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Predictive performance for human skin sensitizing potential of the human cell line activation test (h-CLAT)

2011; Wiley; Volume: 65; Issue: 6 Linguagem: Inglês

10.1111/j.1600-0536.2011.01952.x

1600-0536

Yuko Nukada, Takao Ashikaga, Hitoshi Sakaguchi, Sakiko Sono, Nanae Mugita, Morihiko Hirota, Masaaki Miyazawa, Yuichi Ito, Hitoshi Sasa, Naohiro Nishiyama,

Pesticide Exposure and Toxicity

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.This study was conducted to investigate the predictive performance of the h-CLAT for human skin sensitizing potential.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.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.