Neepa Y Choksi1, James Truax1, Adrienne Layton2, Joanna Matheson3, David Mattie4, Timothy Varney5, Jenny Tao6, Krystle Yozzo6, Andrew J McDougal7, Jill Merrill8, Donnie Lowther9, Joao Barroso10, Brenda Linke11, Warren Casey12, David Allen1. 1. a Integrated Laboratory Systems, Inc , Morrisville , NC , USA. 2. b Division of Pharmacology and Physiology Assessment , U.S. Consumer Product Safety Commission , Rockville , MD , USA. 3. c U.S. Consumer Product Safety Commission , Rockville , MD , USA. 4. d Bioeffects Division, Human Effectiveness Directorate, Air Force Research Laboratory , Wright-Patterson AFB, OH , USA. 5. e Research Institute of Chemical Defense , U.S. Army, Aberdeen Proving Ground, MD , USA. 6. f Office of Pesticide Programs , U.S. Environmental Protection Agency , Washington , DC , USA. 7. g Center for Drug Evaluation and Research , U.S. Food and Drug Administration , Silver Spring , MD , USA. 8. h Dermatologic and Dental Drug Products , U.S. Food and Drug Administration , Silver Spring , MD , USA. 9. i Office of Cosmetics and Colors , U.S. Food and Drug Administration, University Station , MD , USA. 10. j EU Reference Laboratory for Alternatives to Animal Testing , Institute for Health and Consumer Protection , Ispra , Italy. 11. k Health Effects Division 1, Health Evaluation Directorate , Health Canada's Pest Management Regulatory Agency , Ottawa , Canada. 12. l National Toxicology Program , National Institute of Environmental Health Sciences , Morrisville , NC , USA.
Abstract
PURPOSE: Eye and skin irritation test data are required or considered by chemical regulation authorities in the United States to develop product hazard labelling and/or to assess risks for exposure to skin- and eye-irritating chemicals. The combination of animal welfare concerns and interest in implementing methods with greater human relevance has led to the development of non-animal skin- and eye-irritation test methods. To identify opportunities for regulatory uses of non-animal replacements for skin and eye irritation tests, the needs and uses for these types of test data at U.S. regulatory and research agencies must first be clarified. METHODS: We surveyed regulatory and non-regulatory testing needs of U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) agencies for skin and eye irritation testing data. Information reviewed includes the type of skin and eye irritation data required by each agency and the associated decision context: hazard classification, potency classification, or risk assessment; the preferred tests; and whether alternative or non-animal tests are acceptable. Information on the specific information needed from non-animal test methods also was collected. RESULTS: A common theme across U.S. agencies is the willingness to consider non-animal or alternative test methods. Sponsors are encouraged to consult with the relevant agency in designing their testing program to discuss the use and acceptance of alternative methods for local skin and eye irritation testing. CONCLUSIONS: To advance the implementation of alternative testing methods, a dialog on the confidence of these methods to protect public health and the environment must be undertaken at all levels.
PURPOSE: Eye and skin irritation test data are required or considered by chemical regulation authorities in the United States to develop product hazard labelling and/or to assess risks for exposure to skin- and eye-irritating chemicals. The combination of animal welfare concerns and interest in implementing methods with greater human relevance has led to the development of non-animal skin- and eye-irritation test methods. To identify opportunities for regulatory uses of non-animal replacements for skin and eye irritation tests, the needs and uses for these types of test data at U.S. regulatory and research agencies must first be clarified. METHODS: We surveyed regulatory and non-regulatory testing needs of U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) agencies for skin and eye irritation testing data. Information reviewed includes the type of skin and eye irritation data required by each agency and the associated decision context: hazard classification, potency classification, or risk assessment; the preferred tests; and whether alternative or non-animal tests are acceptable. Information on the specific information needed from non-animal test methods also was collected. RESULTS: A common theme across U.S. agencies is the willingness to consider non-animal or alternative test methods. Sponsors are encouraged to consult with the relevant agency in designing their testing program to discuss the use and acceptance of alternative methods for local skin and eye irritation testing. CONCLUSIONS: To advance the implementation of alternative testing methods, a dialog on the confidence of these methods to protect public health and the environment must be undertaken at all levels.
Authors: Thomas Luechtefeld; Alexandra Maertens; Daniel P Russo; Costanza Rovida; Hao Zhu; Thomas Hartung Journal: ALTEX Date: 2016-02-11 Impact factor: 6.043