[Validation and regulatory acceptance of alternative methods for toxicity evaluation]

Area of Science:

• Toxicology
• In vitro testing
• Regulatory science

Context:

• The regulatory acceptance of alternative methods (AMs) to animal toxicity testing hinges on rigorous validation.
• International guidelines, such as those from the OECD, established principles for AM validation and acceptance.
• Several in vitro methods have been successfully evaluated and accepted by bodies like ECVAM and ICCVAM.

Purpose:

• To outline the necessity of intra- and inter-laboratory validation for the regulatory acceptance of AMs.
• To highlight the ongoing cooperation between ECVAM and ICCVAM in validating AMs due to challenges in inter-laboratory studies.
• To emphasize the need for establishing a Japanese Center for the Validation of AMs (JaCVAM) for evaluating novel toxicity tests.

Summary:

• Reproducibility and relevance are key for regulatory acceptance of AMs, necessitating validation.
• International organizations like OECD, ECVAM, and ICCVAM have frameworks for evaluating and accepting AMs.
• Collaborative efforts and new validation centers are vital for the advancement and adoption of non-animal testing methods.

Impact:

• Facilitates the regulatory acceptance of alternative methods, reducing reliance on animal testing.
• Promotes international harmonization in the validation and acceptance of toxicity testing methods.
• Supports the development and evaluation of novel, Japan-originated toxicity tests through JaCVAM.