title: Estimating skin sensitization potency from a single dose LLNA.
abstract: Skin sensitization is an important aspect of safety assessment. The mouse local lymph node assay (LLNA) developed in the 1990 s 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.
authors.affiliation: School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool L3 3AF, England, United Kingdom. Electronic address: D.W.Roberts@ljmu.ac.uk.
authors.forename: David W
authors.initials: DW
authors.lastname: Roberts
mesh_terms: D000818:Animals; D049109:Cell Proliferation / Q000187:drug effects; D003877:Dermatitis, Contact / Q000209:etiology* / Q000276:immunology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D023441:Local Lymph Node Assay; D008213:Lymphocyte Activation / Q000187:drug effects; D051379:Mice; D008954:Models, Biological; D015203:Reproducibility of Results; D018570:Risk Assessment; D012867:Skin / Q000187:drug effects* / Q000276:immunology / Q000473:pathology; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology
keywords: Contact dermatitis; Full local lymph node assay (LLNA); Probit analysis; Reduced LLNA