Report and Recommendations on the Usefulness and Limitations of the Murine Local Lymph Node Assay for Potency Categorization of Chemicals Causing Allergic Contact Dermatitis in Humans

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The NTP Interagency Center for the Evaluation of Alternative Test Methods (NICEATM) announces availability of an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method evaluation report (TMER) that includes recommendations on the usefulness and limitations of the local lymph node assay (LLNA) for categorizing the potency of substances with the potential to cause allergic contact dermatitis (ACD) as strong skin sensitizers. Strong skin sensitizers are substances considered to have a significant potential for causing ACD. ICCVAM recommends that a specific potency criterion for positive results from ACD safety testing using the LLNA can be used to further categorize some chemicals and products as strong skin sensitizers. However, since this criterion only identified approximately half of strong human skin sensitizers, ICCVAM concluded that failure to meet this criterion cannot be used as the basis for determining that a substance is not a strong skin sensitizer. Therefore, the potency criterion should only be used in a screening approach where chemicals that meet the criterion could be categorized as strong skin sensitizers, but chemicals that