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The ethics of research involving animals - Nuffield Council on ...

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T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s<br />

Summary<br />

9.44 In this chapter we have surveyed the ways in which <str<strong>on</strong>g>animals</str<strong>on</strong>g> are used in safety assessments<br />

<str<strong>on</strong>g>of</str<strong>on</strong>g> compounds including medicines, household chemicals, agrochemicals and industrial<br />

chemicals. Various species are used, most comm<strong>on</strong>ly rodents and also larger <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />

including rabbits, dogs and primates. Chemicals (including potential medicines) are assessed<br />

for their potential to be hazardous to humans, and estimates <str<strong>on</strong>g>of</str<strong>on</strong>g> the risk <str<strong>on</strong>g>of</str<strong>on</strong>g> adverse effects<br />

from particular levels <str<strong>on</strong>g>of</str<strong>on</strong>g> exposure are produced. Most toxicity testing is undertaken in the<br />

c<strong>on</strong>text <str<strong>on</strong>g>of</str<strong>on</strong>g> legal and regulatory requirements governing the use <str<strong>on</strong>g>of</str<strong>on</strong>g> particular types <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

chemical in different parts <str<strong>on</strong>g>of</str<strong>on</strong>g> the world.<br />

9.45 A range <str<strong>on</strong>g>of</str<strong>on</strong>g> tests are described including: inhalati<strong>on</strong>, skin irritancy, genotoxicity, acute dosing,<br />

repeated dosing and effects <strong>on</strong> developing fetuses. We observed that a full complement <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

toxicity tests for a pharmaceutical compound that reaches the market usually involves<br />

between 1,500 and 3,000 <str<strong>on</strong>g>animals</str<strong>on</strong>g>. Adverse welfare effects may arise from the envir<strong>on</strong>ment<br />

in which <str<strong>on</strong>g>animals</str<strong>on</strong>g> are kept, and may therefore depend <strong>on</strong> housing and handling c<strong>on</strong>diti<strong>on</strong>s<br />

(see Paragraphs 4.37–4.47). Specific welfare implicati<strong>on</strong>s resulting from toxicity procedures<br />

depend <strong>on</strong> dosing and sampling methods, and the effects <str<strong>on</strong>g>of</str<strong>on</strong>g> the chemical. While<br />

toxicologists emphasise that many procedures affect <str<strong>on</strong>g>animals</str<strong>on</strong>g> <strong>on</strong>ly in minor ways, certain<br />

groups <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>, especially those in the positive c<strong>on</strong>trol group, will be subjected to tests<br />

leading to overt signs <str<strong>on</strong>g>of</str<strong>on</strong>g> toxicity during an experiment, which means that significant pain<br />

and distress could occur, depending <strong>on</strong> the type <str<strong>on</strong>g>of</str<strong>on</strong>g> toxicity elicited. We c<strong>on</strong>sider ways <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

replacing, refining and reducing these effects in Chapters 11 and 12. In the next chapter, we<br />

summarise the discussi<strong>on</strong> presented in Chapters 5–9, and c<strong>on</strong>sider in particular arguments<br />

about the scientific validity <str<strong>on</strong>g>of</str<strong>on</strong>g> animal <str<strong>on</strong>g>research</str<strong>on</strong>g>.<br />

CHAPTER 9 ANIMAL USE IN TOXICITY STUDIES<br />

167

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