Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010

Abstract

The 7th amendment to the EU Cosmetics Directive prohibits to put animal-tested cosmetics on the market in Europe after 2013. In that context, the European Commission invited stakeholder bodies (industry, non-governmental organisations, EU Member States, and the Commission's Scientific Committee on Consumer Safety) to identify scientific experts in five toxicological areas, i.e. toxicokinetics, repeated dose toxicity, carcinogenicity, skin sensitisation, and reproductive toxicity for which the Directive foresees that the 2013 deadline could be further extended in case alternative and validated methods would not be available in time. The selected experts were asked to analyse the status and prospects of alternative methods and to provide a scientifically sound estimate of the time necessary to achieve full replacement of animal testing. In summary, the experts confirmed that it will take at least another 7-9 years for the replacement of the current in vivo animal tests used for the safety assessment of cosmetic ingredients for skin sensitisation. However, the experts were also of the opinion that alternative methods may be able to give hazard information, i.e. to differentiate between sensitisers and non-sensitisers, ahead of 2017. This would, however, not provide the complete picture of what is a safe exposure because the relative potency of a sensitiser would not be known. For toxicokinetics, the timeframe was 5-7 years to develop the models still lacking to predict lung absorption and renal/biliary excretion, and even longer to integrate the methods to fully replace the animal toxicokinetic models. For the systemic toxicological endpoints of repeated dose toxicity, carcinogenicity and reproductive toxicity, the time horizon for full replacement could not be estimated.

Perturbation of physiological systems by nanoparticles

“…176 Adverse effects manifested in the offspring at any point in the life span as a result of parental exposure are defined as developmental toxicity. 177 There is only a temporal difference between these two processes.…”

Developing a framework for assessing chemical respiratory sensitization: A workshop report

“…In 159 order to develop predictive test methods that are able to specifically identify respiratory sensitizers, it is 160 essential to identify the unique mechanisms involved in respiratory sensitization. Decades of intensive 161 research have resulted in a good understanding of the key events in induction of sensitization and 162 elicitation of symptoms for similar to skin (Basketter and Kimber, 2010), culminating in a suggested MOA 163 pathway Adler et al (2011) and AOP for skin sensitization induction (OECD, 2012). 164…”

In Vitro Approaches for Detection of Chemical Sensitization

“…While the available animal models determine organ and organism responses to assess the sensitization potential of chemical, animal-free approaches capture the key events describing the MOA pathway for skin sensitization proposed by Adler et al [3].…”

“…The suggested mode of action (MOA) pathway formed the basis for the recently published flow diagram of the AOP for skin sensitization induction ( Fig. 1) [3,4]. An AOP for respiratory sensitization is currently being discussed.…”