Published: 21 October, 2018
The generation of new studies under REACH is very costly for registrants because (eco)toxicological tests need to be GLP compliant and some will involve vertebrate studies. In 2007 M. Fleischer (3) estimated that endpoint costs could range from a maximum of EUR 60,000 for a registration in the 1-10 tonnage band to a maximum of EUR 425,000 for the 10-100 tonnage band. Although several requirements for vertebrate animal studies have been replaced by in vitro studies, the cost associated with testing to fulfil the requirements of a REACH registration dossier remains often unaffordable for small-medium companies (SMEs). In these circumstances it is paramount that registrants identify testing strategies which will allow a good-quality dossier to be generated at reduced cost by minimising the use of testing.
Existing data on a substance are often not sufficient to address a standard information requirement for an endpoint; however existing data in combination with a weight of evidence approach describing strengths and weaknesses of available studies can be used to reach a conclusion for a particular endpoint. In addition to a combination of existing studies from several sources, read-across data and QSARs can also be used as part of the weight of evidence approach; in general the assessment for the endpoint is stronger and more robust if a high number of evidence are included.
Once the data have been gathered they need to be assessed for relevance and reliability in relation to a particular endpoint. The use of expert judgement is essential to establish and justify a sound assessment and to conclude on an endpoint based on the available evidence. However, experience teaches that the quality and the suitability of the approach to use also depends on individual endpoints, route of exposure and substance’s properties. Therefore, strategies to fulfil endpoints must be designed on a case-by-case basis taking into account information already available on the substance, the type of substance and its uses, potential analogues and the applicability of alternatives such as (Q)SAR, and essential testing which may allow subsequent testing to be reduced.
Over the last years, Yordas has supported several clients with all aspects of the REACH lead registration work including designing substance-tailored testing strategies to avoid unnecessary testing and high costs to clients. If you would like advice or wish to discuss your requirements with one of our experts, contact us on firstname.lastname@example.org or call +44 (0)1524 510278.