Validating and Implementing Alternative Methods
In recent years, many new methods have been developed as an alternative to animal research. After such alternative methods are validated and accepted by regulatory authorities, they are implemented quickly at Bayer and are routinely used to replace animal studies.
Bayer was involved in the development of a phototoxicity test. It detects whether substances become toxic under UV light. This is an unwanted side effect of some drugs. The test was validated by the OECD in 2003 and is now used to replace animal testing.
The Crop Science division co-authored publications showing the redundancy of the one-year dog study in assessing human health risks for the registration of agrochemicals. A data analysis proves that in 99% of cases, there would have been no significant impact on the safe exposure levels by running the one-year dog study in addition to the 90-day dog study. As a consequence of the publications and a series of initiatives the one-year dog study was removed from test requirements for agrochemicals in Europe and USA, Canada and Australia.
These are just a few examples of innovative new methods Bayer has developed. Alternative methods always have to be discussed and accepted by the regulatory authorities. The following table lists several more validated alternative methods established at Bayer or with significant Bayer contribution:
Collaborations to Develop Alternative Methods
Bayer collaborates with other companies and universities to demonstrate the value of alternative methods in the context of validation and feasibility studies. This helps to establish new methods internationally. The following chart lists examples of different national and international projects in which Bayer takes part to reduce the use of animals in legally required studies.
Cooperation with Authorities and Other Associations
The search for new approaches and methods that help minimize animal studies is an important part of our work. We cooperate with regulatory authorities (e.g. COST Imparas), universities (e.g. University of Nebraska) and international associations (e.g. International Life Science Institute, Crop Life International) to develop alternative methods that limit or even avoid the use of animals.
Our cooperation with the Centre for Alternatives to Animal Testing (CAAT) is another important focus of our commitment to the 3Rs. CAAT combines the innovative capacity of many different companies to find new ways to replace animal studies and reduce the number of animals in laboratories.
We use scientifically valid protocols to ensure that all studies provide relevant data without using too many animals. This approach complies with animal welfare regulations which require us to justify all use of laboratory animals.