Retrospective quantitative risk assessment of skin sensitization caused by an antimicrobial agent used in a consumer product: 2,3,5,6‐Tetrachloro‐4‐(methylsulfonyl) pyridine

Abstract

AbstractBackgroundSerious cases of allergic contact dermatitis (ACD) caused by exposure to 3,5,6‐tetrachloro‐4‐(methylsulfonyl)pyridine (TCMSP; CAS no. 13108‐52‐6) used as an antimicrobial agent for desk mats have been reported in Japan.ObjectiveA quantitative risk assessment (QRA) of TCMSP contained in desk mats was performed retrospectively.Materials and MethodsA local lymph node assay (LLNA): BrdU‐ELISA was conducted to determine a reliable EC1.6 value for TCMSP. The acceptable exposure level (AEL) for TCMSP was derived from the EC1.6 value by applying sensitization assessment factors (SAFs). The exposure level was estimated based on the assumption referring to the use conditions of thiabendazole in the same purpose. Then, the estimated exposure level was compared with the AEL to evaluate the skin sensitization risk.ResultsThe AEL was calculated as 0.00458 μg/cm2 based on the EC1.6 value (0.011%, 2.75 μg/cm2) by applying a composite SAF of 600. The estimated TCMSP exposure level from the desk mat was 500 times greater than the AEL, indicating a serious skin sensitization risk.ConclusionsAssessments of skin sensitization potencies of chemicals to be used in consumer products are strongly recommended, and QRAs should be performed at the pre‐marketing stage to avoid the skin sensitization risk in consumers.