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Finding synergies for the 3Rs – Repeated Dose Toxicity testing: Report from an EPAA Partners' Forum

Laroche , Charlesa and Hartmann, Andreas and Cronin , Mark (2019) Finding synergies for the 3Rs – Repeated Dose Toxicity testing: Report from an EPAA Partners' Forum. Regulatory Toxicology and Pharmacology, 108. ISSN 10960295

Abstract

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum on repeated dose toxicity (RDT) testing to identify synergies between industrial sectors and stakeholders along with opportunities to progress these in existing research frameworks. Although RTD testing is not performed across all industrial sectors, the OECD accepted tests can provide a rich source of information and play a pivotal role for safety decisions relating to the use of chemicals. Currently there are no validated alternatives to repeated dose testing and a direct one-to-one replacement is not appropriate. However, there are many projects and initiatives at the international level which aim to implement various aspects of replacement, reduction and refinement (the 3Rs) in RDT testing. Improved definition of use, through better problem formulation, aligned to harmonisation of regulations is a key area, as is the more rapid implementation of alternatives into the legislative framework. Existing test designs can be optimised to reduce animal use and increase information content. Greater use of exposure-led decisions and improvements in dose selection will be beneficial. In addition, EPAA facilitates sharing of case studies demonstrating the use of Next Generation Risk Assessment applying various New Approach Methodologies to assess RDT.

Item Type: Article
Keywords: Alternatives Chemical legislation Cross-sector In silico In vitro Integrated Approaches for Testing and Assessment (IATA) Repeated dose toxicity testing Safety assessment Threshold of Toxicological Concern (TTC) Weight of Evidence (WoE)
Date Deposited: 12 Nov 2019 00:45
Last Modified: 12 Nov 2019 00:45
URI: https://oak.novartis.com/id/eprint/39447

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