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The North American Control Animal Database: A Resource Based on Standardized Nomenclature and Diagnostic Criteria

Safety Assessment, Adolor Corporation, Pennsylvania 19355, ckeenan{at}adolor.com

Angela Hughes-Earle

Global Preclinical Development, R.W. Johnson Pharmaceutical Research Institute, Spring House, Pennsylvania 19355

Marvin Case

Corporate Toxicology, 3M Company, St. Paul, Minnesota 55144

Barry Stuart

Toxicology, Bayer Corporation, Stilwell, Kansas 66085

Stephen Lake

Toxicology, Bayer Corporation, Stilwell, Kansas 66085

Charles Mahrt

Global Toxicology, Pharmacia, Skokie, Illinois 60077

William Halliwell

Drug Safety and Metabolism, Schering-Plough Research Institute, Lafayette, New Jersey 07848

Richard Westhouse

Drug Safety and Metabolism, Schering-Plough Research Institute, Lafayette, New Jersey 07848

Michael Elwell

Global Research and Toxicology, Pfi zer Inc., Groton, Connecticut 06340

Daniel Morton

Global Toxicology, Pharmacia, Skokie, Illinois 60077

Gerd Morawietz

Fraunhofe r Institute of Toxicology and Aerosol Research, 30625 Hannover, Germany

Susanne Rittinghausen

Fraunhofe r Institute of Toxicology and Aerosol Research, 30625 Hannover, Germany

Ulrich Deschl

BayerAG, 42096 Wuppertal, Germany

Ulrich Mohr

Fraunhofe r Institute of Toxicology and Aerosol Research, 30625 Hannover, Germany

Historical control data have been shown to be valuable in the interpretation and evaluation of results from rodent carcinogenicity studies. Standardization of terminology and histopathology procedures is a prerequisite for meaningful comparison of control data across studies and analysis of potential carcinogenic effects. Standardization is particularly critical for the construction of a database that includes incidence data from different studies evaluated by pathologists in different laboratories. Standardized nomenclature and diagnostic criteria have been established for neoplasms and proliferative lesions. Efforts of the National Toxicology Program, the Society of Toxicologic Pathology (STP), and the Registry of Industrial Toxicology Animal-data (RITA) have led to a harmonized pathology nomenclature for the rat and the mouse. This nomenclature with detailed descriptions of lesions is available in publications by the STP and International Agency for Research on Cancer (IARC). A listing of these terms is available on the World Wide Web. Utilizing the model established by RITA and working with the International Life Sciences Institute (ILSI), companies with laboratories in North America formed a working group in 1994 to establish and maintain a database of neoplastic and proliferative lesions from control animals in carcinogenicity studies. The rationale for development of the North American Control Animal Database (NACAD), the factors that influence tumor incidence, operation of the database, and the benefits to be realized by using a standardized approach are discussed.

Key Words: Rat • mouse • histopathology • pathology • historical control data • NACAD • RITA • ILSI • neoplasia • neoplastic lesion.

Toxicologic Pathology, Vol. 30, No. 1, 75-79 (2002)
DOI: 10.1080/01926230252824734


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