[OECD ist accepting test guidelines for validated in vitro toxicity tests in 1996]

Area of Science:

• Toxicology
• Regulatory Science
• In Vitro Methods

Background:

• Development of a scientific concept for validating in vitro toxicity tests in Europe since 1990.
• Workshops by ERGATT and ECVAM in 1990 and 1994 advanced the validation concept.
• Pre-validation stage emphasized for standardizing in vitro tests before formal validation.

Purpose of the Study:

• To facilitate international regulatory acceptance of novel in vitro toxicity testing methods.
• To establish a harmonized validation concept for in vitro tests.
• To enable mutual acceptance of data from in vitro versus animal toxicity tests.

Main Methods:

• Adoption of a validation concept by US Federal Agencies (ICCVAM) in 1995/96, aligning with the European Centre for the Validation of Alternative Methods (ECVAM) approach.
• International agreement on the European/US validation concept at the Organisation for Economic Co-operation and Development (OECD) level in January 1996.
• Ongoing validation of in vitro tests according to OECD criteria.

Main Results:

• Establishment of a unified validation concept accepted by major industrial nations.
• Anticipated OECD acceptance of in vitro skin penetration testing using human skin in 1996.
• Several in vitro local irritancy tests undergoing validation for expected acceptance in 1997/98.

Conclusions:

• The developed validation concept facilitates international regulatory acceptance of in vitro toxicity tests.
• Mutual acceptance of data from in vitro tests will reduce reliance on animal testing.
• In vitro methods for skin penetration and local irritancy are nearing international regulatory approval.