ID#

33

Location:

Room 318/319/320

Time of Presentation:

March 22, 10:05 AM

Workshop (W10):

Assurance of Animal Welfare in Research: Coexistence of Toxicology Studies with Humane Endpoints
(9:30 AM - 12:00 PM)
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Assurance of Animal Welfare in Research: Coexistence of Toxicology Studies with Humane Endpoints - Veterinary Medicine and Animal Welfare Issues
W.S. Stokes¹
1. DHHS/NIH/NIEHS, National Toxicology Program, RTP, NC, USA.

Toxicology studies using laboratory animals are conducted to determine the safety or potential adverse health effects of new chemicals and products. Local or systemic toxicity to animals in these studies may result in injury or disease involving significant pain and distress. Standard veterinary care would normally involve treatment with drugs to minimize or alleviate pain and distress, or removal of the involved animal(s) from the study. However, such veterinary care interventions can become problematic if they interfere with attainment of the study objectives. Decisions on appropriate interventions can be assisted by anticipating possible toxic effects and establishing, prior to the initiation of a study, appropriate criteria that can serve as the basis for ending a procedure when pain and distress become apparent. Such criteria are considered humane endpoints if they reduce the severity and/or duration of pain and distress experienced by an animal. Humane endpoints can also be established by systematic identification of early clinical signs or other physiological parameters that are predictive of specific toxicity outcomes of interest. Mechanism-based biomarkers of toxicity that serve as earlier more sensitive indicators of toxicity that can also be used to end experiments before the onset of significant morbidity or mortality. These biomarkers and endpoints should undergo appropriate validation to determine that they provide equivalent or better prediction than previously used endpoints. International guidance for the use of humane endpoints in toxicology studies has been established and should be considered when designing studies. The incorporation of humane endpoints in toxicology studies can be expected to facilitate decisions on appropriate interventions by veterinary care staff and study directors and provide for improved animal welfare.