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Published on: June 17, 2015
A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing
David A Basketter1, Harvey Clewell, Ian Kimber
1DABMEB Consultancy, Sharnbrook, UK.
ALTEX
|February 7, 2012
Summary
This report outlines a roadmap to replace animal testing for systemic toxicity evaluations. It addresses scientific gaps and prioritizes alternative methods for advancing regulatory science.
Area of Science:
- Toxicology
- Regulatory Science
- In Vitro Testing
Background:
- Traditional animal models for systemic toxicity testing face limitations in predictivity, cost, and ethical concerns.
- A 2013 marketing ban on cosmetic ingredients tested on animals heightened the need for alternative methods.
- Evaluating a growing number of novel substances like nanoparticles and cell therapies requires new testing approaches.
Purpose of the Study:
- To propose a roadmap for replacing animal testing in systemic toxicity evaluations.
- To identify and prioritize scientific gaps hindering the adoption of alternative methods.
- To advance regulatory science through the development and validation of novel testing strategies.
Main Methods:
- Commissioned five whitepapers on key toxicological endpoints: toxicokinetics, skin sensitization, repeated-dose toxicity, carcinogenicity, and reproductive toxicity.
- Convened an expert workshop with 35 participants from Europe and the US to discuss and refine the whitepapers.
- Compiled refined whitepapers into a comprehensive report proposing a roadmap for replacing animal testing.
Main Results:
- Identified scientific gaps that need to be addressed for the full replacement of animal testing in systemic toxicity.
- Prioritized various alternative methods and strategies to overcome these gaps.
- Developed a roadmap to guide the advancement of regulatory science in toxicity testing.
Conclusions:
- A clear roadmap exists to transition from animal-based systemic toxicity testing to alternative methods.
- Addressing scientific gaps through prioritized strategies will facilitate the adoption of novel technologies.
- The proposed roadmap aims to enhance the safety evaluation of substances while considering ethical and scientific advancements.
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