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

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 sensitising potentials of a wide variety of industrial chemicals. Previously, the human cell line activation test (h-CLAT) was developed as a cell-based assay to predict the skin sensitising 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 sensitising potential. A total of 66 test chemicals were selected with known human sensitising potential, and tested with the h-CLAT. The performance of the h-CLAT was evaluated in predicting human sensitising potential. Forty-five of 51 tested sensitisers were positive in the h-CLAT, indicating relatively high sensitivity. Also, 1.0 of 15 non-sensitisers 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 sensitising potential of 23 tested chemicals that were amines, heterocyclic compounds, or sulphur compounds. The data indicates the utility of the h-CLAT for predicting the human skin sensitising potential of a variety of chemicals.

Authors: Nukada, Yuko; Ashikaga, Takao; Sakaguchi, Hitoshi; Sono, Sakiko; Mugita, Nanae; Hirota, Morihiko; Miyazawa, Masaaki; Ito, Yuichi; Sasa, Hitoshi; Nishiyama, Naohiro ;Full Source: Contact Dermatitis 2011, 65(6), 343-353 (English) ;