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Evaluation of Organ Weights for Rodent and Non-Rodent Toxicity Studies: A Review of Regulatory Guidelines and a Survey of Current Practices

¹ Merck Research Laboratories, West Point, Pennsylvania 19586, USA
² The Dow Chemical Company, Midland, Michigan 48674, USA
³ Albert Einstein College of Medicine Bronx, New York 10461, USA
⁴ Wyeth Research, Chazy, New York 12921, USA
⁵ Pfizer, Inc., Groton, Connecticut 06340, USA
⁶ Sanofi-Aventis, Porcheville, France
⁷ Abbott Laboratories, Abbott Park, Illinois 60064, USA
⁸ Vet Path Services, Inc., Cincinnati, Ohio 45249, USA

Correspondence: Address correspondence to Sue Pitsch, Society of Toxicologic Pathology, 1821 Michael Faraday Drive, Suite 300, Reston, VA 20190, USA; e-mail:spitsch{at}toxpath.org

The Society of Toxicologic Pathology convened a working group to evaluate current practices regarding organ weights in toxicology studies. A survey was distributed to pharmaceutical, veterinary, chemical, food/nutritional and consumer product companies in Europe, North America, and Japan. Responses were compiled to identify organs routinely weighed for various study types in rodent and non-rodent species, compare methods of organ weighing, provide perspectives on the value of organ weights and identify the scientist(s) responsible for organ weight data interpretation. Data were evaluated as a whole as well as by industry type and geographic location. Regulatory guidance documents describing organ weighing practices are generally available, however, they differ somewhat dependent on industry type and regulatory agency. While questionnaire respondents unanimously stated that organ weights were a good screening tool to identify treatment-related effects, opinions varied as to which organ weights are most valuable. The liver, kidneys, and testes were commonly weighed and most often considered useful by most respondents. Other organs thatbreak were commonly weighed included brain, adrenal glands, ovaries, thyroid glands, uterus, heart, and spleen. Lungs, lymph nodes, and other sex organs were weighed infrequently in routine studies, but were often weighed in specialized studies such as inhalation, immunotoxicity, and reproduction studies. Organ-to-body weight ratios were commonly calculated and were considered more useful when body weights were affected. Organ to brain weight ratios were calculated by most North American companies, but rarely according to respondents representing veterinary product or European companies. Statistical analyses were generally performed by most respondents. Pathologists performed interpretation of organ weight data for the majority of the industries.

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				R. S. Sellers, D. Mortan, B. Michael, N. Roome, J. K. Johnson, B. L. Yano, R. Perry, and K. Schafer Society of Toxicologic Pathology Position Paper: Organ Weight Recommendations for Toxicology Studies Toxicol Pathol, August 1, 2007; 35(5): 751 - 755. [Abstract] [Full Text] [PDF]