In October 2016, members of the International Cooperation on Alternative Test Methods (ICATM; see below) convened a workshop, “International Regulatory Applicability and Acceptance of Alternative Approaches to Skin Sensitization Assessment of Chemicals.” Workshop participants reviewed current international regulatory requirements for skin sensitization testing, including currently available non-animal approaches for this testing, and considered what steps should be taken to support regulatory acceptance of these approaches. A poster presented at the 2017 Society of Toxicology Meeting (Kleinstreuer et al.) summarizes the workshop and its outcomes.
Discussions at the workshop formed the basis for a proposal to develop a performance-based test guideline (PBTG) for defined approaches for skin sensitization. The proposal was approved at the April 2017 meeting of the Working Group of National Coordinators of the Test Guidelines Programme of the Organisation for Economic Co-operation and Development (OECD).
Approval of the proposed PBTG allows for further development of the test guideline under the OECD annual work plan, and is a first step toward adoption of the test guideline by the OECD. PBTGs describe acceptable performance standards for a general class of test methods that are intended to measure the same biological effect. Approval of a PBTG for defined approaches will facilitate regulatory acceptance of this class of testing approaches, rather than requiring evaluation of individual testing approaches within the class. This is expected to more rapidly advance the goal of elimination of animal use for skin sensitization testing worldwide.
ICATM was originally established by 2009 agreement signed by ICCVAM, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JaCVAM), and Health Canada.
ICATM's goals are:
ICATM works to promote consistent and enhanced voluntary international cooperation, collaboration, and communication among national validation organizations in order to:
An updated Memorandum of Cooperation (MOC) adding the Korean Center for the Validation of Alternative Methods (KoCVAM) to the ICATM agreement was signed in March 2011.
Since 2015, China and Brazil have been participating in ICATM activities as observers. Both countries actively contributed to the 2016 workshop on skin sensitization.
ICCVAM is an interagency committee of the U.S. government that coordinates technical reviews of alternative test methods and cross-agency activities relating to validation, acceptance, and harmonization of test methods.
EURL ECVAM is a unit within the Institute of Health and Consumer Protection in the European Union’s Joint Research Centre. EURL ECVAM coordinates the validation of alternative test methods at the European Union level.
JaCVAM, part of the Japanese National Institute of Health Sciences, coordinates the evaluation of alternative test methods for Japan.
Health Canada’s Environmental Health Science and Research Bureau coordinates the evaluation of alternative test methods for Canada.
Health Canada is a permanent member of the Canadian Council on Animal Care, which oversees the ethical use of animals in science in Canada.
KoCVAM coordinates the evaluation of alternative test methods for South Korea. KoCVAM is part of the National Institute of Food and Drug Safety Evaluation of the South Korean Food and Drug Administration.
On behalf of ICATM, EURL ECVAM prepared an "Alternative Test Method Validation and Regulatory Acceptance Status Report" for the International Cooperation on Cosmetics Regulation. The report includes a comprehensive listing of test method evaluation activities undertaken by the ICATM partner organizations and high-level summaries of ongoing validation studies, validation study peer review status, and harmonized recommendations.