title: Predictive performance for human skin sensitizing potential of the human cell line activation test (h-CLAT).
abstract: BACKGROUND
  Recent changes in regulatory restrictions and social opposition to animal toxicology experiments have driven the need for reliable in vitro tests for predicting the skin sensitizing potentials of a wide variety of industrial chemicals. Previously, we developed the human cell line activation test (h-CLAT) as a cell-based assay to predict the skin sensitizing potential of chemicals, and showed the correspondence between the h-CLAT and the murine local lymph node assay results.
  
  
  OBJECTIVE
  This study was conducted to investigate the predictive performance of the h-CLAT for human skin sensitizing potential.
  
  
  METHODS
  We selected a total of 66 test chemicals with known human sensitizing potential, and tested all chemicals with the h-CLAT. We then evaluated the performance of the h-CLAT in predicting human sensitizing potential.
  
  
  CONCLUSIONS
  Forty-five of 51 tested sensitizers were positive in the h-CLAT, indicating relatively high sensitivity. Also, 10 of 15 non-sensitizers were correctly detected as negative. The overall agreement between human data and h-CLAT outcome was 83%. Furthermore, the h-CLAT could accurately predict the human sensitizing potential of 23 tested chemicals that were amines, heterocyclic compounds, or sulfur compounds. Our data indicate the utility of the h-CLAT for predicting the human skin sensitizing potential of a variety of chemicals.
authors.affiliation: Kao Corporation, Safety Science Research Laboratories, Tochigi 321-3497, Japan. nukada.yuko@kao.co.jp
authors.forename: Yuko
authors.initials: Y
authors.lastname: Nukada
authors.forename: Takao
authors.initials: T
authors.lastname: Ashikaga
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sakaguchi
authors.forename: Sakiko
authors.initials: S
authors.lastname: Sono
authors.forename: Nanae
authors.initials: N
authors.lastname: Mugita
authors.forename: Morihiko
authors.initials: M
authors.lastname: Hirota
authors.forename: Masaaki
authors.initials: M
authors.lastname: Miyazawa
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ito
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Sasa
authors.forename: Naohiro
authors.initials: N
authors.lastname: Nishiyama
mesh_terms: D000485:Allergens / Q000737:chemistry / Q000494:pharmacology* / Q000633:toxicity; D000826:Animal Testing Alternatives; D051940:B7-2 Antigen / Q000378:metabolism; D045744:Cell Line, Tumor; D017449:Dermatitis, Allergic Contact / Q000209:etiology* / Q000276:immunology; D006801:Humans; D018799:Intercellular Adhesion Molecule-1 / Q000378:metabolism; D009000:Monocytes / Q000187:drug effects* / Q000276:immunology / Q000378:metabolism; D009930:Organic Chemicals / Q000737:chemistry / Q000494:pharmacology* / Q000633:toxicity; D011237:Predictive Value of Tests; D012867:Skin / Q000187:drug effects / Q000276:immunology
chemical_list: D000485:Allergens; D051940:B7-2 Antigen; D009930:Organic Chemicals; D018799:Intercellular Adhesion Molecule-1