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STP Position Paper: Recommended Best Practices for Sampling, Processing and Analysis of the Peripheral Nervous System (Nerves and Somatic and Autonomic Ganglia) during Nonclinical Toxicity Studies
Citation:
Bolon, B., G. Krinke, M. Butt, D. Rao, I. Pardo, B. Jortner, R. Garman, K. Jensen, L. Andrews-Jones, J. Morrison, A. Sharma, AND M. Thibodeau. STP Position Paper: Recommended Best Practices for Sampling, Processing and Analysis of the Peripheral Nervous System (Nerves and Somatic and Autonomic Ganglia) during Nonclinical Toxicity Studies. TOXICOLOGIC PATHOLOGY. Society of Toxicology, RESTON, VA, 46(4):372-402, (2018).
Impact/Purpose:
Best practice recommendations from Society of Toxicologic Pathology.
Description:
These Society of Toxicologic Pathology “best” practice recommendations should ensure consistent sampling, processing, and evaluation of the peripheral nervous system (PNS). For toxicity studies where neurotoxicity is not anticipated (Situation 1), PNS evaluation may be limited to one sensorimotor spinal nerve. If somatic PNS neurotoxicity is possible (Situation 2), analysis minimally should include three spinal nerves, cranial nerve V, and their sensory ganglia. If autonomic PNS neuropathy is suspected (Situation 3), parasympathetic and sympathetic ganglia with associated autonomic nerves should be assessed. For dedicated neurotoxicity studies where neurotoxic activity is likely (Situation 4), PNS sampling follows the strategy for Situations 2 and/or 3, as dictated by in-life data or other information for the compound/target. For all situations, bilateral sampling with unilateral processing is recommended. For Situations 1, 2, and 3, PNS is processed conventionally (immersion in formalin, paraffin embedding, H&E staining). For Situation 4 (and if feasible Situations 2 and 3), perfusion fixation with methanol-free fixative (MFF) is recommended. Where PNS neurotoxicity is possible, at least one (Situations 2 and 3) or two (Situation 4) nerve cross sections should be post-fixed with glutaraldehyde and osmium before hard plastic resin embedding; soft plastic embedding is not suitable. Special methods (axonal and myelin stains, etc.) may be used to further characterize PNS findings. Initial PNS analysis should be informed, not masked (“blinded”). Institutions should explain the basis for their sampling, processing, and evaluation strategy.
