Corporate Responsibility and Animal Testing

1
Corporate Responsibility and Animal Testing

• Martin Kayser
• Senior Vice President
• Product Safety

• Chemical Company View

2
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

3
Guiding principle

• 3R concept (Russel Burch, 1959)

Refinement
Reduction
Replacement
4
Success

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

5
Success

• Refinement

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

• Replacement

6
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

7
Success

• Reduction
• Replacement

• Refinement

• However only a few validated and regulatory
  accepted methods available

8
Visions/chances for the future

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

9
Acceptance of alternative methods

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

10
Interims actions

• Innovation needs testing
• Animal testing only if requiredby 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