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Alternativmethoden zum Tierversuch

Was können sie bei der Sicherheitsprüfung chemischer Stoffe im Rahmen von REACH leisten?

Alternative methods to animal experiments. What can they afford in the safety testing of chemical substances under REACH?

  • Leitthema: EU-Recht und nationales Gesundheitswesen: Chemikaliengesetzgebung
  • Published:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Alternativmethoden zum Tierversuch haben bei der Prüfung der lokalen Toxizität und der Mutagenität Anerkennung auf OECD-Ebene gefunden. Auf komplexeren toxikologischen Gebieten, d. h. auf dem Gebiet der systemischen Toxizität nach einmaliger oder wiederholter Exposition, der Toxikokinetik, Sensibilisierung, Reproduktionstoxizität und Kanzerogenität ist absehbar, dass für die Entwicklung und Validierung von Alternativmethoden noch viele Jahre benötigt werden und diesbezüglich zahlreiche wissenschaftliche Hindernisse und regulatorische Hürden zu überwinden sind. Wann Vorhersagemodelle mittels computergestützter Methoden, Testbatterien (in vitro und in silico) und Teststrategien brauchbare Ergebnisse liefern werden, ist ungewiss. Die bereits verfügbaren validierten Alternativmethoden werden im REACH-Zeitrahmen voraussichtlich nur begrenzt zur Verringerung des Bedarfs an Versuchstieren beitragen. Mittelfristig sollte daher die Strategie zur Verringerung der Zahl an Tierversuchen auf deren Verfeinerung und Einschränkung gerichtet sein. Ein Ersatz für Tierversuche zur Bestimmung komplexer toxikologischer Endpunkte ist derzeit noch nicht in Sicht.

Abstract

Alternative methods to safety studies using laboratory animals have been accepted by the OECD in areas such as local toxicity and mutagenicity. In more complex important fields, such as systemic single and repeated dose toxicity, toxicokinetics, sensitisation, reproductive toxicity and carcinogenicity, it is expected that the development and validation of computerised methods, testing batteries (in vitro and in silico) and tiered testing systems will need many years and have to overcome many scientific and regulatory obstacles, which makes it extremely difficult to predict the outcome and the time needed. Therefore, the validated alternative methods available will only have a limited impact on reducing the numbers of animals required under REACH. In the midterm, the strategy should be more directed towards the refinement or reduction of in vivo testing because the replacement concerning complex toxicological endpoints is at present not in sight.

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  1. Dr. Lilienblum Consulting Toxikologie LiCoTox, Hemmingen/Han., BRD

    Werner Lilienblum

  2. Dr. Lilienblum Consulting Toxikologie LiCoTox, 30966, Hemmingen/Han., BRD

    Werner Lilienblum

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Correspondence to Werner Lilienblum.

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Lilienblum, W. Alternativmethoden zum Tierversuch. Bundesgesundheitsbl. 51, 1434–1443 (2008). https://doi.org/10.1007/s00103-008-0717-0

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