Regulation of chemicals is increasing globally and the use of alternative approaches to address health and environmental hazards is gaining more attention.  Testing according to regulatory requirements in general is not cheap and often standard toxicology testing requires extensive use of animals. Some legislations require increased focus on the reduction of number of animals used, refinement of methods, and replacement with non-animal approaches. Recent additions of <i>in-vitro</i> methods for local tolerance as standard information requirements in the European Chemicals legislation (REACH) was due to extensive validation and adoption as OECD testing guidelines. REACH allows for the application of alternative approaches provided they deliver the same amount of information of acceptable quality as standard information requirements.  Alternative approaches include use of surrogate data for materials with similar structure or potential mechanisms of action, weight of evidence, or use of modelling information. The European Chemical Agency (ECHA) reported for substances manufactured/imported at volumes &gt; 100 tons per year, read across or category approach was used in up to 75% of REACH dossiers checked for at least one endpoint.  In their 2016 report, ECHA found poor justifications for alternatives of animal testing, one of four major reasons why “a significant portion of registration dossiers are not of sufficient quality” (ECHA-16-A-03-EN). It reflects our experience - the use of alternative methods requires a review of all available information and expertise in toxicology, chemistry and analytics.  No “one size fits all” alternative approach exists.  Alternative approaches need to be considered on a case by case basis by chemical and endpoint.  Depending on the complexity, alternative methods may not always result in lower cost or time.  When properly used and justified, alternative approaches may be useful to evaluate health and environmental hazards.  Examples of alternative approaches used in selected REACH dossiers submitted to ECHA will be presented.

Use of alternative methods to assess health and environmental hazards

255th National Meeting (2018)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.