Recommendations for Routine Sampling, Trimming, and Paraffin-Embedding of Female Reproductive Organs, Mammary Gland, and Placenta in the Cynomolgus Monkey

Abstract

In toxicity studies, the nonhuman primate is often the species of choice to evaluate the toxicologic potential of chemicals and drugs. Especially in the case of effects on female reproductive organs and mammary glands, other animal species are less predictive for man. To enable reliable histopathologic interpretation allowing a solid safety assessment, it is a prerequisite to obtain material of consistently high quality. Standardization of autopsy techniques, tissue sampling, and fixation and staining procedures will help significantly to obtain the quality that is needed. For this purpose, a detailed description of the procedures from necropsy to microscopic slide preparation of the female reproductive organs of the cynomolgus monkey is given. Procedures to sample and process the placenta are included. These recommendations can be used to achieve consistent, high-quality tissue preparations, allowing pathologists to conduct sensitive, accurate, and meaningful evaluations of the study material. Competing Interests: This article was sponsored by Covance Inc. and Schering- Plough. Martina Zölle and Eberhard Buse are employed by Covance Inc. Eveline P. C. T. de Rijk and Eric Van Esch are employed by Schering-Plough. No other competing interests were declared.