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.

BACKGROUND: Serious 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. OBJECTIVE: A quantitative risk assessment (QRA) of TCMSP contained in desk mats was performed retrospectively. MATERIALS AND METHODS: A 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. RESULTS: The 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. CONCLUSIONS: Assessments 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.

Safety evaluation of recycling process used to produce recycled pulp for adult paper diapers.

Eight contaminants were used to perform a surrogate contamination test to evaluate safety of the process for producing recycled pulp for adult paper diapers. We performed a safety evaluation of the recycling process for producing recycled pulp following the European Food Safety Authority safety assessment for polyethylene terephthalate (PET) bottles using recycled PET. We also compared the first tier safety limit established on the basis of TTC (Climit) in the pulp that contained recycled pulp with residual contaminant concentrations (Cres). If Climit > Cres, there is no concern regarding safety of the recycling process. Climit was determined to be 0.46 mg/kg-pulp based on the human exposure threshold of 0.15 µg/person/day using the scenario in which a bedridden senior citizen uses four adult paper diapers manufactured with pulp containing 10% recycled pulp per day. Cres was derived from the initial concentration in used pulp (0.17 mg/kg-pulp), and decontamination rate was obtained from the surrogate contamination test. The Cres of the eight contaminants were between 0.0017 and 0.10 mg/kg-pulp, which were all below the Climit of 0.46 mg/kg-pulp. These results indicated there was no safety problem regarding this process for producing recycled pulp for adult paper diapers.