title: Evaluation of testicular toxicology: a synopsis and discussion of the recommendations proposed by the Society of Toxicologic Pathology.
abstract: Detection of chemically induced effects on male fertility and on testicular spermatogenesis in particular, has become of increasing concern. More stringent regulatory guidelines, introduced by ICH, EPA and OECD (Table 1) have raised the awareness of toxicologists and pathologists for the need to conduct sensitive and careful evaluation of the male reproductive tract for potential toxic effects of administered compounds. With it has come confusion and in many cases, inappropriate procedures, often based on misunderstanding of what is required and on inadequate understanding of spermatogenesis. This article summarizes and discusses the main recommendations recently proposed by the Society of Toxicologic Pathology on recommended approaches for the evaluation of testicular and epididymal toxicity [Lanning LL, Creasy DM, Chapin RE, Mann PC, Barlow NJ, Regan KS, Goodman DG. Toxicologic Pathology 30:518-531, 2002]. The major recommendations are: Use sexually mature animals to evaluate effects on spermatogenesis. Sample left and right testes and epididymides and record organ weights. Use modified Davidson's fixative to fix testes from all species from studies of 13 wks duration and less. Examine transverse sections of the testes (including part of the rete), and longitudinal sections of the epididymides. Embed tissues in paraffin wax. For rodent studies up to 28 days, examine periodic acid-Schiff's-hematoxylin stained sections. For all other studies examine hematoxylin and eosin stained sections. Microscopic evaluation of the testis should be a qualitative evaluation carried out with an awareness of the spermatogenic cycle. Quantitative procedures are inappropriate for screening studies. Nomenclature and grading of findings for spermatogenic disturbances will vary on a case by case basis.
authors.affiliation: Huntingdon Life Sciences, PO Box 2360, East Millstone, NJ 98875, USA. CreasyD@princeton.huntingdon.com
authors.forename: Dianne M
authors.initials: DM
authors.lastname: Creasy
mesh_terms: D000818:Animals; D004822:Epididymis / Q000187:drug effects / Q000473:pathology; D017408:Guidelines as Topic; D008297:Male; D051381:Rats; D012098:Reproduction / Q000187:drug effects; D012107:Research Design; D012741:Sexual Maturation; D012958:Societies, Scientific; D013091:Spermatogenesis / Q000187:drug effects; D013194:Staining and Labeling; D013737:Testis / Q000187:drug effects* / Q000473:pathology / Q000503:physiopathology; D016610:Tissue Embedding; D016707:Tissue Fixation; D014116:Toxicology / Q000379:methods*