Prediction of skin sensitization potency of chemicals by human Cell Line Activation Test (h-CLAT) and an attempt at classifying skin sensitization potency.
The human Cell Line Activation Test (h-CLAT), an in vitro skin sensitization test, is based on the augmentation of CD86 and CD54 expression in THP-1 cells following exposure to chemicals. The h-CLAT was found to be capable of determining the hazard of skin sensitization. In contrast, the local lymph node assay (LLNA), widely used as a stand-alone method in Europe and US, identifies the same hazard, but also classifies the potency by using the estimated concentration of SI=3 (EC3). In this study, several values calculated from the h-CLAT data were evaluated for its correlation to the LLNA EC3 determination. A statistically significant correlation was observed between h-CLAT concentration providing a cell viability of 75% (CV75), h-CLAT estimated concentration of RFI=150 for CD86 (EC150), and for CD54 (EC200) with LLNA's EC3. From EC150 and EC200, a minimum induction threshold (MIT) was determined as the smaller of either EC150 or EC200. MIT showed a correlation with EC3 (R=0.638). Also, MIT had an approximate 80% accuracy for sub-categories of the globally harmonized system (GHS) when a tentative threshold of 13 μg/mL was used. From these data, the h-CLAT values may be one of the useful tools to predict the allergic potency of chemicals.
Safety Science Research Laboratories, Kao Corporation, 2606 Akabane, Ichikai-machi, Haga-gun, Tochigi 321-3497, Japan. nukada.yuko@kao.co.jp
Yuko
Y
Nukada
Takao
T
Ashikaga
Masaaki
M
Miyazawa
Morihiko
M
Hirota
Hitoshi
H
Sakaguchi
Hitoshi
H
Sasa
Naohiro
N
Nishiyama
D000485:Allergens / Q000145:classification / Q000633:toxicity*; D000826:Animal Testing Alternatives / Q000379:methods*; D045744:Cell Line, Tumor; D002470:Cell Survival / Q000187:drug effects; D003877:Dermatitis, Contact / Q000209:etiology* / Q000276:immunology / Q000473:pathology; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology* / Q000276:immunology / Q000473:pathology; D023441:Local Lymph Node Assay; D009000:Monocytes / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D018570:Risk Assessment; D023422:Skin Irritancy Tests
D000485:Allergens