About this Research Topic

Background

Carcinogenicity to rats and mice is evaluated for substances to which humans are exposed, including pharmaceuticals, agrochemicals, and industrial chemicals. For pharmaceuticals, recent efforts to reduce animal use in long-term studies include an addendum to the International Council for Harmonisation (ICH) guideline S1B(R1) that prioritizes short-term studies in transgenic mice and recommends assessing the weight of evidence available to first determine whether a long-term study in rats would add value. For other sectors, an expert group of the Organisation for Economic Cooperation and Development (OECD) is developing an Integrated Approach to the Testing and Assessment (IATA) of non-genotoxic carcinogens based on common hallmarks of cancers and on key characteristics of carcinogens. Within current regulations, animal use could be reduced by evaluating toxicokinetics in main study animals with microsampling methods, by including only one negative control group, and by genotyping transgenic mice instead of using positive control groups in each study.

The goal of this article collection is to promote the reduction of animal use in carcinogenicity studies, both by increasing the availability of relevant evidence, including from New Approach Methods (NAMs) and existing animal toxicology studies, and by encouraging the adoption of current regulatory guidelines and recommendations.

Submissions to this article collection may discuss either the development of clinical or nonclinical evidence for the assessment of carcinogenicity to humans, without conducting long-term studies in animals, or the adoption of existing recommendations that reduce animal use, including by microsampling for toxicokinetics and by minimizing control groups.

Submission type may include:
• original research reports (including brief reports),
• reviews (including systematic and mini reviews),
• methods, and
• editorials, opinions, and perspectives.

For example, submissions may report or discuss molecular biomarkers, genotoxicity, hormonal perturbation, or immune modulation relating to mechanisms of carcinogenicity and human relevance. Submissions should emphasize the use of NAMs that replace new studies in animals or reduce animal use when studies are conducted; however, refinement of existing animal methods may also be discussed, such as those for measuring chronic and sub-chronic toxicity, to increase their utility in carcinogenicity evaluation.

Keywords: Animal testing alternatives, replacement, refinement, reduction, biomarkers, tumor, carcinogenicity tests, Investigational New Drug Application, Neoplasms, rodent bioassay, chronic toxicity tests, weight of evidence, WoE

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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