Regulatory drivers in the last 20 years towards the use of in silico techniques as replacements to animal testing for cosmetic-related substances

Abstract

A number of initiatives in Europe, North America and at the OECD over the last 20 years have played a significant role in accelerating the use of alternatives to animals for regulatory toxicity testing, including in silico techniques. Strong public opinion about animal testing for cosmetics, scientific concerns about the reliability of animal tests and economic factors have been at the heart of these initiatives. Three pieces of legislation have played a particular role in the drive towards the use of these approaches in Europe; Directive 2010/63 covering the use of animals for all scientific purposes, which includes the requirement to use alternatives, the Cosmetics Regulation 1223/2009 which includes bans on animal testing and the REACH legislation 1907/2006 which both demands animal tests as well as efforts to avoid conducting them where possible. The cosmetics and chemicals industries have had to respond to these regulatory pressures to both conduct and avoid animal testing, which for economic reasons has led them towards the development of alternative approaches. Efforts in North America have been driven more by the desire to improve the scientific basis of toxicology. Scientific bodies in Canada and the USA have driven the development of Adverse Outcome Pathways (AOP) and in silico screening tools. International harmonisation initiatives at the OECD have for largely economic reasons forced companies to reach for cheaper, faster and more scientific ways of predicting the effects of chemicals. In silico techniques have been at the forefront of these developments and now underpin the new- and still developing- toxicological toolbox.