Estimating skin sensitization potency from a single dose LLNA |
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| Institution: | 1. Dow AgroSciences Ltd - European Development Centre, Milton Park, Abingdon, OX14 4RN, UK;2. Dow AgroSciences LLC - Headquarters, 9330 Zionsville Road, Indianapolis, IN 46268, USA;1. Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, United Kingdom;2. Research Institute of Fragrance Materials Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA;3. The University of Tennessee, College of Veterinary Medicine, 2407 River Drive, Knoxville, TN 378996-4543, USA;1. Chemicals Assessment and Research Center, Chemicals Evaluation and Research Institute (CERI), 1600, Shimotakano, Sugito-machi, Kitakatsushika-gun, Saitama, 3450043, Japan;2. The United Graduate School of Veterinary Science, Yamaguchi University, 1677-1 Yoshida, Yamaguchi-shi, Yamaguchi, 7538511, Japan |
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| Abstract: | Skin sensitization is an important aspect of safety assessment. The mouse local lymph node assay (LLNA) developed in the 1990s is an in vivo test used for skin sensitization hazard identification and characterization. More recently a reduced version of the LLNA (rLLNA) has been developed as a means of identifying, but not quantifying, sensitization hazard. The work presented here is aimed at enabling rLLNA data to be used to give quantitative potency information that can be used, inter alia, in modeling and read-across approaches to non-animal based potency estimation. A probit function has been derived enabling estimation of EC3 from a single dose. This has led to development of a modified version of the rLLNA, whereby as a general principle the SI value at 10%, or at a lower concentration if 10% is not testable, is used to calculate the EC3. This version of the rLLNA has been evaluated against a selection of chemicals for which full LLNA data are available, and has been shown to give EC3 values in good agreement with those derived from the full LLNA. |
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| Keywords: | Contact dermatitis Full local lymph node assay (LLNA) Reduced LLNA Probit analysis |
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