[ERGATT/ECVAM Workshop on Acceptance of Validated Alternative Methods: Amden III]

Area of Science:

• Toxicology
• Regulatory Science
• In Vitro Testing

Background:

• Validated in vitro toxicity tests face regulatory acceptance challenges.
• The European Centre for the Validation of Alternative Methods (ECVAM) and European Research on Alternative to Animal Testing (ERGATT) convened a workshop to address these issues.

Purpose of the Study:

• Identify scientific and political barriers to accepting alternative toxicity testing methods.
• Develop strategies to promote the regulatory acceptance of in vitro tests.
• Harmonize criteria for validating and accepting new and existing toxicity tests.

Main Methods:

• The third international ERGATT/ECVAM validation workshop (Amden III) was held.
• Discussions focused on phototoxicity, skin penetration, and skin corrosivity testing.
• Strategies for regulatory acceptance were proposed and discussed.

Main Results:

• Barriers to acceptance in phototoxicity, skin penetration, and skin corrosivity were identified.
• The Organisation for Economic Co-operation and Development (OECD) will harmonize acceptance criteria for new and existing tests.
• In vitro tests for phototoxicity and skin penetration are expected to be accepted by the OECD soon.
• Two in vitro skin corrosivity tests will be submitted to the OECD.

Conclusions:

• The same acceptance criteria should apply to both animal and in vitro tests.
• The OECD should remove obsolete animal tests lacking validated alternatives.
• The Amden III workshop proposed new concepts for regulatory acceptance of alternative toxicity tests, gaining support from European, US, and OECD regulators.