Thus, corporations would often accompany alternative testing methods with more historical animal-based methods ( Stephens and Mak, 2013).

In order to move away from this status quo of toxicity testing, it is important to have an understanding of regulatory testing requirements and assessment and why they were developed ( Fowle et al., 2013). Numerous regulatory GSK-3 inhibitor authorities and systems exist worldwide for the assessment and classification of potentially hazardous substances. Their principal objective is to assess the hazardous potential of substances that may come into contact with the eye in order to supply regulations, guidelines and recommendations for their safe use. This offers consumers or the end user protection via the communication of hazardous information and protective measures ( ICCVAM, 2010b and Wilhelmus, 2001) to prevent misapplication and to minimize accidental Pexidartinib mouse exposure. Regulatory assessment is based upon “informed decisions” that are

not purely scientific in nature. They have to take into account congressional directives, legal precedent, benefit/cost considerations and public values ( Fowle et al., 2013). This sometimes frustrates scientists, alternative-testing supporters and stakeholders alike, since “good science” does not always drive decision making ( Fowle et al., 2013). EURL-EVCAM aims to promote scientific and regulatory acceptance of non-animal tests. Similarly, ICCVAM is an interagency committee made up of 15 US Federal agencies including the Consumer Product Safety Commission (CPSC), National Institute for Occupational Safety and Health Administration (NIOSHA) and the FDA. ICCVAM aims to facilitate the development, validation and regulatory acceptance of new and revised regulatory test methods that reduce,

refine and replace the use of animals. It was originally developed as a committee Cyclin-dependent kinase 3 of the National Committee of Environmental Health Sciences (NIEHS) in 1997, and was made permanent in 2000 under NICEATM. Since then ICCVAM has contributed to 63 alternative testing methods, 38 of which do not require live animals, although not all of them are concerned with ocular tests. Several directives restrict and even prohibit the use of animal testing, for example the Amendment of the Cosmetic European Directive (2003/15/EC) imposed a ban on the use of animals for the testing of cosmetics and their ingredients. However, until recently companies could still market products that had been animal tested outside of the EU. A new cosmetic regulation replaced the Cosmetics Directive in 2009 (Regulation (EC) No. 1223/2009) and since July 2013, cosmetics and cosmetic ingredients tested on animals can no longer be sold in Europe, even if they have been tested elsewhere. This has promoted considerable progress in replacing animal models for chemical toxicology (Alépée et al., 2013).