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Corporate Responsibility and Animal Testing

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 Corporate Responsibility and Animal Testing Powered By Docstoc
					Martin Kayser
Senior Vice President Product Safety

Corporate Responsibility and Animal Testing
Chemical Company View

Dedication

 BASF embraces alternative approaches for safety assessment  BASF is actively engaged in development and validation of alternative approaches  2 Mio € per year for alternative methods  Additional resources for “omics” development  BASF uses alternative methods wherever possible and reasonable
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Guiding principle
3R concept (Russel & Burch, 1959)

Refinement Reduction
Replacement
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Success
 Refinement
 Local Lymph Node Assay for sensitization (OECD 429)  Animal welfare/ environmental enrichment

 Reduction
 Replacement

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Success
 Refinement

 Reduction
 Through harmonization of testing requirements (OECD, etc.)  New test guidelines, e.g.: OECD 423 (ATC method)

 Replacement

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Success
 Refinement

 Reduction

 Replacement
 Skin corrosion (OECD 431), acute phototoxicity (OECD 432), in vitro dermal penetration (OECD 428)  Under validation, e.g.: skin irritation, fish egg, embryotoxicity, absorption
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Success
 Refinement

 Reduction

 Replacement

However: only a few validated and regulatory accepted methods available
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Visions/chances for the future

 Intelligent testing strategies  Short/mid term: Refinement and Reduction  Mid/long term: Endpoint-specific Replacement

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Acceptance of alternative methods
 Responsibility of commission and member states  Acceptance of positive and negative results  Worldwide acceptance and harmonization (OECD, ...)

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Interims actions
 Innovation needs testing  Animal testing only if required by regulations and authorities  Tiered testing strategies  Animal welfare

 In-house development and validation of screening tools

 Improved coordination of all activities

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Interims actions – REACH

 Intelligent testing in REACH  Risk-based, tiered approach  Alternative methods to prioritize substances – no hints for problems  low priority  No regulatory check-box approach  Reduction of time, resources and animal numbers

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Corporate Responsibility
 Sustainable Development  economical success  environmental and  social responsibility  Assure human health and environmental safety  Limit animal testing to unavoidable minimum  Animal welfare as ethical responsibility  BASF is actively engaged in  development  validation  worldwide acceptance of alternative methods
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