BfR
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Annual Report 2014
70
The OECD test guidelines programme
at the BfR
Alternative methods to animal testing, in particular
in-vitro
methods, have taken on special significance in Europe
within the scope of the REACH chemicals regulation. The
most important international organisation for the recogni-
tion of toxicological test methods and assessment strate-
gies is the Organisation for Economic Cooperation and
Development (OECD). In its test guidelines programme,
the OECD deals with the international harmonisation and
standardisation of physical-chemical, ecotoxicological
and toxicological test methods. The OECD member states
develop and improve test guidelines and prepare guid-
ance documents for test methods and related assess-
ment strategies. The national coordinators are of special
importance here as they act as mediators between the
national expertise and the OECD. The Federal Ministry
for the Environment, Nature Conservation, Building and
Nuclear Safety has appointed the BfR as the national co-
ordinator for the OECD in the field of human health.
The OECD methods serve to forecast the effects of in-
dustrial chemicals, nanomaterials, biocides and plant
protection products on human health and the environ-
ment. Results based on OECD test guidelines are ac-
cepted worldwide and contribute towards the avoidance
of double testing. They reduce the number and extent of
animal tests and dismantle trading obstructions. 24 pro-
jects are currently being processed within the thematic
area of health in the OECD test guidelines programme.
They deal mainly with the (further) development of test
guidelines on irritating and corrosive effects on the skin
and eyes, mutagenic properties and endocrine-active
substances.
In Germany, the development of OECD testing methods for the toxicological assessment of substances is coordinated
by the BfR.
The development of animal test-free methods as a sub-
stitute for toxicological long-term studies still poses the
greatest scientific and technical challenge. As substitu-
tion by a single alternative method seems barely possi-
ble, the focus from a scientific point of view is on the
development of integrated test strategies which can il-
lustrate the various aspects of the effects of toxic sub-
stances through the combination of methods.
One of the areas of main emphasis of the OECD in
this field lies in the development of so-called adverse
outcome pathways (AOPs). This constitutes a chain of
reactions which begins with an initial interaction of the
chemicals on the molecular level and then reflects the
effects in cells, tissue and organs which lead to a health
restriction in animals or in humans. The development of
AOPs requires detailed understanding of the effects of
chemicals. High-throughput and high-content analyses
play a major role here as they can test a large number
of chemicals for specific effects within a short period of
time. Through the development of AOPs and the result-
ant test strategies, it will be possible in the future to save
a large number of test animals and make the testing of
chemicals more efficient and economical. The BfR sup-
ports and accompanies the process of developing AOPs
and integrated test strategies.
