Best Practice Approach for Assessment of Microchip-associated Tumors in Preclinical Safety Studies: Position of the Registry of Industrial Toxicology Animal-data (RITA)

Author:

Lapp Stefanie1,Bube Axel2,Colbatzky Florian A.1,Ernst Heinrich3,Kellner Rupert3,Nolte Thomas1,Rinke Matthias4

Affiliation:

1. Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany

2. Sanofi, Frankfurt, Germany

3. Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany

4. Wülfrath, Germany

Abstract

Microchip (passive radio-frequency identification device) implantation is a common and widely employed means of animal identification in laboratory animal facilities. However, these devices have been associated with tumors of the skin and subcutis in rodents. While microchip-associated tumors are rare, they pose a challenge for accurate diagnosis and documentation in preclinical toxicity studies. Documentation of these tumors should differentiate microchip-associated lesions with spontaneously occurring or test article–induced tumors. Standardizing criteria for microchip-associated lesions will aid the diagnostic process and allow for preclinical regulatory standardization. To this end, the Registry of Industrial Toxicology Animal-data have developed clear recommendations for diagnosis and documentation of microchip-associated lesions.

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

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