Patch testing with sodium disulfite: North American Contact Dermatitis Group experience, 2017 to 2018.

BACKGROUND: Sodium disulfite (SD), also known as sodium metabisulfite, is an increasingly recognized cause of allergic contact dermatitis. OBJECTIVES: The objective of this work was to characterize individuals with positive patch test reactions to SD as well as analyse reaction strength, clinical relevance, and sources. METHODS: This is a retrospective analysis of patients patch tested with SD (1% petrolatum) by the North American Contact Dermatitis Group (NACDG), 2017 to 2018. RESULTS: Of 4885 patients patch tested with SD, 132 (2.7%) had a positive reaction. Common primary anatomic sites of dermatitis were face (28.8%), hands (20.5%), and a scattered/generalized distribution (13.6%). Compared with SD-negative patients, SD-positive patients were more likely male (odds ratio 2.81, 95% confidence interval 1.98-4.00) and/or over 40 years (odds ratio 1.95, 95% confidence interval 1.30-2.94). Reactions were most commonly + (50.4%) or ++ (34.1%); 65.2% were considered currently relevant. About 15.2% were definitively confirmed in sources, commonly personal care products (18.9%, especially hair dye), and drugs/medications/alcoholic beverages (9.1%). Only 2.3% of positive reactions were linked to occupation. CONCLUSIONS: Positive reactions to SD occurred in 2.7% of tested patients. Reactions were often clinically relevant and linked to personal care products and drugs/medications/alcoholic beverages.

Follow-up of the re-evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228).

Sulfur dioxide-sulfites (E 220-228) were re-evaluated in 2016, resulting in the setting of a temporary ADI of 0.7 mg SO2 equivalents/kg bw per day. Following a European Commission call for data, the present follow-up opinion assesses data provided by interested business operators (IBOs) and additional evidence identified in the publicly available literature. No new biological or toxicological data addressing the data gaps described in the re-evaluation were submitted by IBOs. Taking into account data identified from the literature search, the Panel concluded that there was no substantial reduction in the uncertainties previously identified in the re-evaluation. Therefore, the Panel considered that the available toxicity database was inadequate to derive an ADI and withdrew the current temporary group acceptable daily intake (ADI). A margin of exposure (MOE) approach was considered appropriate to assess the risk for these food additives. A lower confidence limit of the benchmark dose of 38 mg SO2 equivalents/kg bw per day, which is lower than the previous reference point of 70 mg SO2 equivalents/kg bw per day, was estimated based on prolonged visual evoked potential latency. An assessment factor of 80 was applied for the assessment of the MoE. At the estimated dietary exposures, when using a refined exposure scenario (Data set D), MOEs at the maximum of 95th percentile ranges were below 80 for all population groups except for adolescents. The dietary exposures estimated using the maximum permitted levels would result in MOEs below 80 in all population groups at the maximum of the ranges of the mean, and for most of the population groups at both minimum and maximum of the ranges at the 95th percentile. The Panel concluded that this raises a safety concern for both dietary exposure scenarios. The Panel also performed a risk assessment for toxic elements present in sulfur dioxide-sulfites (E 220-228), based on data submitted by IBOs, and concluded that the maximum limits in the EU specifications for arsenic, lead and mercury should be lowered and a maximum limit for cadmium should be introduced.