Bayer and animal studies - Research

3R principle
(also known as the “3R strategy”):
This principle was first formulated in 1989 by the zoologist, W. M. S. Russel, and the microbiologist, R. L. Burch, in the standard work, “The Principle of Human Experimental Technique”. It relates to efforts and measures to reduce (1st R) the number of laboratory animals, to continuously refine (2nd R) the study methods used and to develop new methods to replace (3rd R) animal studies and make them redundant.

3T3 NRU phototoxicity test:
An alternative method to animal studies developed with the involvement of Bayer: the skin can be rendered more sensitive to light by certain chemicals and drugs. Animal studies have previously been used to test for this adverse effect. The 3T3 NRU phototoxicity test makes such animal studies redundant, because it is an in vitro test: skin cells are exposed to ultraviolet light in a Petri dish. The OECD (Organization for Economic Cooperation and Development) accepted this test in 2003 in its test procedure OECD 432, 3T3 NRU test.

Animal study:
Definition according to the Animal Welfare Law (TSchG §7.1): “Animal studies within the meaning of this law are interventions or treatments for research purposes
1. in animals, if they may be associated with pain, suffering or injury for these animals or
2. in animal genomes, if they may be associated with pain, suffering or injury for the genetically modified or carrier animals.”

Alternative methods:
In connection with animal studies, this term means study and test methods which reduce or dispense with the need to use animals. Example: studies in cells or tissue components. The concept is usually used synonymous with “replacement and refined methods”.

Active substance research for the Bayer drug Glucobay

Animal studies: the number is decreasing

With goals such as maximum safety and optimum efficacy, it is not possible in drug research to do without animal studies. But wherever the number of these studies or the distress to animals can be reduced, it is. Bayer adopts the principle of the "3Rs" where this is concerned.

This means continuously:

reducing the number of animals used in studies
refining study methods
replacing animal studies with new methods

How are these principles put into practice? Replacement and refined methods with which certain tests can also be performed (e.g. enzymes, cells, genetically modified cells, tissue samples) are being developed all the time. In other words, they have made animal studies redundant in certain areas.
This goal can also be achieved by continuous improvements in the design of study methods - because fewer and fewer animals are needed to produce statistically meaningful data.

Number of animals used in studies at Bayer, 1989-2005

Remote measurement of body temperature
Refining test methods helps to minimize the distress experienced by animals. This can be achieved by means of technical innovations. One example of this is where rodents being used to test the efficacy of new antibiotics are implanted with a transmitter the size of a kidney bean. This enables body temperature and physical activity to be measured without the animal being removed from its accustomed environment. Evaluating body temperature and/or activity enables researchers to draw important conclusions about whether an infection is present (fever) and about its course. Another example is the use of high-resolution ultrasound devices which enable investigations to be performed without the need to penetrate the body.

	3R Research Foundation Foundation to promote alternative methods

	OECD Organisation for Economic Co-operation and Development



Ultrasound examination of an anesthetized rat. The cardiac ultrasound signal can be seen in the background.

How can laboratory animals be dispensed with completely?
Many new methods have resulted in a large number of animal studies being replaced completely by test tube methods in recent years. Bayer, for example, was involved in the development of a laboratory test which detects whether the skin is made more sensitive to light by an active ingredient (a dangerous side effect of many substances). In this “3T3 NRU phototoxicity test”, skin cells are exposed to ultraviolet light in a Petri dish. The sensitivity of this test was recognized by the OECD in 2003. Previously, animal studies were required to research this effect. These are now completely redundant.

Promoting development
Bayer promotes the development of new methods and takes part in studies conducted jointly by pharmaceutical companies and universities which are intended to demonstrate the informative value of alternative methods compared with animal studies (“validation studies”). This also helps to establish these new methods internationally. Bayer is thus involved in various projects sponsored by the German Ministry of Education and Research. One such project is concerned with the detection of genetic effects caused by light, project no. BE0 0311396: “Development and comparison of methods to detect photomutagenic changes”.

Last update: February 13, 2007