title: Validation study of the new criteria for sensitizer using German sensitizers of Deutschen forschungsgemeinschaft (DFG).
abstract: The globally harmonized system of classification and labeling of chemicals (GHS) was recommended by United Nations (UN) and became available in 2008 all over the world. The classification criteria for skin and airway sensitizers in GHS include evidences from animal studies, for example, OECD Guideline 406 (guinea pig maximization test, GPMT and Buhler guinea pig test) and Guideline 429 (local lymph node assay, LLNA). According to Deutschen Forschungsgemeinschaft (DFG) in Germany and European Chemical Bureau (ECB), the criteria for sensitizers also include evidences from validated animal studies. At present recognized and validated animal models for the testing of respiratory hypersensitivity are not available. In Japan, the criteria from the Japan Society for Occupational Health (JSOH) for sensitizers do not include evidences from animal studies. We revised the criteria for sensitizers of JSOH and adopted evidences of animal studies. We organized the research group for sensitizer in 2005 and reviewed the criteria of Germany, EU, GHS and so on (19 experts). The meetings were held twelve times and made the revised criteria for sensitizer which adopted animal studies. We tried to validate the criteria using 28 German sensitizers of DFG, which were not sensitizers in JSOH. We could correctly classify 24 sensitizers by our revised criteria, however, 4 sensitizers could not be classified at first. Therefore, we visited the secretariat of the committee of DFG in Freising, Germany to investigate the evidenced papers of these 4 sensitizers in October, 2008. We could find out the evidenced papers of 2, however, 2 sensitizers could not be classified at last. We could correctly classify 24 of 26 sensitizers. We concluded that our revised criteria were appropriate and that this validation study was successful.
authors.affiliation: Research group of classification and listing of sensitizer. Department of Environmental Health, School of Medicine, University of Fukui, Eiheiji-cho, Fukui, Japan. satokazu@u-fukui.ac.jp
authors.forename: K
authors.initials: K
authors.lastname: Sato
mesh_terms: D000485:Allergens / Q000145:classification*; D002621:Chemistry / Q000145:classification*; D005858:Germany; D012867:Skin / Q000187:drug effects*; D018675:Toxicity Tests / Q000592:standards*; D014480:United Nations
chemical_list: D000485:Allergens