National Toxicology Program

The "Abstracts of NTP Short-term Toxicity Studies" includes the abstracts as taken from the published toxicity reports (TOX) of the NTP. The chemical exposure period for most of these studies was up to 13-weeks. Studies are conducted in compliance with Food and Drug Administration Good Laboratory Practice Regulations (21 CFR, Part 58). In addition, as records from the studies are submitted to the NTP Archives, they are audited retrospectively by an independent quality assurance contractor. Separate audits covering completeness and accuracy of the pathology data, pathology specimens, final pathology tables, and preliminary review draft of NTP Toxicity Reports are conducted. Audit procedures and findings are presented in the reports and are on file at NIEHS. The audit findings are reviewed and assessed by NTP staff so that any discrepancies are resolved or otherwise addressed during the preparation of each Technical report.

These NTP toxicology studies have been reviewed by a Technical Reports Review Subcommittee, a standing subcommittee of the NTP Board of Scientific Counselors, which provides peer review of the draft toxicity reports. This committee is aided by an ad hoc Panel of Experts chosen primarily to encompass expertise in toxicology, pathology, and biostatistics. The date and the list of chemical studies to be reviewed by the subcommittee are announced in the Federal Register.

Definition of Toxicity Results:

The National Toxicology Program describes the results of individual experiments on a chemical agent and notes the strength of evidence for conclusions regarding each study. Negative results, in which the study animals do not have a greater incidence of toxicity than control animals, do not necessarily mean that a chemical is not a toxic agent, inasmuch as the experiments are conducted under a limited set of conditions. Positive results demonstrate that a chemical is toxic for laboratory animals under the conditions of the study and indicate that exposure to the chemical has the potential for hazard to humans. The terms toxicity and toxicology are defined in several well known references.

Abstracts are taken from the published reports for the individual studies. A link to the full report is listed at the end of each abstract. For NTP study information, e-mail Central Data Management, if you have your return mail address in your Web browser preferences, or contact:

Central Data Management
National Institute of Environmental Health Sciences
P.O. Box 12233
Mail Drop EC-03
Research Triangle Park, NC 27709-2233

Telephone number: (919) 541-3419; FAX number: (919) 541-3687