Consensus report on the future of animal-free systemic toxicity testing.

Area of Science:

• Toxicology and risk assessment
• In vitro and in silico methods
• Systems biology in toxicology

Background:

• The ban on animal testing for cosmetics in Europe necessitates alternative safety assessment methods.
• Traditional animal experimentation faces limitations in providing human-relevant data for safety testing.
• Increasing demand for human-relevant information drives the need for novel toxicity testing strategies.

Framework:

• A scientific roadmap for animal-free toxicity testing was developed by international experts.
• The roadmap focuses on implementing the US National Research Council's vision for Toxicity Testing in the 21st Century.
• Key areas include systemic toxicity (repeat dose organ toxicity, carcinogenicity, reproductive toxicity, skin sensitization) and toxicokinetics.

Implementation:

• Recommendations emphasize improving existing methods, integrating hazard testing with toxicokinetics, and developing integrated test strategies.
• Incorporating high-content endpoints, evolving validation procedures, and promoting data sharing are crucial.
• Adopting systems biology, high-throughput screening, and early regulator involvement are key implementation steps.

Implications:

• Mapping test information to adverse outcome pathways and utilizing systems biology models enable probabilistic risk assessment.
• This approach allows flexible adaptation to exposure scenarios and individual risk factors.
• Focus on data quality and scientific rigor will drive the adoption of these new testing paradigms.