title: Exploring waiving opportunities for mammalian acute systemic toxicity tests.
abstract: A survey was carried out to explore opportunities for waiving mammalian acute systemic toxicity tests. We were interested in finding out whether data from a sub-acute toxicity test could be used to predict the outcome of an acute systemic toxicity test. The survey was directed at experts in the field of toxicity testing, and was carried out in the context of the upcoming 2018 final registration deadline for chemicals under the EU REACH Regulation. In addition to the survey, a retrospective data analysis of chemicals that had already been registered with the European Chemicals Agency, and for which both acute and sub-acute toxicity data were available, was carried out. This data analysis was focused on chemicals that were administered via the oral route. The answers to the questionnaire showed a willingness to adopt waiving opportunities. In addition, the responses showed that data from a sub-acute toxicity test or dose-range finding study might be useful for predicting chemicals that do not require classification for acute oral toxicity (LD50 > 2000mg/kg body weight). However, with the exception of substances that fall into the non-classified category, it is difficult to predict current acute oral toxicity categories.
authors: European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), European Commission, Joint Research Centre, Ispra, Italy.
authors: Rabea
authors: R
authors: Graepel
authors: European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), European Commission, Joint Research Centre, Ispra, Italy.
authors: David
authors: D
authors: Asturiol
authors: European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), European Commission, Joint Research Centre, Ispra, Italy.
authors: Pilar
authors: P
authors: Prieto
authors: European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), European Commission, Joint Research Centre, Ispra, Italy.
authors: Andrew P
authors: AP
authors: Worth
mesh_terms: D000826:Animal Testing Alternatives; D000827:Animal Welfare; D000818:Animals; D005062:European Union; D007880:Legislation, Drug; D008322:Mammals; D019055:No-Observed-Adverse-Effect Level; D004364:Pharmaceutical Preparations; D023382:Toxicity Tests, Acute / Q000592:standards*; D059551:Toxicity Tests, Subacute
chemical_list: D004364:Pharmaceutical Preparations