BARRIERS TO THE ACCEPTANCE OF IN-VITRO ALTERNATIVES

Despite a considerable effort by the scientific community over many ye ars. the replacement of traditional animal tests by in vitro alternati ves has not yet been achieved. Why are in vitro alternatives not more widely accepted by scientists and regulators? Barriers to acceptance, both overt and covert, must be recognized and surmounted if further pr ogress is to be made. At least seven barriers to acceptance of an in v itro method will be discussed. Validation : has it been adequately val idated? Scientific: is it based on good science? Legislative: can it r eplace an OECD Guideline? Development: has it been developed in anothe r laboratory? Psychological: will it make traditional skills redundant ? Litigation: will it stand up to legal scrutiny in court? Regulatory: will regulators modify their traditional hazard assessment criteria?