ABSTRACT
The recent Scientific Committee on Health, Environmental and Emerging Risks Final Opinion on "The need for nonhuman primates in biomedical research, production and testing of products and devices" (2017 SCHEER) highlights approaches that could significantly contribute to the replacement, reduction, and refinement of nonhuman primate (NHP) studies. Initiatives that have the potential to affect NHP welfare and/or their use are expected to be appropriate, fair, and objective and publicly disseminated information focused on NHPs in biomedical research, which includes toxicologic and pathologic research and testing, should be objectively evaluated by stakeholder scientists, researchers, and veterinarians. Thus, IQ Consortium member companies convened to develop an informed and objective response, focusing on identifying areas of agreement, potential gaps, or missing information in 2017 SCHEER. Overall, the authors agree that many positions in the 2017 SCHEER Opinion generally align with industry views on the use of NHPs in research and testing, including the ongoing need of NHPs in many areas of research. From the perspective of the IQ Consortium, there are several topics in the 2017 SCHEER that merit additional comment, attention, or research, as well as consideration in future opinions.
Subject(s)
Animal Use Alternatives/trends , Biomedical Research/methods , Drug Evaluation, Preclinical/trends , Primates , Animal Use Alternatives/ethics , Animal Use Alternatives/legislation & jurisprudence , Animal Welfare , Animals , Bioethics , Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Drug Evaluation, Preclinical/ethics , Drug Evaluation, Preclinical/methods , European Union , Government RegulationABSTRACT
The urine concentration test is a potentially stressful procedure used to assess renal function. Historically, animals have been deprived of water for 24 h or longer during this test, creating the potential for distress. Refinement of the technique to lessen distress may involve decreasing the water-deprivation period. To determine the feasibility of reduced water-deprivation time, 10 male and 10 female rats were food- and water-deprived for 22 h. Clinical condition and body weights were recorded, and urine was collected every 2 h, beginning 16 h after the onset of food and water deprivation. All rats lost weight (P < 0.001). All rats were clinically normal after 16 h, but 90% of the males and 30% of the females appeared clinically dehydrated after 22 h. After 16 h, mean urine specific gravities were 1.040 and 1.054 for males and females, respectively, and mean urine osmolalities were 1,362 and 2,080 mOsm/kg, respectively, indicating the rats were adequately concentrating urine. The rats in this study tolerated water deprivation relatively well for 16 h but showed clinical signs of dehydration after 22 h. Based on this study, it was concluded that the urine concentration test can be refined such that rats are not deprived of water for more than 16 h without jeopardizing test results.
