National Toxicology Program

[Federal Register: Draft approved May 6, 1998 May 14, 1998 (Vol. 63, Number 93]
[Notices]
[Page 26818-26820]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

National Toxicology Program; Availability of the Report on Carcinogens, Eighth Edition

Background

The National Toxicology Program (NTP) announces the availability of the Report on Carcinogens, Eighth Edition.

The Report on Carcinogens (RoC) is a Congressionally-mandated listing of known human carcinogens and reasonably anticipated human carcinogens and its preparation is delegated to the National Toxicology Program by the Secretary, Department of Health and Human Services (HHS). Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, (HHS), shall publish a report which contains a list of all substances (1) which either are known to be human carcinogens or may reasonably be anticipated to be human carcinogens; and (2) to which a significant number of persons residing in the United States (US) are exposed. The law also states that the reports should provide available information on the nature of exposures, the estimated number of persons exposed and the extent to which the implementation of Federal regulations decreases the risk to public health from exposure to these chemicals.

The new entries for the 8th RoC have undergone a multiphased peer review process involving two Federal scientific review groups and one non-government, scientific peer review body (a subcommittee of the NTP Board of Scientific Counselors) which met in an open, public meeting that included a public comment session. All data relevant to the criteria for inclusion of candidate agents, substances or mixtures in the RoC have been evaluated by the three scientific review committees.

In the 8th RoC, the NTP is adding 14 agents, substances or mixtures to the existing list. In addition, thiotepa, which is currently listed in previous Reports on Carcinogens as reasonably anticipated to be a human carcinogen is moved to the known human carcinogen list. These agents, substances or mixtures are provided in the following table with their Chemical Abstracts Services (CAS) Registry numbers and listing. The 8th RoC also contains an appendix which is a reference to certain "Manufacturing Processes, Occupations and Exposure Circumstances" that have not yet been formally reviewed by the NTP for RoC listing but have been classified by IARC as sources which are known to be carcinogenic to humans because of the associated increased incidences of cancer in workers in these settings. In the interest of public health and for completeness, these occupational exposures have been referenced in an appendix to the Report with the corresponding IARC citation given.

Hard copies of the 8th RoC, or the 8th RoC Summary (which contains the same information that is in the full Report with the exception of specific information on regulations promulgated by regulatory health agencies) can be obtained by contacting the NIEHS Environmental Health Information Service, ATTN: Order Processing, P.O. Box 12510, Research Triangle Park, NC 27709-2510 , fax number (919) 541-0763, email: ehis@niehs.nih.gov. The 8th RoC Summary is also available on the internet and can be accessed from the NIEHS Environmental Health Information Service Home Page at: http://ehis.niehs.nih.gov/ or from the NTP Home Page at: http://ntp.niehs.nih.gov/ntp/.

Questions or comments concerning the 8th RoC should be directed to: Dr. C. W. Jameson, National Toxicology Program, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 541-2242, email: jameson@niehs.nih.gov.

Attachment

Dated: May 6, 1998

____________________________
Kenneth Olden, Ph. D.
Director
National Toxicology Program

[Billing Code 4140-01-P]

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Attachment

Summary for
Agents, Substances or Mixtures newly listed in
the Report on Carcinogens, Eighth Edition

CHEMICAL/ CAS NUMBER	PRIMARY USES	Newly LISTED AS
AZACITIDINE/ 320-67-2	Used as a cytostatic agent in the treatment of acute leukemia.	Reasonably Anticipated to be a Human Carcinogen
p-CHLORO-o-TOLUIDINE and its HCl salt/ 95-69-2	Used to produce azo dyes for cotton, silk acetate and nylon and as intermediate in production of Pigment Red 7 and Pigment Yellow 49. Also an impurity in and a metabolite of the pesticide chlordimeform.	Reasonably Anticipated to be a Human Carcinogen
CHLOROZOTOCIN/ 54749-90-5	Used as a cytostatic agent in the treatment of cancers of the stomach, large intestine pancreas and lung; melanoma; and multiple myeloma.	Reasonably Anticipated to be a Human Carcinogen
CYCLOSPORIN/ 59865-13-3	Used as an immunosuppressive agent in the prevention and treatment of graft-vs-host reactions in bone marrow transplantation and for the prevention of rejection of kidney, heart, and liver transplants.	Known to be a Human Carcinogen
DANTHRON/ (1,8-Dihydroxyanthraquinone) 117-10-2	Used as a laxative and as an intermediate in the manufacture of dyes.	Reasonably Anticipated to be a Human Carcinogen
1,6-DINITROPYRENE/ 42397-64-8	Not used commercially, detected in ambient atmospheric samples and as a constituent of diesel exhaust.	Reasonably Anticipated to be a Human Carcinogen
1,8-DINITROPYRENE/ 42397-65-9	Not used commercially, detected in ambient atmospheric samples and as a constituent of diesel exhaust.	Reasonably Anticipated to be a Human Carcinogen
DISPERSE BLUE 1/ (1,4,5,8-Tetraaminoanthraquinone) 2475-45-8	Used as an anthraquinone based dyestuff in hair color formulations and in coloring fabrics and plastics.	Reasonably Anticipated to be a Human Carcinogen
FURAN/ 110-00-9	Used as an intermediate in the synthesis and production of other organic compounds.	Reasonably Anticipated to be a Human Carcinogen
o-NITROANISOLE/ 91-23-6	Used as a precursor in the synthesis of o-anisidine which is used in the manufacture of over 100 azo dyes.	Reasonably Anticipated to be a Human Carcinogen
6-NITROCHRYSENE/ 7496-02-8	Not used commercially, detected in ambient atmospheric samples.	Reasonably Anticipated to be a Human Carcinogen
1-NITROPYRENE/ 5522-43-0	Not used commercially, detected in ambient atmospheric samples and as a constituent of diesel and gasoline engine exhaust.	Reasonably Anticipatedto be a Human Carcinogen
4-NITROPYRENE/ 57835-92-4	Not used commercially, detected in ambient atmospheric samples.	Reasonably Anticipated to be a Human Carcinogen
THIOTEPA/ 52-24-4	Used as a cytostatic agent in the treatment of lymphomas and a variety of solid tumors, such as breast and ovary. It has also been used at high doses in combination chemotherapy with cyclophosphamide in patients with refractory malignancies treated with autologous bone transplantation.	Known to be a Human Carcinogen
1,2,3-TRICHLOROPROPANE/ 96-18-4	Used as a polymer crosslinking agent, paint and varnish remover, solvent and degreasing agent. It has been found as an impurity in certain nematicides and soil fumigants and has been detected in drinking and ground water in various parts of the United States.	Reasonably Anticipated to be a Human Carcinogen