2.5, 25UG), DMBA 441
(DMBA/TPA/BPO/MNNG) init/prom. 2.5, TPA 5UG, BPO 20MG, DMBA/TPA
(.25, 2.5, 25/5UG), DMBA/BPO
(2.5, 25UG/20MG) and MNNG/Acetone
(1000, 500, 100UG), MNNG 100UG,
TPA 5UG, BPO 20MG, MNNG/BPO (100,
500, 1000UG/20MG), MNNG/TPA
(1000, 1000UG/5UG)..
Init/prom comparative mouse study Phar...... Sp........ Mm..... DMBA/Acetone (25, 2.5, .25UG): 441
(DMBA/TPA/BPO/MNNG) init/prom. DMBA 2.5:TPA 1UG:BPO 20MG: DMBA/
TPA (.25, 2.5, 25/1UG): DMBA/BPO
(2.5, 25UG/20MG) and MNNG/Acetone
(1000, 500, 100UG): MNNG
100UG:TPA 5UG:BPO 20MG: MNNG/BPO
(100, 500, 1000 UG/20MG).
1-trans-delta-9-tetrahydro- Phar...... Gav....... Rm..... R: 0, 12.5, 25, or 50; M: 0, 125,
cannabinol, 1972-08-3. 250, or 500 MG/KG; 50/group.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review November 29-30, 1994
----------------------------------------------------------------------------------------------------------------
2,2-Bis(Bromomethyl)-1,3- Flam...... Feed...... Rm..... R: 0, 2500, 5000, or 10000 PPM; 70/
Propanediol, 3296-90-0. 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........
Nickel (II) oxide, 1313-99-1....... Intr...... Inhal..... Rm..... R: 0, .62, 1.25, or 2.5 M: 0,
1.25, 2.5, or 5.0 MG/M3; 50/group.
Nickel sulfate hexahydrate, 10101- Intr...... Inhal..... Rm..... R: 0, 0.125, 0.25, or 0.5 M: 0,
97-0. .25, .5, or 1.0 MG/M3; 50/group.
Nickel subsulfide, 12035-72-2...... Envh...... Inhal..... Rm..... R: 0, 0.075, or 0.15 M: 0, 0.6, or
1.2 MG/M3; 50/group.
Triethanolamine, 102-71-6.......... Dtrg...... Sp........ Rmm.... MR: 0, 32, 63, or 125; FR: 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, 85-68-7.... Plas...... Feed...... Rr..... MR: 0, .3%, .6%, or 1.2%; 60/group
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
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, Mice:
trimethylquinoline (monomer), 147- 0, 6, or 10 MG/KG (core).
47-7.
1,2-dihydro-2,2,4- Rubr...... Sp........ Rm..... Rats: 0, 36, 60, or 100 MG/KG,
trimethylquinoline (monomer), 148- Mice: 0, 3.6, 6.0, or 10.0 MG/KG.
47-7.
Salicylazosulfapyridine, 599-79-1.. Phar...... Gav....... Rm..... R: 84, 168, or 337.5 MG/KG; 70/
group M: 675, 1350, or 2700 MG/
KG; 60/group.
Scopolamine hydrobromide Phar...... Gav....... Rmm.... R&M: 0, 1, 5, or 25 MG/KG; 70/
trihydrate, 6533-68-2. group diet restriction, Mice: 0
or .25 MG/KG; 70/group.
----------------------------------------------------------------------------------------------------------------
Chemicals Tentatively Scheduled for Peer Review Fall 1995
----------------------------------------------------------------------------------------------------------------
D & C yellow No. 11, 8003-22-3..... Dye....... Feed...... R...... Rats: 0, 0.05, 0.17, or 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, 1313-27-5..... 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.
Tetrafluoroethylene, 116-14-3, PPM: Food...... Inhal..... Rm..... Mice & FR: 0, 312, 625, or 1250
50/group. MR: 0, 156, 312, or 625.
----------------------------------------------------------------------------------------------------------------
Abbreviations Used in the 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 or Products
Envh Environmental (Air/Water) Pollutants
Flam Flame Retardants
Food Food, Beverages, or Additives
Fuel As or in Fuel or Oil Products
Germ Germicides, Disinfectants, Antiseptics
Herb Herbicide(s)
Ind Industrial Uses
Intr Chemical Intermediate or Catalyst
Labc Unspecified Chemical Uses not Fitting in Solv, Intr, or Reag
categories
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
Spec Species:
R=Rats
M=Mice
Table 2.--Short-Term Toxicity Studies Schedule for Peer Review by the NTP Board of Scientific Counselors'
Technical Reports Review Subcommittee during 1994
----------------------------------------------------------------------------------------------------------------
NTP
Chemical name/CAS No. Use Route Species Exposure levels TR
No.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review January 1994
----------------------------------------------------------------------------------------------------------------
Beta-bromo-beta-nitrostyrene, 7166- Pest...... Gav....... Rm..... R&M 0, 0.037, 0.075, 0.3, 0.15, 0- 40
19-0. .6 G/KG; 10/group.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review February 1994
----------------------------------------------------------------------------------------------------------------
1,3-diphenylguanidine 102-06-7..... Rubr...... Feed...... Rm..... R&M: 250, 500, 750, 1500, 3000 PPM/ 42
10 Per Group.
1-nitropyrene 5522-43-0............ Labc...... Inhal..... R...... R: 0, 0.5, 2.0, 8.0, 20.0, OR 50.0 34
MG/M3 12/S/group (CORE); 5/S/group
for lung burden.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review April 1994
----------------------------------------------------------------------------------------------------------------
Dibutyl phthalate 84-74-2.......... Plas...... Feed...... Rm..... In utero with F344 Rats; see 30 30
C62022B.
Dibutyl phthalate 84-74-2.......... Plas...... Feed...... Rm..... R: 0, 2500, 5000, 10000, 20000, OR 30
40000 Ppm R: 0, 1250, 2500, 5000,
10000, 20000 PPM (10/S/S).
Methapyrilene hydrochloride 135-23- Phar...... Feed...... R...... Male rats: 0, 50, 100, 250, 1000 46
9. PPM; 40/group.
----------------------------------------------------------------------------------------------------------------
Short-Term Toxicity Studies Scheduled for Peer Review May 1994
----------------------------------------------------------------------------------------------------------------
Cyclohexanone oxime 100-64-1....... Plas...... Water..... M...... 0, 625, 1250, 2500, 5000, OR 50 50
10000 PPM; 10/group.
Lead ores leadores................. Metl...... Feed...... R...... Ores: Males rats, 30/Group; lead 48
sulfide used as standard: male and
female 30/Group; 10 add'l males
treated 180 days (PB sulfide) 0,
10, 30, & 100 PPM; particle size
<38 microns;="" 30,="" 60,="" 90-day="" sacrifice.="" lead="" sulfide="" 1314-87-0.............="" pnt.......="" feed......="" r......="" rats:="" male="" and="" female="" 0,="" 10,="" 30,="" 48="" 100="" ppm,="" 10/group="" 30,="" 60,="" 90,="" 180="" day="" sac.="" methylene="" blue="" trihydrate,="" 7220-79-="" dye.......="" gav.......="" rm.....="" r&m:="" 0,="" 0.125,="" 0.25,="" 0.5,="" 1.0,="" 2.0="" 51="" 3.="" gm/kg="" body="" wt.="" r:="" 20/group/sex;="" m:="" 10/group/sex.="" methyl="" ethyl="" ketoxime,="" 96-29-7.....="" pnt.......="" water.....="" rm.....="" r&m:="" 0,="" 625,="" 1250,="" 2500,="" 5000,="" or="" 10000="" ppm;="" 10/group.="" ----------------------------------------------------------------------------------------------------------------="" short-term="" toxicity="" studies="" scheduled="" for="" peer="" review="" june="" 1994="" ----------------------------------------------------------------------------------------------------------------="" class="" study="" of="" halogenated="" ethanes:="" 1,2-pitchloro-1,1-difluoroethane="" ind.......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" 1649-08-7.="" day;="" 5/group.="" 1,2-difluror-1,1,2,2-tetra-="" solv......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" chloroethane="" 76-12-0.="" day;="" 5/group.="" hexachloroethane="" 67-72-1.........="" solv......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" day;="" 5/group.="" pentabromoethane="" 75-95-6.........="" ind.......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" day;="" 5/group.="" pentachloroethane="" 76-01-7........="" solv......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" day;="" 5/group;="" 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/group.="" 1,1,2,2-tetrabromoethane="" 79-27-6.="" flam......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" day;="" 5/group.="" 1,1,1,2-tetrachloroethane="" 630-20-="" intr......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" 6.="" day;="" 5/group.="" 1,1,2,2-tetrachloroethane="" 79-34-5="" solv......="" gav.......="" r......="" male="" rats="" 0,="" 0.62,="" 1.24="" mmol/kg/="" 45="" day;="" 5/group.="" 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/group.="" ----------------------------------------------------------------------------------------------------------------="" short-term="" toxicity="" studies="" scheduled="" for="" peer="" review="" 1994="" ----------------------------------------------------------------------------------------------------------------="" cadium="" oxide="" 1306-19-0.............="" elec......="" inhal.....="" rm.....="" r,m:="" 0,="" 0.025,="" 0.05,="" 0.1,="" 0.25="" or="" 39="" 1.0="" mg/m3="" (10/s/s).="" cadium="" oxide="" 1306-19-0.............="" elec......="" inhal.....="" rm.....="" rats="" &="" mice:="" 0,="" 0.025,="" 0.05,="" 0.1,="" 39="" 0.25="" or="" 1.0="" mg/mg="" (10/s/s).="" ----------------------------------------------------------------------------------------------------------------="" short-term="" toxicity="" studies="" scheduled="" for="" peer="" review="" august="" 1994="" ----------------------------------------------------------------------------------------------------------------="" methacrylonitrile="" 126-98-7.........="" plas......="" gav.......="" rm.....="" r:="" 0,7.5,15.0,30.0,0,60.0,120.0="" mg/="" 47="" kg/day;="" m:="" 0,0.75,1.5,3.0,6.0,12.0="" mg/kg/day;="" rats:="" 20/grp;="" mice:="" 10/="" group.="" ----------------------------------------------------------------------------------------------------------------="" short-term="" toxicity="" studies="" scheduled="" for="" peer="" review="" september="" 1994="" ----------------------------------------------------------------------------------------------------------------="" benzophenone="" 119-61-9..............="" phar......="" feed......="" rm.....="" r&m:="" 0,0.125,0.25,0.5,1.0,2.0%;="" r:="" 20/sex/grp;="" m:="" 10/sex/group.="" m-chloroaniline="" 108-42-9...........="" intr......="" gav.......="" rm.....="" r&m="" 0,="" 10,="" 20,="" 40,="" 80,="" 160="" mg/kg,="" 43="" 20/grp="" (rats);="" 10/group="" mice.="" o-chloroaniline="" 95-51-2............="" dye.......="" gav.......="" rm.....="" r&m="" 0,="" 10,="" 20,="" 40,="" 80="" &="" 160="" mg/kg,="" 43="" 20/group="" (rats);="" 10/group="" mice.="" 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/group..="" 3,3',4,4'-tetrachloro-azobenzene="" 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).="" 3,3',4,4'-tetrachloro-azobenzene="" 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).="" o-toluidine="" hydrochloride="" 636-21-5.="" dye.......="" feed......="" r......="" o="" and="" 0="" altered="" microflora;="" 20/="" 44="" group;="" 5000="" ppm;="" 60="" group.="" ----------------------------------------------------------------------------------------------------------------="" short-term="" toxicity="" studies="" scheduled="" for="" peer="" review="" october="" 1994="" ----------------------------------------------------------------------------------------------------------------="" oxymetholone="" 434-07-1..............="" phar......="" gav.......="" rm.....="" r:="" 0,="" 80,="" 160,="" 315,="" 625,="" or="" 1250="" mg/="" 49="" kg;="" 20/sex/group="" m:="" 0,="" 160,="" 320,="" 630,="" 1250,="" or="" 2500="" mg/kg;="" 10/sex/="" group.="" 1,1,1-trichloroethane="" 71-55-6......="" solv......="" micro.....="" rm.....="" r&m:="" 0,="" 0.5,="" 1.0,="" 2.0,="" 4.0,="" and="" 8.0="" %="" (10/s/s).="" ----------------------------------------------------------------------------------------------------------------="" 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="" or="" products="" envh="" environmental="" (air/water)="" pollutants="" flam="" flame="" retardants="" food="" food,="" beverages,="" or="" additives="" fuel="" as="" or="" in="" fuel="" or="" oil="" products="" germ="" germicides,="" disinfectants,="" antiseptics="" herb="" herbicide(s)="" ind="" industrial="" uses="" intr="" chemical="" intermediate="" or="" catalyst="" labc="" unspecified="" chemical="" uses="" not="" fitting="" in="" solv,="" intr,="" or="" reag="" categories="" 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="" spec="" species:="" r="Rate" m="Mice" [fr="" doc.="" 94-5493="" filed="" 3-9-94;="" 8:45="" am]="" billing="" code="" 4140-01-m="">