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The palgrave international handbook of a 396

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396 A Menache Education and training 1.56 % Other 9.27 % Diagnosis of disease 1.61 % Toxicological and other safety evaluation 8.75 % Production and quality control of products for veterinary medicine 2.94 % Biological studies of a fundamental nature 46.1 % Production and quality control for products for human medicine and dentistry 10.97 % Research and develop human + veterin + dentist 18.8 % Fig Purpose of animal experiments in 2011, as reported to the EU in 2014 inhalation toxicity that may last from several hours up to 14 days), chronic (repeated dose) poisoning tests that last 90 days, as well as tests to establish skin irritancy, skin sensitisation, eye irritation, reproductive toxicity studies, carcinogenicity studies and more As an example, Test Guideline 423 (Section - one of the Acute Oral toxicity methods) requires administering the test substance to female rats in a single dose by gavage using a stomach tube: Three animals are used for each step The dose level to be used as the starting dose is selected from one of four fixed levels, 5, 50, 300 and 2000 mg/kg body weight The starting dose level should be that which is most likely to produce mortality in some of the dosed animals Animals are observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first four hours, and daily thereafter, for a total of 14 days, except where they need to be removed from the study and humanely killed for animal welfare reasons or are found dead (OECD 2015b) The above Test Guideline is one of a series of toxicity tests aimed at reducing the number of animals used per procedure and was developed to help replace the ‘median lethal dose’ or LD50 for a substance, which is the dose required to kill half the number of a test population after a specified time (Gribaldo et al 2005) This policy is in line with Directive 2010/63/EU, which promotes the 3Rs concept of ‘replacement, reduction, refinement’ of animal experiments wherever

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