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

Since validated in vitro toxicity tests have so far not been accepted by regulators the third international ERGATT/ECVAM validation workshop was held from January 26-30, 1998, in Amden/Switzerland. Scientific and political reasons for a delay of the acceptance of alternative methods were identified in the areas of phototoxicity, skin penetration and skin corrosivity and strategies to promote the acceptance were suggested. The OECD will harmonise the formal of criteria for the regulatory acceptance of new experimentally validated tests and of established tests from industry for which in-house and literature data exist. In vitro tests for phototoxicity and skin penetration will be accepted shortly by the OECD. For skin corrosivity two in vitro tests will be put forward to the OECD later this year. The Amden III workshop suggests that, the same acceptance criteria must be used for animal and in vitro tests. Finally, the OECD should remove tests that cause pain and distress to test animals from the official OECD list of official test guidelines if validated alternative methods exist. When obsolete animal tests are taken from the list of official OECD test guidelines, they will not any longer be accepted at the international level. Thus, the third Amden workshop has contributed new concepts for the regulatory acceptance of alternative toxicity tests which are supported by regulators in Europe, the USA and the OECD.