[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] ----------------------------------------------------------------------- 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