02-17655. National Toxicology Program; National Toxicology Program Board of Scientific Counselors Technical Reports Review Subcommittee Meeting; Review of Draft NTP Technical Reports

Pursuant to Public Law 92-463, notice is hereby given of the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors Technical Reports Review Subcommittee on September 5 and 6, 2002, in the Rodbell Auditorium, Rall Building, South Campus, National Institute of Environmental Health Sciences (NIEHS), 111 T.W. Alexander Drive, Research Triangle Park, North Carolina. The meeting will begin at 8:30 a.m. each day.

Agenda

The primary agenda topic is the peer review of seven draft Technical Reports (TR) of rodent toxicology and carcinogenesis studies conducted by the NTP. The reports are listed in the table below in the tentative order of their review for each day. The NTP Technical Reports will be reviewed over two days: reports numbered TR 510 to TR 514 on September 5 and reports numbered TR 516 and TR 517 on September 6. There will also be brief presentations on September 6 concerning the use of transgenic models in carcinogenic hazard identification and NTP studies.

The agenda and roster of subcommittee members will be available prior to the meeting on the NTP Web home page at http://ntp-server.niehs.nih.gov and upon request to the NTP Executive Secretary, Dr. Mary S. Wolfe, P.O. Box 12233, 111 T.W. Alexander Dr., MD A3-01, Research Triangle Park, NC 27709, T: 919-541-0295; e-mail: [e-mail]. Following the meeting, summary minutes will be available on the NTP Web home page and in hard copy upon request to the Executive Secretary. Plans are also underway for making this meeting available for viewing on the Internet (http://www.niehs.nih.gov/​external/​video.htm).

The NTP Board of Scientific Counselors Technical Reports Review Subcommittee meeting is open to the public. Attendance at this meeting is limited only by the space available. Individuals who plan to attend are asked to register with the NTP Executive Secretary (see contact information above). The names of those registered to attend will be given to the NIEHS Security Office in order to gain access to the campus. Persons attending who have not pre-registered may be asked to provide pertinent information about the meeting, i.e., title or host of meeting before gaining access to the campus. All visitors (whether or not you are pre-registered) will need to be prepared to show 2 forms of identification (ID), i.e., driver's license and one of the following: company ID, government ID, or university ID. Also, those planning to attend who need special assistance are asked to notify the NTP Executive Secretary in advance of the meeting (see contact information above).

Draft Reports Available for Public Review and Comment

Approximately five weeks prior to the meeting, the draft reports will be available for public review, free of charge, through the Environmental Health Perspectives (EHP) at http://ehp.niehs.nih.gov/​. Printed copies can be obtained, as available, from Central Data Management (CDM), NIEHS, 111 T.W. Alexander Dr., P.O. Box 12233, MD EC-03, Research Triangle Park, NC 27709, t: 919-541-3419, fax: [phone], e-mail: [e-mail].

Comments on any of the NTP Technical Reports are welcome. Time will be provided at the meeting for public comment on each of the reports under review. In order to facilitate planning for the meeting, persons requesting time for an oral presentation on a particular report are asked to notify the Executive Secretary at 919-541-0530, fax: [phone], e-mail: [e-mail]. Persons registering to submit comments are asked to provide a written copy of their statement to the Executive Secretary on or before August 28, 2002, to enable review by the Subcommittee and NTP staff prior to the meeting. Written statements can supplement and may expand the oral presentation or may be submitted in lieu of an oral presentation. Each submitter is asked to provide his/her name, affiliation, mailing address, phone, fax, e-mail, and supporting organization (if any). Each speaker will be allotted at least seven minutes and, if time permits, up ten minutes for presentation of oral comments. Each organization is allowed one time slot per report being reviewed. Registration for making public comments will also be available on-site. If registering on-site to speak and read comments from printed copy, the speaker is asked to provide 25 copies of the statement. These copies will be distributed to the Subcommittee and NTP staff and will supplement the record.

Request for Additional Information

The NTP would welcome receiving toxicology and carcinogenesis information from completed, ongoing or planned studies as well as current production data, human exposure information, and use patterns for any of the chemicals listed in this announcement. Please send this information to CDM at the address given above. CDM will forward the information to the appropriate NTP staff scientist.

NTP Technical and Toxicity Report Series

The NTP conducts toxicology and carcinogenesis studies of agents of public health concern. Any scientist, organization, or member of the public may nominate a chemical for NTP testing. Details about the nomination process are available on the NTP Web site (http://ntp-server.niehs.nih.gov). The results of short-term rodent toxicology studies are published in the NTP Toxicity Report series. Longer-term studies, generally, rodent carcinogenicity studies, are published in the NTP Technical Report series. Study abstracts for all reports are available at the NTP Web site under NTP Study Information. Hard copies and PDF files of published reports can be obtained through subscription to the EHP (http://ehp.niehs.nih.gov/​ or 1-800-315-3010).

NTP Board of Scientific Counselors

The Board is a technical advisory body composed of scientists from the public and private sectors who provide primary scientific oversight and peer review to the NTP. Specifically, the Board advises the NTP on matters of scientific program content, both present and future, and conducts periodic review of the program for the purpose of determining and advising on the scientific merit of its activities and overall scientific quality. The Technical Reports Review Subcommittee of the Board provides scientific peer review of the findings and conclusions of NTP Technical Reports. The Report on Carcinogens Subcommittee of the Board provides scientific peer review of nominations to the Report on Carcinogens, a Congressionally mandated listing of agents known or reasonably anticipated to be human carcinogens.

The Board's members are selected from recognized authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment, carcinogenesis, mutagenesis, molecular biology, behavioral and neurotoxicology, immunotoxicology, reproductive toxicology or teratology, and biostatistics. The NTP strives for equitable geographic distribution and minority and female representation on the Board.

Dated: July 5, 2002.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

Technical Reports Tentatively Scheduled for Review by the NTP Board of Scientific Counselors Technical Reports Review Subcommittee on September 5-6, 2002

Chemical CAS No.	Report No.	Primary uses	Route & exposure levels	Review order
September 5, 2002:
Dipropylene glycol, 25265-71-8	TR 511	A component of air and room fresheners, household cleansers, cosmetic formulations, auto paints, and antifreeze	Two-year exposure via drinking water: 2,500, 10,000, or 40,000 ppm to male and female F344/N rats and 10,000, 20,000, or 40,000 ppm to male and female B6C3F1 mice	1
Elmiron, 37319-17-8	TR 512	Used in treatment of thrombosis and hyperlipidemia and for relief of urinary bladder pain associated with interstitial cystitis	Two-year exposure by gavage in deionized water: 14, 42, or 126 mg/kg body weight to male F344/N rats; 28, 84, or 252 mg/kg to female F344/N rats; 56, 168, or 504 mg/kg to male and female B6C3F1 mice	2
Decalin, 91-17-8	TR 513	An industrial solvent for fats, resins, oils, waxes, and naphthalene; a substitute for turpentine; a constituent of motor fuels and lubricants	Two-year inhalation exposure (25, 100, or 400 ppm in air) to male and female F344/N rats and B6C3F1 mice	3
Urethane + ethanol, 51-79-6, 64-17-5	TR 510	Urethane is a by-product of fermentation and occurs in breads and alcoholic beverages. The effect of urethane was studied in combination with alcohol (ethanol)	Two-year drinking water exposures of 10, 30, or 90 ppm urethane in 0, 2.5%, or 5% ethanol mixtures to male and female B6C3F1 mice	4
Cinnamaldehyde, 14371-10-9	TR 514	A flavoring and fragrance ingredient; the primary component of cinnamon oil	Two-year exposure of microencapsulated chemical in feed (1,000, 2,100, or 4,100 ppm) to male and female F344/N rats and B6C3F1 mice	5
September 6, 2002:
Trimethylolpropane triacrylate, 15625-89-5	TR 516	A representative multifunctional acrylate used in photocurable inks and coatings, acrylic glues, paper and wood impregnates, wire and cable extrusion, and polymer-concrete composites	Six-month dermal applications (0.75, 1.5, 3, 6, or 12 mg/kg body weight) to male and female Tg.AC hemizygous mice	6
Pentaerythritol triacrylate, 3524-68-3	TR 517	Representative multifunctional acrylate used in photocurable inks and coatings and as an ingredient of acrylic glues, adhesives, and sealants	Six-month dermal applications (0.75, 1.5, 3, 6, or 12 mg/kg body weight) to male and female Tg.AC hemizygous mice	7