Background: Disperse dyes, widely used in synthetic textiles, continue to represent a cause of allergic contact dermatitis despite restrictive European regulations. Objectives: To assess prevalence, clinical features, and exposure patterns of Italian patients with positive reactions to the Textile Dye Mix (TDM) 6.6% pet., and to contextualise these findings within European surveillance data and current regulatory frameworks. Patients and methods: A retrospective multicentre study was performed using the SIDAPA database on patients consecutively patch-tested with the SIDAPA baseline series from January 2020 to March 2025 in 10 Italian dermatology centres. Demographic, clinical, and occupational data were statistically analysed. Results: A total of 7633 patients were included. Positive reactions to TDM were found in 281 patients (3.68%), mainly females (77.22%). The mean age was 46.43 ± 17.66 years. Clinical relevance was established in 59.79% of reactions, mainly non-occupational (89.88%). Disperse Orange 3 (tested in 22 TDM positive patients) resulted positive in 14 patients (63.64%). Co-sensitization with para-phenylenediamine occurred in 54.8% of TDM-positive subjects. Conclusions: The observed prevalence (3.68%) exceeds that of previous Italian (1.5%) and European (2%-3%) studies, possibly reflecting imports from non-EU countries with limited chemical regulation and e-commerce channels that bypass controls. Improved traceability, updated patch test formulations, and REACH compliance enforcement are essential to mitigate this growing dermatological concern.

Contact Allergy to Textile Dye Mix in Italy: A SIDAPA Multicentre Observational Study

Cataldo Patruno;
2026-01-01

Abstract

Background: Disperse dyes, widely used in synthetic textiles, continue to represent a cause of allergic contact dermatitis despite restrictive European regulations. Objectives: To assess prevalence, clinical features, and exposure patterns of Italian patients with positive reactions to the Textile Dye Mix (TDM) 6.6% pet., and to contextualise these findings within European surveillance data and current regulatory frameworks. Patients and methods: A retrospective multicentre study was performed using the SIDAPA database on patients consecutively patch-tested with the SIDAPA baseline series from January 2020 to March 2025 in 10 Italian dermatology centres. Demographic, clinical, and occupational data were statistically analysed. Results: A total of 7633 patients were included. Positive reactions to TDM were found in 281 patients (3.68%), mainly females (77.22%). The mean age was 46.43 ± 17.66 years. Clinical relevance was established in 59.79% of reactions, mainly non-occupational (89.88%). Disperse Orange 3 (tested in 22 TDM positive patients) resulted positive in 14 patients (63.64%). Co-sensitization with para-phenylenediamine occurred in 54.8% of TDM-positive subjects. Conclusions: The observed prevalence (3.68%) exceeds that of previous Italian (1.5%) and European (2%-3%) studies, possibly reflecting imports from non-EU countries with limited chemical regulation and e-commerce channels that bypass controls. Improved traceability, updated patch test formulations, and REACH compliance enforcement are essential to mitigate this growing dermatological concern.
2026
REACH
SIDAPA baseline series
azo‐dyes
contact dermatitis
e‐commerce
patch testing, textile dye mix
p‐phenylenediamine
textile allergy
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.12317/123040
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