title: Wind of change challenges toxicological regulators.
abstract: BACKGROUND
  In biomedical research, the past two decades have seen the advent of in vitro model systems based on stem cells, humanized cell lines, and engineered organotypic tissues, as well as numerous cellular assays based on primarily established tumor-derived cell lines and their genetically modified derivatives.
  
  
  OBJECTIVE
  There are high hopes that these systems might replace the need for animal testing in regulatory toxicology. However, despite increasing pressure in recent years to reduce animal testing, regulators are still reluctant to adopt in vitro approaches on a large scale. It thus seems appropriate to consider how we could realistically perform regulatory toxicity testing using in vitro assays only.
  
  
  CONCLUSIONS
  Here, we suggest an in vitro-only approach for regulatory testing that will benefit consumers, industry, and regulators alike.
authors.affiliation: German Federal Institute for Risk Assessment (BfR), Center for Alternative Methods to Animal Experiments (ZEBET), Berlin, Germany.
authors.forename: Tewes
authors.initials: T
authors.lastname: Tralau
authors.forename: Christian
authors.initials: C
authors.lastname: Riebeling
authors.forename: Ralph
authors.initials: R
authors.lastname: Pirow
authors.forename: Michael
authors.initials: M
authors.lastname: Oelgeschläger
authors.forename: Andrea
authors.initials: A
authors.lastname: Seiler
authors.forename: Manfred
authors.initials: M
authors.lastname: Liebsch
authors.forename: Andreas
authors.initials: A
authors.lastname: Luch
mesh_terms: D000826:Animal Testing Alternatives / Q000295:instrumentation / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D000818:Animals; D054750:Ecotoxicology / Q000295:instrumentation / Q000379:methods / Q000592:standards; D004785:Environmental Pollutants / Q000633:toxicity*; D033161:Government Regulation; D006801:Humans; D018675:Toxicity Tests / Q000295:instrumentation / Q000379:methods* / Q000592:standards
chemical_list: D004785:Environmental Pollutants