Animal Welfare Information Center Bulletin, Summer 2000, Vol. 11 No. 1-2

International News...

Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation

Now available from the Organization for Economic Co-operation and Development (OECD)

OECD Environmental Health and Safety Publications
Series on Testing and Assessment No. 19
http://www.olis.oecd.org/olis/2000doc.nsf/4f7adc214b91a685c12569fa005d0ee7/c125692700623b74c12569bb005aa3d5/$FILE/00087372.PDF

The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests. The OECD encourages the humane use of animals in regulatory toxicity and safety evaluation studies and fully endorses the principles of the 3rs, Replacement, Reduction, Refinement, which were defined by Russell and Burch as:

• Replacement--the substitution for conscious living higher animals of insentient material
• Reduction--reduction of animals used to obtain information of given amount and precision
• Refinement--any decrease in the incidence or severity of inhumane procedures to those animals which still have to be used

This document specifically addresses Refinement.

This guidance is based on best current knowledge available from OECD Member Countries’ experts, through personal contacts with investigators, peer-reviewed literature, and presentations at meetings and symposia, and is intended to be flexible so that it can change with improved knowledge in the future. It is expected that with increasing knowledge and experience, investigators in animal research will be able to identify more specific, early humane endpoints in the form of clinical signs for impending death or severe pain and distress. This would permit international harmonization of these humane endpoints.

Although the principles of the 3Rs are applicable to all animal species, it is generally accepted that there are differences among species in many clinical signs of pain or distress. Variables due to the species and strain of animal involved, the type of toxicity study being performed, and the types of materials being tested, are not addressed in detail. Although there are a number of similarities between mammals and other vertebrate species, the differences among the different families do not allow them to be easily addressed in a single document. The general principles contained in this guidance document are specifically designed to be applicable for all mammalian species used in toxicity testing and other experimental studies.

Topics covered include:

• Definitions, explanations, and examples of relevant terminology
• Guiding principles
• Initial considerations
• Recognition and assessment of pain, distress, and suffering as an approach to detecting clinical signs and abnormal conditions
• Making an informed decision to humanely kill animals
• Methods for humane killing
• Guidance on the humane conduct of specific types of toxicity testing
• References
• Summary of clinical signs observed in rats during the validation studies of the acute toxic class method
• Questions to determine whether earliest possible endpoints have been sought
• Clinical signs and conditions indicating the need for closer observation or humane killing
• Clinical signs and conditions of animals requiring action by animal care staff and study directors

This publication is available electronically, at no charge. For the complete text of this and many other Environmental Health and Safety publications, consult OECD’s World Wide Web site ( http://www.oecd.org/department/0,2688,en_2649_34365_1_1_1_1_1,00.html) or contact: OECD Environment Directorate, Environmental Health and Safety Division, 2 rue André-Pascal, 75775 Paris Cedex 16, France, fax: (33-1) 45 24 16 75, e-mail: ehscont@oecd.org.

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