CRR 399/200 - Development of the local lymph node assay for risk assessment of chemicals and formulations

Allergic contact dermatitis is a common and important occupational health problem. Although there is available a number of predictive test methods for the identification of chemicals that have the potential to cause skin sensitization, traditional assays are inappropriate for assessment of relative potency. Describes a project to examine the utility of an approach to potency assessment based on the murine local lymph node assay (LLNA), a validated method for the identification of skin sensitization hazard in which activity is measured as a function of induced proliferative responses in the lymph nodes draining the site of topical application of material. An extended dose response LLNA protocol which allows the mathematical derivation of the concentration of chemical required to induce a threshold positive response was used . Correlations have been made between activity in the LLNA and apparent risk to man. The influence of vehicle and formulation upon stimulation index of three (EC3 value). EC3 values has been examined also. Collectively, these data demonstrate that the LLNA and derived EC3 values provide a robust and reliable approach to the determination of skin sensitization potency as a first step in the risk assessment process.

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Updated 2021-04-14