Evaluation of organ weights for rodent and non-rodent toxicity studies

a review of regulatory guidelines and a survey of current practices.

Bindhu Michael, Barry Yano, Rani S. Sellers, Rick Perry, Daniel Morton, Nigel Roome, Julie K. Johnson, Ken Schafer, Sue Pitsch

Research output: Contribution to journalArticle

122 Citations (Scopus)

Abstract

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 that break 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.

Original languageEnglish (US)
Pages (from-to)742-750
Number of pages9
JournalToxicologic Pathology
Volume35
Issue number5
DOIs
StatePublished - 2007
Externally publishedYes

Fingerprint

Organ Size
Toxicity
Rodentia
Guidelines
Industry
Weighing
Brain
Body Weight
Veterinary Drugs
Geographic Locations
Consumer products
Pathology
Adrenal Glands
North America
Liver
Toxicology
Inhalation
Uterus
Reproduction
Surveys and Questionnaires

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Toxicology
  • Health, Toxicology and Mutagenesis

Cite this

Evaluation of organ weights for rodent and non-rodent toxicity studies : a review of regulatory guidelines and a survey of current practices. / Michael, Bindhu; Yano, Barry; Sellers, Rani S.; Perry, Rick; Morton, Daniel; Roome, Nigel; Johnson, Julie K.; Schafer, Ken; Pitsch, Sue.

In: Toxicologic Pathology, Vol. 35, No. 5, 2007, p. 742-750.

Research output: Contribution to journalArticle

Michael, B, Yano, B, Sellers, RS, Perry, R, Morton, D, Roome, N, Johnson, JK, Schafer, K & Pitsch, S 2007, 'Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices.', Toxicologic Pathology, vol. 35, no. 5, pp. 742-750. https://doi.org/10.1080/01926230701595292
Michael, Bindhu ; Yano, Barry ; Sellers, Rani S. ; Perry, Rick ; Morton, Daniel ; Roome, Nigel ; Johnson, Julie K. ; Schafer, Ken ; Pitsch, Sue. / Evaluation of organ weights for rodent and non-rodent toxicity studies : a review of regulatory guidelines and a survey of current practices. In: Toxicologic Pathology. 2007 ; Vol. 35, No. 5. pp. 742-750.
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