The Experts below are selected from a list of 69 Experts worldwide ranked by ideXlab platform
Horst Spielmann - One of the best experts on this subject based on the ideXlab platform.
-
Validation and Regulatory Acceptance of New Carcinogenicity Tests
Toxicologic Pathology, 2003Co-Authors: Horst SpielmannAbstract:The 3 Rs concept, which was developed by Russell and Burch in 1959, was implemented into the legal framework in the European Union(EU) for the protection of vertebrate animals used for experimental and other scientific purposes, when Directive 86/609/EEC was adopted in 1986. To reduce or replace animal testing for regulatory purposes, Nonanimal Tests must be independently validated to prove that they can provide information that is relevant and reliable for hazard prediction in vivo. At the end of the 1980s, no scientific concept existed for the formal validation ofin vitro toxicity Tests, so a small group of European and American scientists developed a set of principles for experimental validation, which was accepted internationally by the OECD in 1996. A major breakthrough was the acceptance in the EU of the scientifically validated in vitro toxicity test for phototoxic potential in 2000, which was accepted by the OECD at the worldwide level in 2002. Taking the progress in the development and validation of alternative toxicity Tests during the past decade into account, the current concepts of developing alternatives to the standard 2-year rodent bioassay for carcinogenicity testing are discussed.
Herman B.w.m. Koëter - One of the best experts on this subject based on the ideXlab platform.
-
Test guideline development and animal welfare: Regulatory acceptance of in vitro studies
Reproductive Toxicology, 1993Co-Authors: Herman B.w.m. KoëterAbstract:Abstract Toxicity studies are necessary in order to be able to identify the potential hazards of chemical interference with human reproduction. Until today, most useful contributions to the assessment of possible human reproductive toxicity are considered to be made by animal studies. The OECD Test Guidelines provide the international standards for safety testing and, consequently, have traditionally focused on animal studies. However, the OECD Member countries consider the welfare of laboratory animals also of importance and are of the opinion that animal welfare considerations should significantly influence the work in the OECD Chemical Programme. A constant effort is being made to discover alternative testing systems and to achieve their regulatory acceptance. However, activities predominately focus on finding alternatives to existing animal studies, rather than developing Nonanimal Tests that could contribute significantly to the hazard identification process. An approach based on the selection of endpoints essential for hazard identification that would focus on demonstrating similarities with the “real life” target events is considered likely to achieve regulatory acceptance much earlier than an approach based on high correlations between the alternative method and the existing animal study it is supposed to replace, simply because it is never better than the existing method, but at most “almost as reliable.”
Ernie Hood - One of the best experts on this subject based on the ideXlab platform.
-
Alternative test models: ocular safety assays accepted.
Environmental health perspectives, 2008Co-Authors: Ernie HoodAbstract:In a significant step forward for alternative safety test methods designed to reduce, refine, or replace the use of live test animals, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) recently announced the regulatory acceptance of two new in vitro ocular safety assays by the U.S. Food and Drug Administration, Environmental Protection Agency, and Consumer Product Safety Commission. The acceptance was based on recommendations made by ICCVAM after an extensive evaluation of the methods. The United States tallies an estimated 125,000 eye injuries in the home each year caused by accidental exposure to common household products such as bleach and oven cleaner, according to the American Academy of Ophthalmology. Proper identification and labeling of substances that can damage the eye is one way to combat such injuries. Several agencies require manufacturers to test new products for their potential to cause temporary or permanent blindness, irritation, or other eye injuries. Working with the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), ICCVAM evaluated and recommended the bovine corneal opacity and permeability (BCOP) and the isolated chicken eye (ICE) test methods—the first Nonanimal ocular safety test methods to be accepted by the regulators. In both cases, the animal eyes used for the Tests are slaughterhouse waste, so no animals are euthanized specifically to obtain these tissues. The assays have been in development since the early 1990s. Now that the BCOP and ICE assays have earned regulatory acceptance, they must be considered as the first option for ocular safety testing under the Animal Welfare Act, which requires the consideration of alternative methods before animals are used for procedures that may cause more than slight or momentary pain or distress. “If you get a positive result in either of these assays, you can use that as a positive for the purposes of classifying and labeling [a material] as a severe irritant,” says Marilyn Wind, chair of ICCVAM and a deputy associate executive director with the Consumer Product Safety Commission. “If it’s negative, then [manufacturers] have to go to the next step and test in animals. This eliminates the most corrosive and severe chemicals from having to be tested in animals, so there is a reduction in potential pain and distress.” Although precise numbers are not available for the use of live animals in ocular testing, William Stokes, director of NICEATM and executive director of ICCVAM, estimates that based on the relative distribution of adverse effects, use of the two assays could reduce the use of live animals for eye safety testing by 10% or more. “The overall goal is to come up with an integrated testing strategy using several Nonanimal Tests that will accurately predict whether chemical products have the potential to damage the eye or not,” he says. ICCVAM and NICEATM are in the process of evaluating other in vitro methods for ocular safety, hoping to eventually eliminate altogether the need for in vivo testing in this realm. In the near term, ICCVAM is working with its counterparts in Europe and Japan to expedite approval of the BCOP and ICE assays at the international level by the 30-member Organisation for Economic Co-operation and Development. This group includes the United States, Canada, Japan, and most of the European Union, where a ban on live animal testing of cosmetic ingredients takes effect in March 2009 and the newly implemented REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) legislation will require testing of thousands of chemicals by 2018.
Katherine A Stitzel - One of the best experts on this subject based on the ideXlab platform.
-
Tiered testing strategies--acute local toxicity.
ILAR journal, 2002Co-Authors: Katherine A StitzelAbstract:More work has been done to develop alternatives to animal use in the areas of eye and skin irritation than in any area other than carcinogenicity. There has long been a belief both in the scientific community and among the public that the development of Nonanimal Tests in these areas should be simple and straightforward. After more than 20 yr of research, we can identify materials corrosive to the skin without using animals, but the assessment of irritation using in vitro methods alone is still an illusive goal. This review of current recommendations and industry practices that reduce the number of animals needed for these two Tests concludes that animal use for skin irritation testing is not necessary today, with currently available and accepted methodology, except for regulatory reasons. Scientifically sound improvements in current eye irritation methods are also available. Advances in the understanding of the mechanisms of eye irritation that have been made in the last 5 yr should lead to improved in vitro methods for this endpoint. In the meantime, changes should be made in the current animal protocol to reduce pain and distress. This paper provides an overview of the progress that has been made toward discontinuing the use of animals in Tests to determine the potential of materials to cause skin or eye damage after a single acute exposure. It also discusses some additional changes that could be made now to reduce animal use further or to reduce pain and distress in the testing that must still be done until such time as we can meet the ultimate goal--validated and accepted Nonanimal methods for these endpoints.
Beata Krecisz - One of the best experts on this subject based on the ideXlab platform.
-
Irritant contact dermatitis. Part II. Evaluation evaluation of skin irritation potential of chemicals
Medycyna pracy, 2009Co-Authors: Dorota Chomiczewska, Marta Kieć-swierczyńska, Beata KreciszAbstract:The evaluation of skin irritation potential of chemicals is essential to secure the safety of individuals exposed to several substances designed for industrial, pharmaceutical or cosmetic use. Until recently, preclinical safety assessment of chemicals was largely based on animal experiments. Ethical concerns and the limited value of animal models in evaluating human skin irritation potential resulted in the development of alternative in vitro methods, such as EpiDerm, EPISKIN or SkinEthic, to assess irritation, i.e. cell cultures and human epidermis models. International organizations like the European Centre for the Validation of Alternative Methods (ECVAM) promotes and monitors the development of Nonanimal Tests. Human patch Tests and use Tests also provide an opportunity to identify substances with significant skin irritation potential without recourse to the use of animals. These Tests are useful to assess skin irritation potential of cosmetics and detergents.